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Executive Summary

Documentation to support FDA approval of ICN's Virazole (ribavirin) for treatment of respiratory syncytial virus will be the focus of a hearing expected in April or May before Rep. Dingell's House Commerce/Oversight Subcommittee. Dingell (D-Mich.) has been studying the approval of Virazole for at least two months. In a Feb. 9 letter to FDA Commissioner Young, he requested all agency documentation regarding ribavirin, its approval, and adverse experience reports ("The Pink Sheet" Feb. 16, T&G-1). Dingell's staff is reportedly investigating whether Virazole side effects were under-reported from studies that were relied upon by FDA in approving the antiviral for RSV. Dingell is also said to be concerned about allegations that ICN press statements exaggerated positive results from IND uses of ribavirin in AIDS. The Michigan Democrat reportedly is particularly concerned about the effect of such public statements, based on preliminary data, on the investment community. The National Institute for Allergy & Infectious Diseases has been drafting Phase II protocols for ribavirin. The company previously announced preliminary results of a clinical trial that, ICN maintained, demonstrated efficacy in treating AIDS patients with lymphadenopathy syndrome. However, some AIDS researchers disputed ICN's conclusions and said the firm's positive analysis of the study was not supported by available data. NIAID's protocol would permit other researchers would be designed to verify ICN's results ("The Pink Sheet" March 2, T&G-5). Dingell's interest in treatment IND use of ribavirin is likely to lead the hearing to an examination of FDA's treatment IND proposal, published on March 19 as part of the agency's proposed IND reg rewrite. The congressman could pursue the reasoning that opening up treatment INDs could make it easier for companies like ICN to market and overstate the benefits of experimental drugs. FDA's treatment IND proposal may also offer the Oversight Subcommittee the opportunity to pursue a smoldering issue where the agency is perhaps most vulnerable to oversight: the influence on FDA scientific and regulatory judgment by the upper echelons of the Administration. In March 13 letters to the Administration, the Michigan Democrat said his House Commerce/Oversight Subcommittee "seeks to learn more about the direction of the Task Force on Regulatory Relief, the announced [IND] proposal, and the implementation of that proposal." Dingell sent identical letters to Vice President Bush, Office of Management & Budget Director James Miller III, and HHS Secretary Bowen. He asked for "all books, records, documents, memoranda, letters, and other papers," including "all drafts of the proposal, press releases, and legal memoranda." Noting that the subcommittee has oversight responsibility over "the adequacy of existing laws and the necessity or desirability of enacting new or additional legislation," Dingell asked that the material be provided to the subcommittee by March 27. In a written statement from Bush, which was distributed at a March 10 press conference to announce the treatment IND proposal, the Vice President pointed out that the new rules were developed "at the direction of the Presidential Task Force on Regulatory Relief." HHS Assistant Secretary for Health Robert Windom asserted that the Vice President's attention to the proposal demonstrates that "it is a top priority of this Administration ... to improve the FDA drug review process." Rep. Dingell's subcommittee has often looked into issues in which FDA's scientific and regulatory judgments have been delayed or modified by HHS or OMB. Most recently, the congressman examined FDA-OMB correspondence concerning a delay in requiring that pediatric liquids containing aspartame include warnings to phenylketonurics. In previous cases FDA decisions were forestalled. The instance of FDA-Administration interaction regarding the treatment IND proposal is unique in that the agency may have been spurred into action and that the order came from the Vice President.

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