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Executive Summary

Rep. Dingell's House Commerce/Oversight Subcommittee is keeping up the pressure on HHS to pursue greater legislative authority for FDA retribution against NDA/ANDA holders in cases of fraud. In a Jan. 10 letter to HHS Secretary Sullivan, Dingell pointed out the "absence of the remedial legislative proposals you promised to submit to Congress last August." Dingell said his subcommittee suspects that HHS staff are tying up proposals prepared by FDA. "The subcommittee has reason to believe," Dingell declared, "that the proposed legislation which clarifies the agency's authority to act administratively against firms which have paid off FDA employees or have filed fraudulent documents with the FDA has been successfully opposed to date within the department by officials outside FDA who do not appear to view such violations of the public trust as serious enough to warrant effective sanctions." FDA reportedly has sent two versions of suggested legislative changes regarding recalls and withdrawals to HHS since the issue of retribution was raised in a Barr Labs petition submitted to FDA in mid-June. Dingell's subcommittee is implying that a conspiracy explains the delay in seeking more authority for FDA. The subcommittee is apparently trying to flush out the HHS proposal before making its own effort. Dingell's staff continues to work on a report from the 1989 generic hearings -- scheduled for completion by the end of the first quarter of this year. The report would be the basis for a congressional proposal for changes. None of the parties likely to be affected by the potential revisions to the FD&C Act's drug provisions are moving quickly. Subcommittees established by the Pharmaceutical Manufacturers Association to look into possible changes were originally supposed to make a report prior to the end of the year. That report was delayed. PMA has divided the task of looking at the changes into two groups: one charged to look at the changes PMA would like; the other to determine what changes PMA could not accept. To try to pinpoint responsibility for the delays in the FDA/HHS proposal, Dingell asked Sullivan in the Jan. 10 letter for all FDA and HHS records relating to the petition from Barr Labs that started the discussion of the revocation of approvals. Dingell also requested all records regarding "FDA's response to that petition and legislative or other administrative proposals which address the problems raised in the Barr petition." In one of his last official acts as head of the agency, FDA Commissioner Young wrote to Barr on Dec. 15 denying the request to withdraw all approvals received by companies during the period that officials were known to be making payments to FDA reviewers. Young based his denial on the view that FDA does not have statutory authority to withdraw ANDAs without evidence tying the illegal gratuities to specific ANDA approvals. Young, however, suggested that FDA was attempting to satisfy the "intent" of the petition with its ongoing effort to recall and/or suspend distribution of drugs for which quality assurance, bioequivalence, or compliance with approval conditions are found lacking and to initiate ANDA withdrawal procedures for products approved with fraudulent data submissions ("The Pink Sheet" Jan. 8, T&G-4). In his letter to Sullivan, Dingell questioned whether the Dec. 15 response to Barr represented the departing commissioner's opinion. The congressman said he had "reason to believe that the response to the Barr petition does not reflect Commissioner Young's true position but instead that of persons within the department who are far more sympathetic to the scofflaws in the generic drug industry than was former Commissioner Young." The secretary was also asked to supply a list of all HHS employees who had a role in responding to the Barr petition. "That listing should include a concise but complete description of the role played by each individual," Dingell said. The congressman further requested a list of "each contact the employee in question had with other HHS employees or officials, administration employees or officials, and officials or employees of private parties or their agents regarding the questions raised in the Barr petition."

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