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FDA "ENFORCEMENT AMENDMENTS" HEARING SET JUNE 27 BEFORE WAXMAN SUBCOMMITTEE; WAXMAN AND DINGELL INTRODUCE HR 2585, SIMILAR TO ADMINISTRATION PROPOSAL

Executive Summary

Rep. Waxman (D-Calif.) is getting the FDA "enforcement amendments" off to a fast legislative start in the House: the first hearing on the bill is scheduled for June 27, less than three weeks after its introduction. Waxman and House Energy & Commerce Committee Chairman Dingell (D-Mich.) introduced HR 2585 (the Food, Drug, Cosmetic and Device Enforcement Amendments of 1991) on June 7 within two weeks of the introduction of the generic debarment bill (HR 2454). After reaching the more sensitive agreement on the topic of specific enforcement powers for FDA in the generic drug area, Waxman and Dingell are moving rapidly to begin the legislative process on the two measures. A legislative hearing on the debarment bill is scheduled for June 26. The Oversight Subcommittee canceled the hearing it had scheduled for June 27 to review the FDA Denver office's regulation of generic drug firms. The generic debarment bill had broad support among members of Dingell's Energy & Commerce Committee in 1990. The bill was stalled effectively by Waxman's opposition in the House and Sen. Metzenbaum's (D-Ohio) opposition in the Senate. With Waxman as a cosponsor of the debarment bill this year, it appears to face a relatively smooth congressional path. In the Senate, Labor and Human Resources Committee Ranking Republican Hatch (Utah) has introduced generic debarment legislation, but committee member Metzenbaum is prepared to introduce an alternative bill based on white collar crime legislation. Committee Chairman Kennedy (D-Mass.) is withholding support until he reviews them both. Waxman disclosed the upcoming hearing on FDA enforcement powers in a June 12 exchange with HHS Secretary Sullivan. Pressing Sullivan for information on the Bush Administration's version of a similar bill, Waxman said: "We have a hearing scheduled for June 27; I hope that we have the Administration position by that time." Sullivan was testifying before Waxman's subcommittee on June 12 on the recommendations of the Edwards Committee report on the future of the FDA (see related story, p. 5). The Administration has had an authorities bill circulating for comment since early this spring. At the June 12 hearing, Waxman asked Sullivan for his general comments on that draft and for a status report on the progress of the Administration's drafting process. "Our department review is largely completed," Sullivan reported. The bill "is under further review within the Administration." Sullivan declined to predict whether the Administration bill would be ready for the June 27 hearing. He noted, however that "it has been my experience that we have enjoyed good cooperation in addressing these issues by and large, so I expect it will not be a long time" until the bill is ready. In response to a question from Waxman, Sullivan said he was satisfied by the recommendations that had emerged from HHS after its review of the bill. The Health Subcommittee staff appears to be concerned that the Administration may tack additional amendments and changes onto its version of the FDA authorities bill. On prompting from key health subcommittee staff, Rep. Sikorski (D-Minn.) asked Sullivan three times if the Administration plans to ask for any amendments to the FD&C Act beyond the enforcement recommendations of the Edwards Committee. Sullivan avoided the question twice, finally answering that he would have to get back to the subcommittee in writing. For several years, Waxman has been understood to be reluctant to undertake across-the-board reforms of the FD&C Act because of the potential for opening up the legislation to a wide variety of changes. Sikorski's questions appear to reflect similar concerns. Waxman's subcommittee may be watching the Administration's authorities bill for changes in the drug approval process -- specifically for an attempt to link the concept of a conditional approval to more enforcement powers. FDA Commissioner Kessler frequently has been attending meetings of Vice President Quayle's Competitiveness Council. Recently, he attended meetings on May 28 and June 5. That group is said to be working on the issue of expedited drug approvals. FDA's own internal working group on conditional approvals is reportedly waiting for the Competitiveness Council to reach its conclusion before proceeding on its on recommendations. Separate work to correct the open label trial situation that Bristol-Myers Squibb has experienced with ddI (Videx) is apparently under way by key Republicans in both the Senate and House (see related item, T&G-1). The Waxman and Dingell Enforcement Amendments bill roughly mimics the draft legislation floated by the Administration last March. Despite momentum in the House and support by the Administration, the measure faces a hurdle in the Senate, where Sen. Hatch (R-Utah) opposes it. Sen. Kennedy (D-Mass.) endorses the legislation but reportedly will try to accommodate Hatch's concerns before trying to move it through the Labor & Human Resources Committee. The bill provides court recall authority for products that are in violation of the FDA&C Act and involve fraud or present a significant health risk. The measure also provides administrative recall authority, similar to that granted to the agency during the last Congress. Enhanced FDA seizure/embargo authority, as FDA received for devices last year, is also provided under the measure. In an introductory statement on the House floor, Waxman said that this provision would "refine the agency's seizure authority" to permit FDA to embargo products while it is obtaining a court seizure order. The measure also authorizes FDA to issue subpoenas in connection with an administrative investigation. Waxman noted that FDA "currently has this authority only in connection with a civil penalty hearing for medical devices." It also provides FDA administrative civil penalty authority for all the products that it regulates. The agency has the authority for devices. The bill also provides stronger import inspection authority that, for example, would permit FDA to destroy products that pose health hazards. Such products can now be re-exported. One provision that differs from the FDA/Administration proposal involves the interstate commerce standard FDA must meet for federal litigation. Currently, FDA must prove in court cases that violative products have been sold in interstate commerce. Although the agency generally has been able to do so successfully, meeting the standard consumed considerable resources. The bill would require FDA to prove only that the product "affected" interstate commerce. The U.S. Supreme Court recently has ruled that even products sold for private use can affect interstate commerce to the extent that the private sale reduced interstate sales. Introducing the bill, Dingell said it is one of "a number of legislative options to help improve FDA's ability to carry out its important regulatory functions." The options include "a restructuring of FDA within HHS; the imposition of [user] fees to increase agency resources; and the enactment of adequate statutory authorities to enable the enforcement of the FD&C Act."
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