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Executive Summary

Rx-TO-OTC SWITCHES SLOWING TO "A TRICKLE," NDMA SUGGESTS at the Sept. 27 meeting of the Edwards Committee's Subcommittee on Human Drugs and Biologics. Nonprescription Drug Manufacturers Association President James Cope described the OTC industry as a "stepchild" at FDA. "The problems are more a lack of proper organization and priority rather than resources and money," he said. "Just one of the negative results is that switch decisions have slowed to a trickle. Thirty-four ingredients are available to consumers in other developed countries that are not now available to Americans for use in self-care." Cope reported that an in-house survey found that NDMA member firms are "planning to put in about 50 switch applications in the next three to five years." He asserted: "I can assure you that FDA is in no way prepared to handle [them]." However, FDA Office of Drug Evaluation I Director Robert Temple, MD, told the subcommittee that only a handful of switch applications are pending at the agency. "What we have pending is one muscle relaxant, one nonsedating antihistamine which has recently developed some difficulties with potential adverse cardiac [effects] which clearly has to be evaluated, and one hydrocortisone/antibiotic combination -- and that's it." Temple continued: "There's a lot of hope [for additional switches] that we recognize. Our own view is that we're prepared to deal with those when they come through and feel that the track record in dealing with quite controversial ones, like ibuprofen, is that they can be handled." He noted that ibuprofen, "which was controversial, went through a regular advisory committee...[and] was handled in about nine months, start to finish. So the idea that these are second class [at FDA] doesn't seem true." An NDA to market Marion Merrell Dow's terfenadine nonsedating antihistamine (Seldane) as an OTC product was submitted in 1988. More recently, the company has submitted to FDA a protocol to provide additional data on cardiovascular effects. The company recently revised Seldane labeling to reflect an "extremely rare" number of cases of prolonged QT intervals and other cardiovascular effects ("The Pink Sheet" Aug. 27, T&G-1). The side effects, which apparently are not unique to terfenadine, have been seen in patients taking overdoses of the drug, those with impaired hepatic function, patients taking ketoconazole or macrolide antibiotics concomitantly, and patients with underlying cardiovascular disease ("The Pink Sheet" June 18, p. 6). The protocol's design has not been made final, but the company hopes that the research will be completed before the end of 1991. Cope presented three longstanding NDMA recommendations for improving the OTC drug-related activities within FDA: establish an Office of OTC Review; set up a standing OTC Advisory Committee; and issue a regulation specifying that FDA rules override any duplicative or conflicting state rules. NDMA's testimony was part of two days of presentations by FDA officials and outside groups to the subcommittee ("The Pink Sheet" Oct. 1, p. 10). The report of the full committee, formally named the "Advisory Committee on the FDA," is due in the spring. Hoffman-La Roche President and CEO Irwin Lerner, who chairs the Pharmaceutical Manufacturers Association's Board Committee on FDA Issues, and PMA President Gerald Mossinghoff outlined a series of association concerns and recommendations. These include: providing a clear FDA "mission statement" that balances safety with "timely availability" of drugs; focusing resources on safety and efficacy reviews rather than "ever increasing" requirements for other data; increasing the reliance on advisory committees, including expanding member terms to six years to help remedy turnover problems; increasing personnel "accountability" for performance; and separating policy and biomedical issues and assigning them to appropriate staffers. Subcommittee member Lawrence Horowitz, MD, of the California investment banking firm James D. Wolfenshon, Inc., posed a series of questions to PMA attempting to pin down what the association sees as the most important problem at FDA, and whether the situation has changed over the past 10 years. Lerner replied: "I think the problem is probably more similar than dissimilar, in the sense that I am not sure, personally, whether there is a clear understanding by the reviewing staff at FDA of what they're in business for. Is it to keep unsafe and ineffective products off the market or is it to move safe and effective products on the market?" As a corporate executive, Lerner said he would advise that "in approaching this problem, this commission should develop or should ask to have developed a clear statement on the mission of the Food and Drug Administration. Many perhaps think it's all been done and there's no need to reiterate it. I don't agree with that." The mission statement, he continued, "should be followed by a clear statement of the objectives of the agency and then some kind of a forward plan that looks at the issues facing the agency, what strategies are going to be necessary to resolve those issues, followed by a clear statement of the resources required." He described this process as establishing "fundamental management principles" tying agency objectives to personnel and resource requirements.

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