NRC proposed amendments: too little, too late?

the Nuclear Regulatory Com mission (NRC) by the Society ofNuclear Medicine and the American College ofNuclear Physiciansover four years ago is finally getting some response. The reaction from the peti tion's original author, however, has been less than favorable. Carol S. Marcus, PhD, MD, Director of Nuclear Medicine and Outpatient Clinic atHarbor-UCLAMedicalCenter and the principalauthorof the petition is not overwhelmed by the NRC's response. “This is not the great panacea we were hoping for after four years of tug-of-war,― she says. According to Dr. Marcus, the NRC has alreadypoorly addressedone proposal in the SNM-ACNP petition regarding package inserts. In August 1990, an interim rule was established for a three year period that allowed modification of FDA-approvedpackageinsertsby autho rized user physicians only if medical resultswere not otherwiseattainableor ifthe departurewould reduce medical risks to panicuiarpatienta because of their medical conditions. One change currently under consider ation is to allow departuresfrompack age insertsapprovedby theFDA regard ing the diagnostic preparationand use of therapeutic radioactive drugs by deleting the remaining restrictions of the interim rule making NRC regulations and license conditions consistent with state medical and pharmacy laws and the Food, Drug and Cosmetics Act. “Physi cians practicingnuclearmedicine must be able to use theirbestjudgmentabout drug preparation and use regardless of package inserts,―Dr. Marcus says. Another proposed change is to include the concept of “authorized nuclear pharmacist―and specify train ing and experience requirements.“The only thing the NRC has to worry about is whether or not a person is qualified to use radioactive materials safely,― Dr. Marcus says. “A nuclear pharmacist's rights and privileges are decided by each individualstate.Medicalandphar macy decisions are outside the jurisdic tion ofthe NRC.― The NRC also is considering an amendmentallowing physician autho rized users and authorized nuclear phar macists to use any necessary nonra dioactive or byproduct material to prepare radioactive drugs and to perform research involving human subjects. “Nuclearmedicine physicians and nuclearpharmacistsfind it appropriate, advisable or necessary to compound radiopharmaceuticals on occasion,― says Dr. Marcus. “Some necessary drugs are not commercially available at present and may never become commercially available.― Concerningthe researchaspectof the new proposal,Dr. Marcussays thatthis is an effort to repairan earliermistake the NRC made in 1987when it was revising its regulations and research criteria were unintentionally omitted. “When the FDA lifted its exemption for radiopharma ceuticals in 1975, both clinical use and researchwenttotheNRCfromtheFDA. WhentheNRCrevisedits 1OCFRPart35, it forgotto permitthe activity, even though the FDA regulatesit, not theNRC,― Dr. Marcus says. The use ofradiolabeled biologics ccn taming byproduct material is anot @r proposal under consideration. “We'@ e been using radiolabeledbiologics sin @ the late 1940s!―says Dr. Marcus. “The problem is really another NRC mistake. Radiolabeled biologics used to be reviewedby the Centerfor DrugEvalu ation and Research at the FDA; they wereableto be sold commerciallywhen they had approved New Drug Applica tions (NDAs). Some radiolabeled bio logics are now being reviewed in the Center for Biologics Evaluation and Research; approved products have Prod uct License Applications(PLAs). NRC required licensees to use products with NDAs, which automatically disqualified approved biologics with PLAs (or approveddevices). We never did actu ally decide on products with ANDAs (Abbreviated NDAs) but went on and used them anyway. What the NRC meant to say was †̃accepted or approved by the FDA' and it should forget the FDA's †̃alphabet soup.' “The proposedregulationsalso con tam some inappropriatelabeling require ments,― says Dr. Marcus.“Drug labels are the business ofthe FDA and Boards ofPharmacy.TheNRC hasno statutory authority here except for information needed for radiation protection pur poses. Hopefully, this section will .be omitted in the final rule so that we won't have anymoreniistakesto fix.― Dr. Marcus says the unfortunate prob lem with NRC's proposedrule is thata major issue of the petition, “license abuse,― is not addressed. “The state ments ofconsideration are so misleading thatit is astonishingtheNRC signedoff onthem.Seedsaresewn foranew round oflicense andinspectionabuse. Accordingto a spokeswomanfor the NRC any statementsregardingthe pro posed regulations should be submitted in writingto the commission.“We want theseregulationsto assurethatthe prac tice of nuclear medicine is not ham pered,― says CharleenRaddatz,nuclear physicist with the NRC. “And we want to ensure the health and safety of patients undergoing treatment with radiopharmaceuticalsas well as physi cians, technologists and the general public.― MarkA. Newman