ML20012G772
| ML20012G772 | |
| Person / Time | |
|---|---|
| Issue date: | 03/09/1993 |
| From: | NRC COMMISSION (OCM) |
| To: | |
| References | |
| REF-10CFR9.7 NUDOCS 9303160114 | |
| Download: ML20012G772 (68) | |
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UNITED STATES OF AMERIC A NUCLEAR REGULATORY COMMIS SION
-=
( 3l BRIEFING ON PROPOSED RULEMAKING FOR PREPARATION AND USE OF RAD 10 PHARMACEUTICALS i
LOCatiOD:
RoCKVILLE, MARYLAND haI6 MARCH 9, 1993 PagGS 53 PAGES NEALR.GROSSANDC0.,INC.
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DISCLAIMER This is an unofficial transcript of a meeting of the United States Nuclear Regulatory Commission held on March 9, 1993, in the Commission's office at one White Flint North, Rockville, Maryland.
The meeting was open to public attendance and observation.
This transcript has not been reviewed, corrected or edited, and it may contain inaccuracies.
The transcript is intended solely for general informational purposes.
As provided by 10 CFR 9.103, it is not part of the formal or informal record of decision of the matters discussed.
Expressions of opinion in this transcript do not necessarily reflect final determination or beliefs.
No pleading or other paper may be filed with the Commission in any proceeding :as the result of, or addressed to, any statement or argument contained herein, except as the Commission may authorize.
O e
e NEAL R. GROSS court REPORTERS AND TRAH5CRittR5 1323 RHoDE 11 LAND AVINUE, N.W.
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___ UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BRIEFING ON PROPOSED RULEMAKING FOR PREPARATION AND USE OF RADIOPHARMACEUTICALS PUBLIC MEETING l
l Nuclear Regulatory Commission One White Flint North Rockville, Maryland Tuesday, March 9, 1993 The Commission met in open
- session, I
pursuant to
- notice, at 2:00 p.m.,
Ivan
- Selin, Chairman, presiding.
l COMMISSIONERS PRESENT:
IVAN SELIN, Chairman of the Commission KENNETH C. ROGERS, Commissioner JAMES R.
CURTISS, Commissioner FORREST J. REMICK, Commissioner E. GAIL de PLANQUE, Commissioner NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVENUE, N.W.
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STAFF SEATED AT THE COMMISSION TABLE:
SAMUEL J.
CHILK,_ Secretary j
i MARTIN MALSCH, Deputy _ General Counsel ~
HUGH
- THOMPSON, Deputy Executive Director for i
Operations ROBERT BERNERO, Director, NMSS BILL
- MORRIS, Director, Division of Regulatory Applications, RES JOHN TELFORD,_ Reg. Dev.
Br.,
Division of Regulatory Applications, RES JOHN GLENN, Chief, Medical Licensing Branch, NMSS I
t l
i
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i a
f t
I i
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P-R-O-C-E-E-D-I-N-G-S 2
2:00 p.m.
3 CHAIRMAN SELIN:
Good afternoon,. ladies 4
and gentlemen.
5 The Commission is here to receive a
6 briefing from the NRC staff on a proposed rulemaking, 7
concerning the preparation and use of pharmaceuticals 8
and related matters.
The staff's recommendation and 9
its rulemaking were provided to the Commission in a 10 staff paper from March 2nd, from last week, copies of 11 which are supposed to be available in the room.
This.
12 rulemaking responds to and largely is intended' to 13 grant a petition for rulemaking submitted by the 14 American College of Nuclear Physicians and by the 15 Society of Nuclear Medicine.
There are some other 16 changes that the staff proposes as well.
17 This meeting serves as a means for'the 18 staff to explain directly to the Commission and i
19 through us to the public what changes are being 20 recommended for proposal on the basis of these 21 changes.
In this regard, the Commission is concerned 22 to hear what the staff has to say abou't one issue.
i 23 By substantially granting the petition, 24 the proposed rules, if made final -- and I'd like to.
25 stress that all that's being. asked is permission to
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print the rule for comment, but that the-proposed rule 2
would provide much greater flexibility for qualified 3
individuals to prepare and use radioactive drugs by 4
eliminating certain restrictions.
The staff states 5
that it believes these changes are consistent with the 6
Commission's policy on medical use of isotopes and 7
that the additional safeguards being recommended will 8
ensure adequate protection.
The Commission clearly 9
needs to fully understand the staff's thinking in this 10 regard.
11 Commissioners, do you have any other 12 opening comments?
13 Mr.-Thompson, you may proceed.
14 MR. THOMPSON:
Thank you, Mr. Chairman.
15 Commissioners, today the staff will brief 16 you on the proposed rule.
It is a proposed rule 17 developed in response to a petition submitted by the 18 Society of Nuclear Medicine and the American College 19 of Nuclear Physicians in June of 1989.
This petition 20 did call for NRC to relax some of the current NRC 21 regulatory requirements and to fully recognize the 22 activities that licensed nuclear pharmacists and 23 physicians are permitted to conduct under state law.
24 When the regulation of radioactive drugs 25 shifted from the NRC to the FDA in 1976, the NRC made-NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N.W.
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FDA approved labeling a regulation by requiring our 2
licensees.to follow the package inserts or to_get 3
specific license approval for deviations.
The 4
revision of Part 35 in April of 1987 and the 5
subsequent inspection and enforcement actions that 6
followed that regulation has resulted in this request.
7 to the Commission that we are proposing today.
8 This proposed rulemaking is the result of 9
almost four long years of evolutionary and sometimes 10 controversial effort.
We've met with the regulated 11 community, the academic institutions, the professional i
12 societies, the state regulators, including the 13 agreement states, the advisory committee, and the FDA.
j 14 I would also like to note that considerable input was 15 received from NRC's medical visiting fellows and their
'16 input was very helpful in preparing the proposed rule.
17 This proposed rule will decouple NRC l
18 regulations from the FDA package inserts, but it is 19 not intended to diminish the responsibilities of NRC l
20 licensees to follow all applicable state and federal 21 regulations and in particular the FDA regulations.
22 This decoupling will modify certain restrictions on 23 our licensees, thus allowing greater flexibility 0
24 within existing FDA and state regulations for the use 25 of radioactive drugs prepared by a licensed nuclear NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N.W.
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4 6.
1
-pharmacist o r.
under the direct supervision of an 2
authorized user physician.
3-It is our belief that this proposed 4'
regulation will allow greater flexibility without 5
compromising public health and safety.
It will only 6
be permitted under the supervision of medical.
7 professions, physicians and licensed radiopharmacists 8
who meet the training requirements in the proposed 9
rule.
10 With that, Mr. Chairman, I'd like to turn f
11 the briefing over to Doctor Morris of the Office of l
12 Research, and we also have with us today John Telford i
13 from the Office of Research, Bob Bernero and John
[
14 Glenn from the Office of Nuclear Material Safety and 15 Safeguards.
-t 16 CHAIRMAN SELIN:
Thank you.
17 DOCTOR MORRIS:
Thank you, Hugh.
i 18 Before moving on with the discussion in t
19 the handout, I did want to acknowledge the efforts of 20 all those staff members who have contributed to the 21 development of the rulemaking that is proposed to you
{
22 here today.
In addition to John Glenn and John 23 Telford here at the table, behind us are Sher Bahadur, 24 Tony Tse and Sam Jones of the Office of Research, and 25 Larry Camper and Josie Piccone from NMSS.
Stu Treby i
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1 and Marjorie Rothschild from the _ office of the General 2
Counsel'were also part of the team to develop this 3
package.
All those-individuals spent a lot of hours l
4 working on this project and their efforts are l
'I 5
appreciated for the outstanding job they did.
i f
6 (Slide)
Moving on to the handouts, the 7
first page is simply an outline of the presentation.
8 (Slide)
And therefore, moving on to page
[
9 3,
Hugh has essentially given you the big picture as 10 to why this petition was submitted and the thinking of 11 the petitioners.
- i 12 Just to get to the point, let's look at i
13 the first bullet and I will indicate there that what 14 the petitioners are requesting is the relaxation of
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15 Part 35 which currently limits use of byproduct
}
16 material ts cases where the Food and Drug 17 Administration has accepted a claimed exemption for an 18 investigation of a new drug, an IND, or has approved 19 a new drug application, NDA.
20 When the petition was submitted, 35 also i
21 required compliance with the package insert 22 instructions regarding indications for use and methods i
23 for administration.
Of course the interim final rule 24 has now provided temporary relief from
_these 25 restrictions, but that relief would expire next NEAL R. GROSS
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Augurt.
The petitioners describe several situatior 2
where-these restrictions would impede physicians in 3
providing treatment which in the physicians' judgment 4
would be in the best interest of patients, however.
S they asserted that such modes of treatment would not 6
violate any regulations or requirements of any-7 regulatory agency, state or federt.1, other than the 8
NRC.
The petitioners asserted also that the 10 restrictive nature of the NRC's regulations which 11 require that drugs containing byproduct material only 12 be prepared in accordance with the manufacturers' 13 instructions have the effect of disenfranchising 14 radiopharmacists, nuclear pharmacy as a profession.
15 They requested that the NRC regulations recognize the 16 profession of radiopharmacy and the traditional 17 activities of these professions and they specifically 18 cited compounded should be permitted.
19 The petitioners describe sevrrm
-e
,les 20 of medical research in different settings thac provide 21 important new methods and information for treating 22 patients.
They point out that there are modes of 23 oversight such as institutional review boards and 24 radioactive drug research committees for assuring the 25 safety of such research, but that NRC's regulations do NEAL R. GROSS COUR1 REPORTERS AND *RANSCRIBERS 1323 RHODE ISLAND AVENUE, N.W.
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1 not provide a general license for conducting such 2
activities.
3 I might point out that currently research 1
4 may be carried out by NRC licensees provided they've t
5 got an exemption from the NDA and IT 7strictions and 6
have a specific entry on their license to allow 7
research.
8 The petition pointed out that the expanded _
9 use of, for instance, radiobiologics is an example of 10 the potential benefits of research.
Radiobiologics t
11 are essentially substances that would be developed in-12 vitro from animal cellular material which also would 13 contain a radioisotope.
Thsy're using specific kinds j
i 14 of cells to grow the biologic.
There would be a high 15 affinity for certain target cells in the body of a 16
- patient, for
- instance, and by attaching the 17 radioisotope you would provide the capability for high 18 resolution imaging and, in the case of treatment for 19 cancer, high localized doses to the infected cells.
20 CHAIRMAN SELIN:
Do the monoclonal v
21 antibodies fall under that?
22 DOCTOR MORRIS:
Monoclonal antibodies is l
23 one of the radiobiologics.
24 (Slide) Moving on to the next page of the
[
i 25 handout, we took the NRC's Medical Use Policy as the i
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foundation for our review. These principles were used 2
with the objective to grant the flexibility sought by 3
the petitioners to 'the extent possible while 4
continuing to ensure an adequate level of radiation 5
safety.
To achieve this goal, as Hugh mentioned, 6
staff sought input from a number of sources as 7
indicated on page 5 of the handout.
l 8
on hearing and learning what the l
9 petitioners had in mind and hearing of their' concern 10 that the NRC's regulations might be, in fact, having 11 a negative impact on providing patient care, a series 12 of consultations with the Food and Drug Administration 13 was begun and as a result of that we were able to 14 develop the interim final rule.-
That would have 15 allowed -- that did allow the physician-directed 16 deviation from package inserts stated in SECY-93-050.-
17 The rule would be extended now until December 31st, l
18 1993 and this has been done,. again, after the i
19 continued consultation with the Food and Drug 20 Administration.
Also, we were able to arrive at a 21 decision last year to remove the documentation 22 requirements that went with the interim final rule l
t i
23 that required the physicians to state their rationale
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24 for these departures.
25 Af ter issuance of the interim final rule,
[
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1 the staff began to develop a succession of straw man l
2 versions of the proposed amendments which were 3
generally responsive to the petition. These proposals 4
were discussed at several meetings.
At the meeting
~
5 with the agreement states which was held in Atlanta
[
i 6
last July, the straw man rule language was discussed 7
and, in addition, the issue of compatib'lh ' was a 8
major concern to the agreement states and 70'11 come I
9 back to that issue later on.
10 The meetings with the series of groups 11 mentioned at the bottom of page 5 and on the next page i
12 of the handout, the focus of the discussion was to 13 define the responsibilities of those professional i
14 radiopharmacists to be formally recognized in the 15 NRC's regulations and to develop proposed training and l
L 16 experience criteria to be met by these individuals.
j 17 The concept under consideration was to establish in 18 the regulations the position of the authorized nuclear 19 pharmacists as the analogue to the physician 20 authorized user.
l 21 (Slide)
Moving on to the next page, on i
22 page 7, I just wanted to mention again the valuable i
23 advice we've received from Doctor Polycove and Mark i
24 Rottman. They assisted in evaluating the petition and 25 developing the proposed amendments.
And again NEAL R. GROSS l
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1 mentioning the presence of the advisory committee as j
i 2
a resource'of expertise to the staff through meetings 3-in May and October of 1992, we were able to come to
{
4 arrive at the proposed amendments that we've developed i
5 and proposed to you in the SECY paper.
Those are 6
discussed in some detail on page 8 now.
i 7
(Slide) Although we didn't' adopt the rule 8
language that was proposed by the petitioners, 'we 9
believe that these proposed amendments fully.have the i
10 practical effect of fully granting the petition.
11 The first bullet here refers to the fact i
12 that we would now no longer refer in our regulations 13 to the concept of the new drug application and the 14 investigation of new drug processes that the FDA has i
15 established and licensees would be able to administer 16 unsealed byproduct material to patients provided that 17 the material was prepared by or under the supervision t
18 of qualified individuals and the doses administered 19 are measuro; using properly calibrated instruments.
20 Those meastres are essentially focused on the.
21 radiation safety issue and are intended to be that and 22 only that and not to interfere with the judgment or P
23 the professional expertise of physicians and 24 pharmacists.
25 To avoid any confusion about the Agency's i
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1 intentions in taking this step, the amendments do 2
include a statement that nothing in NRC's regulations 3
relieves licensees from complying with the applicable 4
FDA, federal or state requirements.
l 5
The third item on page 8 refers to the 6
staff's proposal to permanently grant the relaxation
{
7 of the interim final rule. This is being accomplished j
8 by simply eliminating reference to package inserts in 9
the revised regulation.
l 10 Regarding the final bullet on this page,
-[
11 as I discussed earlier, licensees will now be able to 12 administer byproduct material prepared by or under the 13 supervision of properly qualified individuals.
One.
14 group of such qualified individuals would be those 15 with the title
" authorized nuclear pharmacist."
i 16 Authorized nuclear pharmacist would work under either 17 a Part 32 or a Part 35 license and would be either 18 board certified by the Board of Pharmaceutical 19 Specialties or would meet the specified training and 20 experience criteria contained in a new paragraph, 21 Paragraph 35.980.
l 22 COMMISSIONER REMICK:. I have a question.
23 Would they be certified as nuclear pharmacists or 24 certified as pharmacists?
l I
25 MR. TELFORD: The former. They'd be board j
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1 certified as nuclear ' pharmacists by the Board of'-
[
2 Pharmaceutical Specialties.
3 COMMISSIONER REMICK:
I see.
4 CHAIRMAN SELIN:-
Is this procedure
~!
5 comparable to the way we recognize nuclear physicians 6
or other professionals?
In other words, the idea is 7
that in most cases there's a board' that's properly i
8 constituted to recognize a specialty and that this 9
gives us an out.
It says that even if somebody is not 10 recognized by a Board for some reason or other,
[
11 there's an alternative way to become certified.
I 12 DOCTOR GLENN: It's completely parallel to t
13 the system that we set up for the nuclear physicians.
14 CHAIRMAN SELIN:
So that reading the 15 language about what it takes to satisfy us outside the t
i 16 board, there's nothing to be read into that about 17 further requirements to what a board has to be t
{
18 satisfied with to certify a pharmacist?
That's a 19 pretty poorly put question.
20 If the board decides somebody is-7 21 certified, that person is certified, right?
l 22 DOCTOR GLENN:
That's correct.
We would j
23 not have an additional requirement on top of the
_.t 24 certification.
{
t 25 CHAIRMAN SELIN:
Okay.
Thank you.
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MR. MORRIS:
I started to mention that 2
there would be an alternative grandfathering clause l
?
3 that would state that a licensed or registered l
4 pharmacist who is designated now as an authorized user j
5 on a nuclear pharmacy license, this is different from i
6 a physician authorized user, could be grandfathered r
7 now as an authorized nuclear pharmacist.
[
8 (Slide)
Moving on now to page 9,
9 continuing with the proposal.
l 10 COMMISSIONER REMICK:
What would that 11 person have to do to grandfathered?
l 12 MR. MORRIS:
I believe we just notify --
13 COMMISSIONER REMICK:
Has to request?
t 14 MR.
THOMPSON:
You mean what was his l
15 qualifications to be an authorized --
16 COMMISSIONER REMICK:
No, if we are going
[
17 to grandfather somebody, is there anything that person f
18 has to do or is it automatic?
l 19 DOCTOR GLENN:
I would say if they're l
20 listed on the license, it is automatic.
21 MR. TELFORD: They are currently listed on i
22 a license, on a commercial nuclear pharmacy's license.
23 They're currently listed.
We know they have a state 24 license to practice pharmacy.
The assumption is that 25-they already meet the training and c:perien% criteria 1
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that we have specified in 35.980.
Therefore, there's 2
nothing else they need to do.
They're already on the 3
license, as Doctor Glenn said.
i 4
COMMISSIONER REMICK:
So, they can just-5 assume then if they're listed on their license, if i
6 this rule goes into effect that they are --
t 7
MR. TELFORD: If they have a state license 1
8 to practice pharnacy.
9 MR. THOMPSON:
But we should clarify.the 10 statement of considerations to make that clear if it's i
11 not very clear now.
f i
12 COMMISSIONER REMICK:
Because I think in f
-t 13 some cases in the past we've asked people to do l
14 something to get that into effect.
I'm thinking back
[
15 when senior reactor operators came into effect.
t 16 People had to initiate something.
[
17 MR. THOMPSON:
You're probably the only I
18 one here that can remember that.
[
6 COMMISSIONER de PLANQUE:
Perhaps you're 19 20 going to mention this later and if so fine, but you f
f 21 also mentioned considering the individual's character
.r i
i 22 for this.
Is this something new and how are you going 23 to do that?
24 MR. MORRIS:
I think this is new because f
25 in the past we had to have a licensing action to enter i
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the person onto the license. Now, the staff wanted to 2
have the option after hearing through a notification f
3 of a proposal that a person is going to become an 4
authorized nuclear pharmacist, to be able to look at 5
whether there had been any problems with that person's 6
record.
7 COMMISSTJNER de PLANQUE: Are you going to 8
have written criteria for making this determination or 9
how will this go?
10 DOCTOR GLENN:
This determination,-as I 11 see it, is made on the basis of has an action been 12 taken against this person, either by the Commission 13 through an order or if we become aware of a criminal 14 action taken against the person.
But certainly we 15 will maintain lists of t_ lose who, based on our 16 deliberate misconduct rule, have been issued an order 17 suspending them from practicing at another facility.
t 18 MR. MALSCH:
I should add, this is not 19 different from any other category of licensees and 20 would have been an issue even without this regulation -
i f
21 change if a character issue were raised before we r
22 granted authorized user status. The reason we find it i
i 23 here is because we're sort of raising it automatically
[
t 24 and are providing a reason for NRC staff to step in 25 after they're already authorized.
But the issue is a 1
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longstanding one.
It's not been very prominent at I
2 this stage, but it's a prominent area of legal 3
regulation.
4 For example, we have had cases -where
[
5 people have been, let's say, convicted.of misusing 6
drugs, had local licenses -- still be an NRC user --
7 COMMISSIONER de PLANQUE:
But you feel 8
that in this particular application the criteria are 9
pretty clear-cut?
10 MR. THOMPSON: I think I agree with Marty.
11 We probably don't have any specific criteria written 12 down, but it has been a practice where we look at the 13 case by case circumstances and there may be 14 convictions or they may have willful violations of NRC 15 regulations and we take all those factors into 16 consideration in making our judgments as to whether l
17 this is an individual that you can rely on to follow 18 NRC rules and regulations or, in this-case, just to i
19 rely on to carry out the functions that they-are f
[
20 proposed to do under the nuclear pharmacy.
21 COMMISSIONER ROGERS:
Well, do we use the 22 term " character" elsewhere in our regulations or do we 23 specify the kinds of deficiencies that we look for i
24 rather than character defects?
25 MR. MALSCH:
I think we've used the word i
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" character" and it may even appear in the statutes, 2
but I don't think we have any place in the regulations 3
any further specificity about this.
I mean it's left t
4 to be a case by case judgment.
5 MR. MORRIS: I might mention in the access 6
authorization area we have established access 7
authorization criteria to try to make sure that we 8
have trustworthy and reliable individuals having 9
access to the equipment in nuclear plants. That comes 10 close to the character issue, but I don't recall the 11 word " character" having been used there.
12 COMMISSIONER ROGERS:
Well, I think the i
13 concern that I have, and maybe Commissioner de Plangue 14
- also, is the broad interpretation of the word 15
" character."
If we're looking for certain specific I
16 problems and that those are really pretty much the 17 extent to which we've looked, then I don't know that i
18 you'd want to characterize that as a
character 19 examination.
Character involves an awful lot.
It's I
20 another possible area of great sensitivity because if 21 you specify what it is you're looking for, that's one j
l 22 thing.
That's all very well and good.
But a 23 character defect in one person's eyes is_a character 24 plus in another person's eyes.
25 I occasionally say that I have a character l
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20 1
defect because I like to be a regulator and some of my 2
former colleagues think that is a character defect.
3 I'm not sure it is.
But I think the point is that the 4
word " character" itself really encompasses a very 5
broad sweep and if you don't have to use it, I don't 6
see any reason why we should.
If we could be more 7
specific by example --
8 MR. THOMPSON:
We'll take a look at tumt, 9
Commissioner.
I think, as I remember, it is a part of 10 the statute which is where we derived it from, but I 11 think we could probably give some better articulation 12 of what it is that we are really looking for in the 13 statement of consideration.
And if we need to make t
14 some modification, we'll work with the General Counsel i
15 on that 16 COMMISSIONER ROGERS:
I think that the 17 language in the material here really sort of raises a 18 red flag in some people's eyes.
19 MR. THOMPSON:
In the traditional use of 20 the word " character," I think it probably does.
I 21 think we just really went back to the Atomic Energy i
i 22 Act to select that word.
F 23 CHAIRMAN SELIN:
Mr. Morris?
24 MR.
MORRI!::
Again on page 9,
the i
25 regulations would now simply state that qualified NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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I
.~ -
21 1
individuals may prepare or supervise preparation of 2
radioactive drugs. This would be understood according 3
to the traditional interpretation of that term 4
" prepared drugs" to include compounding.
That's one 5
of the traditional functions of the pharmacist.
The 6
current restrictions that drugs be prepared only in 7
accordance with the manufacturer's instructions would 8
now be eliminated. This would allow the full practice 9
of pharmacy as a profession.
10 Similarly, this broad interpretation of f
11 what drug preparation entails would encompass 12 preparation and use of radiobiologics.
Many of these i
13 radiobiologics would be anticipated to involve alpha 14 and beta emitters.
The proposed amendments include 15 new requirements to measure alpha and beta doses to be 16 administered to patients using calibrated instruments.
17 These requirements supplement similar provisions for 18 gamma emitters already includ ;d in the regulations and 19 this is one of the guid pro quos for the new mode of 20 freedom that we're granting.
21 Finally, the revised regulations would-l 22 provide a general license under Part 35 to conduct 23 research using byproduct material involving human
-l 24 subjects.
The conditions of this general license' l
25 would be first that all the provisions of Part 35 now NEAL R. GROSS
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afforded to patents would also be applicable to human
[
I 2
subjects of research.
This would
- include, for i
3 example, requirements to measure and administer doses 4
using properly calibrated instruments and the 5
provisions of the quality management rule to prevent 6
misadministrations and for reporting 7
misadministrations.
8 Second, the key provisions of the federal 9
policy on human research must be followed.
10 Specifically, licensees would need to obtain the 11 informed consent of the human subject in the prior 12 review and approval of an institutional review board.
13 This to flesh out this issue of this federal policy on 14 human research.
We included on page 10 some 15 information about that policy.
16 (Slide)
The policy has been adopted in 17 regulations of 15 agencies and departments, including i
18 the Food and Drug Administration, specifically in Part i
19 21 -- I'm sorry, 21 CFR Parts 50 and 56 of the FDA l
20 regulations.
The policy includes criteria for the 21 approval by an institutional review board for research 22-that address risk to issues such as the minimization 23 of risk to subjects, that these risks are reasonable
{
24 in relation in relation to the anticipated benefits of
{
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t 23 1
safety of subjects, provisions for informed consent 2
and measures to achieve compliance, such as written 3
assurances to the agency heads and reports of any-4 anticipated problems involving risk to subjects or 5
continuing noncompliance or any suspension of IRB 6
approval.
So, this policy goes quite far, we believe, 7
in protecting human subjects during research and would 8
now be through the coverage of the other agencies, for l
9 the most part, cover the research that we conducted 10 under the new regulations.
11 CHAIRMAN SELIN:
But again, generally 12 speaking, it says if the research is consistent with-13 FDA guidelines, we will not add further restrictions 14 to that?
15 MR. MORRIS:
That essentially is it.
16 CHAIRMAN SELIN: And it gives us a case by 17 case way of dee. ling with research which for some 18 reason or another falls outside of FDA guidance?
19 MR. MORRIS:
- Yes, t
20 CHAIRMAN SELIN:
So, all of these 21 complicated conditions are really supplementary -- not 22 additional.
They're ors in Boolean logic, not ands.
I 23 You can either have an -IND or any type of FDA 24 approval or meet these conditions and be allowed to 25 carry out the research.
I r
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24-1 MR. MORRIO: Yes. The idea is that if you 2
are now conducting research under one of these other 3
- agencies, including the FDA's implementing the 4
regulations for the policy, the proposal envisions no 5
need to do anything other than just have a solid 6
compliance with that, including the IRB approvals and 7
the informed consent.
That would be the focus of any 8
inspections we might conduct.
I 9
CHAIRMAN SELIN:
Apart from things like 10 technician safety and calibration.
11 MR. MORRIS:
Those things already come i
12 under our Part 20 --
13 CHAIRMAN SELIN:
Exactly.
14 MR. MORRIS:
-- or the existing Part.35.
15 CHAIRMAN SELIN:
Okay.
16 COMMISSIONER REMICK:
Are those 15 t
b 17 agencies that have endorsed those guidelines all l
18 research-granting agencies?
19 MR. MORRIS:
That was the intent of the 20 federal policy, that all research granting-agencies i
21 would endorse them and the policy states that as its 22 objective.
The FDA is not primarily a research I
23 granting agency, it's more of a regulatory agency.
24 But all the research under the Department of Health 25 and Human Services would come under this heading.
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25 1-COMMISSIONER REMICK:
What are the pros 2
and-cons of the NRC specifically ' endorsing those
(
3 guidelines?
You indicate that we have not 4
specifically endorsed them, but you're asking for 5
comment.
What are the pros and cons of the NRC 6
adopting those also?
7 DOCTOR MORRIS:
Well, the approach we're 8
taking here in my mind was taken to some extent to 9
avoid some of the resource implications of trying to 10 implement a very complicated policy that involves a 11 lot of issues that go beyond radiation safety, such as 12 the make-up of the board needs to include advocates 13 for different types of individuals who might be the 14 subject of research.
Many issues that seem new and i
l 15 complex for us would, if we tried to, essentially 16 adopt the policy through a rulemaking, for instance.
17 That would be part of the baggage that would come with 18 that.
So, to me, that seems to be one issue that has i
19 to be kept in line.
So, our approach has been to 20 avoid that extra work and effort when we' can have 21 confidence.
For the most part, the other federal 22 agencies are doing a responsible job in taking care of f
23 that.
.i 24 COMMISSIONER REMICK:
One of the 25 observations I had in reading that, I was wondering if i
-i 6
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26 1
you're asking for public comment.
Do you think in f
2 general the people who might provide comments will 3
understand what that federal policy is?
Eventually-4 the IRBs and so forth, but --
5 DOCTOR MORRIS: ~ Well, what we' re trying to.
6 gauge here to some extent is just where and under what t
7 circumstances research might be conducted that is not 8
currently under the federal policy.
If we learned 9
that for the most part we find that there are just 10 hardly any exceptions, we would wonder whether we need-11 to even bother.
We'd just rely on the federal policy i
12 completely.
So, that was one reason that we thought i
13 it would be worthwhile exploring that area.
14 COMMISSIONER ROGERS: How are you going to.
15 explore that?
How are you going to get the answer to 16 that question?
17 DOCTOR MORRIS:
Well, we're going to 9
18 assess the comments that come in.
But I 19 agree --
20 COMMISSIONER ROGERS: That isn't going to i
21 give you the answer to the question necessarily.
f 22 DOCTOR MORRIS:
I understand that we I
23 cannot be sure that those comments will be dispositive 24 as to whether there are exceptions and a number to be I
25
.placed on the institutions or clinics or hospitals.
1 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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1 27 I
which do research that don't fall under one or more of 2
those agencies' regulations.
3 COMMISSIONER ROGERS:
It's certainly 4
conceivable to me that there could be a significant 5
amount of research that's not federally funded at all, 6
wouldn't fall under those agencies that could use 7
byproduct materials in private hospitals or something 8
of this sort. Why should they respond to this and why 9
should they tell you that they would like to be under 10 the same federal policy? They'd just remain silent on 11 it.
Then you'd never even know that they exist.
12 MR. THOMPSON:
Well, we would know when 13 they existed because we'd have a requirement if they 14 wanted to conduct those activities, now to get a 15 specific license from us that would permit them to do 16 that.
So, they would either have to --
17 COMMISSIONER ROGERS:
Well, do they need 18 a specific license to do research?
l 19 MR. THOMPSON:
I think if they were using 20 humans involved in the research, we have a requirement
-l 21 that they get a specific license from us.
22 Is that right, John?
I i
23 COMMISSIONER ROGERS:
There is a special
)
24 license for -- I mean a licensee who already has a a
25
.icense but hasn't done any research now contemplates i
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'28 1
doing some research using human subjects has to get a
~
2 special license or a license amendment?
3 DOCTOR GLENN:
Well, they don't have to 4-get a special license, they would have to get a 5
license amendment --
6 COMMISSIONER ROGERS: A license amendment.
and it would be a 7
DOCTOR GLENN:
8 specific authorization on the license to do research.
i 9
COMMISSIONER ROGERS:
I see.
10 DOCTOR GLENN:
Currently that is a
11 condition that is on almost all of our broad scope 12 medical licenses.
13 COMMISSIONER ROGERS:
Excuse me.
I don't l
14 understand what you said.
15 DOCTOR GLENN:
Currently we have --
l 16 COMMISSIONER ROGERS: Is it on the license 17 explicitly now?
They have it but it says that they 18 have to apply?
l i
19 DOCTOR GLENN:
The authorized use as 20 specified on most of our license is a broad scope for 21 the large teaching institutions. It will say " medical
- {
i 22 diagnosis therapy and research on humans."
{
23 COMMISSIONER ROGERS:
So they've already 24 got it then?
j 25 DOCTOR GLENN:
The large teaching NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE N.W.
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j 29 l
1 institutions already have it.
2 COMMISSIONER ROGERS:
- Well, then your 3
answer to my question won't give you -- you won't get 4
any additional information from them on this federal 5
policy.
6 MR. TELFORD: However, we're saying in the 7
Federal Reaister notice that these are the conditions I
8 under which we would allow all licensees, in 9
particularly the licensees that Doctor Glenn are 10 talking about, the ones that we call the specific 11 licensee.
This is the notice to them that these are 12 the conditions under which we would allow research and f
13 we're asking the question, "If you are not federally 14 funded, et cetera, and don't fall under the policy, 15 please let us know that you're outside of that area 16 and you would like - "
f 17 COMMISSIONER ROGERS:
That would be a 18 specific requirement that they do it?
{
19 MR. TELFORD:
That's a specific question 20 in the FRN currently, which is to try to gauge the j
21 amount of activity that's outside of the sphere that
[
22 we're creating.
]
23 COMMISSIONER ROGERS: Okay. But you still l
5 t
24 don't have any way of knowing how responsive those 25 people will be to that request.
~
.f NEAL H. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 2344433 WASHINGTON D C. 20005 (202) 234-4433 i
I 30 1
MR. TELFORD:
Well, that's true except 2
that we're going to give a copy to all the licensees 3
and if they anticipate doing research -- if I were a 4
licensee and I anticipated doing research in the 5
future, I would certainly speak up.
Of course there's 6
no guarantee that they would have to, but --
7 COMMISSIONER ROGERS:
Or if they're 7
8 already doing it but don't fall under any federal 9
guidelines or federal support.
10 MR. BERNERO:
But this would be a new 11 constraint on them.
This would be a notice by the i
12 Commission that there would be a new constraint or set
~
13 of constraints.
If they would want to avert those l
l 14 constraints, they'd have to comment.
15 COMMISSIONER ROGERS:
Okay.
16 COMMISSIONER REMICK:
My guess is -- one 17 time I had responsibility for implementing that and if 18 I recall I think it applies to institutions ~ that 19 accept any kind of federal funds It does not have to i
20 be federal funds for that specific research.
But if i
21 you accept a dollar here, you're obligated. The drug-22 free work place was like that and I think the human i
23 subjects was also.
So, the chances are that almost J
24 any institution would receive some federal funds, that i
25 presumably be -- but what I was worried about is if l
l NEAL R. GROSS i
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what you have in the document is clear enough for 2
people to make comment. It seems like you're assuming 3
that everybody would know what that federal policy is.
4 You outline it very briefly, but I don't know if you j
5 even give them a federal register reference to track i
6 it down.
i 7
MR. THOMPSON:
We can certainly modify -
l 8
this to be much more specific than the previous i
9 Federal Reaister notice and we'll be glad to do that.
l f
10 DOCTOR MORRIS:
(Slide)
I think we can 11 move on now to the issue of compatibility on page 12 12 of the handout.
13 Currently most provisions of Part 35 are-14 Division 3 items of compatibility.
The agreement j
15 states have expressed their view that these amendments f
16 not be a matter of compatibility or in any case the l
17 lowest level of compatibility possible, Division 3.
18 We based our proposal to you on the current criteria 19 for compatibility determinations used by the Office of 20 State Programs and our judgment about how to interpret-.
21 that policy.
We understand that this compatibility i
22 policy is currently under review and could change, but 23 this is the current practice.
24 The staff believes that definitions, as 25 according to that policy, which are the basic mode and i
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32 1
the basis for effective-communication between 2
regulated agencies and the regulated community should 3
be Division 1 and that certain new provisions, which 4
in this case are those that address basic principles 5
of radiation safety, should be Division 2 items of 6
compatibility.
That's the way we've sorted this out.
7 For example, manufacturer and preparation I
8 of transfer of byproduct material, drugs, provisions 9
for research, radiation safety committee provisions, 10 supervision, possession, use, calibration of dose f
11 calibrators, possession, use and calibration of i
12 instruments to measure doses, measurement of doses, 13 training of physician authorized user and authorized 14 user nuclear pharmacist, and their recentness of 15 training are all under the umbrella in our proposal l
16 for Division 2 compatibility at this time.
17 CHAIRMAN SELIN:
Could you
- please, r
18 Commissioner Curtiss.
19 COMMISSIONER CURTISS:
You may have the 20 same question I do.
?
21 CHAIRMAN SELIN:
We'll see if I get the 22 same answer.
23 COMMISSIONER CURTISS:
Maybe we'll ask it
.j 24 twice.
i t
25 I guess at least at this point there's not NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N.W.
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a meeting of the minds. on the. question of how how ' these provisions 2
compatibility ought to be 3
ought to be. treated in the context of compatibility.
4 4
Do you attribute the states' position to a
1 5
disagreement or lack of understanding on the substance 6
of what' you're proposing here or is it attributed more i
7 generally just to the state's desire to have as much 8
flexibility as possible?
Why is it that we seem to 9
have on their behalf such a strong consensus that 10 these not be matters of compatibility and on our 11 behalf a different view?
12 DOCTOR GLENN:
Let me answer --
13 DOCTOR MORRIS:
Because I was not at the 14 meeting, John.
Go ahead, f
15 DOCTOR GLENN:
I was going to refer to the 16 specific meeting we had in Atlanta last summer where 17 we did discuss the issue of compatibility with the 1
18 agreement states and where they did express their 19 strong preference that it be as low a level ~ of 20 compatibility as possible.
I think one thing that 21 they were very clear about is they didn't.necessarily 22 disagree with where we wanted to end.up, but they-23 didn't like us specifying how they got there.
i
~
24 There was a considerable amount of comment 25 that they would prefer to accomplish the same end NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N.W.
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34 1
through license conditions, through licensing guidance 2
rather than through regulations.
They also impressed 3
upon us the difficulty they have in getting their 4
regulations changed and to get them to come into full 5
compatibility with our regulations.
6 So, to a large degree, the discussion was 7
on practical -- how hard it was for them to come into 8
the level of compatibility that we might request.
9 MR. THOMPSON:
That's my understanding.
10 I wasn't at the meeting, but clearly some states have 11 to go to the legislation to get new regulations in 12 place and it's a very long and complicated process.
13 They may prefer to just each new license come in, 14 place those conditions on the license and achieve the i
15 same level of " protection" that you would through our.
16 regulation.
It kind of leaves you with a bit of 17 uneasiness in knowing precisely.that the state has i
L 18 every license with this same amount of regulatory 19 oversight that you would if they had regulations that 1
20 covered all of their licensees.
21 COMMISSIONER CURTISS:
I guess I'm 22 generally comfortable with this approach as a starting 1
23 point.
It would.be useful, as I'm sure you will, to 24 solicit comment and continue to interact with the 25 states for the purpose of determining whether there NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N.W.
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35.
1 are approaches that can be taken that will achieve the 2
same health and safety objective that we're desiring 3
here without, on our side, unduly straining resources 4
to evaluate all those individual approaches as well as 5
on their side not requiring them to undertake an i
6 approach that may be difficult in terms of legislative 7
enactment of new regulations or unduly strain already 8
limited resources in some of these states and perhaps 9
with an eye on what the objective here is from the 10 health and safety standpoint, see if we can't reach i
11 some consensus or meeting of the minds here on tho 12 state compatibility question.
13 MR. TELFORD: I would like to emphasize in 14 response to your first question that we did spend the 15 better part of a day discussing this rale language.
16 So, I'm sure that they understand exactly what we want 17 to achieve.
18 COMMISSIONER CURTISS:
Okay.
19 MR. TELFORD:
And as Doctor Glenn said, 20 depending upon the state, there are different ways.
21 that the state would like to achieve compatibility.
22 And perhaps that might rest in how the Commission 23 would define how the states can achieve compatibility.
24 Some states will simply adopt our regulations verbatim l
25 because they have small staffs and they don't want to NEAL R. GROSS t
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36 b
1 do anything else.
Other states will want to have an f
2 umbrella type of regulation, as Doctor Glenn was 3
saying, that's a very broad thing, like he shall have i
4 4
procedures and practices which bring about radiation 5
safety and then basically exercise that through the 6
licensing conditions or regulatory guides.
Other 7
states will want to write their own regulations and go 8
through their own process.
But it seems to me that 9
it's more of a Commission decision as to how you will 10 allow the states to achieve compatibility.
9 i
11 At this point the staff would have to say, 12 "Given the current guideline, this is what we i
-r 13 propose."
f 14 COMMISSIONER CURTISS:
I think it's an
. i-15 appropriate starting point.
16 MR. THOMPSON:
And we are going to be 17 working on the compatibility issue with agreement 18 states.
l 19 CHAIRMAN SELIN:
That's a key point.
I l
20 did have the t ime question as Commissioner Curtiss, yhrase it to see if'I get the same 21 but I won't i
22 answer.
I was impressed with the answer because it f
23 was neither of the two alternatives.
It wasn't a 24-substantive disagreement and it wasn't just a knee-
[
25 jerk reaction that says less is better and more is l
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37 i
1.
worse, but some specific problem.
-i 2
Before I comment on that, I'd like to ask i
3 you a question, Mr. Thompson.
What is the generic 4
situation when we require something to be Division 1 l
l 5
compatibility? What happens if the state doesn't get 6
the legislation through their legislature or what have 7
you?
They could be in --
l l
8 MR. THOMPSON: First they have a period of 9
time for which they are allowed to get their j
10 regulations in.
Aftar
- that, when we do our l
11 evaluations, we do not find their regulations i
12 compatible and we will basically meet with them and l
P i
13 understand their plans to go about achieving that i
14 level of compatibility.
If it continues, we will I
15 elevate within the state governmental organization the 16 concern that the Commission has and eventually it 17 would come up to you.
18 CHAIRMAN SELIN:
In that event, I would i
19 like to follow up on our comment, Mr. Thompson.
The 20 question of whether this is Division 1 compatibility 21 or not is no different here from many other areas.
22 It's a subject that's being discussed in the general-23 consideration of compatibility that the staff and the i
24 Commission are discussing.
So, I personally would r
25 suggest that you consider 'some kind of language in the l
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i 38 I
statement of considerations or the introduction that 2
says -- I mean this is just a suggestion. You have to t
3 decide this.
The Commission might decide that it's 4
not a good idea, but that somehow you just make it 5
clear that by the draft rule requiring that this be 6
Division 1,
what we intend is, number one, we hope 7
that you the staff will have an answer on i
8 compatibility in general before the rule goes final, 1
i 9
and that of course would be reflected in the rule.
i 10 And the second, that this does not mean that the staff 11 has disregarded the agreement states' discussion that, e
12 in fact, both in the specific case and the generic 13 case of different ways of achieving the same r
I 14 objectives that you'd be open to comment from the 15 states on how the substantive compatibility be 16 achieved. I personally don't feel comfortable at this 17 point in effect rejecting the states' arguments and I
t 18 saying that's done because that's an issue that's 19 generally before us, but neither would I like to hold l
20 up the publication of the rule in order for the 21 Commission to answer what is a thorny question.
It's I
22 not such a difficult question, it's just go so many 23 different special cases that we have to make sure that 24 we carry it out in a way that we intend to.
25 MR. THOMPSON: Well, as you might remember NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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from the Commission's regulations they put in place l
2 after the Riverside misadministration, we did not make 3
that amount of compatibility.
Some states actually t
4 imposed or adopted regulations very similar to ours 5
and others --
6 CHAIRMAN SELIN:
But this is different.
7 You really feel strongly, and as far as I can see 8
you're probably right, that one way or another the 9
states need to have the functional equivalent of f
10 Division 1 compatibility.
but as they point out, in 11 many cases just flat out saying it that way causes f
i 12 them some problems and on a general basis we're trying 13 to see if there are other ways of achieving this 14 compatibility.
So, I personally don't want to hold
(
15 you up and I don't want to second guess for now that 1
i 16 these are issues that require the equivalent of 17 Division 1 or Division 2 compatibility as appropriate, 18 but nor do I want to go out with a message that says 19 to the states, "We've considered your arguments and we 20 have definitively rejected them."
l 21 So, if you can fudge on that, if you-can
'22 leave the option open --
23 MR. THOMPSON:
We will certainly explain 24 the circumstances in the statement of consideration.
25 MR. MALSCH:
Mr. Chairman, I just want to E
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add something to what Mr. Telford said, which makes 1
2 this an especially sensitive compatibility issue.
3 That is if you literally made every word and phrase of l
4 the regulation a matter of strict compatibility t
5 Division 1, the effect would be that states would be 6
forced to issue general licenses where they would 7
prefer to issue licenses on a case specific basis and 8
that could be a sensitive issue for agreement states.
i 9
CHAIRMAN SELIN:
I sort of lost track, i
10 Doctor Morris.
Have you finished your presentation?
i 11 DOCTOR MORRIS:
Well, I just wanted to 12 just summarize and bring us back to the point that you j
i 13 had addressed earlier.
We believe that with the 14 promulgation of these amendments the NRC regulations 15 would no longer include unnecessary restrictions on 16 the use of byproduct material which might limit 17 physicians and pharmacists in using their knowledge 18 and skills and treatment of patients or in conducting 19 research to develop new techniques or knowledge to i
20 improve treatment.
[
21 The new provisions for calibration of 22 instruments and for measurement of doses, for training t
23 and experience for personnel involved in the 24 preparation of drugs containing byproduct material and 25 the proposals for safe conduct of research on human I
NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N.W.
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41 f
i i
subjects we believe will assure that the adequate
{
2 level of protection will continue.
I think that l
3 addresses a key question that was raised earlier and 4
those are the kinds of things, those radiation safety 5
requirements, that we've put in here we believe buy 6
that assurance.
e 7
COMMISSIONER REMICK:
Those are the j
8 additional safeguards you refer to?
You have a 9
statement in there that there are some restrictions 10 being
- relieved, but you feel they're additional i
11 safeguards.
Are those the ones you had in mind?
l i
12 DOCTOR MORRIS:
Yes.
Yes.
Training 13 requirements, calibration requirements, protecti'on of
{
14 human subjects, those kinds of things.
15 CHAIRMAN SELIN:
Commissioner Rogers?
16 DOCTOR MORRIS:
That's all.
17 COMMISSIONER ROGERS: In looking over your -
t i
18 Table 1 in the SECY, the summary of the comparison 19 between the petition requests and our. response, I 20 notice that in three of the items the term used is 21 greater discretion in each of our responses.
That 22 really doesn't say very much by itself.
A very small 23 amount of additional discretion is greater discretion.
24 A wide degree of discretion is greater discretion.
25 There's a fuzziness there that I really couldn't get i
i NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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}
42 1
very much from.
So, I looked to see how you dealt r
2 with, in particular, Section 35.100 compared to the 3
petition.
I must say I didn't understand -- I saw 4
differences in the wording and I couldn't tell whether s
5 there was a substantive difference here or not or 6
whether this was a rewriting of the language of the 7
petition, but basically adopting it, or whether there 8
was something else.
It seemed to me that there was a 9
difference, a significant difference in the wording i
10 proposed in the petition for that text and what the 11 proposed rule has.
12 I wonder if you could say something about i
13 that.
Do you -- what is your view?
Were there 14 significant differences in your thinking between what L
15 you saw emerging from the requests in the petition and l
16 what you felt was appropriate language in the new 17 rule, or was this really just simply a different way 18 of expressing the same thing using somewhat different i
s 19 terms?
20 I saw it in this particular case as 21 perhaps something substantially different.
I wonder i
22 if you could respond to that.
23 DOCTOR GLENN:
Okay.
My view is that we,
~2 4 in fact, granted what the petitioners requested.
But 25 the wording that we ended up with was a
very i
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43 I
t 1
evolutionary process.
We received quite a bit of i
2 criticism the first time around when we attempted to j
i 3
draft language where we essentially said what was and i
l 4
what was not permitted.
I will give credit to the f
t f
5 agreement states that at the Atlanta meeting they are t
6 the ones who opened our eyes to the particular 7
approach that we used here, which was to avoid using 8
FDA terms in order to say what could or could not'be 9
done, but to say, "You may use byproduct material 10 without any excuse from any other pharmacy or FDA 11 regulation, but with certain additional radiation l
12 safety standards applied over the existing regulatory
[
13 scheme."
So, out of that meeting I think is where the 14 approach that you see here developed.
So, there is a t
i 15 change in the way we approach the task.
I think the 16 end result though is very responsive to the petition.
17 CHAIRMAN SELIN: Do I hear you saying that 18 it wasn't the pride of authorship, your language has 19 evolved from a process whereby each change in this l
)
20 case away from the petition was to carry out some i
i 21 specific objective and that would seem to you to be --
)
22 DOCTOR GLENN:
That's correct.
As we 23 tried things out, we got input from the different T
24 groups about what was good or bad about what we were 25 doing and this was the end of that evolutionary I
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44 i
1 process.
2 COMMISSIONER ROGERS:
Well, I was trying
[
3 to understand what this greater discretion meant l
t 4
really and just tried to pick one example to see and 5
I ran into a little bit of difficulty.
I don't want l
6 to prolong this unduly, but the petition on page 10 7
had certain language and in the rule on page 60, the 8
- notice, I
- guess, on page 67, the same section 9
addresses this issue.
In the petition, the wording 10
- was, "A
1.,2nsee may use for medical use," and it 11 seems to me that's a statement by itself right there, 12 "any byproduct material in a radiopharmaceutical and 13 for a diagnostic use involving measurerents of uptake, 1
14 dilution or excretion in which," and then there are r
15 certain things. The proposed language here is simply, 16 "A licensee may use for uptake, dilution or excretion 17 studies any unsealed byproduct material prepared for l
18 medical use that is either," and then there are 19 certain conditions.
20 It seems to me there's a big difference 21 between those two statements because the one in the 22 petition says a licensee may use for medical use.
It-23 doesn't say what that medical use is, and then gives l
24 an example of uptake, dilution or excretion, whereas 25 your statement just simply says a licensee may use for t
NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE tSLAND AVENUE, N W.
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45 1-uptake, dilution or excretion studies.
So, their 2
- language, it would seem to me, was much broader 3
because there was, in a sense, any medical use but in 4
particular and for a
diagnostic use involving 5
measurements of uptake, dilution or excretion.
So, 6
you see, I would see a very big difference between 7
thcL_ two, the application of those two sections.
I 8
was wondering whether that was in your mind or whether 9
that's just the way it came out or whether that was 10 the intent.
11 DOCTOR GLENN:
I think if you look at the 12 existing setup of Part 35, you will in fact see that 13 the 100, 200, 300 sections in their titles include 14 those terms which we have maintained herc.
So, there 15 was not an attempt to, I think, 'L.t the uses.
We 16 think we provided for more discretion in the kinds of 17 uses that were already being permitted in --
18 COMMISSIONER ROGERS:
Well, I may have 19 just picked, you know, one part of it to focus on.
My 20 question is really what the greater discretion really 21 amounts to in each of those cases.
Perhaps it would 22 be easier if you could spell that out in each of those 23 three responses where you've indicated greater 24 discretion has been afforded exactly what that greater j
25 discretion is.
NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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I 46 1
'MR. - BERNERO:
If I could volunteer an 2
opinion here, I think we're saying greater discretion 3
than past permitted practice rather than greater f
l 4
discretion than requested by the user or by the i
5 petitioners.
In pages 34 and 35 of the discussion of 6
the regulation, on 35.100, we tried to make the point
,i I
7 of how to achieve the objective requested and achieve 8
it to give the discretion for the use of unsealed 9
material and avoiding the word " pharmaceutical."
f 10 CHAIRMAN SELIN: Let me make a suggestion.
i 11 There are three specific instances that Commissioner 12 Rogers has brought up.
There's no obligation that we 13 should take the petition language and start with that, j
14 but it would be useful.
I perhaps might suggest that 15 if you would in each of those cases prepare a note j
16 that suggests either what you read is the difference 17 between the petition language and what you're 18 proposing to grant or a reason that you didn't follow 19 petition language.
In this case I gather you're 20 saying that your recommended language is closer to the l
21 structure of Part 35 than the petition language and i
22 there's no reason to get out of the structure.
So, if 23 it's something like that, that would be --
24 COMMISSIONER ROGERS:
I was just looking i
25 to see whether here was something in the minds of the_
i NEAL R. GROSS COURT REPORTERS AND TRANSCRIDERS 1323 RHODE ISLAND AVENUE, N W.
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47-1 petitioners that they were requesting that you address 2
that you decided you would not address and something 3
that you decided you would address, and just to get 4
that clear so that we understand how far we've gone 5
and maybe no further than somebody else requested, but 6
where we stop short of that.
I would be helpful,.I 7
think.
So, I'd appreciate very much your responding 8
as the Chairman suggested.
9 The other point that troubled me a little 10 bit as the use of the word " patient" as a subject in 11 research.
I can understand why you did it, because it 12 just sweeps the regulations right over that and you 13 don't have to worry about it anymore.
But I don't 14 know, I don't really like applying terms that aren't 15 exactly the common term and a subject of research is 16 not necessarily a patient.
It might be, it might not 17 be.
18 DOCTOR MORRIS: Yes. I could mention that 19 we stand prepared if that is a problem to change it.
20 We would, ist use patient and human subject everywhere 21 that patient now occurs pretty much is what we would 22 have to do if we took that step.
23 COMMISSIONER ROGERS:
Yes.
Okay.
24 DOCTOR MORRIS:
So, it we; just a device 25 and we could chant it.
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COMMISSIONER ROGERS:
I think it's just a 2
little too much of a corner cut.
3 DOCTOR GLENN:
We anticipated some 4
criticism for that.
We did check it out with Doctor 5
Seigel who is chairman of the committee.
At first he l
6 had the same reservations.
He - did come around 7
eventually to saying he thought it might be a very 8
useful mechanism in this particular case.
f 9
COMMISSIONER ROGERS:
Okay.
That's all I 10 have.
11 CHAIRMAN SELIN:
Commissioner Curtiss?
.t 12 COMMISSIONER CURTISS:
No questions.
I 13 CHAIRMAN SELIN:
Commissioner Remick?
l 14 COMMISSIONER REMICK:
On page 1 of the 15 SECY document, the footnote I thought was kind of r
16 interesting. Are we setting people up for litigation?
17 We say that we're now permitting people to digress 18 from the package inserts, but we innediately point out i
19 that some people have been taken to court --
20 MR. MALSCH:
It's quite possible that 21 licensees operating under these regulations would be 22 violating FDA requirements. That's the effect in some 23 cases of eliminating restrictions currently in the 24 regulations.
25 Now, in most cases, that's probably not NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N.W.
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1 49 1
going to be the case because the FDA would have no 2
jurisdiction.
But in cases where the FDA would have 4
3 jurisdiction, then we would be authorizing something 4
which the FDA would be prohibiting.
That's why it's 5
necessary to have something that says, "This doesn't 6
relieve you from those other requirements."
7 CHAIRMAN SELIN:
Is that answering 8
Commissioner Remick's question about the footnote?
9 MR. MALSCH:
The footnote points out 10 that --
11 CHAIRMAN SELIN:
People have ignored the 12 inserts and gotten zapped.
I 13 MR. MALSCH:
In general, the FDA has no 14 jurisdiction to force physicians treating patients to 15 follow the package inserts.
16 CHAIRMAN SELIN:
Right.
17 MR. MALSCH:
So, they ordinarily don't 18 have jurisdiction directly over the practice of 19 medicine as such. They wouldn't exercise jurisdiction 20 there.
But in some cases where physicians have gone 21 beyond just the practice of medicine, and for example 22 advertise a certain product for a use not approved by 23 the FDA or engaged in some sort of interstate commerce 24 in the product, then they have been prosecuted not for 25 practicing medicine, but for engaging in an activity NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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'50 1
. subject to FDA jurisdiction.
Now, those cases are 2
kind of unusual and I think that's all the footnote 3
was pointing out.
4 COMMISSIONER ROGERS:
- Well, it says 5
though, "Due to certain practices in which drugs were 6
not prepared or used in accordance with the package 7
insert."
8 MR.
MALSCH:
Right.
The emphasis on 9
practices, and the practices would normally involve 10 not just preparing or using in accordance with the 11
- insert, but something
- else, like advertising or 12 distribution of interstate commerce or something else.
13 It's usually, as a general rule, merely using not in 14 accordance with the insert would not violate any FDA 15 requirement.
16 In fact, that's why our provisions that 17 we're now eliminating from the regulations actually 18 had a substantial impact on our licensees because they 19 would otherwise be authorized to depart from package 20 insert instructions.
It was only the NRC at the 21 federal level which was prohibiting them from doing That's why this whole regulation relaxation is so 22 so.
23 meaningful.
24 COMMISSIONER REMICK: Well, if you hadn't 25 explained it, Marty, I'm not sure I would have read NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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51 1
into certain practices what you just told me it means.
2 I'm not sure others would either.
3 MR. MALSCH:
It is a little vague.
l 4
COMMISSIONER REMICK: One other question.
5 The staff certainly feels, I think, that this is the 6
right way to go.
At least that's the impression one l
l 7
gets from the presentation.
Are there any downsides
[
i 8
that we should know of of the proposed rule of the 9
potential downsides, if there are --
10 MR. MALSCH:
I'll identify a downside and 11 it's the policy issue.
That is generally whether our 12 relaxation is here, what you are doing is replacing a i
13 requirement for case specific licensing with a general j
14 license.
So, as with any general license, you're 15 removing from yourself the discretion to do case by 16 case reviews.
So, outliers might be missed.
17 COMMISSIONER REMICK:
I see.
Okay.
Any 18 others come to mind?
19 CHAIRMAN SELIN:
- Well, you already 1
20 identified the fact that this might put some of the 21 agreement states into a bind unintendedly.
22 MR.
BERNERO:
Yes.
Certainly the j
23 implementation of it there.
That's a very real difficulty with the agreement states.
But as was 24 25 discussed a little while ago, that is a characteristic j
NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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53' 1
difficulty not unique to this rulemaking.
The 2
- administrative burden of implementing a consistent 3
national program is a generic' problem.
4 COMMISSIONER REMICK:-
Thank you.
i 5
CHAIRMAN SELIN:
Commissioner de Planque?
1 6
COMMISSIONER de PLANQUE:
No further 7
questions.
i
)
8 CHAIRMAN SELIN:
Okay.
I'd like-to thank 9
you on behalf of the Commission for really quite'a 10 lucid discussion of a complex issue.
It seems pretty r
11 clear that there's no very strong opposition to going 12 forth with the statement.
But as you listen to the 13 different Commissioners, we have some reservations and 14 we would like to make sure that one way or another 15 these reservations are reflected in the material to 16 say that in some of these cases the fact that the 17 Commission is permitted -- but assuming the Commission 18 permits the publication, that this doesn't mean that i
19 we consider these closed issues.
i 20 MR. THOMPSON:
I understand.
I i
21 CHAIRMAN SELIN:
We understand that I
i 22 there's a comment period from here on in, that the i
I 23 petition does not replace the comment period on the 24 proposed rule and we want to make sure that that's y
F 25 clear in the instructions.
L NEAL R. GROSS i
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1323 RHODE ISLAND AVENUE, N.W.
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l 53 1
'Okay.
Thank you very much.
2 MR. THOMPSON:
Thank you, Mr. Chairman.
3 (Whereupon, at 3:04 p.m.,
the above-4 entitled matter was concluded.)
~
5 6
7 8
9 10 11 12 13 14 15 16 17 18 19 20 21 22 L-23 24 25 1.
NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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l-1
'I I
l CERTIFICATE OF TRANSCRIBEF.
This is to certify that the attached events of a meeting i
t of the United States Nuclear Regulatory Commission entitled:
i TITLE OF MEETING: BRIEFING ON PROPOSED RULEMAKING FOR PREPARATION j
AND USE OF RAD 10 PHARMACEUTICALS j
PLACE OF MEETING: ROCKVILLE, MARYLAND L
r DATE OF MEETING:
MARCH 9, 1993 l
-r were transcribed by me. I further certify that said transcription f
is accurate and complete, to the best of my ability, and that the-transcript is a true and accurate record of the foregoing events.
t 1
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Reporter's name:
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BILL M. M0nnIs PHONE:~
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F OUTLINE OF PRESENTATION e
PETITION SUBMITTED BY ACNP AND SNM e
NRC MEDICAL USE POLICY PARTICIPATION OF OUTSIDE GROUPS e
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'.' ~ 1880 CARBON 01 M ET e TomaANCE., CAUF0WeA OMOD "
~
r Hugh L. Thompson, Jr.
Deputy Executive Director for Nuclear ~ Materials, Safety, Safeguards
.and Operation Support j
U.S. Nuclear. Regulatory Commission
?
Washington,.DC 20555
Dear Mr. Thompson:
This letter is-written as a member of thh general p6Niic, and not as a member of NRC's Advisory, Committee.'on Medicaly0ses of l
Isotopes.
i I wish to comment on NRC's 2 Mar. 91 documents pai taining to.
Proposed Amendments on Preparation,, Transfer, and Use;of:
l Byproduct Material for Medical Use,.Secy-93-050.- ~The.? documents-are flawed and should not.be publishedliN.their presently inaccurate state.
Doing'so would befdangerous to'NRC,(as-it; would appear from these. documents that.:NRC:is permitting hazardous behavier to go unchecked.
~-
These documents refer to the ' CNP/SNM Petition of June, 1989.
A However, the. reason for,the ACNP/SNM, Petition;was;not,;.as stated
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by NRC,.to " provide greater. flexibilityM.;f The reason:~for the 3
Petition'was that NRC regulations;and license, conditions-had i
become. incompatible with State: Medicineiand ~ Pharmacy" Law, and
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were incompatible with the efficient:?and. effective:l delivery.of '
healthcare services by.professionalfpractitioners 6C nuclear medicine and' nucle'ar pharmacy.c'These.professionarsi: vers being i
forced by NRC to;subje'ct pati unnecessary costs,, and.. danger,ents-to unnecessary - risk;s' -
l ous. alternatejprocedures.- In some cases, potentially life-saving therapy. Wasi.being ' denied.:
Professionals were jeopardizing their. ability'torpractice their-profession in order to act'in.the bestiinterest's of;their patients.
NRC had loomed:as.a bigger danger to patients and
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profassionals,than the radioactiive-. material (being regulated...
Clearly, this:was_~a' remarkable aberration ~.of regulatory. behavior i
that required-immediate corrective actionfon.NRC's}:part..
The rest of the Commission document ih isleading.~in terms-of l
vhat we'" asked'for",. what the(ImmediatelyiEffactive?.' Interim Final'-
Rule "gives";us (actually, essentially nothing), ' and What this l
Proposed Rule "gives" us.
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Dee's of QoDIOLOGY
,.$J P.oD 21DStoO5oo.
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March 8, 1993
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Eugh Thompson, Jr.
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The most important failing in'.this.docuiment,.and i.n$the Fedaral t
Register notice as well, is,that NRC.cpapletely'aiss%di.the. major point of the Petition..
Once.a physidian.isl,licens,edito/ practice
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nuclear medicine, he must be free to.use.3everything.he.knows or can learn to. help his' patient.- ' The-saa' fisc,true. gor.l nuclear e
pharmacists.-..If NRC is licensihp physicians wholar6;really not capable of intelligently handling. byproduct. inater.ialiand'.not intelligently' directi.ng. and ' managing itsLuses, then}NRCl1s. guilty of criminal negligence, having.'not fulfill'ed itsirasponsibility to the public.
If NRC. licenses.1a physician::(ori a. pharmacist) and then restricts him from using his,bestOjudgment',Khe71s' essentially an " impaired physician",;-land? bis pa,tiantsjare at risk.
Patients do not'do well.if their/ physician 4.has[had.a
" regulatory. lobotomy".
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- e If you do not understand this,4 let:me try.a~militaryennalogy.
Let us assume that a group of Marines'ips. undergoing" basic training, and some of them misn'a' lot o'fjtarget practice"for some reason or other.
Nevertheless,, tha' platoon 'lateriliarids cn a hostile beach to fight an' enemy.
At theilast!ainute'.xthe platoon 1cader takes.the guns'avay from the. guys.'who mi~sseditarget' l
practice, but expects them to fight anywayL Now,.ithef. leader could presumably have required extra, target practice.-and-refused to let them join their platoon at that time.
Howe'ver,;fonce thev I
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hit the beach. they need'a'cun. 'NRCJis'bahaving-like:.this foolish platoon leader.
The other,.really malevolent thing about'.this document is that in deciding which nuclear physicians:an'd.whigh'pucleir pharmacists l
Will be permitted to practice:their.professionfaccording to state
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Law, "NRC can consider 'an 1ndividual's!ch'aracter in(addition to credentials in determining-whether.th'e:. individual /ihould be approved as an authorized. user.or! authorized nuclear'. pharmacist, such as verifying that the ' individual has-hot. committed.'or caused others to commit _any willfulo violations?ofitbe commissions regulations".
This is a " Catch-22"g Every nuclea'rrphysician and nuclear pharmacist worth his salt has, Willfully ~ violated HRC's regulations in order to providetapproprir,te-services and. patient That is whv we wrote the Petition!.;Indeedi;.NRC.-1s actually care.
encouraging physicians to violate.the Interin Fina19 Rule by removing the recordke'eping.requirementy 711would-argue that not a single legitimate package. insert 1 departure.is:parmitted according to the dastardly definition inc.that, Rule,.which wasl.naver made available for.public comment beforehand,E,and was'not changed i
despite the requests of SNM and ACNP.-
There are.other: problems with this Proposed _ Rule, such.as the fact that a byproduct drug is presently. going through=rnA review
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Dep's of QADIoLoGY 2136100500 p,c4
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March 8, 1993 Hugh Thompson, Jr.
Page as a device, and the manuf acturer! vill;most. likely; bE. listed as a device manufacturer, not a cruc manufacturer.
Your Proposed Rule, which did not pay. attention to the. Petit' ion',Dwill cause a problem here.
NRC also does not understand. the ' Federal. Policy for the Protection of-Human Subjects,'and I:cannot'coilcur.with the concept of considering," human., subjects" (for'reseirch_
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purposes):as." patients" jseparate: laws'.and/ considerations apply to then.
This is an,inadvisablepregulatorff" convenience? that is a set-up for. trouble with things:Jihe;procedura manuals.and the so-called " Quality Management" Prograp.) "There are," problems with labeling, 'something NRC should avoid corpJetely andjle' ave:in the co=petent hands of others wuch as FDAi andjBoards Jof? Pharmacy.
NRC is overly prescriptive-with'"timaland date" of.3 dose.
calibration.
If NRC left it -tol professional: judgment,{ it would be done right.
Indeed, NRC has neverJshovnethattthere~was any need for a regulation here.at'al.1. Whensit comaarto C.14,'I do not care about the time, date, weak, conth, year,4or decade.
The nearest century will do just fine ~.
Some items in the Federal Register. notice are not oply< wrong, but dangerous.
The Petition never asked tha@ wa # compound;~
radiopharmaceuticals whose manufacture-and distribution are not regulated by the Stata or FDA".
I.canft?think~ofianything nqt regulated by the State Board ofjMedicine,' the State: Board of Pharmacy, the State FDA, or. the'. Federalj FDA.'
The problem.is that I believe this document is a " set up"..
.I';11' bet it is(alreadv in the hands of the Cleveland Plain Dealeri.all. ready-for~an
" expose" as ugly as the last.- However,cyourvill.havei.no defense, because your defense is that you made' untrue: statements in the Federal Reaister, and you can never admitf.to.that.-
Think about the following f acts. - Why did an.NRC inforner lie to the Plain Dealer abou,t the writing.of[this.Petitio of the reporters bragging that-he.has an.uncensoren?; Jmy is one d^ version of the I-G report on McElroy.andLthis Petit' ion?. (Thisfis a1 security violation that calls for an FBI investigation;).
.1This Petition had nothing to do with the Plain De.aler article s.. lgj;. The reporter argues that he has nothing1against; medicine,ibut is presenting the views of an employee of..NRC who feels.that NRC is dangerously lax.
Then, NRC publishes.naterial suggesting that NRC is perfectly happy to let physicians farid pharmacists do dangerous things.
The connection is. obvious.
I'll.. bet.the Plain Dealer even has old FDA letters' relating;to.the: Interim' Final Rule and Syncor's lawsuit..~This is. going:to be.very unfortunate.
Print this material in the Federal Register,.'and'the Rule is
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going to become politically difficult..to sustain.
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Doc's of ncD20s.ocY 21sotoocco p,og March 8, 1993 Hugh Thompson, Jr.
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t Therefore. T'urce you nest stronalv,lo cancel cubitcation of this natorial.
Please correct It. and think of it as a tress release to the Plain Dealer as you do so..
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Sincerely, Carol S. Marcus, Ph.D., M.D.
Director, Nuclear Med. Outpt. Clinic, and 1
Assoc. Prof. of Radiological Sciences UCLA CSM:sfd i
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