ML19002A566
| ML19002A566 | |
| Person / Time | |
|---|---|
| Issue date: | 12/11/2018 |
| From: | Sarah Lopas NRC/NMSS/DMSST/MSEB |
| To: | |
| Sarah Lopas | |
| References | |
| NRC-0001 | |
| Download: ML19002A566 (84) | |
Text
Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION
Title:
Public Meeting to Accept Comments on the NRC's Evaluation of Training and Experience Requirements for Different Categories of Radiopharmaceuticals Docket Number:
(n/a)
Location:
Rockville, Maryland Date:
Tuesday, December 11, 2018 Work Order No.:
NRC-0001 Pages 1-84 NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433
1 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION
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PUBLIC MEETING TO ACCEPT COMMENTS ON THE NRC'S EVALUATION OF TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
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- TUESDAY, DECEMBER 11, 2018
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ROCKVILLE, MARYLAND
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The meeting convened in the Commissioners' Hearing Room at the Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, at 1:00 p.m.,
Joan Olmstead, NRC Facilitator, presiding.
2 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 NRC STAFF PRESENT:
JOAN OLMSTEAD, NRC Facilitator SARAH LOPAS, Project Manager, Office of Nuclear Material Safety and Safeguards MARYANN AYOADE, Health Physicist, Office of Nuclear Material Safety and Safeguards CHRISTIAN EINBERG, Chief, Medical Safety and Events Assessment Branch, Office of Nuclear Material Safety and Safeguards JENNIFER FISHER, Office of Nuclear Material Safety and Safeguards*
ALSO PRESENT:
JANICE CAMPBELL*
RALPH LIETO, St. Joseph Mercy Health System*
ARIA RAZMARIA*
JOE RUBIN, United Pharmacy Partners JEFF NORENBERG, National Association of Nuclear Pharmacies JOHN WITKOWSKI, United Pharmacy Partners*
- Present via teleconference
3 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 C O N T E N T S Page Welcome and Introduction...........................4 Review Agenda and Ground rules.....................7 General Meeting Information........................9 Presentation on the NRC's T&E Evaluation..........12 Current Evaluation Efforts........................18 Questions.........................................23 Comments..........................................31 Thank you and Adjourn.............................84
4 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 P R O C E E D I N G S 1
1:04 p.m.
2 MS. OLMSTEAD: Good afternoon. Welcome 3
to the Nuclear Regulatory Commission's webinar to 4
accept comments for the staff evaluation of training 5
and experience requirements for different categories 6
of radiopharmaceuticals.
7 My name is Joan Olmstead. And I'll be 8
facilitating today's meeting. I am joined here at the 9
NRC's headquarters by Chris Einberg, who is staff of 10
-- Chief of the Medical Safety and Events Assessment 11 Branch.
12 And Sara Lopas, a member of the Medical 13 Radiation Safety Team, and project manager for the NRC's 14 training and experience evaluation. And Maryann 15 Ayoade, who is a Health Physicist on the NRC's Medical 16 Radiation Safety Team, and the technical lead on the 17 training and experience evaluation.
18 This is a Category Three public meeting 19 to encourage active participation and information 20 exchange for the public. The NRC staff will provide 21 information on our current evaluation efforts, and then 22 solicit comments on what could be potential issues that 23 should be considered in the Commission paper being 24 prepared on this topic.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 I'd like to go over some logistics before 1
we start the meeting. Hopefully everyone has signed 2
in and received copies of the handouts, the presentation 3
slides, the August 18 training and experience 4
information paper that was developed for the 5
Commission, and the training and experience Federal 6
Register Notice that was published on October 29, 2018.
7 If you haven't signed in, the sheets are 8
near the handout table by the left entrance to this 9
room. For those of you on the phone who haven't signed 10 in, please contact Sarah Lopas to ensure that we have 11 your contact information.
12 You can get Sarah's contact information 13 from a slide that the NRC staff are about to present.
14 And also from the public meeting announcement.
15 All web conferencing participants that 16 wish to ask questions or give comments, can type them 17 into the webinar if they would like. People on the 18 teleconference line can also tell the Operator that 19 they would like to ask questions or give comments by 20 pressing star one on their telephones.
21 The Operator will be putting the 22 teleconference on mute and form a queue for 23 participants. I'll make sure to ask the Operator if 24 there are people that have comments during our comment 25
6 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 period.
1 This meeting is being transcribed. So in 2
order to get a clean transcript and minimize 3
distractions during the meeting, we'll ask that you 4
turn off or mute anything that rings, buzzes, beeps 5
or alarms.
6 For folks on the phone, please put your 7
phone on mute unless you're speaking. Please try to 8
minimize loud side conversations. We'll try to have 9
only one speaker at a time.
10 When speaking, please use the microphone 11 so people on the phone can hear you. We have two standup 12 microphones and one handheld microphone that I can bring 13 to you if you would prefer to stay seated during your 14 comments.
15 Restrooms are out this door, the one on 16 the left door. And then when you go in the hallway, 17 it's on the left. If we have to evacuate, please 18 follow directions from the security officers.
19 Are there any questions about the 20 logistics?
21 (No response.)
22 MS. OLMSTEAD: Okay. Next slide, please.
23 After the welcome, Sarah Lopas will go into some more 24 detailed information for the webinar participants.
25
7 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 And Maryann Ayoade will give a presentation 1
about the current training and evaluation regulations, 2
and NRC's evaluation process.
3 After that we'll have a comment period, 4
which will also include seeking comments on particular 5
questions that were raised in the Federal Register 6
Notice.
7 We'll be taking a short, ten minute break 8
beginning maybe between 2:00 and 2:15 p.m. When we 9
break, we will ask that those of you participating 10 remotely, stay on the phone line and stay logged into 11 the webinar.
12 Chris Einberg, Chief of the Medical Safety 13 and Event Assessment Branch will start us off with a 14 short welcome and the purpose of today's meeting. I'll 15 now hand the meeting over to Chris.
16 MR. EINBERG: Thank you Joan. Good 17 afternoon everyone. Thank you for taking the time to 18 attend today's meeting both in person and on the 19 webinar.
20 Today's meeting is the second of the four 21 comment acceptance meetings that the NRC will be 22 conducting on our training and experience requirements 23 evaluation.
24 The purpose of today's meeting is twofold.
25
8 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 First, to provide background information on the NRC 1
Staff's planned evaluation of developing tailored 2
training and experience requirements for administering 3
different categories of radiopharmaceuticals, from 4
which a written directive is required in accordance 5
with our regulations in 10 CFR, Part 35.
6 Which are our regulations for the medical 7
use of byproduct material in Subpart E, under Part 35, 8
which covers unsealed byproduct material written 9
directive required. And most importantly listen to 10 and record your comments on the evaluation.
11 The comments we receive from the medical 12 community, the agreement
- states, and other 13 stakeholders, are critical to the NRC staff's decision 14 in making -- to the NRC staff decision making on whether 15 our existing training and experience requirements 16 should be revised.
17 If you do not provide your comments today, 18 we encourage you to participate in one of our future 19 comment meetings in January. Or submit written 20 comments using the Regulations.gov by January 29, 2019.
21 Later in the presentation we will cover 22 how you can submit your written comments. And now I'll 23 hand the presentation over to Sarah Lopas.
24 MS. LOPAS: Hi everybody. I'm going to 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433
-- and so Chris's welcome, thank you for taking the 1
time to be here today.
2 So for folks on the phone, if you aren't 3
logged into the webinar that's okay. Because you can 4
still access our slides. They are posted on our Meeting 5
Notice.
6 So, if you go to Google and you Google NRC 7
Public Meeting, the first result that will pop up will 8
be the NRC's Public Meeting Schedule website. If you 9
click on that link, it will take you to the meeting 10 schedule webpage.
11 And one of the first couple of meetings 12 listed is this meeting, the training and experience 13 meeting. If you click on more, then scroll down, you'll 14 see a link to our slides.
15 And also, if you were registered for the 16 webinar, you should have gotten a reminder email at 17 about 12:00 p.m. Eastern. And in that reminder email, 18 there was a link to our slides as well.
19 So, also for logged into -- if you are 20 logged into the webinar, I have uploaded a few handouts 21 on the right-hand side of your webinar under the handout 22 tab.
23 You can find the same handouts that we have 24 here in the room. So that's our information paper that 25
10 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 we created for the Commission back in August 2018.
1 We also have the Federal Register Notice.
2 And then we also have the slides for today. So you 3
can download those onto your computer if you're on the 4
webinar.
5 And of course folks here in the room, feel 6
free to grab those copies here now or on your way out.
7 So, today we're going to be discussing the 8
NRC's evaluation of our -- of training experience 9
requirements for certain categories of 10 radiopharmaceuticals. And so we're often going to 11 refer to training and experience as T&E.
12 And then similarly, we will refer to 13 authorized users, i.e., those physicians who are 14 authorized to administer radiopharmaceuticals as AUs.
15 So AUs and T&Es are what you'll hear for short a lot 16 of times today.
17 As we mentioned, today's webinar is being 18 transcribed by a court reporter. So, we will have a 19 full transcript of today's meeting available for you 20 in a couple of weeks in our Agency-wide Document Access 21 and Management System, or ADAMS as I'm sure you're 22 familiar with.
23 And I'll be posting a link to that 24 transcript on our training and experience website.
25
11 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 So, all the information from the meeting we have on 1
November 14, you know, an identical webinar on November 2
14, I've already posted that meeting summary and 3
transcript, and slides from that meeting on that 4
website. So the same thing will happen for this meeting 5
and future meetings.
6 All the comments today are going to be 7
captured on the T&E docket. So we'll be combing through 8
the transcript and pulling out your comments and your 9
questions for inclusion in our evaluation effort.
10 And if you speak a comment today, you don't 11 necessarily need to repeat it again, then submit it 12 written on the -- via regulations.gov. I mean, you 13 can certainly if you want.
14 But, there is no difference. We treat the 15 comments the same whether you speak them over the phone, 16 or you submit them via the webinar and I read them aloud, 17 or you stand up and use the microphone today. There's 18 no difference.
19 So, we will be opening the phone lines after 20 the NRC presentation for comments. And we'll be going 21 to folks in the room for comments.
22 And as a reminder, the folks on the phone, 23 you're in listen only. And you're just going to have 24 to press star one to make a comment.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 And so now I'm going to go to Maryann 1
Ayoade. She's our health Physicist. And she's the 2
technical lead on our project. And she'll give you 3
some additional background on what we're doing here.
4 MS. AYOADE: Great. Thank you Sarah. So 5
today I will be presenting information on an overview 6
of the Regulations on training and experience for 7
radiopharmaceuticals that require a written directive, 8
some background information on the related stakeholder 9
concerns that we have received thus far for this 10 evaluation, and NRC's efforts on the evaluation this 11 far.
12 So the current NRC Regulations on training 13 and experience for radiopharmaceuticals requiring a 14 written directive are under 10 CFR, Part 35, Subpart 15 E.
16 These training and experience requirements 17 provide three pathways that a physician maybe 18 authorized to administer radiopharmaceuticals that 19 require a written directive.
20 A physician can be authorized to administer 21 these radiopharmaceuticals if they're certified by a 22 medical specialty board whose certification process 23 is recognized by the NRC or an agreement state.
24 A physician can also be authorized if they 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 satisfy the training and experience requirement via 1
an alternate pathway, which includes the completion 2
of seven hundred hours of training and experience.
3 Including a minimum of two hundred hours of classroom 4
and laboratory training in the relevant topic areas 5
as listed in the Regulations. And, five hundred hours 6
of supervised work experience in the relevant areas 7
as listed in the Regulations.
8 And a physician can also be authorized if 9
they are -- if they have been previously identified 10 as an authorized user of NRC or agreement state license 11 or permit.
12 For this training and experience 13 evaluation is focused on the ultimate pathway. And 14 NRC staff are looking into what tailored training and 15 experience requirements for a limited authorization 16 and limited administration of certain categories of 17 radiopharmaceuticals would look like.
18 And that is what we will be referring to 19 as a limited authorized user status. Next slide.
20 In Subpart E there are four sections that 21 pertain to training and experience requirements. The 22 first section is under 10 CFR 35.390.
23 And that is for the training for the use 24 of all radiopharmaceuticals in Subpart E. All of which 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 require a written directive.
1 The second is under 10 CFR 35.392. And 2
that is for training for oral administration of sodium 3
iodide, iodide-131, requiring a written directive in 4
quantities less than or equal to 33 millicuries.
5 The third is under 10 CFR 35.394, to train 6
for oral administration of sodium iodide, iodide-131, 7
requiring a written directive in quantities greater 8
than 33 millicuries.
9 And the fourth section is under 10 CFR 10 35.396 for training for the parenteral administration 11 of any radiopharmaceutical requiring a written 12 directive.
13 And I want to point out that all of these 14 sections are training and experience, including the 15 pathway for experienced authorized users already listed 16 on a license.
17 Also, all the Sections except 10 CFR 35.396 18 include training and experience under the board 19 certification and alternate pathways. However, 10 CFR 20 35.396 is for training exclusively under the alternate 21 pathway.
22 And it really is for the radiation 23 oncologists that are looking to become authorized 24 users. And they can do this by completing some 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 additional hours of training and experience.
1 I also want to point out that the alternate 2
pathway under 10 CFR 35.392 and 394 is for the physician 3
to successfully complete 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and lab 4
training that is relevant to the type of use for which 5
they are seeking to be authorized.
6 Whereas the ultimate training pathway 7
under 10 CFR 35.390 is for the physician to successfully 8
complete seven hundred hours of training and 9
experience, which includes two hundred hours of 10 classroom and laboratory training. Next slide.
11 This slides some background information 12 on stakeholder concerns with these related to these 13 training and experience requirements.
14 Since the revision to the training and 15 experience requirements in 2002 and again in 2005, 16 stakeholders have raised concerns about the effects 17 of some of the requirements of patient access to certain 18 therapeutic pharmaceuticals.
19 Specifically, some stakeholders have 20 asserted that the seven hundred hour requirement in 21 10 CFR 35.390 is overly burdensome for physicians who 22 are not certified by medical specialty boards.
23 And that the extensive requirements have 24 resulted in a shortage of authorized users. Which 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 thereby limits patient access to certain 1
radiopharmaceuticals.
2 And so as a result, in 2015 and '16, in 3
separate efforts, the NRC staff and the NRC's Advisory 4
Committee on the Medical Uses of Isotopes, which is 5
the ACMUI, independently reviewed the training and 6
experience requirements for the medical uses authorized 7
under Subpart E.
8 Specifically, the NRC staff reviewed the 9
regulatory basis and comments that were received on 10 past rulemakings that were related to the medical use 11 of byproduct materials. And did not identify any new 12 information that would call into question the basis 13 of the existing requirements.
14 As a result, the NRC staff did not propose 15 any changes to the regulation at that time. And the 16 NRC staff is continuing to work with ACMUI on this 17 ongoing training and experience evaluation effort.
18 Next slide.
19 As part of the staff requirement's 20 memorandum dated August 17, 2017, and that information 21 is publically available in ADAMS in the hyperlink that's 22 referenced on this slide.
23 The Commission directed the NRC staff to 24 evaluate whether it makes sense to establish tailored 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 T&E requirements for different categories of 1
radiopharmaceuticals.
2 To evaluate how those categories should 3
be determined, such as by risks posed by groups of 4
radionuclides, or by delivery method to determine what 5
-- to evaluate what the appropriate training and 6
experience requirements would be for each category.
7 And to evaluate whether the requirements 8
should be based on hours of training and experience, 9
or focus more on competency. Next slide.
10 In response to the Commission direction, 11 the NRC staff solicited feedback from some medical and 12 regulatory stakeholders in April and May 2018. That 13 evaluation including the NRC staff analysis and the 14 feedback that was received of the training and 15 experience requirement in Subpart E of 10 CFR Part 35, 16 that was documented in SECY-18-0084.
17 And the results of the evaluation concluded 18 that it maybe be feasible to establish tailored training 19 and experience requirements for different categories 20 of radiopharmaceuticals. And to create a means of 21 authorizing the administration of certain categories 22 of radiopharmaceuticals, which is the limited 23 authorized user status.
24 It also concluded that there are viable 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 options for creating a competency-based approach to 1
demonstrate acceptable training and experience for a 2
limited authorized user status.
3 But however, the staff needs to conduct 4
more extensive outreach to stakeholders in the medical 5
community, to the agreement states, and to other members 6
of the public before making any recommendation to the 7
Commission.
8 And this brings us to our current 9
evaluation to date. So, I will now hand over back to 10 Sarah, who will be discussing our current evaluation 11 efforts, and how you can participate.
12 MS. LOPAS: Thank you Maryann. So, the 13 end product of our evaluation is going to be a paper 14 that we're going to send up to our five member 15 Commission.
16 And that paper will either document our 17 reasoning for recommending no changes to the T&E 18 requirements, or if we do recommend changes to our T&E 19 regulations, if we conclude that these changes are 20 warranted, we will document our reasoning and our plan 21 for rulemaking in what we call a rulemaking plan paper.
22 This is a simplified diagram on this slide.
23 The information that we're going to consider in our 24 development of a recommendation to the Commission on 25
19 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 whether changes to our existing T&E regulations are 1
required.
2 The diagram -- this diagram illustrates 3
why this comment period is so important. Because in 4
a large part, the feedback that we receive on the 5
questions that we've asked in the Federal Register, 6
are going to inform our recommendation to the 7
Commission.
8 So, other important feedback that will also 9
come from our coordination with our co-regulators, the 10 agreement states, and the NRC's ACMUI, the Advisory 11 Committee on Medical Use of Isotopes.
12 In addition to the input that we received 13 from the public, medical stakeholders, the agreement 14 states, and the ACMUI, the NRC is going to examine the 15 issue of patient access.
16 So our staff is going to determine -- is 17 going to attempt to determine the number of current 18 authorized users and their geographic distribution 19 across the United States.
20 An authorized user and associated 21 geographic location data is not quite easily and readily 22 available, so we're spending the next month or so 23 pulling that data together from our web-based licensing 24 system, and putting that data set together.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 So, staff is also going to be reviewing 1
training and experience requirements in other 2
countries, in an effort to benchmark the U.S. against 3
international medical regulations.
4 And then the third piece that we're going 5
to look at is, we're going to do a review of medical 6
and radiation safety events to see if any of those have 7
a nexus to training and experience.
8 And it's important to note that if staff 9
does end up recommending a rulemaking, which we would 10 again, document in a rulemaking plan, the Commission 11 would then proceed to the vote on that rulemaking plan.
12 And that would determine whether or not the staff would 13 proceed with the Part 35 rulemaking effort.
14 If rulemaking is recommended and approved 15 by the Commission, that would start the NRC's extensive 16 rulemaking process. Which I'm sure you're all 17 painfully familiar with, right?
18 So, I wanted to highlight that process 19 information. Because I think it's important that 20 everybody understands where we are at this point in 21 time with this process.
22 And where we are is that we're still in 23 the information gathering stage, to help us determine 24 whether rulemaking is even warranted at this point in 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 time.
1 So, I hope -- I hope at this point folks 2
have read it. But our Federal Register Notice was 3
published on Monday, October 29.
4 And that Federal Register Notice can be 5
accessed via the link on this slide. Or you can also 6
Google the citation. Which is 83 FR 54380. And it 7
will pop up at the top of the search results.
8 So the Federal Register Notice, it 9
announced our public comment period, which ends on 10 January 29, 2019. It announced the dates for these 11 public meetings and webinars.
12 And I'm going to talk a little bit about 13 the remaining meetings we have. But most importantly, 14 the Federal Register Notice asked a series of questions 15 on which we would like medical community, stakeholder 16 input.
17 And I'm going to take a moment to just read 18 through those questions right now. I'm just kind of 19 going to buzz through them. And it's more to give 20 everybody a context of what the information that we're 21 looking for.
22 When we do get to the comment portion of 23 the meeting momentarily, you know, I'm going to open 24 it up for general comments. And everybody can make 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 their general statements.
1 And then depending on time, and interest, 2
I will attempt to maybe walk us through some of the 3
more specific areas, the more specific questions to 4
see if I can draw out some additional information on 5
top of maybe some of the general statements that we're 6
going to get from folks today.
7 Okay. So, the first set of questions, 8
extensively covers the crux of what we're evaluating.
9 Whether the NRC should create a tailored training and 10 experience requirements for certain categories of 11 radiopharmaceuticals.
12 So, A1, are the current pathways for 13 obtaining AU status reasonable and accessible? Are 14 they adequate for protecting public health and safety?
15 A2, should the NRC develop a new tailored 16 T&E pathway? What would be the appropriate way to 17 categorize radiopharmaceuticals for tailored T&E 18 requirements?
19 A3, Should the fundamental T&E required 20 of physicians seeking limited AU status need to have 21 the same fundamental T&E required of physicians seeking 22 full AU status?
23 A4, how should the requirements for this 24 fundamental T&E be structured for a specific category 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 of radiopharmaceuticals?
1 The next set of questions focuses on the 2
NRC's recognition of medical specialty boards. So the 3
NRC procedure for recognizing these boards is located 4
on our medical uses licensing toolkit website. Which 5
I hope that folks are familiar with.
6 So, our first question is, what boards, 7
other than those already recognized by the NRC, could 8
be considered for recognition for medical uses under 9
10 CFR 35.300.
10 And the second question, B2, are the 11 current NRC medical specialty board recognition 12 criteria sufficient? If not, what additional criteria 13 should the NRC use?
14 The next set of questions, the third set 15 of questions focuses on patient access to nuclear 16 medicine.
17 C1, is there a shortage in the number of 18 AUs for medical uses under 10 CFR 35.300? And if so, 19 is the shortage associated with the use of a specific 20 radiopharmaceutical?
21 C2, are there certain geographic areas with 22 an inadequate number of AUs?
23 C3, do current NRC regulations on AU T&E 24 requirements unnecessarily limit patient access to 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 procedures involving radiopharmaceuticals?
1 And C4, Do current NRC regulations on AU 2
T&E requirements unnecessarily limit research and 3
development in nuclear medicine?
4 And the last set of questions was just 5
asking for more general input or opinions on the NRC's 6
regulation of training and experience in general.
7 So, the first question was, should the NRC 8
regulate the T&E of physicians for medical uses?
9 Second question, are there requirements in the NRC's 10 T&E regulatory framework for physicians that are 11 non-safety related?
12 And the third question, how can the NRC 13 transform its regulatory approach for T&E while still 14 ensuring that adequate protection is maintained for 15 workers, the general public, patients, and human 16 research subjects.
17 So those are the questions that we've asked 18 in the FRN. And we are hoping to get some feedback 19 on.
20 So how can you submit your comments or 21 respond to these questions? Well, in addition to 22 speaking during today's meeting, and during the 23 additional meetings we have scheduled in January, which 24 are January 10 and January 22, you can also just provide 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 written comments via regulations.gov.
1 And this link in this slide, the direct 2
comment submission link, that will get you right to 3
the comment submission portion of the T&E docket. And 4
you can either upload a comment, you know, a Word 5
document or a pdf, or kind of anything along those lines, 6
or you can type directly in the text box.
7 I just want to note that at the NRC I have 8
immediate access to those comments as they're like 9
submitted via regulations.gov. But there is a little 10 bit of a lag time due to processing we do here at the 11 NRC, where you won't be able to see your comments 12 immediately.
13 I won't get into the details. But, you 14 won't see your comments immediately, but I will get 15 them immediately. And we work to get them up there 16 as quickly as we can, back up on regulations.gov.
17 So you should be able to see other folks 18 comments up there as well. We -- right now I will be 19 honest, we have only submitted -- we only have six 20 comments up there.
21 We've only had six written comments 22 submitted so far. But, I actually -- I have also posted 23 on that T&E docket the transcript from the November 24 14 meeting as well, so.
25
26 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 If you encounter any issues with 1
regulations.gov, just email me. And I can help you 2
out.
3 And at the end of this public comment 4
period, we will be compiling all the comments that we 5
receive, both written and oral, and we'll be publishing 6
them in one easily accessible comment reports.
7 And that comment report will not only, you 8
know, lift out all the comments received, but it will 9
also summarize the input that we receive. So, that 10 comment report, that's going to be available on the 11 NRC's T&E website.
12 And we are going to -- also, we'll make 13 sure it's posted to the regulations.gov docket. And 14 we will probably reference that heavily in our 15 Commission paper.
16 And it's important to note that because 17 this is in a rulemaking, that the purpose of collecting 18 your comments is to help inform us. So, we aren't going 19 to be responding to individual comments like you would 20 kind of see in a rulemaking.
21 Or if anybody's seen how we respond to 22 comments like in an environmental impact statement.
23 It won't be like that. We're simply intaking comments 24 at this point.
25
27 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 So we have two more public meetings, 1
January 10 that's going to be -- January 10 and January 2
- 22.
3 January 10 is similar to this meeting where 4
it's a webinar, but it's also in person. And that will 5
be over in our Three White Flint building across the 6
street on -- across Marinelli by the other Metro.
7 And then January 22 will just be one last 8
chance. It will be a two-hour webinar again to just 9
kind of capture any last comments.
10 And again, all those details are on our 11 public meeting website.
12 So just briefly, I'll cover our next steps.
13 After the comment period ends on the 29th of January, 14 we're going to begin organizing and evaluating all the 15 comments that we've heard from everybody.
16 And the NRC still will also, right now and 17 into that period, we are working on conducting that 18 additional research that I noted earlier. Doing that 19 additional work involving, you know, looking at patient 20 access, international bench marking to see what other 21 countries are doing, and then assessing the medical 22 and radiation safety events.
23 And then the ACMUI Subcommittee on training 24 and experience will provide the NRC a report of their 25
28 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 findings and recommendations regarding the T&E 1
requirements, sometime in the spring of 2019, like in 2
March 2019.
3 And the NRC staff is going to consider that 4
as well, their input as well in developing our draft 5
recommendations.
6 And then both the agreement states and the 7
ACMUI will have an opportunity to provide their comments 8
on our draft Commission paper when we get that together.
9 And the NRC will consider and incorporate their 10 comments on our draft paper.
11 We'll incorporate that then into our final 12 paper. And that final paper will be going up to the 13 Commission in the fall of 2019.
14 So, for additional information, I just want 15 to point out that we do have this website, our training 16 and experience website. I'm doing my best to keep that 17 updated with everything that you could possibly need 18 on this effort.
19 So, the SECY papers, and anything that we 20 publish or make publically available like our meeting 21 summaries, and the transcripts, and all that good stuff.
22 The T&E docket, that's associated with 23 regulations.gov. So that number, that NRC-2018-0230, 24 that's the docket on regulations.gov.
25
29 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Like I said, probably the best thing about 1
that is you will see all the comments, all the written 2
comments that everybody else has submitted, on 3
regulations.gov. And that's probably the best place 4
to go there.
5 And then of course Maryann and myself are 6
your points of contact. I think if you have technical 7
questions, I would please ask that you contact Maryann.
8 And then if you have more process type questions, I 9
can help you out with those.
10 And I think that's it. I think we can get 11 into comments. We're kind of right on time more or 12 less, 1:33.
13 So, I do want to remind that folks on the 14 phone, so you can go ahead and press star one. I am 15 going to start with comments in the room, because I 16 do want to acknowledge the fact that there are some 17 folks here in the room that did travel.
18 So I appreciate that you guys came out here 19 to the NRC. So we'll start in the room. And we have 20 to use microphones so that folks on the phone can hear 21 and our court reporter can hear.
22 And if you can begin by introducing 23 yourself, I mean, of stating your name clearly. If 24 you have an affiliation that you would like to state, 25
30 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 you certainly can. You don't need to provide an 1
affiliation.
2 And I think that's it. So we will just 3
get started. Does anybody want to -- we can either 4
run a mic to you, Joan can run a mic to you. Or you 5
can use a -- use one of the stand mics.
6 Go ahead. Yeah. And folks on the phone, 7
just go ahead and press star one. And we'll check in 8
with you in just a moment.
9 And folks on the phone -- on the webinar 10 as well, you can also submit a comment via the webinar 11 using the question function. And I can read it aloud 12 for you.
13 Okay.
14 MR. RUBIN: Good afternoon. I'm happy to 15 go first. My name is Joe Rubin. I'm appearing on 16 behalf of United Pharmacy Partners, and alliance of 17 83 independent commercial nuclear pharmacies and 18 affiliate nonprofit academic medical center 19 radiopharmacies across the country, which are focused 20 on delivering prepared radiopharmaceuticals for 21 diagnostic, molecular imaging, and therapeutic patient 22 needs.
23 UPPI and affiliate pharmacies provide more 24 than eight thousand unit dose prescriptions for 25
31 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 diagnostic imaging and radiotherapy every day.
1 John Witkowski is the President of UPPI, 2
and he's on the phone to help address any questions 3
that may come up in this discussion.
4 The two primary issues I'd like to address 5
today, the first is the geographic distribution of AUs, 6
and the impact that has on patient access to 7
radiopharmaceuticals.
8 And second was how the NRC's regulatory 9
approach can be transformed to ensure that public 10 protection is maintained while expanding access to 11 radiopharmaceuticals, by expanding the role of nuclear 12 pharmacists.
13 Nuclear pharmacies play a vital role in 14 the distribution and administration of alpha and beta 15 emitter therapies to patients across the country. The 16 training to become an authorized user as a nuclear 17 pharmacist, is the same as the training for physicians.
18 The same seven hundred hour requirements.
19 And NPs maybe listed on the radioactive materials 20 license as the AU and radiation safety officer.
21 To help address the likely disparate 22 geographic distribution of authorized users, which is 23 having a detrimental effect on patient care, 24 particularly in rural areas, UPPI urges the Commission 25
32 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 to consider enabling the teaming of onsite nuclear 1
pharmacists and the specialist physician with limited 2
hours of specific training.
3 This
- concept, which was previously 4
submitted to the ACMUI committee, would enable the 5
nuclear pharmacist and specialist physician team to 6
fill the AU requirement as it pertains to radiation 7
protection, patient care, and safety.
8 This would enable the specialist physician 9
to handle the patient care aspects of treatment, and 10 the radiopharmacist to handle the radiation safety 11 aspects of the procedure.
12 The team would continue to ensure that the 13 experience and training necessary of the AU is present 14 for the administration of a radiotherapy of a particular 15 procedure.
16 It would dramatically expand the service 17 area for nuclear medical procedures utilizing alpha 18 and beta emitters, protecting patients, and expanding 19 patient opportunities.
20 So first, let me talk a little bit about 21 the role of nuclear pharmacists. Nuclear pharmacists 22 are trained authorized users, but generally have far 23 more radiation safety responsibilities then physicians 24 and others.
25
33 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 NPs have responsibility for creating 1
- doses, performing quality control of the 2
radiopharmaceutical preparations, handling the 3
radioactive waste of doses dispensed.
4 There are currently more than one thousand 5
licensed authorized user nuclear pharmacists across 6
the country. And unlike physicians, they are spread 7
more broadly across rural markets.
8 Nuclear pharmacists are responsible for 9
receiving and safe keeping of raw nuclear material such 10 as molybdenum-99 generators, and converting the highly 11 radioactive elutions into technetium-99.
12 Nuclear pharmacists must then draw the unit 13 doses into the correct amount of technetium 14 radioactivity required by the physician, or other 15 radiopharmaceutical to make patient ready doses.
16 This step requires sophisticated analysis 17 and understanding of the decay rate of the emitter, 18 the time of day that the procedure will be administered, 19 and the necessary amount of materials that must be 20 available at the time the procedure is administered, 21 to ensure that the patient receives the correct amount 22 in the dose.
23 If the emitter has decayed too much at that 24 time, the procedure maybe less effective. And if it 25
34 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 has not decayed enough, then the patient may receive 1
a stronger dose of radiation then is necessary.
2 Further, nuclear pharmacies like UPPI 3
members, generally create a number of doses in one 4
central location, which are delivered across the 5
geographic area.
6 For example, one UPPI member with labs in 7
eastern and western Florida, distributes more than five 8
hundred unit doses per day across Florida, from 9
Gainesville to Miami and from Ocala to Fort Myers.
10 The nuclear pharmacists know and 11 understand the nuclear safety challenges, preparing 12 many hundreds of doses, and delivering them across such 13 great distances. And how to handle any radiation 14 safety concerns.
15 Let me talk a little bit about the shortage 16 of authorized users. Antidotal and statistical 17 evidence strongly supports the contention that there 18 is a shortage of AUs in rural areas.
19 There appears to be no definitive answer 20 as to whether or not there's a shortage of AUs, or if 21 there's an uneven geographic distribution of AUs across 22 the country. And if so, what that impact on patient 23 care maybe.
24 And we appreciate that the NRC is going 25
35 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 to look very closely at that. However, antidotal 1
evidence strongly suggests there is a strong regional 2
disparity.
3 And this is having a major adverse effect 4
on rural healthcare. For example, according to the 5
National Rural Healthcare Association, there are 6
critical shortages of physicians in rural communities 7
across the country.
8 The patient to primary care physician ratio 9
in rural areas is 39.8 physicians per 100 thousand 10 people. Compared to 53.3 physicians per 100 thousand 11 in urban areas.
12 In an emergency, rural patients must travel 13 twice as far as urban residents to the closest hospital.
14 The distribution disparity among specialists is even 15 more acute.
16 While there are 263 specialists for every 17 100 thousand citizens in urban areas, that number drops 18 to 30 specialists per 100 thousand residents in rural 19 areas.
20 There's no reason to believe that the 21 distribution of physician AUs is any different than 22 the general distribution.
23 This assumption is supported by antidotal 24 evidence as well, that clearly demonstrates there are 25
36 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 several areas of the country that face acute shortages 1
of AUs. For example, testimony provided by Bayer to 2
the ACMUI, describes in detail the difficulty it is 3
facing in rural Michigan because of a shortage of AUs.
4 So, measuring the actual distribution 5
again, we agree with the NRC and the American College 6
of Radiology that there is a need to find trustworthy 7
data about current active AU populations.
8 The UPPI has submitted to the NRC a Freedom 9
of Information Act request to attempt to help ascertain 10 the number, type, and training and locations of AUs.
11 And we'd love to work with you on fulfilling that, 12 and the process that you guys have undertaken.
13 So here's our partial solution at least, 14 as I mentioned earlier. Allow AU nuclear pharmacists 15 to work in direct concert with the limited trained 16 physician specialists, oncologists, or other 17 specialists in the administration of patient prepared 18 doses.
19 Nuclear pharmacists are authorized users 20 who arguably have more responsibility for radiation 21 safety, handling, use, and transport, then anyone else 22 in the system. They're also on call to rural areas 23 that may not have AU locations as they deliver patient 24 ready doses.
25
37 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 This availability gives them far great 1
reach then the current system. Particularly if they 2
are able to team with a limited trained specialist 3
physician to provide patient care.
4 Enabling licensed, trained, responsible 5
nuclear pharmacists to assist the limited trained 6
specialist physician to administer patient ready doses 7
of alpha and beta radiotherapies, would dramatically 8
expand patient access.
9 In other words, instead of reducing the 10 AU training for certain procedures, the Commission 11 could maintain its current AU training standards. And 12 expand the availability of AUs by enabling nuclear 13 pharmacists to work with a limited trained specialist 14 physician.
15 Accompanying our submission, are UPPI's 16 comments from 2016 that first raised this suggestion.
17 We will be submitting a more detailed comment later 18 in this process.
19 We wanted to raise this proposal at this 20 public meeting to give the NRC and other commentators 21 an opportunity to ask questions, and consider this 22 proposal, so that we may help address these questions 23 as part of the RFI process.
24 Thank you. And with that, I'm happy to 25
38 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 take any questions.
1 MS. LOPAS: I have one question for you.
2 Do you know -- this is Sarah Lopas. Do you know when 3
you guys submitted that FOIA?
4 Because I'm looking at my coworker and --
5 MR. RUBIN: It was within the last two or 6
three days.
7 MS. LOPAS: Okay. We'll get it soon then.
8 MR. RUBIN: Yes.
9 MS. LOPAS: All right, excellent. Thank 10 you.
11 MR. RUBIN: Thank you. Thank you very 12 much.
13 MS. LOPAS: Okay. Does anybody want to 14 go next in the room? Or should I go to the phones?
15 Okay, I'm seeing some looking around in 16 the room here. So, Candy, do we have anybody who's 17 pressed star one on the phone?
18 OPERATOR: Yes. We do have John 19 Witkowski. Your line is open.
20 MS. LOPAS: Okay.
21 MR. WITKOWSKI: Thank you. I'm the 22 President of UPPI. And Joe Rubin offered our statement 23 there.
24 The comment I wanted to add is that there 25
39 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 will be a growth of alpha and beta radiotherapeutic 1
products in the future. That the regulations should 2
consider expansion of these products becoming a greater 3
portion of the therapies available to patients as time 4
moves forward.
5 The process of having a nuclear pharmacist 6
team with a limited trained authorized user medical 7
specialist, such as a medical oncologist, is similar 8
to a dual authorized user situation that has been 9
familiar with the NRC in the past.
10 We think this is an opportunity to reach 11 out to areas where patient populations can better be 12 served, because alpha and beta therapies may require 13 more than a single injection. So if we go for a course 14 of -- and that's radium-223, for a course of therapy, 15 it is six infusions.
16 And to have a patient from a rural area 17 make six trips over many, many months to a location 18 to receive the radiotherapy, when it could be done with 19 a dual authorized user situation, would save the patient 20 a lot of time and expense. And then there would be 21 better follow up to patient care.
22 Thank you.
23 MS. LOPAS: Okay. Thank you very much. So a reminder 24 for folks on the phone, press star-one. And I also 25
40 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 want to just let you know that you can submit a question 1
or a comment to me using the question function on the 2
webinar, and I can certainly read it aloud for you, 3
if you would -- if you would feel more comfortable doing 4
that.
5 Candy, do we have any other questions or 6
comments on the -- on the phone?
7 OPERATOR: We are showing no questions at 8
this time.
9 MS. LOPAS: Okay. Does anybody in the 10 room want to make a general comment or statement?
11 Okay. All right, guys. I'm going to just 12 walk us through some of these questions, and it might 13 be radio silence and that's okay, but I'm going to try.
14 I'm going to try here, and maybe we -- we end our meeting 15 very early, depending on if we just really get no --
16 no input.
17 So here I just want to focus on some of 18 the specific questions that the NRC asked in our Federal 19 Register Notice, because we are looking at -- we would 20 like to get some specific feedback on these questions.
21 It is going to help us develop our paper for the 22 Commission.
23 So here we have these questions about --
24 there's four general questions under tailored training 25
41 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 and experience requirements. And if you open up the 1
FRN, the Federal Register notice, if you have that on 2
-- with you now or if you're on the webinar, that's 3
one of the handouts that I uploaded, we actually asked 4
a whole bunch of subquestions underneath these 5
questions.
6 So there really are a ton of questions that 7
we could -- we could delve into here, but I'm wondering 8
if anybody has any specific feedback. The last webinar 9
we had, we got some feedback that -- that it would be 10 difficult if the NRC created additional categories for 11 radiopharmaceuticals, that if new -- we got one comment 12 that said that if new radiopharmaceuticals came in and 13 they didn't kind of fit precisely under our categories 14 that then we'd have to figure out where they fit, and 15 that could delay patient access to getting these new 16
-- these new therapies.
17 So that was one comment that we got where 18 somebody was against creating more specific categories 19 for training and experience.
20 And I just want to add another point of 21 thought, just kind of summary of what we heard in our 22 last meeting maybe, and maybe it will jog some -- jog 23 some comments. Somebody did give the point that they 24 thought that some of the more patient-ready doses of 25
42 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 radiopharmaceuticals just really did not merit the 500 1
and 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />, so total 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, and then that was 2
adversely affecting patient access.
3 And then a converse point to that was that 4
if we allow physicians to just kind of come in with 5
a limited amount of training, like 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> or whatever 6
it might be, that that wouldn't help advance the general 7
field of -- of nuclear medicine in the United States, 8
that the physician pointed out that nuclear medicine 9
and the advancements and developments in this field 10 of medicine are lagging behind other countries because 11
-- for whatever reason. And that if we just kind of 12 let these specialists come in and just kind of do one 13 thing, and they only do the one thing, and they don't 14 do any advancements in the field, that that wouldn't 15 help the overall nuclear medicine field.
16 So those are some of the -- some of the 17 things. I'm trying to -- a number of things in our 18 last webinar on November 14th, but I don't know if that 19 jogs any comments that folks would have, anybody wants 20 to comment on creating specific categories?
21 Candy, is there anybody on the phone?
22 OPERATOR: Currently, we are showing no 23 questions. Again, for questions or comments, press 24 star-one.
25
43 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MS. LOPAS: All right. Or you can submit 1
a comment via the webinar.
2 We have the fourth question the slide, the 3
fourth part of the questions that we had.
4 Question 5 here, this was the part that 5
had all sorts of -- all sorts of subquestions, so if 6
anybody has any thoughts on this one. We did get some 7
input last time around, but there should be -- the 8
radiopharmaceutical manufacturers should be able to 9
provide preceptor attestation. We did get that input.
10 And feel free to jump up and use a mic.
11 You look like you want to comment. All right. We've 12 got a taker. I like it. I like it. Okay. And 13 star-one on the phone, and we'll come back to you folks 14 on the phone.
15 DR. NORENBERG: Hi. I'm Dr. Jeff 16 Norenberg. I am the Chairman and the Executive 17 Director of the National Association of Nuclear 18 Pharmacies. We are a trade association. Our 19 membership is exclusively comprised of nuclear 20 pharmacies that provide the unit-dose, patient-ready 21 radiopharmaceuticals that are used in diagnostic and 22 therapeutic nuclear medicine, some 35,000 doses per 23 day. About 10 million per -- patients per year are 24 affected by the drugs that flow through the nuclear 25
44 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 pharmacies.
1 Our mission as a trade association is to 2
identify and communicate the best practices in nuclear 3
pharmacy that can ensure patients have access to safe 4
and effective radiopharmaceuticals and thereby improve 5
the quality of medicine that is delivered in the nuclear 6
medicine departments by the customers who we serve.
7 So our feeling on this issue is that all 8
avenues should be explored, that we should identify 9
opportunities to provide greater access to patients, 10 acknowledging the shortages of some of the specialists 11 and practice settings that are often required, which 12 do negatively impact patients and require the need to 13 travel, as a previous commenter alluded to.
14 We are also aware that physicians can play 15 a critical role, and there may be opportunities for 16 enhanced training, additional competencies to be 17 demonstrated, which would improve patient access. So 18 I think were agnostic to -- at this point to the specific 19 remedy, but we do think that patients should have access 20 to the right drugs, the standard of care necessary to 21 alleviate the suffering from the bad diseases that they 22 suffer.
23 And we do believe that the current paradigm 24 has shown us that there are limitations, and some of 25
45 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 it is scope of practice and maybe beyond the mandate 1
of this group, but we want to make sure that we balance 2
the needs to ensure public safety and the safety of 3
the occupational workers who participate in these 4
therapies.
5 So our participation today is really just 6
to encourage the dialogue about learning more for 7
specific categories of radiopharmaceuticals, specific 8
routes of administration, unique practice setting 9
requirements that can be identified and resolved 10 through additional opportunities for training and 11 education, leading to competencies that would allow 12 a greater number of patients to receive these vital 13 therapies.
14 And so I think there have been a number 15 of important points made today, and through the written 16 comments there are a lot of thoughtful questions being 17 asked, and I'm glad to see that the NRC is revisiting 18 this issue. I was a little bit -- our members I think 19 were a little bit discouraged by the previous 20 subcommittee dialogue that occurred -- not being broad 21 enough, perhaps ignoring some inputs -- and we're glad 22 to see that this is on the docket and getting a full 23 public treatment, and we look forward to providing more 24 specific information about the training and education 25
46 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 that can be provided.
1 As an aside, my full-time job is I am a 2
professor of radiopharmaceutical sciences and the 3
Director of Radiopharmaceutical Sciences at University 4
of New Mexico.
5 We developed Nuclear Education Online, 6
which is an education and training platform 7
specifically to deliver authorized nuclear pharmacist 8
training. We started in 2000. That program is a 9
web-based program that provides 200 didactic hours, 10 and then we have a -- we work in partnership with 11 training sites, and we have promulgated a training guide 12 which has task-specific, competency-driven exercises 13 that can be effected in a practice setting, and we mentor 14 the preceptors to deliver those 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of tactical 15 experience.
16 Over 25,000 students have participated in 17 courses offered by Nuclear Education Online, not all 18 nuclear pharmacists, but a
lot of nuclear 19 cardiologists. We do a lot of training for shippers 20 and receivers of radioactive material, seeking to 21 comply with DOT requirements for training and 22 education. And in that way, the Nuclear Education 23 Online has endeavored to provide a full suite of 24 didactic and experiential components that can serve 25
47 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 a variety of different audiences.
1 And we believe that similar mechanisms can 2
be brought to bear to overcome some of the obstacles 3
that we encountered that led to the formation of Nuclear 4
Education Online to address the needs of pharmacists, 5
nuclear cardiologists, and other workers in this area.
6 Prior to 2000, this education and training 7
was done exclusively onsite. At the University of New 8
Mexico, we have trained over 300 nuclear pharmacists, 9
but not everybody wants to go to New Mexico and spend 10 the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />. It's hard to imagine that people 11 wouldn't love to go to New Mexico, but it is a hardship 12 to transplant oneself and to move to that geography.
13 And so we tried to provide an anytime, 14 anyplace, any base, any pace kind of an education 15 platform that could overcome some of those geographic 16 barriers. And, really, we see today more and more 17 education is moving beyond bricks and mortar and getting 18 into more of a just in time, you know, professional 19 adult learning kind of environment. I don't want to 20 throw too much pedagogy, you know, buzzwords at you, 21 but there is a lot of science behind the efforts at 22 online learning.
23 We have grown a lot in the 18 years since 24 this program was launched. We have learned a lot about 25
48 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 the environment, and this has led to our graduates and 1
certificate holders being accepted in virtually every 2
jurisdiction, agreement states, NRC regions, et cetera.
3 And so we have a lot of faith and confidence 4
in our ability to deliver those online and to validate 5
the outcomes that the students' competencies 6
demonstrate, and similar efforts could be brought to 7
bear to overcome the training needs in this area.
8 And so I would just encourage everyone to 9
have an open mind and think about not only historical 10 data but also future opportunities that we have for 11 education and training. And I think we all want the 12 same thing; we all want patients to get those necessary 13 therapies.
14 And whatever the education necessary, if 15 it's 700 or 200 or 80, I'm confident that we can develop 16 high-quality programming and educational opportunities 17 that can satisfy those needs, and we can do it in a 18
-- in a very facile way that can lead to a reproducible 19 outcome and impart competencies that would satisfy the 20 need to balance the protections of the public and the 21 occupational workers with those needs of patient 22 access.
23 So with that, I will stop talking and take 24 any questions that I might have raised.
25
49 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MS. LOPAS: That was great. Thank you.
1 I appreciate that. Do you know how many folks -- I'm 2
just curious how many folks you -- since you started 3
that online training, how many folks have kind of --
4 do they graduate from your program, or how does that --
5 DR. NORENBERG: Yeah. We've had over 400 6
nuclear pharmacists, and we've had some 13 -- 1,300 7
or so radiation workers. We've done a lot of DOT 8
because the frequency of training is every two years, 9
and some employers would like it done every year to 10 overcome any training requirements that DOT might 11 interpret.
12 And then, probably about another 300 or 13 so authorized nuclear cardiologists, COCAPs, sort of 14 changed their model for the pre-qualifications for the 15 exam. So we had a large bolus of those nuclear 16 cardiologists that came through the program about five 17 to seven years ago, but there still are some.
18 And then we provide ongoing opportunities 19 for, you know, nuclear pharmacists. There is 20 about -- as the previous speaker alluded to, there is 21 over 1,000. We like to think there is about 1,700 22 nuclear pharmacists in the U.S., about 1,200 full-time, 23 and every year there is about 100 or more turnover.
24 Pharmacy has a
lot of practice 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 opportunities. People often move from one practice 1
setting to another. And having the unique skills to 2
work with aseptic processing, radiation safety, and 3
specialized parenterals, a lot of nuclear pharmacists 4
find opportunities to work in hospital or specialized 5
infusion areas, and vice versa.
6 So we see pharmacists that come in and out 7
of nuclear pharmacy throughout their career, and some 8
of them, you know, may need to address the recentness 9
of training requirements. And so we have done a lot 10 of sort of refreshers where people come back and repeat 11 the course because it has been 10 years since they 12 worked in a nuclear pharmacy, or whatever.
13 And so we see, you know, 100 or so people 14 coming into nuclear pharmacy or refreshing their 15 training a year. And I -- I would guess that trend 16 will continue as we see sort of the dynamics of the 17 workforce and the aging population, that there will 18 be a consistent need for slightly more than 100 nuclear 19 pharmacists a year.
20 MS. LOPAS: All right. We've been doing 21
-- Dr. Donna-Beth Howe and Maryann have been doing 22 recent public meetings on our -- changes to our Part 35 23 regulations, which go into effect on January 22, 2019.
24 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 I'm trying to think of some of the questions 1
that we have been getting about recentness of training, 2
and so that's interesting to hear.
3 MS. AYOADE: Yeah. That's correct. I 4
just wanted to correct for everybody on the record, 5
it's January 14th for the NRC licensees, and for 6
agreement states it's three years from that date, which 7
would be January 14, 2022.
8 MS. LOPAS: All right. Thank you so much.
9 DR. NORENBERG: Thank you.
10 MS. LOPAS: All right. Candy, do we have 11 anybody on the phone, any star-ones on the phone?
12 OPERATOR: We do. We have a question from 13 Janice Campbell. Your line is open.
14 MS. CAMPBELL: Hello. Yes, I have a 15 question. I am a medical physicist specializing in 16 nuclear medicine, and, you know, one of my -- I guess 17 I just want to clarify in my mind, you know, we currently 18 have authorized users authorized to oversee diagnostic 19 radiopharmaceuticals for imaging.
20 And as -- as I oversee these types of 21 programs and do a lot of teaching, I think of those 22 as sort of lower risk radionuclides, and it sounds like 23
-- but, please, you know, clarify for me -- what we're 24 looking at is changing the training and experience 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 requirements for the higher risk radionuclides, the 1
ones that actually are for treatment.
2 And when I say "higher risk," I guess these 3
are the ones that could, you know, cause harm, that 4
a medical event could occur with.
5 And are we asking for these to be able to 6
be administered in a special practice setting, you know, 7
something like where they would have an independent, 8
you know, license? One of the -- you know, a special 9
license specifically for one radiopharmaceutical, and 10 that specific or special doctor would -- or authorized 11 user would oversee the staff and the safe use of just 12 that radiopharmaceutical? Is that what we're kind of 13 looking at?
14 MS. AYOADE: Yes. So we are evaluating 15 the training and experience requirements for 16 radiopharmaceuticals under Subpart E, which is for the 17 10 CFR 35.300. It is primarily therapy uses and for 18 iodine -- iodine risks.
19 MS. CAMPBELL: So --
20 MS. AYOADE: I mean, greater than 30 --
21 30 microcuries.
22 MS. CAMPBELL: Right. So, in essence, so 23 what I'm saying is correct, we would be --
24 MS. AYOADE: Yes.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MS.
CAMPBELL:
requiring these 1
authorized users to have less training than the lower 2
risk diagnostic radiopharmaceuticals.
3 MS. AYOADE: If you -- yes, but we are just 4
evaluating our current training and experience 5
requirements. We are not putting out, you know, any 6
-- anything yet.
7 MS. CAMPBELL: Right, right. No, but I 8
just wanted to make sure that that was part of what 9
we're looking at. And the reason is because there is 10 not enough physician-authorized users in rural areas, 11 and -- but these physicians would have to get their 12 own license, correct?
13 MS. AYOADE: Yes. They would have to get 14 their license to be able to practice in NRC states.
15 MS. CAMPBELL: I see. So they would have 16
-- that would have to be part of their training, I would 17 think. Okay. I just -- I just wanted to clarify, 18 because earlier one of the speakers from UPPI was 19 discussing a lot of the diagnostic doses that are 20 delivered and the difficulty in the regions and 21 geography, et cetera.
22 And so it made me start to think that we 23 were talking about diagnostic doses as well that these 24 authorized users would be able to, you know -- would 25
54 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 be overseeing. But it sounds like it's specifically 1
just for the therapies.
2 MS. AYOADE: That's correct.
3 MS. CAMPBELL: Okay. Okay. Thank you 4
very much.
5 MS. LOPAS: Thank you. Thank you for 6
commenting.
7 OPERATOR: Thank you. Again, for 8
questions or comments from the phone, it's star-one.
9 We do have another question on the phone. Ralph Lieto, 10 your line is open.
11 MR. LIETO: Thank you. I am a medical 12 physicist and a former radiation safety officer, and 13 my question is actually -- my first question actually 14 goes back to questions 1 through 3. I thought I 15 understood what the NRC was driving at when they used 16 the term "current pathways for obtaining authorized 17 user status."
18 But now I'm a little -- I think maybe the 19 NRC might need to clarify that because -- and what the 20 previous commenters were saying about nuclear 21 pharmacists, is the intent of the NRC to look at pathways 22 other than licensed physicians obtaining, say, any of 23 the requirements of certain board certification, having 24 certain qualifications, and completing that board 25
55 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 certification?
1 Or are you -- do you intend to make this 2
open-ended? You would have pharmacists that they use 3
providing this administration? Because I could see 4
that this pathway is sort of an open-ended thing. You 5
could have highly qualified nuclear medicine 6
technologists, you know, providing an end-use status 7
qualification that's not going to be a physician.
8 So could you clarify what you mean by "the 9
current pathways"?
10 MS. AYOADE: This is Maryann Ayoade for 11 NRC. When we say "the current pathways," we're looking 12 at the current NRC requirements. So that is for 13 physicians right now.
14 Now, as part of our evaluation, we are, 15 you know, taking comments, and you have received 16 comments, you know, several comments regarding taking 17 a look at pathways for other than physicians. And so 18 that's part of, you know, what we're -- we're going 19 to be looking to use as part of our evaluation.
20 MS. LOPAS: Right. So I think the point 21 is that we are welcome -- we are open to -- to all 22 comments essentially, that we have heard that, that 23 ANPs should be considered. So we're open. We're in 24 this information-taking-in period.
So that's 25
56 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 something that we are open to hearing as well for sure.
1 MR. LIETO: Okay. So my understanding, 2
that this current pathway was pretty much an open-ended 3
road by which any medical professional with the proper 4
training and experience could become an AU to administer 5
these Part 300 radiopharmaceuticals.
6 MS. AYOADE: Yes, that's correct.
7 MR. LIETO: Okay. My next question goes 8
back to regarding number 5. And, again, you make 9
a -- your clarification from NRC staff. These issues 10 about the requirements for training and experience 11 address the -- what I'll call the radiation safety 12 aspects of the worker training and experience.
13 Is the intent of the NRC to also have some 14 understanding that this must include the clinical 15 patient care aspects and appropriateness of patient 16 care? Which the NRC is pretty clear that they do not 17 regulate.
18 So I'm trying to understand where the NRC 19 has drawn the line between radiation training, safety, 20 and -- radiation safety training and experience, and 21 which it, obviously, it would be an appropriate way 22 to regulate as opposed to the training and experience 23 that is required by getting some type of clinical 24 competency and appropriateness, and so forth, which 25
57 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 they are not supposed to be involved with.
1 MS. AYOADE: So I'm just -- I think I'm 2
trying to understand exactly what your question is.
3 But, again, with this question, just like we said 4
before, we -- and I'm thinking you're referring to the 5
work experience section. You know, we focus on 6
radiation safety as it relates to some of our training, 7
and there is always the talk of, you know, where we 8
draw the line with impinging on the practice of 9
medicine.
10 But, again, for these questions, we -- we 11 want to hear, you know, from the public. We want to 12 hear what you guys think in terms of what you want to 13 see NRC doing for work experience and where we should 14 draw the line. That's something we will consider based 15 on the feedback that we get as we move forward in 16 evaluating this current training and experience 17 requirement.
18 MR. LIETO: Thank you.
19 MS. LOPAS: All right. Thank you.
20 Candy, do we have anybody else on the phone?
21 OPERATOR: We're showing no questions at 22 this time.
23 MS. LOPAS: Okay. Star-one for the folks 24 on the phone, if anybody wants to make a comment in 25
58 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 response to anything that you've heard so far today, 1
or talk about something new; that's great, too. Or 2
you can send me something via the webinar software.
3 That's fine, too.
4 Is there anybody in the room here that wants 5
to make any additional comments? Yes, please.
6 DR. NORENBERG: All right. This is Jeff 7
Norenberg. I'm speaking as an individual. Is that 8
better? Sorry. Jeff Norenberg, speaking as an 9
individual.
10 I wanted to fill in some context and perhaps 11 help us understand some of the common features of 12 licensed independent practitioners that are designated 13 through the CFR and recognized by medical boards, 14 pharmacy boards, TMS, and others.
15 The status of the license independent 16 practitioner is granted by virtue of a professional 17 degree and then a state licensure by a medical board 18 or a pharmacy board. And I think that's different than 19 what we see happening for technical personnel that go 20 through a voluntary registration that don't have a 21 national standardization of their training and 22 experiential requirements. It's on a state-by-state 23 basis.
24 And I think this has bearing on the 25
59 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 consideration of some of the issues that have come 1
forward today. In many states, pharmacists are granted 2
independent prescribing authority to administer 3
vaccinations, do TB testing, birth control, hormonal 4
contraception, and other things that benefit public 5
health. And they do this after receiving training and 6
education and demonstrating competency in a very 7
specific category or task-specific practice setting.
8 In addition to the independent 9
practitioner status that allows prescribing authority 10 without monitoring, a number of states have pharmacist 11 clinicians where pharmacists work under the supervision 12 of a physician to administer the entire spectrum of 13 therapies to diagnose and treat the chronic diseases 14 that require intensive drug management, things like 15 diabetes, HIV, hemophilia.
16 These are things that are treated per 17 protocol that require intensive medication 18 intervention. And as the medication experts that are 19 duly professionally licensed and receive special 20 training, pharmacists are identified as the best 21 resource for many of these patients.
22 So I can't say today that I see the similar 23 cadre available for therapy, but I could engage in their 24 future state, that certainly radiopharmacists today 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 have the most experience handling 1
radiopharmaceuticals. The volumes and the expertise 2
and the manipulations that they do far exceed any other 3
category of occupational operator in this paradigm we 4
are discussing.
5 And I think, you know, back to my days doing 6
therapy with investigational therapeutic 7
radiopharmaceuticals, we have treated approximately 8
70 patients with investigational therapeutic 9
radiopharmaceuticals, and oftentimes, you know, 10 plumbing is really the key to getting the drug into 11 the patient.
12 And there are -- there are some technical 13 just staff's eye on this that experienced 14 radiopharmacists bring that can overcome potential 15 barriers. This is why most of nuclear medicine today 16 is delivered as patient-ready doses that get 17 administered directly to patients.
18 And so I could see a future state where 19 patient-specific therapies with a dose that is prepared 20 unique to a patient is delivered to a clinic, and then 21 it really becomes a matter of getting it into the patient 22 safely and avoiding untoward occupational exposure.
23 And those are the kinds of things that I 24 think pharmacists have some unique capacity to do.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 It's not to make treatment decisions, but it's, rather, 1
to effect therapies that have been so directed under 2
the written directive.
3 And so I could see that there are 4
opportunities to overcome some of these barriers 5
through that specialized training, and it should 6
probably be drug or isotope-specific, practice 7
setting-specific, and I think that that's a way where 8
we have a track record of being able to ensure the safety 9
of occupational workers and the public through the 10 10 million doses or so that travel through nuclear 11 pharmacies today.
12 And so I see that there is a lot of different 13 ways we could solve this. There is a bill in Congress 14 right now to amend the Social Security Act and designate 15 pharmacists as providers. That could have some bearing 16 on the practice.
17 But I think from a radiation safety 18 perspective and the health physicists patient control 19 initiative, it is really about controlling exposures 20 to the public, the occupational exposures, and making 21 sure that we don't have untoward medical events that 22 result in reportable errors.
23 And those are the kinds of things that I 24 think we perhaps haven't recognized some of the unique 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 skills and depth of training that pharmacists have.
1 So however we can solve this, and I'd like to see all 2
powers brought to bear, physicians getting additional 3
specialized training, technical staff improving their 4
competencies, and other nuclear pharmacists and others, 5
radiologists taking more interest in this practice 6
setting.
7 So thank you for that opportunity to 8
provide context. And if there's any questions, I'll --
9 MS. LOPAS: Candy, do we have anybody on 10 the phone? Star-one on the phone.
11 OPERATOR: Thank you. Currently, we're 12 showing no questions at this time.
13 MS. LOPAS: All right. Folks on the 14 phone, star-one. I think since it's 2:16, the comments 15 are kind of coming in slowly, we will not take a break.
16 We will just kind of, you know, push forward, since 17 we will likely be ending early. I don't think we need 18 a break.
19 So star-one on the phone, and let's give 20 folks a few more minutes. And then, in the room, just 21 feel free to raise your hand or jump up. Yes, jump 22 right up.
23 Okay. Let's see, does anybody have any 24 input on our recognition medical specialty boards?
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 I don't know if there is anybody in the medical branch 1
who wants to talk about anything that we're doing.
2 No? I see heads shaking. Okay.
3 Okay. Let's see, and so the patient access 4
issue, I can talk for just a moment on this because 5
I'm working on this. So I will -- full disclosure, 6
you know, right now we are limited with the data that 7
the NRC has, and that data is of the NRC licensees, 8
which is only 13 states. So, and there are limitations 9
to the information that we could ask from our agreement 10 states.
11 So the NRC is starting by looking at the 12 facilities that are licensed to administer 300 drugs.
13 We're mapping those for NRC licensed facilities, and 14 we're also looking at the AUs associated with those 15 licensees. So we will have that information for our 16 13 states where we are -- we are doing the licensing 17 there.
18 So for the agreement states, we do not have 19 that information, but that is kind of an evolving --
20 it's an evolving data set that we are working on. So 21 we are looking at that carefully, but I do want to point 22 out that that is a limitation we have.
23 But we -- we did get a question as to why 24 we were asking this. We got a recent question asking, 25
64 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 "Well, don't you have that information at NRC? Why 1
are you asking for that that input in the FRNs?" And 2
we wanted to -- I mean, we are asking this because we 3
want to hear, you know, specifically from folks that 4
may be experiencing the impact. You know, if folks 5
are being negatively impacted, and they think it has 6
to do with our training and experience requirements, 7
we want to hear that. So that's why we're asking these 8
questions.
9 And, for instance, we do know that some 10 stakeholders have given us information on this, like 11 Bayer, and so we're encouraging -- we would like to 12 hear more data from that end. So that's why we're 13 asking about patient access.
14 Candy, can I check in on the phones?
15 Star-one on the phone.
16 OPERATOR:
Currently, there is no 17 questions. And, again, yes, as a reminder, it's 18 star-one.
19 MS. LOPAS: Okay. And then, so then this 20 last set of questions, just to provide some context 21 on this and then we'll check in for any more comments, 22 you know, so the NRC in general has been looking at 23 how they are -- how they should potentially transform 24 their regulatory environment to continue to transform 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 the technology that is going on around us and the changes 1
in our industry that we regulate. So this is kind of 2
our -- our attempt at seeing if we could get any input 3
or opinions from our stakeholders on maybe how we could 4
continue to evolve and change as an agency when it comes 5
to regulating the T&E of physicians for medical uses.
6 So, you know, we did hear a little bit about 7
somebody -- I guess Mr. Lieto or Dr. Lieto mentioned 8
about not impinging on the practice of medicine. So 9
it is a fine line to walk.
10 So let me just check back in the room here, 11 for the folks that traveled, anybody want to make any 12 last comments? I'm getting silent looks here in the 13 room.
14 And, Candy, can I check one last time on 15 the phone?
16 OPERATOR: Yes. We do have Ralph Lieto.
17 Your line is open.
18 MS. LOPAS: Hi, Ralph. Go ahead. Are you 19 there? Ralph?
20 OPERATOR: Sir, your line is open, in case 21 you might have muted your line. Again, Ralph, do we 22 have you on the phone?
23 MR. LIETO: Sorry about that. Yes, I was 24 muted. I just wanted to clarify on the point that you 25
66 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 made about collecting the data of users for Subpart 1
E. Did you say you are only going to get it from the 2
non-agreement states? Or that you are also going to 3
include some of the agreement states?
4 MS. LOPAS: So right now the NRC, we only 5
have non-agreement state data at our disposal 6
immediately. There is a couple complicating factors.
7 If we were to go out and ask the agreement states for 8
all this data, it could be a pretty heavy lift, and 9
we wouldn't need to apply for -- it's a little -- it's 10 kind of, you know, government parlance, the Office of 11 Management and Budget clearance information, 12 collection clearance, and that's quite a process.
13 We are going to -- we are working with the 14 Organization of Agreement States. We are in active 15 discussions with them, and we may broach with them if 16 there are states that maintain a database kind of 17 similar to what we do. But if there are states that 18 could kind of easily pull this information for us and 19 give it to us, maybe even if it's just kind of raw and 20 then we kind of sort through it, we will do our best.
21 So, but at the moment, the only data that 22 we can get is NRC licensees. I don't know if -- Chris, 23 if you have anything to add to that.
24 MR. EINBERG: That was a good summary.
25
67 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MS. LOPAS: So, yeah, Ralph, more or less 1
that -- that's the answer. Right now, we only have 2
the 13 states of the licensees that we regulate.
3 MR. LIETO: So are you going to do any type 4
of -- I imagine there is an issue that -- you realize 5
that the largest state is going to be Michigan, and 6
everything else is going to be basically extremely rural 7
areas with few licensees.
8 MS. LOPAS: Right. I mean, I would 9
imagine, I mean, there -- and we don't have -- we haven't 10 pulled the map yet, you know, but we are -- we've got 11 Michigan, Delaware, Vermont, Wyoming. Even though 12 Wyoming is an agreement state, we still have their 13 medical uses. Puerto Rico.
14 I mean, I think we're going to see that 15 this tracks with physician access in general, right?
16 I mean, you can't get brain surgery in a little teeny 17 tiny town. You have to go to a major metropolitan city, 18 right? I think it is going to be a little similar.
19 So I think you're right, and I will say 20 that we struggle a little bit with what to do with the 21 data that we are going to get, the maps that we're going 22 to present. I mean, I think we kind of know what it's 23 going to show us. So then the question will become, 24 well, what -- what do we glean from those maps? So 25
68 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 it's a little tough, but -- I don't know if you have 1
any additional thoughts on that.
2 MR. LIETO: Are you asking me?
3 MS. LOPAS: Yeah, I am. I am. I mean, 4
there is -- I'm mean, that's kind of where --
5 MR. LIETO: You automatically collected 6
the number of licensees that are in each state, and 7
so forth. I kind of agree with one of the commenters 8
before that -- or I think they -- they had asked a 9
question like, don't you have that data already?
10 I think it's something that has been asked 11 a number of times over the last probably two to three 12 years. I would think at least the agreement states 13 would be put on some kind of a request that they start 14 to put this data together because there is obviously 15 a demand for it. And I think it's kind of surprising 16 that you don't have any idea on the number of licensees 17 that are authorized for these high-risk 18 radiopharmaceuticals.
19 I mean, it doesn't have to be, you know, 20 exact, but at least some kind of a distribution, even 21 by the states, who is authorized for this. And it's 22 kind of surprising, that's all. And I think if the 23 intent is not being able to do it in the timeframe of 24 this comment period, I think the agreement states still 25
69 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 should be asked to start to generate that kind of data 1
on a routine basis.
2 I think it -- I think it's quite important.
3 You know, they're going to have future needs also.
4 Just my thoughts.
5 MR. EINBERG: Thanks, Ralph. This is 6
Chris Einberg. So we do collect that -- or we do collect 7
data on the number of licensees on an annual basis.
8 But we don't have the exact location of use for the 9
licensees. So that has been the difference here.
10 You know, as far as, you know, collecting 11 the information in the future, as Sarah pointed out, 12 there is a lengthy Office of Management and Budget 13 clearance process to start collecting that data. But 14 that doesn't preclude us from starting the dialogue 15 with the agreement states, which we have started, and 16 we'll have actually a telecon with them on Thursday.
17 And this is an area of discussion that we 18 plan on discussing with them on how best to collect 19 this data and how -- or do they have this data available, 20 so that we can help map out the authorized users at 21 specific locations for these authorized users. So 22 we're working, but it's a -- it's a work in progress.
23 MS. LOPAS: All right. We've got another 24 comment here in the room. Star-one on the phone.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 DR. NORENBERG: Hi. This is Jeff 1
Norenberg with the National Association of Nuclear 2
Pharmacies. I just want to comment on nomenclature 3
for a moment. I think it's risky to accept the 4
designation "high-risk radiopharmaceuticals" to create 5
any sort of a nomenclature around that notion.
6 There are specific terminologies that the 7
Institute for Medication Safe Practices uses to 8
designate high-alert medications, high-risk 9
medications, and others. And I think we ought to really 10 be disciplined and stick to that 35.300 definition of 11 radiopharmaceuticals requiring a written directive and 12 avoid the common casual references to other terms that 13 we might want to apply.
14 Thank you.
15 MR. EINBERG: Thank you.
16 MS. LOPAS: Okay. Candy, do we have any 17 other comments on the phone?
18 OPERATOR: Yes. I have a question from 19 Jenny. Your line is open.
20 MS. FISHER: Hello. This is Jenny Fisher 21 from the NRC, and I just wanted to comment, to go back 22 to when we were talking about the different states and 23 to clarify that we're not just regulating the rural 24 states, that we do have a couple of states -- Missouri, 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Indiana, and Michigan -- and each one of those states 1
have authorized users in the hundreds. So we're not 2
just doing your limited access states as far as NRC 3
regulations.
4 MS. LOPAS: Thanks, Jenny. That's 5
helpful. Yeah. I couldn't think off the top of my 6
head the 13 states that we -- we are looking at.
7 Okay. Candy, is there anybody else on the 8
phone?
9 OPERATOR: We're showing no questions from 10 the phone.
11 MS. LOPAS: Okay. All right. So I'm 12 going to give folks just one more minute -- star-one 13
-- to make any comments on the phone. And while I do 14 that, I just want to close out with just a thought that 15 we -- and I didn't mention this during our last webinar, 16 but we do have meeting feedback forms. They're online, 17 however. They -- if you go to our meeting notice after 18 this meeting closes out, give it a couple hours, like 19 if you go tomorrow, there will be a link for you to 20 provide meeting feedback, and it's online now instead 21 of our old paper and -- you know, paper, put it in the 22 mail thing.
23 And I do remind folks, if you could, if 24 you -- if you could just sign in, if you forgot to sign 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 in on your way in, that would be helpful for us for 1
my meeting summary.
2 And our comment period closes January 29th.
3 So if you are submitting those official written 4
comments, we ask that you get them in by that date on 5
regulations.gov. If you have any issues, again, you 6
can just email me and I can take your comments as well 7
and get them on the docket.
8 Candy, one last check? Comments on the 9
phone? Questions on the phone?
10 OPERATOR: Thank you. And, again, as a 11 reminder, star-one. I think we do have one in queue.
12 Standby, please.
13 MS. LOPAS: Okay.
14 OPERATOR: We do have a question on the 15 phone. We do not have a name recorded. So if you could 16 press star-on, your line is open for your question.
17 Go ahead, please.
18 DR. RAZMARIA: Hello? Can you hear me?
19 OPERATOR: Yes. Your line is open. Go 20 ahead, sir. And your name, please?
21 DR. RAZMARIA: Hi. How are you? This is 22 Aria Razmaria talking on behalf of nuclear medicine 23 regulator issues. I just kind of thought that, kind 24 of listening to the open public comments today, and 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 I cannot really --- can just offer my -- but I can, 1
basically, just wanted to provide a comment as a 2
physician in training and also in terms of what kind 3
of scope of practice and how the future of nuclear 4
medicine is going to be.
5 Again, I am really perplexed and asked 6
myself, okay, why did I go to medical school where they 7
have more than 10 years of training? And basically 8
they are, you know, training in nuclear medicine in 9
general, medicine in other areas, to be able to provide, 10 you know, professional care of patients. And that's 11 why I was listening to the comments today.
12 So respective of all of the providers that 13 are contributing to patient care in terms of pharmacy 14 technology -- but you kind of have to -- for myself, 15 I think there is a clear delineation of practice. So 16 we -- you heard about, you know, from -- a nuclear 17 pharmacist being able to provide professional, you 18 know, input to the clinic. But, again, what is -- from 19 that point on, what is the clinical decision that is 20 made based on? You know, what is the role of a 21 physician?
22 Again, I don't -- I know I don't want to 23 be --- I have really got to hold myself back and kind 24 of listen to what you are talking about, and, you know, 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 have -- you know, just debate what the pros and cons 1
are. And I kind of just think to myself, okay, you 2
know, if one of my family members needs to have ---
3 be in nuclear medicine study or anything, nuclear 4
therapy, whom do I kind of go to, trust to?
5 And I kind of really -- kind of taken aback 6
by some of the comments or, you know, asking, you know, 7
that this is kind of public, you know, open forum where 8
basically anyone can have these things, which is fine, 9
which is correct, but, again, what is the quality of 10 care that you are looking? What is the future of 11 nuclear medicine?
12 Again, now, if you look outside borders, 13 nuclear medicine in
- Europe, it has advanced 14 significantly. All these therapies that we are 15 currently talking about that are being able to be 16 admitted to patients have been in the majority of cases 17 coming from Europe, in countries that have a clear 18 nuclear medicine delineation, scope of practice, who 19 work on these therapies and develop in clinical trials 20 and have brought it to fruition. And because of the 21 regulatory framework in these countries, allowing this 22 specialty to thrive and move forward. So I'm just 23 really taken aback by comments made today, with all 24 due respect to all of the teams and groups that are 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 working in the benefit of patients. And it's not about 1
profit, about benefit, it's about patient care and 2
quality of care.
3 And I will ask everybody in the audience, 4
who would you like to send your loved ones to? Who 5
wants to -- what do want to have your loved ones taken 6
care of? Someone who has, you know, access of medicine 7
who is trained in dealing with complications in 8
different areas.
9 These new therapies are not just a simple 10 injection. If you talk about new therapies, this has 11 significant toxicities that come with it, like having 12 chemotherapy administered by someone who is not trained 13 in administering chemotherapies or newer therapies.
14 So it is not trivial, and I think the 15 regulatory framework in the U.S. in the past has caused 16 significant harm and detriment to the field of nuclear 17 medicine. And the discussion that we are having today, 18 everyone seems to want to have a part of the cake, but 19 it is not about this. It's about patient care and the 20 quality of care and some, you know -- some people that 21 are dedicated to taking it forward, not about one 22 pharmaceutical that is now the drug of the future, what 23 other cancers can be treated with radiopharmaceuticals.
24 Again, with respect to all of the 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 participants that are taking care of patients and doing 1
their best to provide professional care, but there is 2
an area that, you know -- you know, who has just 3
financial benefit and maximization of profit, which 4
obviously industry is significantly interested in, but 5
not losing, you know, the goal that we have, the quality 6
of care, patient safety in mind.
7 It's not just radiation safety. It's just 8
the clinical expertise in how that patient, what 9
sequence of the therapy is indicated, which, you know, 10 once a radiopharmaceutical therapy fails, what other 11 option is there, in collaboration with oncology, with 12 radiology, with other specialties that are interested.
13 So, again, I am surprised, I do really know 14 that, you know, opening up all training requirements 15 for, you know, the public. You know, I could just, 16 you know, have, for example, my grocery store providing 17 me my, you know, medicine that I need. So it's -- and 18 there is expertise that goes with like pharmacies that 19 can provide professional information about the 20 medicines, the contraindications, or if there is 21 observed side effects.
22 But there is an expertise that comes with 23 the clinical practitioners that have read diagnostic 24 studies, you know, and just are not focusing on one 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 treatment but know what the imaging aspects that their 1
study looks at, what therapies are indicated in certain 2
scenarios. What radiation dose is there, for that 3
specific tumor burden is indicated.
4 So it is not simple. You know, I am --
5 just listening to the conversation, I am thinking if 6
one of my loved ones needs access to nuclear medicine, 7
whether the U.S. would be the right place to go or 8
another -- go across country, go to Europe, and have 9
it done by, you know, centers that specialize on these 10 type of treatments.
11 And we won't be enhancing future of this 12 type of treatments by opening up -- and specialized 13 therapeutic treatments to, you know, public access.
14 So I know the concern, and I'm really 15 surprised by how NRC is approaching this question with 16 all the respect and all the -- you know, due respect 17 in the field and that the federal agency has. I am 18 kind of really surprised by the approach that is being 19 taken.
20 It is -- it is not a simple -- there is 21 a reason that medical specialties are present. There 22 is a reason that the training program asks for those 23 medical specialties. And all of this discussion and 24 approach that NRC is taking undermines all reasoning 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 in terms of why these medical specialties are allowed, 1
why there is a medical board of radiology, why there 2
is a board of nuclear medicine.
3 So they have specific training 4
requirements that, you know, involve the clinical 5
expertise and knowledge that is needed for practicing 6
that field. So it is -- the way I perceived this by 7
NRC is opening up, you know, training to -- I mean, 8
don't take me wrong, I am all open for patient access, 9
but the patient access is just meaning, okay, opening 10 up center for cardiothoracic surgery, and, you know, 11 having family practitioners doing that.
12 And I am, as a nuclear medicine person, 13 not able to understand what -- how to do surgery, so 14 this is kind of expertise that a medical specialist 15 would have developed to provide guidance. So I don't 16
-- I just wanted to provide a comment. And I really 17 have tried to hold myself back, but just wanted to have 18 that thought in.
19 And then, just expecting that surprise, 20 how NRC is approaching this and how it is basically 21 really to detriment of a medical specialty.
22 Thank you.
23 MS. AYOADE: This is Maryann Ayoade with 24 NRC. Thank you for your comments. We appreciate that.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Just to clarify, again, we are not -- you know, our 1
intention with this evaluation is not because we are 2
moving in any direction right now with making changes 3
to our training and experience requirements.
4 We have had, you know, several public 5
meetings. We have had different people coming in to 6
talk to us about this topic. And so -- and so we have 7
to do our due diligence and taking a look at our training 8
and experience requirements as it relates to 9
radiopharmaceuticals, and that's what we're doing here.
10 And in being open, you know, as part of, 11 you know, what we try to do is we try to share with 12 the public what we're doing. And so part of what we're 13 doing right now is an evaluation process, as Sarah 14 discussed as it relates to patient access, is we are 15
-- we are hearing -- we are taking comments and we are 16 working with the agreement states, and we are looking 17 to see if there are any issues.
18 But this does not conclude or bring -- or 19 say that we are concluding that there is going to be 20 any changes to our regulations, and that we're acting 21 upon it at this moment. We're, again, evaluating what 22 we're doing.
23 And then I just had a question as it relates 24 to -- I believe you talked about some of the different 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 countries and what they are doing. Do you -- I guess 1
can you tell us some of the countries that you were 2
referring to that have maybe different processes that 3
we might be -- that we should be looking at?
4 DR. RAZMARIA: I can just refer to two main 5
countries where these targeted therapies have been --
6 who have been pioneering this new targeted radiological 7
therapies. One would be Germany, and the other is 8
Australia. In those countries, you see that there is 9
a clear line what requirements are needed in terms of 10 training to be able.
11 And that has -- you know, there is a 12 development -- atomic energy organization that is 13 standardizing what training is needed to be able to 14 practice nuclear medicine. And there is -- one of the 15 countries that has the least command of kind of really 16 minimal is the U.S. So we are lagging behind 17 significantly in terms of, you know, delineating what 18 in fact, training and experience requirements, and just 19 really delineating the minimum.
20 So, and if any -- if anything, there is -- in 21 the U.S., there is a need to increase the training and 22 the clinical expertise. You are focusing so much on 23 radiation safety but there is also the whole vast 24 clinical expertise of using the radiopharmaceuticals 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 for therapeutic purposes.
1 So, again, the country -- you just need 2
to look to Europe. You just need to open the Journal 3
of Nuclear Medicine, and you can see that, you know, 4
the majority of studies are coming from outside of U.S.
5 And this is really kind of disheartening if you 6
consider that nuclear medicine was in fact developed 7
in the U.S.
8 So this is something that, again, there 9
is a need for people who, you know, just not take, you 10 know, discoveries from abroad and just use it here, 11 but just come forward in developing new therapies for 12 new cancers, new indications.
13 The U.S. has been historically kind of the 14 leading edge of development, and we are just kind of 15 lagging now behind in this area, because I kind of really 16 believe because of the regulatory framework that hasn't 17 really enabled the field of information to thrive.
18 So, again, putting all of the financial 19 benefit to the side, looking at what the future will 20 have, all of the areas of medicine move towards 21 specialization in medicine. So just -- just opening 22 up an area to kind of broad -- well, in our intent we 23 have to always keep in mind patient access, obviously.
24 But patient access to expertise therapy, not just --
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 just someone who is coming in, injecting a therapy and, 1
okay, what are the complications, what are the 2
contraindications, what other steps after the initial 3
therapy are indicated?
4 So just forgetting about all of that, just 5
having that unit dose available, injecting them, okay, 6
we are done. That's not how patient care is done, so.
7 MS. LOPAS: All right. Thank you, Dr.
8 Razmaria. That was -- that was very helpful, and I 9
appreciate that you didn't -- I think you said you were 10 trying to hold back, but I'm glad you didn't.
11 Okay. Candy, do we have anybody else on 12 the line?
13 OPERATOR: We're showing no questions at 14 this time.
15 MS. LOPAS: Okay. All right. Folks, I 16 think -- unless anybody in the room has any last comments 17 that they would want to make? Seeing none, Chris, do 18 you want to close us? No? Okay. I will close us 19 out then.
20 Okay. So our next meeting on here, if you 21 feel like you want to come and spend some time with 22 us again, would be January 10th, and that's the same 23 time, 1:00 p.m. to 4:00 p.m., and it will be webinar 24 and bridge line accessible as well. And then that last 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 webinar will be on January 22nd, and we will be in 2019.
1 Can you believe it?
2 Okay. Thank you very much, everybody.
3 And I will stay on the bridge line for our court 4
reporter, but thank you, and this concludes our meeting 5
on training and experience. Thanks.
6 (Whereupon, the above-entitled matter went 7
off the record at 2:44 p.m.)
8 9
10 11 12 13 14 15 16