OTC MONOGRAPH SUPPLEMENTS WOULD PROVIDE FLEXIBLE ROUTE FOR PRODUCT CHANGES OUTSIDE NDA FILING -- GILBERTSON TO P-A; PROPOSES STANDING OTC ADVISORY PANEL
The OTC approval process needs a flexible route for product changes that could side step the NDA process by making use of the OTC monographs, FDA OTC Division Director William Gilbertson, PharmD, recommended at the Proprietary Association's (P-A) Research and Development Conference in New York on Dec. 10. "We need to devise a system that does not always require an NDA for every marketing change," Gilbertson stated. "Otherwise every change that you make will require an NDA and we have no recourse because that is the way the laws are written." Considering the agency's current resources for OTCs, Gilbertson continued: "I feel that its going to be bleak in the future to get things approved in a timely fashion." As one solution, Gilbertson suggested that "a monograph supplement drug approval" process be developed. "I believe that we should develop a system that allows for those petitions to be granted prior to going through the Federal Register." He noted the full comment procedure "could take years." In addition, Gilbertson proposed the possibility of a streamlined OTC NDA "without . . . all the requirements that you would have under an NDA." The monograph supplement approval, said Gilbertson "is my invention, which does not exist in the regulations, but some version of it should be considered, I think, by industry, the government, and by all parties." Explaining the proposed system, Gilbertson said it "would be public. It would allow marketing with approval. All parties would know the regulatory status. There would be no surprises -- the data would be public [and] the product approval would be on public file." In his comments, Gilbertson also recommended that some mechanism be built into the OTC approval process that "provides some marketing advantage to manufacturers along the line of what we have now for exclusivity with Waxman/Hatch." He suggested that "limited exclusive marketing" could be worked into a monograph supplement system and that other companies "with a similar petition" could also seek exclusivity. "After a period of time passes," Gilbertson continued, "then I believe it should then revert back into a proposed rule for consideration for the Federal Register amendment." Gilbertson noted that in order for such a regulation to be developed, "industry, consumers, consumer groups and others" would have "to come forward with such a plan or suggestion [and] work with the government for development of such a regulation in the future." Even with new approval mechanisms, Gilbertson noted that FDA's approval resources would have to be bolstered. "Existing agency personnel are scarce to do this and they are largely accustomed to new chemical entities," Gilbertson acknowledged. "In reality, OTCs continue to have a very low priority at FDA although we are using more outside consultants." Gilbertson said he was in favor of the creation of a standing OTC advisory committee. He said he has spoken personally to FDA Commissioner Young on the subject. "We would still like to have a standing OTC advisory panel or some public process to do these things on a more timely fashion," Gilbertson told the P-A meeting. Gilbertson suggested that an OTC advisory committee would provide "tremendous advantages in terms of resources and time" and it would provide "the public process which is so essential to general recognition." He noted that he has "apprised [Commissioner Young] of it privately on several occasions now. He's attuned to it. He's exploring various avenues to do such." However, Gilbertson noted that "the current problem continues to be the funding of such a panel."
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