ML20006B578
| ML20006B578 | |
| Person / Time | |
|---|---|
| Issue date: | 01/16/1990 |
| From: | Rathbun D NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA) |
| To: | Stump B HOUSE OF REP. |
| References | |
| RULE-PRM-35-9 CCS, NUDOCS 9002050095 | |
| Download: ML20006B578 (2) | |
Text
{{#Wiki_filter:...-. 4. /y 1 as 1 p Cao ' (". NUCLEAR REGULATORY COMMISSION UNITED STATES . * ?, ' f . wasmwoTow. u. c. noses \\*...*/ January 16.1990 q 4 1 The Honorable Bob. Stump Member, United States House of s i Representatives. 5001 Federal Building l Phoenix, Arizona 85025
Dear. Congressman Stump:
1 This is to acknowledge receipt of your letter dated January 2,1990, transmitting correspondence from your constituents, Mr. James J. Burnis o and Dr. Richard J. Peterson,- in support of a_ petition for rulemaking to L revise 10.CFR 35 Regulations. I l The petition for rulemaking was submitted to the Nuclear-Regulatory Comission-(NRC) by the American College of-Nuclear Physicians and the-Society of Nuclear Medicine. The petitioners requested thatlthe:NRC modify current regulations to allow: (a) the use of radiopharmaceuticals' for therapeutic indications not listed in the package insert-(diagnostic indications are not restricted by current regulations),L(b) deviations from the manufacturer's instructions in preparing radiopharmaceuticals', and (c) compounding radiopharmaceuticals from reagent chemicals.- t The NRC-published a Federal' Register notice:(54 FR 38239, September 15, 1989), announcing receipt of the petition and providing a 90-day public comment period. We have received more.than 400 coment letters. 'In light of the information submitted by the petitioners and the -l commenters, the NRC is currently reexamining its regulations governing the use of radiopharmaceuticals in nuclear medicine. -The issues raised will. i be addressed in-a rulemaking. proceeding.specifically designed to resolve the petition. During this rulemaking process, the NRC will. consult with Administration, which approves the package inserts ~ and. theFoodandDru[sinstructions,andtheStateBoardsofPharmacy'and-the manufacturer l-invite their views regarding the' resolution'.ofithis petition. .I want to assure you that the comments of your constituents will?be - r considered;along with the othersLinLreexamining-our regulations. However, it would be premature'to predict the outcome of the reexamination before-completion of the rulemaking proceeding. I trust'this information is responsive to your request. .j Sincerely, q i WASCliSCAN t Dennis M a A r irector-1 Congres3 Tonal Affairs 9002050095 900116 Office of Governmental and M.1 PRM Public Affairs. ./ p l c ,a.. c
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t .i 1 ' ~ ) 1 i i fon3ttBS of f. t[niich flalM (Mause srf h ',*treertiatives I l Js hingter., pr '20 sis l 'd January 2 1990 - TO: CONGRESSIONAL LIAISON - Mr. Dennis Rathbun I l-Director,. Congressional Affairs-U.S. Nuc3 ear Regulatory Comm. Washington,,Dc 20555 i REF: Burnis_and Peterson - + l RE.American College of Nuclea Physicians' petition for gj,',rulemaking The attached communication is sent for _ i your consideration. Please investigate the i 1 statements contained therein and forward - me the necessary information for reply'- i i Yours truly, - 1 r. BOB STUMP, M.C. Third District.- Arizona - l PLEASE RETURN TO: 5001 Federal Building r Phoenix, Arizona 85025 Attn:~-Bruce,Bartholomew-i: ( q. i s !-t 1 j' ? 4 t 4 NM ~ o ..... --.-~._..._.. --...._.-.-.i._,...i....-.....-_. ..~!.. .L.....-._.--,.',,
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On.'iM^ cut'0 o. "^ma,37,vg ag ASSOCIATED PADIOLOGl5TS, LTD. g,"f,'g g ",c,h"g h, eso wtst rartM PLact MLSA. AMZONA 85201 PHONE (602) 969 3537 DI AGNOSTIC IM AOlNG November 29,'1989 a -The Honorable Bob Stump 230 North First Avenue Phoenix, Arizona 85003
Dear Representative Stump:
I am writing to. express my strong support for the Petition for! -{ Rulemaking filed by the American College of Nuclear Physicians and the Society of-Nuclear Medicine. I am a practicing Nuclear Medicine physician at Desert Samaritan, Mesa Lutheran and. Valley Lutheran-hospitals in Mesa,~ Arizona. I am deeply concerned overSthel revised" 10 CFR 35 regulations (ef fective April, '1987). governing the medical. use of~ byproduct material as they significantly impact my ability-to practice high-quality Nuclear Medicine / Nuclear Pharmacy and~are preventing me from-providing optimized care to-individual patients. TheNRCshouldrecognizeitbatithe.FDAdoes' allow, and>often-encourages, other clinical uses of. approved: drugs,;and; actively-1 discourages the rubmission'of' physician-sponsored.IND's that-l describe-new indications for approved = drugs. .The1 package insert was- ) never intended to prohibit physicians:from. deviating from it for 0 -other indications:.on the contrary, such1 deviation is necessaryJfor growth inLdeveloping new. diagnostic'and therapeutic procedures.; In a many cases, manufacturers:will never go-backito the-FDA to: revise"a j package insert-to include'a new indication.because it'isenot: required' by-the FDA and there is simply no1 economic: incentive to do so. 1 Currently, the regulatory provisions:in:Part-35 (35.100,j35.200, 1 35.300 and 33.17 (a) (4)) ' do: not : allow practices-which are' legitimate q ~ and' legal under FDA' regulations'and1 State medicinelandl pharmacy laws.- l These regulations therefore inappropriately interfere with:the practice of medicine, which 'directly contradicts the NRC's : Medical. Policy : statement against such interference. i Finally, I would:like to-point out that' highly restrictive NRC regulations;will:only jeopardizefpublic health;andcsafety by:, d restricting access to appropriate: Nuclear Medicine procedures; i exposingLpatients to higher radiation' absorbed doses.from: alternative-legal, but!non-optimal, studies;1and exposing' hospital personnel to higher radiation absorbed doses because of unwarranted, repetitive procedures.- The NRC1should not strive to. construct proscriptive (Continued) s 1 o -l 0
j I November 29, 1989 Page two regulations to cover all aspects of medicine, nor should it attempt to regulate radiopharmaceutical tre. Instead, the NRC shou'.d rely on the expertise of the FDA, State'BoardsLof Pharmacy, State Boards of Medical Quality Assurance, tae Joint commission on Accreditation of Heal ~thcare Organizations,. radiation safety committees, institutional-O/A' review procedures, and most importantly, the professional judgment of physicians and pharmacists who have been well-trained to administer and prepare these materials. Since the NRC's primary regulatory focus appears to be based on the unsubstantiated assumption that misadministrations, particularly thoce involving diagnostic radiopharmaceuticals, pose a serious threat to the public health and safety, I strongly urge the NRC to pursue a comprehensive study by a reputable scientific panel,,such as the National Academy of Sciences or the NCPP, to assess the radio-biological effects of misadministrations from Nuclear Medicine diagnostic and therapeutic studies.. I firmly believe that the results of.such a study will demonstrate that the NaC's efforts to impose more and more stringent regulations are unnecessary and not cost-effective in relation to the extremely low health risks of these. studies. In closing, I strongly urge the NRC to adopt the ACNP/SNM Petition for Rulemaking as expeditiously as possible. -Sincerely, Richard J. Petersen, M.D. 'FACNP, FACR RJP:me l T
,t + E = Lutheran Healthcare Network Valley. Lutheran Hospital 6644 Baywood Avenue Mesa, Arizona 85206 (602) 081 2000 1 November 30, 1989-Congressman Robert Stump. ?30 N. ht Avenue Phoenix,~Az
Dear Congressman Stump:
I am writing to express my_ strong suppo_rt for the: Petition for Rulemaki.ng filed by the American. College of Nuclear Physicians and the Society of Nuclear Medicine. I am a l practicing-Nuclear Medicine technologist at! Valley Lutheran l Hospital in Mesa, Arizona. 1 am deeply concerned over the revised -10 CFR 35. 4 regulations.(effective April,- 1987), governing the - medical? use of. byproduct material as they significantly impact myiability to1 practice; high-quality. Nuclear Medicine / Nuclear; Pharmacy land are -preventing: me from providing optim'ized care to individual _ patientsi The NRC should recognize-that the.FDA: does -allow s and.oftenh encourages - other clinical uses of approved. drugs, and; actively ~ discourages the submission - of physician-sponsored u IND's that; describe; - new indications ; for ' approved drugs. The package insert _ was never intended to prohibit physicians from deviating from it for other'. indications; L on _ the~ contrary,t such devi.ation 'is necessary for growth -in Ldeveloping new l diagnostic J and-- thera peutic - procedures. In many cases - manufacturers wil11 never = go back - to, the: FDA to revise a package insert to include a new indication' becauseiit is;not required by the FDA and there is simply no economic tincentive to do'so, i Currently, the' regulatory ' provisions fin Part ' 35"(35.000, ;35.200, 35.300 and 33.17(a)(4) do not _ allow practices; which -arellegitimate'and legal'~ under . FDA regulations, and-State medicine-and pharmacy laws. c These - regulations therefore inappropriately interfere with theE practice l:of medicine,1 whiche directly contradicts the'-NRC's Medical-Policy. statement against - such ] interference. Finally,. I would. like! :to point? out that. <highlyi restrictive l NRC regulations will. only; jeopardizeL public health and safety. by: restricting ~ h 1 ' access-to appropriate: Nuclear Medicine procedures;' exposing patients to higher radiation absorbed doses from alternative 1egal,L but non-optimal, studies; and' ) exposing hospital, personnel _ too higher ; radiation absorbed doses because. ofi unwarranted, repetitive. procedures.f The NRC should not;; strive to constructL 1 proscriptive Eregulations to cover 'allfaspects of medicine, nor - should it attempt. to regulate.radiopharmaceutica1 use. Instead, 'the1NRC should rely :on-E the expertise of thei FDA -~ State Boards of Pharmacy.- State. Boards Lof: Medical' c; Quality 1 Assurance, the ' Joint. Commission on Accredita' tion 1of -Healthcare j Organi zations, radiation ' safety. committees, ' insti tutional Q/A. review. procedures, and most ' importantly, the professional ~~judgmentJof physicians: and d i
pharmacists who ha ve been well-trained to' administer and prepare these ^ material s. Since the. NRC's priruary regulatory focus appears to be based on the I unsubstantiated assumption that misadministrations, particul arly - those I involving diagnostic radiopharmaceuticals, pose a serious threat to the-public i health and-safety. I strongly urge the NRC to pursue a-comprehensive study'by a reputable scientific panel, such as the National Academy of Sciences or the NCRP, to assess the radiobiological effects of misadministrations from NuclearL Medicine. diagnostic and therapeutic. studies. I fi rmly believe that the results of such a study will demonstrate that the NRC's efforts-to impose.more-and more stringent regulations 'are unnecessary. and. not cost-effective in-relation to the extremely low health' risks of these studies. -In closing,. I strongly urge the NRC to adopt the ACNP/SNMl Petition for' Rulemaking as expeditiously as possible. Sincerely. j. James J. Burnis, CNMT . Valley Lutheran. Hospital JJB/bg cc: Senator Dennis DeConcini Senator John Mc Cain-l- Congressman John-J. Rhodes, III. l: Congressman Robert Stump Congressman Jon Ky1 1-l L i t ( ' ~. a}}