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FDA SEEKING OUTSIDE ADVICE ON IMPLEMENTING PATENT RESTORATION PROVISIONS

Executive Summary

FDA SEEKING OUTSIDE ADVICE ON IMPLEMENTING PATENT RESTORATION PROVISIONS of the Waxman/Hatch law. In April 24 letters to trade associations and public interest groups, FDA Associate Com. for Health Affairs Stuart Nightingale, MD, invited outside participation in the agency's development of patent extension procedures. "The questions that arise about Title II in these early stages, and the agency's response to these questions, inevitably will influence our development of Title II procedures," Nightingale stated. "Recognition of the importance of FDA's early experience with Title II has encouraged us to invite ideas and recommendations from various interested parties." Nightingale's efforts to create a dialogue between FDA and the groups concerned with patent restoration is a continuation of Com. Young's Pathway B meetings, which were held to assist in formulating an agency Action Plan. At the Pharmaceutical Mfrs. Assn. annual meeting April 15, Young stressed the importance of outside community participation in agency review activities. In particular, he noted that the Action Plan will utilize the advice of outside academic communities in NDA reviews ("The Pink Sheet" April 22, p. 11). FDA's letter seeking feedback on the implementation of Title II of the Drug Price Competition and Patent Restoration Act was sent to such groups as the Pharmaceutical Mfrs. Assn. the Generic Pharmaceutical Industry Assn., the Natl. Assn. of Pharmaceutical Mfrs., the American Assn. of Retired Persons, and the Health Research Group. Text of an April 24 letter from FDA Associate Com. for Health Affairs Stuart Nightingale to Pharmaceutical Mfrs. Assn. President Gerald Mossinghoff. On March 8, 1985, Commissioner Frank E. Young delegated the authority for implementing Title II of the Drug Price Competition and Patent Term Restoration Act of 1984 (Act) to the Associate Commissioner for Health Affairs. As part of our efforts to implement the patent restoration provisions of the Act, we are writing to you and to other organizations to provide you with an opportunity to participate in the Agency's development of patent extension procedures. Your April 4 letter to Commissioner Young regarding Title II indicates PMA's interest in the Agency's implementation of the Act. Although the patent extension provisions of the Act have only recently taken effect, we have already received 17 patent extension applications, 16 of which concern drugs. The questions that arise about Title II in these early stages, and the Agency's response to these questions, inevitably will influence our development of Title II procedures. Recognition of the importance of FDA's early experience with Title II has encouraged us to invite ideas and recommendations from various interested parties. As the Title II program evolves, it may be useful for the Health Assessment Policy Staff in our Office of Health Affairs, which is responsible for the day-to-day administration of FDA's Title II duties, to communicate with your organization. Please inform us whether we should continue to correspond directly with you or with someone else in your organization. This will provide an opportunity for us to send correspondence and proposals to you and allow us to get your input on issues that arise from our efforts to exercise FDA's patent extension responsibilities. Such issues might include product eligibility, regulatory review period determinations, due diligence challenges, and general appeal procedures. If you have ideas or recommendations regarding the Agency's development of patent extension procedures, we would like to consider them. Please write or call the Health Assessment Policy Staff -- (301) 443-1382. Congress enacted Title II to encourage innovation in FDA-regulated industries. We hope that increased communication between the Agency and organizations like the Pharmaceutical Manufacturers Association will further this purpose by resulting in fair and effective procedures for restoring a portion of the patent life lost during regulatory review. Nightingale noted that the issues arising from FDA implementation of the law might include product eligibility, regulatory review period determinations, due diligence challenges, and general appeal procedures. Nightingale said the agency has already received 17 patient extension applications, 16 of which pertain to drugs. Of these requests at least eight (Inocor, Capozide, Catapres-TTS, Indocin, Normodyne/Trandate, Opticrom, Trental and Triphasil-2) have been denied by the Patent Trade-mark Office. FDA said a notice will soon be published in the Federal Register inviting comments from other interested persons. The agency noted that the feedback it receives will be put together in some form and made available to the public. FDA has no required time frame from promulgating regulations for Title II, as it does with Title I of the Act, but anticipates publishing a regulation on patent restoration provisions toward the end of 1985.
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