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Executive Summary

Rep. Waxman's (D-Calif.) Energy & Commerce/Health subcommittee has scheduled a hearing on Rep. Dingell's "emergency" FDA reform bill for June 28. Waxman has refused to join Dingell in co-sponsoring HR 4810. The California Democrat has expressed concern that the bill's sanctions target only generic firms, and not brandname companies, and that the proposed reinstatement of HHS Inspector General oversight of FDA enforcement activities might inappropriately supersede agency investigations into violations of the FD&C Act. At a June 20 hearing before Dingell's Energy & Commerce/Oversight subcommittee, four Washington pharmacy associations expressed their support for the bill. While expressing their support for quick passage of the emergency measure, the American Pharmaceutical Association, the American Society of Hospital Pharmacists, and the National Association of Chain Drug Stores also suggested further reforms of the FD&C Act to be considered by the congressman at a later date. NARD also testified in behalf of the bill. ASHP's Government Affairs Division Director Fern Liang told Dingell that her organization supports "the kinds of stringent penalties" found in the bill. "Your message is very clear," Liang said. "If you tamper with the FDA process, you'll be punished and punished severely." Suggesting that the measure would function as a restorative, Liang cited two recent surveys on shaken public confidence in the safety of generics. Prescriptions for the 12 most widely-used generics hit an "all time low last December" according to one survey, Liang noted, and a 1989 Gallup poll revealed that "more than three-fourths of all consumers had lost at least some confidence in generic products." ASHP dealt with the generic drug scandal last fall by tightening up its guidelines for selecting pharmaceutical manufacturers and distributors. The amended guidelines recommend that the name and address of the manufacturer of the final dosage form and the packager or distributor be present on product labeling and that suppliers provide bioequivalency data along with the identity and supporting data of the testing lab providing it. Liang said other hospitals appear to have tightened up their P&T committee procedures for accepting multisource drugs on the formulary. * APhA President Philip Gerbino called the measure a "critical first step" that is needed to "fill the void" before further FDA reform is legislated. Dingell has indicated that he plans to look at the FD&C Act de novo in the 102nd Congress. Gerbino's written testimony reiterated a wish-list of FDA reforms that APhA first presented to Dingell in a March 1 letter ("The Pink Sheet" March 19, p. 6). The list of proposed changes includes making FDA actions against drug manufacturers available to health care providers; agency review of pre-1938 drugs; a rating system on the dependability of manufacturers; and mandatory two-year post-marketing surveillance programs. NACDS VP-Pharmacy Affairs Leonard DeMino also suggested changes to the emergency bill, noting that while NACDS would prefer a "broader bill which would address the reform of all FDA approval processes," it is cognizant of political realities and the short time left before the end of the current session. NACDS supports provisions currently in the bill providing for mandatory and permissive debarment proceedings; the measure's "employee protection" provisions; and the granting of suspension authority. However, DeMino urged "the consideration of a more flexible suspension period" rather then the mandatory three-year suspension of a company convicted of wrongdoing now included in the bill. NACDS disagrees with the measure's retroactive application of suspension to acts dating back to Sept. 1, 1984. "Current information does not indicate an existing safety and efficacy problem that requires" such a long retroactive period, DeMino said.

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