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Executive Summary

A hearing that had been scheduled for June 27 to review the House version of the FDA enforcement bill (HR 2597) was delayed because Commissioner Kessler's testimony was not ready to be delivered. The postponement of the hearing indicates either that the bill has met firm resistance from high-ranking officials within the Bush Administration or that further review was needed before FDA's official endorsement of the legislation could receive the administration's imprimatur. The hearing was planned by Rep. Waxman's (D-Calif.) House Energy & Commerce/Health Subcommittee. Because Congress is not in session the week of Independence Day, the earliest the hearing can be rescheduled is the week of July 8. Waxman, who with full committee Chairman Dingell (D-Mich.) is a principal cosponsor of HR 2597, reportedly believes the delay is a result of the administration's further review and fine-tuning of the testimony, rather than a roadblock to Kessler's coming out in support of the bill. The California Democrat hopes to reschedule the hearing by mid-July. FDA and HHS previously have indicated their support for HR 2597. The bill was based on a legislative proposal floated by FDA in March, and Kessler has said repeatedly in public that legislation will be needed to enhance at least some of the agency's enforcement tools ("The Pink Sheet" March 4, p. 6). Kessler was a key member of the HHS-appointed (Edwards) Advisory Committee on FDA. The committee's final report endorsed the FDA draft proposal and urged Congress to enact enforcement legislation ("The Pink Sheet" May 20, p. 12). Furthermore, at a recent hearing on the Edwards Committee report, HHS Secretary Sullivan told Waxman's Health Subcommittee that the department had forwarded the draft to the Office of Management and Budget for clearance ("The Pink Sheet" June 17, p. 3). HHS also proposed broad FDA enforcement legislation in the summer of 1989, after the generic drug scandal broke. House Government Operations/Intergovernmental Relations Subcommittee Chairman Weiss (D-N.Y.) and Kessler were slated to testify in support of HR 2597. Weiss has often criticized the agency in oversight hearings for not enforcing the FD&C Act with sufficient strictness. In addition, testimony endorsing the legislation was expected from John Rother, director of legislation and public policy for the American Association of Retired Persons. The administration's desire to further review the bill probably was prompted by widespread industry opposition, only recently expressed publicly. Pharmaceutical Manufacturers Association President Gerald Mossinghoff and Health Industry Manufacturers Association Executive VP Ted Mannen were scheduled witnesses who oppose the legislation. PMA and HMA were among 23 trade associations that jointly signed a June 21 letter of opposition sent to Reps. Dingell (D- Mich.), Waxman and other cosponsors of HR 2597 ("The Pink Sheet" June 24, T&G-1). The letter contended that the enforcement authority that would be provided to FDA in the bill (such as powers to recall, embargo and seize products and to impose civil money penalties) is "sweeping and unjustified." A Senate version of the legislation has not yet been introduced. Labor & Human Resources Committee Chairman Kennedy (D- Mass.) is a likely sponsor, but a key committee member, Ranking Republican Hatch (Utah) reportedly opposes the bill.

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