FDA OTC ADVISORY COMMITTEE WOULD NOT BE "PANACEA"

Executive Summary

FDA OTC ADVISORY COMMITTEE WOULD NOT BE "PANACEA" for industry's concern over slow agency reviews in the OTC area, FDA Center For Drug Evaluation and Research Deputy Director Gerald Meyer suggested at the Nonprescription Drug Manufacturers Association legal conference in Washington, D.C. Oct. 17. Meyer told NDMA that the agency is "sensitive" to industry suggestions for speeding the review of OTC issues and is considering the possible use of such an advisory group. However, he added, "I don't personally think that an advisory committee is a panacea. What I think we need is a vehicle for quicker decisions by people who are competent to make them." Meyer noted that center Director Carl Peck is considering a plan to staff the OTC division with "its own clinical pharmacologists, adequately trained to make those kinds of decisions." While he acknowledged that there are "other reasons" for having an advisory committee, Meyer reiterated: "My experience in 34 years in government is...that advisory committees [do not] hurry things up. Trust me, that hasn't been my experience." Acknowledging that he is "very uncomfortable with the speed" in which FDA is moving on OTC issues, Meyer explained that recruitment problems and scarce resources are responsible for the slow pace of such activities. Addressing criticism that FDA is holding up the flow of Rx-to-OTC switch applications, Meyer pointed out that the actual number of applications pending is very small. "I think it's important to realize we have three pending applications in-house," he said. "We don't have 55. We don't have 155. We have three." FDA Office of Drug Evaluation I Robert Temple told the drugs and biologics subcommittee of the Edwards Committee at its Sept. 27 meeting that FDA currently has only three switch candidates pending: a muscle relaxant, a hydrocortisone/antibiotic combination, and a nonsedating antihistamine, which presumably is Marion Merrell Dow's Seldane ("The Pink Sheet" Oct. 8, T&G-12). Meyer said that FDA is working with other firms on potential Rx-to-OTC switches. "We're working closely with [several] sponsors on where we believe there ought to be an OTC indication -- we're helping the sponsor develop one and...develop the data he needs," Meyer said. He noted that the agency also is working with some sponsors in situations where "we have some problems with the products and we haven't yet figured out how to work it out." Meyer also addressed the question of whether FDA is ready to develop guidelines for Rx-to-OTC switches. He suggested that FDA is not "real anxious to write narrow guidelines that we're not sure about ourselves." However, he added: "We'd like to leave room for some innovative thought about [the guidelines] and I hope we do."