ML20006B550

Ack Receipt of 891205 & 23 Ltrs Re Jj Burnis & Rj Peterson Support of Petition for Rulemaking to Revise 10CFR35 to Allow Use of Radiopharms for Therapeutic Indications Not Listed in Package Insert

ML20006B550
Person / Time
Issue date:	01/11/1990
From:	Rathbun D NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA)
To:	Kyl J HOUSE OF REP.
Shared Package
ML20006B551	List: ML20006B550 ML20006B554
References
RULE-PRM-35-9 CCS, NUDOCS 9002050060
Download: ML20006B550 (2)

Text

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4 Ef:0 UNITED STATES

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NUCLEAM REGULATORY COMMISSION 5

I WASHINGTON, D. C. 20066

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January 11, 1990 The honorable Jon Ky1 United States House of Representatives Washington, D. C.

20515

Dear Congressman Ky1:

This is to acknuwiedge receipt of your letters dated December 5 and December 23, 1989, transmitting correspondence from your constituents, Mr. James J. Burnis and Dr. Richard J. Peterson, in support of a petition for rulemaking to revise 10 CFR 35 Regulations.

The petition for rulemaking was submitted to the Nuclear Regulatory Consnission (NRC) by the American College of Nuclear Physicians and the Society.of Nuclear Medicine. The petitioners requested that the NRC modify current regulations to allow:

(a) the use of radioph*4rmaceuticals for therapeutic indications not listed in the package insert (diagnostic indications are not restricted by current regulations), (b) deviations from the manuf acturer's instructions in preparing radiopharmaceuticals, and (c) compounding radiopharmaceuticals from reagent chemicals.

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 comment lettert.

In light of the information submitted by the petitioners and the consnenters, the NRC is currently reexamining its regulations governing the use of radiopharmaceuticals in nuclear medicine. The' issues raised will be addressed in a rulemaking proceeding specifically designed to resolve the petition. During this rulemaking process.:the NRC will consult witn-the Food and Drug Administration, which approves the package' inserts and the manufacturer's instructions, and the State Boards of Pharmacy and invite their views regarding the resolution of this petition.

I want to assure you that the comments of your constituents will be considered along with the others in reexamining.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.

' Sincerely, M

Dennis K. Rtthbun, Director FULL 7 EXT ASCll SCAy Congressional Affairs office of sovernmental and Public Affairs Cdl

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Letter also verbally approved by Jim Blaha and Mike Weber (per Dennis Rathbun/Betsy Keeling) prv /-//- 90 k

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i HOUSE OF REPRESENTATWES, U.S.

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....... P.ecember. 5......, 19. 8 9....

Mr. Dennit Rathbun Director of. Congressional Afra.

I Nuclear Regulatory Consiscion' I

.l Washingto'.. D.C.

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i The attached communication is subir.it-ted for your consideration, and to ask that the request made ther'ein be complied with, if possible.

If you will advise me of your action in.

r this matter and have the letter returned to me with your reply, I will appreciate it..

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Lutheran Healthcare Network Valley Lutheran Hospital 6644 Baywood Avenue Mesa, Anzona 85206 (602) 981 2000 November 30, 1989 Congressman Jon Ky1 4250 E. Camelback Rd.

Phoenix, AZ

Dear Congressman Ky1:

I am writing to express my strong support for the Petition for'Rulemaking l

filed by the American College of Nuclear Physicians and the Society-of Nuclear Medicine.

I am a practicing Nuclear Medf eine technologist at Valley Lutheran Hospital in Mesa, Arizona.

I am deeply concerned over the revised 10-CFR 35 regulations - (effective April, 1987) governing the medical use of byproduct -

material as they significantly impact my ability to prar.tice high-quality Nuclear Medicine / Nuclear Pharmacy and are - preventing 'ne ' from providing optimized care to individual patients.

Tne NRC should recognize that the FDA does allow, and often ' encourages, other clinical uses of approved drugs, and actively discourages the. submission of physician-sponsoredi 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; on the contrary, such: deviation:is necessary for growth in developing new diagnostic and thera peutic procedures.

In many cawes, manufacturers will never go back to the FDA to revise a package insert to include a new indication because it is not required by the FDA and there is simply no economic incentive to do so.

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Currently, the regulatory provisions in Part. 35 (35.000, 35.200,. 35.300

' and 33.17(a)(4) do not allow practices which are legitimate and. legal' under i

FDA regulations and State medicine and pharmacy laws.

.These: regulations therefore inappropriately interfere with the practice of medicine, which directly contradicts the NRC's Medical Policy statement against such interference.

Finally, I

would like to point out I that-highly' restrictive NRC regulations will only jeopardize public health and safety. by:. restricting s

i access to appropriate Nuclear Medicine procedures; exposing patients to higher radiation absorbed. doses from alternative legal, but non-optimal, studies; and exposing hospi tal personnel to higher radiation absorbed doses. because.of unwarranted, repetitive procedures. -The NRC should not strive ' to construct proscriptive. regulations to' cover all ; aspects of medicine, :nor should; it attempt-to regulate radiopharmaceutical use. Instead, the NRC should: rely on the expertise of the FDA, State Batrds of Pharmacy, State' Boards of ' Medical Quality Assurance, the Joint C on.a.i s sion on Accreditation of Heal thcare Organizations,

' radiation safety ccamittees, insti tutional Q/A review procedures, and'most importantly, the professional judgment of physicians 'and I

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p 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, pa rt'r.al a rly those 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 NCRP, to assess the radiobiological effects cf misadministrations from Nuclear Medicine diagnostic and therapeutic studies.

I firmly believe tha t the.

results of such a study will demonstrate that the NRC's efforts to impose more and more rtringent 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,

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t James J. Burnis, CNMT Valley Lutheran Hospital JJB/bg cc: Senator Dennis '9Concini Senator John Mc Lain Congressman John J. Rhodes, III.

Congressman Robert Stump Congressman Jon Kyl l

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