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DESI II PROGRAM COULD USE FDA THEOPHYLLINE POLICY AS A MODEL

Executive Summary

DESI II PROGRAM COULD USE FDA THEOPHYLLINE POLICY AS A MODEL for reviewing pre-1962 drugs, FDA Division of Drug Labeling Compliance Director Rudolf Apodaca suggested at a meeting of the international and western sections of the Regulatory Affairs Professional Society (RAPS) in Newport Beach, California April 12. One course the agency could follow in establishing regulations for pre-1962 drugs not covered by the original DESI program, Apodaca said, would be to follow the pattern of the "grandfathered" drug theophylline and "consult on an ad hoc basis with outside expert advisory panels, or again, use our in-house evaluation and publish a notice requiring submission of an ANDA or NDA within the specified time frame." Conditional approval would then be granted, Apodaca explained, "if certain basic labeliong or formulation criteria are satisfied, and continued marketing permitted while other more significant long term studies are carried out. If a firm does not reformulate or relabel as required by the Federal Register notice, a product would be misbranded or adulterated or both, and subject to regulatory action. If the product is modified as required, but no ANDA or NDA is submitted, it loses its grandfather exemption and is in violation of the new drug provisions." Apodaca noted that FDA is in the process of establishing the DESI II procedures "for bringing the remaining universe of unapproved [pre-1962] drugs into the system," but that "it is premature now to state what exact mechanism will be used to achieve this or when the plan will be implemented." Noting he was expressing his personal opinion, the FDAer suggested several approaches, based on past agency actions, FDA might take with the non-NDAed drugs. The compliance officer suggested that "a flexible approach utilizing a number of different avenues can be utilized by the agency on a case-by-case basis tailoring the action to a particular circumstance." This approach, he said, could "eliminate a considerable amount of unnecessary paper shuffling, red tape, and permit the agency to put its resources where it will do the most good." FDA could repeat the original DESI process, Apodaca said. However, noting that DESI took 20 years to complete, Apodaca observed that the agency probably does not "have the energy to repeat that process for another 2,400 drugs." Another course of action is suggested by the agency's handling of drugs such as chloroform and methapyriline, Apodaca said. The agency might "conduct in-house reviews, and when significant safety or efficacy issues are involved, merely publish a notice declaring the products are illegal with a time frame for removal from the market." Or, he suggested, as in the case of the grandfathered drug papaverine, data could be requested by the agency to support safety and efficacy, and no NDA or ANDA be required for marketing until a final determination is made. Another possibility, Apodaca said, would involve the agency conducting in-house reviews of the various drugs and taking selected class actions against those for whom marketing was not deemed justifiable. Regulatory letters would be issued "without prior notice on a class action basis that the products are illegal; that if marketing is not promptly discontinued, seizure action will be quickly initiated." There have been several such class actions over the last 10 years. Apodaca noted, involving such products as starch blockers "that were rather widely marketed."
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