FDA OTC DECISION PROCESS COULD GET RE-EVALUATION: RECENT ADVISORY COMMITTEE FORMATIONS AND BLUE RIBBON PANEL REVIEW MAY AUGUR WELL FOR OTC INDUSTRY

FDA has at least three pending requests for special advisory committees, requests which may act to support the OTC industry's decade-long attempt to have a committee convened to address OTC drug issues. (1) As an outgrowth of the 1989 investigations into the generic drug approval process, FDA is moving toward the establishment of a "technical scientific advisory committee" to look into generic drug issues. The agency announced its intent to establish the committee at the height of the Capitol Hill furor over alleged payoffs to FDA reviewers last August ("The Pink Sheet" Aug. 21, p. 13). FDA confirmed its interest in the generics advisory committee in a Feb. 20 Federal Register notice. (2) More directly relevant to OTC manufacturers, FDA is considering the establishment of an advisory group to review the gingivitis and plaque reduction claims by oral rinse products. The agency first promised to convene that group in December 1988. In February of this year, an agency drug labeling compliance official said that FDA was still holding to that plan. (3) In the troublesome orphan drug designation area, the agency has been asked by 22 molecular biologists to put together an expert group to resolve issues of product differentiation that affect exclusive marketing rights under the Orphan Drug Act ("The Pink Sheet" March 5, T&G-3). The three special advisory groups would address problems on the fringe of the expertise of existing FDA prescription drug advisory committees. Their creation could create a more fertile atmosphere for a pet project of the Nonprescription Drug Manufacturers Association -- the quest for a separate OTC advisory group at FDA. Last year at NDMA's 1989 annual meeting, Sen. Hatch (R-Utah) held out the possibility of establishing an OTC special committee by legislation as part of his FDA revitalization bill. The legislation, which called for private funds to supplement federal funding of FDA through a trust arrangement, passed committee last session without the trust fund proposal and awaits a Senate floor vote ("The Pink Sheet" Oct. 23, T&G-3). NDMA Chairman William Learnard (SmithKline Beecham) referred to the generic drug advisory committee as a potentially important precedent in his address to the NDMA annual meeting in White Sulphur Springs, W.V. on May 7. Noting that the agency recently published its call for the generic committee, Learnard declared "that the agency can no longer argue effectively that no specialized advisory committees are needed because the present advisory committee system is sufficient." Learnard observed that the precedent "also shows that FDA can name new committees when it wants to." NDMA also views the "blue ribbon" panel established by HHS Secretary Sullivan to review FDA's mission and structure as a positive event for OTC drug regulation. NDMA President Jim Cope pointed out in his May 7 address to the annual meeting that the blue ribbon panel is being chaired by former FDA Commissioner Charles Edwards, currently president of the Scripps Clinic and Foundation. Edwards, Cope observed, was the commissioner of FDA when the OTC Review was originally undertaken in 1972. A former management consultant with Booz Allen prior to joining FDA under the Nixon Administration, Edwards was credited with a significant reorganization of the agency during his tenure. Under his guidance, the agency also began to make more use of advisory committees. The OTC Review was set up specifically to permit advisory committees to take much of the burden of the retrospective review of existing OTC ingredients off the hands of FDA's internal staff. "You can be sure," Cope said, "we will be talking to the panel about the importance of self-care/self-medication, and why -- and how -- FDA should pay more attention to it." The blue ribbon panel is scheduled to hold its first formal meeting on May 17-18. NDMA would like to present its position on OTC reviews and the establishment of a special advisory committee to the panel in the autumn. In a recent background paper on the association's major issues and objectives, NDMA emphasized two points in favor of a special OTC advisory committee. It would: (a) provide an OTC perspective to OTC decisions; and (b) preserve the monograph system. "An 'OTC perspective'," NDMA said, "means an understanding that people who use nonprescription medicines are consumers who are engaged in self-care/self-help rather than patients under a physician's care." NDMA noted that OTCs differ from prescription drugs in "labeling, distribution, promotion and sale" and suggested that the people who review those drugs should be aware of the differences. NDMA dismisses the criticism that a special OTC advisory committee would be too expensive, estimating that it would cost FDA between $35,000 and $70,000 annually. "The basic premise of FDA's OTC Review," NDMA said, "is that it is inefficient if not impossible to regulate OTCs case-by-case." The association expressed concern that without a special advisory committee, FDA would experience a "regulatory drift" and OTC reviews would slip back to a case-by-case approach. NDMA's argument against "regulatory drift" is especially interesting in light of the association's own position at a recent FDA meeting on guidelines for Rx-to-OTC switches in the NSAID (nonsteroidal anti-inflammatory) class. At that meeting, NDMA made a presentation in favor of case-by-case determinations of switch in the NSAID class and opposing any effort to create guideline (drug class) cookbooks for OTC approval criteria ("The Pink Sheet" Feb. 26, p. 9). NDMA's testimony at that meeting dovetailed with that of the Pharmaceutical Manufacturers Association. The apparent contrast between NDMA's general objective to keep OTC reviews from slipping into NDA-style new drug evaluations and the real pressures from switch sponsors to pursue the potential regulatory advantages of individual reviews (reflected by the position at the NSAID meeting) indicate a renewed urgency of addressing FDA's OTC review process. Without FDA enforcing the rules for general ingredient reviews, the regulatory and competitive pressures will continue to work toward case-by-case evaluations. NDMA's concern about post-monograph regulatory procedures at FDA goes hand-in-hand with its continued effort to encourage Rx-to-OTC switches. The association now lists two dozen ingredients that are available without prescription in other countries with developed regulatory systems (see box, p. 10). Adopting a familiar catch-phrase from the prescription area, Cope declared that NDMA continues "to worry about a possible self-care 'drug lag' in the U.S." Short of specific action by FDA to address future OTC regulatory issues, NDMA has been attempting to keep top agency staff informed and interested in OTCs. The association continued its "dialogue" sessions with top FDA staff during 1989-1990. The most recent dialogue session was held May 2 on switches. The guideline issue was reportedly raised again in relation to the February NSAID advisory committee review. Significantly, the FDA group represented at the meeting were all from the agency's new drug evaluation operations. FDAers at the May 2 meeting reportedly included Center for Drug Evaluation and Research Carl Peck, Special Assistant to the Director Mary Doug Tyson, Office of Drug Evaluation I Director Robert Temple, and Pilot Drug Evaluation Staff Director John Harter. Representatives from NDMA companies at the meeting included association staffers Senior VP William Soller and Scientific Associate Lorna Totman, William Cooley (Procter & Gamble), George Blewitt (Bristol-Myers Squibb), John Clayton (Schering-Plough), Barry Dash (Whitehall) and Edward Marlowe (Warner-Lambert).