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Executive Summary

The openness and flexibility of the OTC panels of the 1970s are a good model for FDA's OTC Drugs Advisory Committee, attorney Peter Hutt (Covington & Burling) suggested in a Dec. 16 presentation on behalf of the Nonprescription Drug Manufacturers Association to the new committee. Hutt, who served as FDA's chief counsel at the time the OTC panels were established, characterized the process adopted by the panels as "literally the paradigm of scientific peer review. It is that process that...I urge upon you today." "The hallmark of OTC drug review was [that] it was not just the panel that debated. The rule was developed very early in the process that any member of the audience...could raise their hand," Hutt explained. The chair, he noted, always had control over recognition of participants but every person in attendance could make a presentation "if they chose to do so." The open format, Hutt said, provided a fair hearing for all constituencies and gave the panel the opportunity to ask for additional scientific information. The process adopted by the panels also allowed them to designate known scientific experts from academia and industry to be brought in to discuss specific issues, Hutt pointed out. In addition, "no artificial deadlines were imposed by the panel, FDA or industry" so that, when necessary, additional time was set aside in the next panel session to further discuss an issue. Hutt emphasized to the committee that FDA's "existing advisory committee not constrain you in any way. They provide flexibility and in particular provide the opportunity for the chair to call on anyone at anytime for any purpose." Also speaking on behalf of NDMA, the association's Senior VP William Soller, PhD, commented on three areas: "the scientific basis of OTCness"; "the presumption in the law for OTCness"; and the "three cornerstones of OTCness -- safety, effectiveness and labeling." The medical and scientific basis required for determining OTC safety and effectiveness, Soller asserted, "has worked extremely well" under the OTC review and with NDAed OTCs. Citing the 1938 FD&C Act and the Durham-Humphrey amendments, Soller stressed that the "legal and regulatory interpretation of the law is: if it can be OTC, it should be OTC." He added that "in practice, this OTC presumption in the law is also cost-effective. Six of 10 medications bought by consumers are non-Rx yet the spending for OTC medications is less than 2% of the total U.S. health care spending. The typical OTC is about $4, the typical Rx drug about $16." National Consumers League President Linda Golodner called on FDA to establish a third class of drugs to provide a transition phase during an Rx-to-OTC switch. Declaring that there will be "too many switches, too soon," Golodner said, "it is time to look at an extra measure of safety" for consumers. She noted that mandatory pharmacy counseling is currently required in over 20 states for Medicaid patients and will be required by all states after Jan. 1 under the Medicaid rebate law. In addition, she pointed out that many countries have a pharmacy-legend class and that four states -- Rhode Island, Iowa, California and Illinois -- have looked at the issue. In a separate presentation to the committee, NARD Third Party Programs Director Kenneth Whittemore also called for the establishment of a pharmacy-legend class of drugs. Health Research Group Director Sidney Wolfe, MD, lauded the creation of the advisory committee and FDA's commitment to increase resources and staff within the OTC office and to bring "better science into the agency." Wolfe suggested that the committee could help FDA " issues" and move quickly when such problems arise. In addition, Wolfe admonished the committee to protect against any moves to reduce FDA's level of regulation "to a lower common denominator." Also, he urged the committee "to push FDA to set a timetable" for the monograph review process. He noted that HRG has a pending lawsuit against the agency that was initially filed in 1981 to speed up the OTC review. Ironically, House health subcommittee staffer William Schultz, who was with HRG at the time of the initial filing of the lawsuit, is reportedly being considered for the chief counsel position at FDA under the Clinton Administration.

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