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This article was originally published in The Gray Sheet

Executive Summary

PET CYCLOTRON AND "BLACK BOX" REGULATION SHOULD REMAIN UNDER STATE AUTHORITY for regulating the practice of medicine and pharmacy, the National Electrical Manufacturers Association maintains in March 18 comments to FDA. NEMA says that it supports "the regulation of existing and future [positron emission tomography] sites by the continued operation of these sites under the existing local authorities." The association submitted the comments in response to a recent FDA position paper on the regulation of radiopharmaceuticals used in PET procedures. In its paper, the agency proposes requiring new drug applications for radiotracers and premarket approval applications or 510(k)s for the cyclotrons and associated equipment used to produce the radiotracers. Since publication of the paper, FDA has shifted its position on the regulatory requirements. At a March 5 hearing, FDA said it was considering a policy under which information about cyclotrons and automated synthesis systems (black boxes) would be reviewed as part of the NDAs for PET radiopharmaceuticals ("The Gray Sheet" March 8, p. 24). NEMA takes issue with FDA's initial proposal requiring regulation of cyclotrons and black boxes, maintaining that both types of devices "are appropriately viewed as general purpose laboratory equipment rather than medical devices because they are simply tools...which are used by appropriately trained and experienced individuals to achieve a chemical synthesis." NEMA notes that, to date, particle accelerators (of which cyclotrons are one type) have not been "regulated by FDA as devices, but rather have been adequately covered by existing regulatory mechanisms on the state and federal level and have demonstrated a history of safe operation." The "black boxes" are general purpose chemical synthesis instruments because they comprise "an integrated collection of well understood hardware" that replaces labor normally done by the radiopharmacist, NEMA says. Further disagreeing with FDA's intention to make use of drug manufacturing requirements to regulate radiopharmaceutical production facilities, NEMA says that "it has not been the policy of FDA to apply current good manufacturing practice regulations to pharmacies as these regulations are not specifically applicable to pharmacy operations." The association also points out that "the 1984 FDA Nuclear Pharmacy Guidelines specifically state that a pharmacy is exempt from the need to register as a drug establishment when it operates an accelerator or nuclear reactor." NEMA's comments were among several submitted to FDA since its March 5 hearing. Other parties voicing concerns with the proposed regulations include General Electric Medical Systems and Syncor International Corp. GE agrees with NEMA that "there is no precedent for regulation of non-therapy accelerators or tracer synthesis equipment as medical devices." The firm adds that "the present approach to regulating the tracers themselves as drugs has proved to be unworkable since the tracers and the manner of their formulation and use differ from conventional drugs in so many ways that routine regulatory processes simply do not fit." The firm proposes that FDA instead make use of the U.S. Pharmacopoeia, which publishes monographs to standardize "generally recognized" radiotracers. GE suggests that after publication of its monograph, a PET radiopharmaceutical could be reviewed by a panel of experts, which would make a recommendation to FDA for its approval. The comments note that the preparation of the compounds "will be regulated by the states in accordance with their licensure and oversight of the practice of pharmacy and the practice of medicine." In Syncor's comments on the FDA proposal, the firm refers to a citizen petition it filed in 1992 that urged FDA to regulate cyclotrons and black boxes as medical devices in lieu of requiring NDAs for the radiotracers themselves. The firm's current comments, however, state that "the discussions within the nuclear medicine community that FDA's hearing prompted now leads Syncor to conclude that state laws regulating medicine and pharmacy, augmented by professional practice standards, can and should form the basis of the regulation of PET radiotracers." Syncor says that it believes FDA has no legal authority to regulate PET radiotracers through NDAs because these compounds, made locally due to their short half-lives, are not shipped in interstate commerce. The firm asks FDA to explore other avenues of regulation and notes that if the agency chooses not to consider alternatives, "Syncor believes that the only legal option available to FDA is to adopt some form of device regulation."

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