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Executive Summary

The Nonprescription Drug Manufacturers Association is urging FDA to develop a system for requiring adverse drug reaction reports for nonprescription drugs based on the agency's current system for reporting adverse reactions for non-NDA prescription products. The key elements of a new system for collecting adverse reaction reports on OTC drugs, from NDMA's point of view, are (1) that it only apply to reports in the future and that it not require past reports -- i.e. that it be "prospective" not "retrospective" in scope, (2) that it deal only with reports from the U.S., and (3) that it not be as comprehensive as the reporting requirements for NDA-approved products. NDMA supports the development of a regulation by FDA as opposed to a voluntary program or one dictated by new legislation from Congress. An NDMA contingent met with FDA on September 2 to propose the outlines for a new FDA regulation. The suggested model for the reporting requirements are the rules added by FDA in 1986 to require adverse reaction reporting for prescription products marketed without NDAs. Those regs (21 CFR 310.305) were proposed in the wake of the deaths of 30 premature infants associated with E-Ferol in the early 1980s. The non-NDA product reporting regs require contacting FDA within 15 days of serious and unexpected adverse events. Companies are also required to review at least once each year the data on serious, expected reactions to determine if there is any change in frequency. The NDMA contingent at the Sept. 2 meeting was headed by two committee chairmen for the association: J&J Associate General Counsel Peter Bewley (Legal) and Lederle Consumer Director of Development and Scientific Affairs Joseph Tempio, PhD (Scientific Affairs). NDMA Senior VP-Science & Technology William Soller and Senior VP Daniel O'Keefe were present from the association staff. In early May, FDA had asked NDMA to comment on the feasibility of establishing a voluntary reporting system. NDMA rejected that approach, saying that a third party could not be expected to act as an effective regulatory surrogate for FDA. The September meeting followed five months of correspondence between the agency and the association on the subject and one Congressional hearing. FDAers report that the NDMA proposal was received favorably as providing some positive ideas. An official account of the meeting notes that it "concluded amicably." The Congressional hearing catalyzing the recent activity occurred in late April before Rep. Wyden's (D-Ore.) House Small Business/Regulation and Aging/Consumer Interests Subcommittees. The hearing caught the attention of both FDA and NDMA and has accelerated their efforts to arrive at a workable system for collecting OTC ADRs. FDA believes it has a short period of time to develop its own approach to OTC ADR reporting without instructions from Capitol Hill. In a recent letter to NDMA, the agency said that it does not believe that industry and FDA have the luxury of a long period of time to discuss an approach. On May 5, FDA's Office of OTC Drug Evaluation Acting Director Paula Botstein, MD, told NDMA's Soller that "events are moving at too rapid a pace for a protracted series of meetings." FDA Deputy Commissioner for Policy Michael Taylor expressed the sense of urgency about the OTC ADR issue in remarks to the Sept. 16 meeting of NDMA's Legal Section in Washington, D.C. Taylor urged NDMA members to continue to work "affirmatively" with FDA on the issues associated with adverse drug reaction reporting to prevent them from becoming "big public issues." "The best thing that this industry can do -- and that FDA has to do," Taylor declared, "is to assure that those issues [of ADR reporting] are being addressed very forthrightly." Acknowledging the talks between NDMA and FDA, Taylor said: "There are discussions going on about the possibility of an adverse drug reaction reporting system." The deputy commissioner told the Sept. 16 meeting that "this is a very important topic that deserves our mutual attention." Taylor described the developing interest in more ADR reporting in the context of the increasing activity of nonprescription products. "The more that products do for consumers -- the more that [marketers] want to get products out there that do more for consumers," Taylor said, "the more complexity you encounter, and the more issues that will come up." A strong proponent of self-regulation systems on a number of topics in the past, NDMA finds itself in the unusual role of urging FDA to take a more formal regulatory approach on this issue. The major hang-up for NDMA on a voluntary system for adverse reaction reporting is apparently the question of how a voluntary group could handle enforcement. NDMA believes it would not be appropriate for the association to act as a regulatory surrogate for FDA. Practically, the association would find it difficult to require companies to report adverse reactions and would have little recourse if companies failed to make those reports. Similarly, NDMA does not want FDA to delegate the authority for collecting OTC ADRs to a third party. While NDMA does not want a voluntary reporting system, the association would prefer to work with FDA to work out a regulatory system instead of working with Congress on a system required by legislation. At the April hearing on OTC warnings before the House Small Business/Regulation and Aging/Consumer Interests Subcommittees, NDMA outside counsel Peter Hutt (Covington & Burling) declared that a legislative fix for OTC drug reaction reporting was unnecessary. Asked by Subcommittee Chairman Wyden (D-Ore.) whether NDMA would participate in helping to craft legislative language to define the types of serious events which should be reported to FDA, Hutt said: "You don't write statutes to solve problems that don't exist." ("The Pink Sheet" May 4, p. 12). Those same issues of definition and identification of important events for reporting, however, are the types of questions which the association is addressing with FDA. NDMA has suggested, for example, that the definitions of "expected" and "unexpected" adverse events be developed from a list of recognized medical and drug information texts, such as the AMA Drug Evaluations, USP Drug Information, and ASHP Dispensing Information. The distinctions between the types of adverse effects cannot be drawn as easily from OTC labeling as from the more detailed prescription labeling. NDMA notes that "OTCs do not have fully descriptive package inserts on which the definitions of expected and unexpected can be based." NDMA also suggests deleting the section in the reporting requirements that would require manufacturers to open their complaint files to FDA investigators. OTC manufacturers are currently excluded from having to make their manufacturing records available to FDA investigators and the association intends to try to preserve that status. One of the reasons for promoting a lesser level of reporting for OTCs is that many of the products that FDA would be most interested in tracking carefully are already covered under the stricter reporting requirements. The agency already requires adverse reaction reporting on more than 200 nonprescription products based on that agency's authority to require ADRs on products marketed under NDA approvals. Most Rx-to-OTC switch products will be covered under that existing authority.

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