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Executive Summary

Rep. Waxman (D-Calif.) is casting a wide net in his attempt to uncover undue influence by the White House Council on Competitiveness on FDA operations. On Dec. 4, the House Health Subcommittee chairman wrote to FDA asking for all correspondence between FDA and the council during a 31-month period. In addition, Rep. Weiss (D-N.Y) is seeking from FDA any correspondence between the agency and the industry since the Competitiveness Council announced its recommendations to speed up the drug approval process on Nov. 13. The two letters to FDA Commissioner Kessler, which request documentation of FDA communications with industry representatives directly and indirectly through Vice President Quayle's Council on Competitiveness, follow up on inquiries begun in mid-November ("The Pink Sheet" Nov. 18, p. 9). Waxman wrote Commissioner Kessler to ask for "copies of all records written or received by FDA personnel since April 1, 1989 that are in any way related" to the Competitiveness Council. Waxman asked that the documents include notes, memoranda, electronically transmitted communications, draft Federal Register notices and "other drafts, analyses and reports." In addition, the congressman requested that FDA include in its response a list of the dates of any meetings or phone conversations between FDA and the Council, the participants in any phone conversation or meeting, and "copies of any notes, memoranda, correspondence, or any other documents written or received by FDA personnel related to the meetings or phone conversations." Waxman asked that the material be submitted to his House Health Subcommittee by Dec. 6. Waxman also has written to Eli Lilly to inquire into that company's ties to the White House. Among other things, a Nov. 18 letter to the company sought information about technical assistance Lilly provided the Competitiveness Council for use in formulating proposals to speed FDA's new drug review process ("The Pink Sheet" Dec. 2, p. 15). Waxman's subcommittee apparently is doing research for a possible hearing on the Council recommendations sometime in January or February. Weiss sent a Nov. 27 request to Kessler for documents of communications between FDA and pharmaceutical manufacturers "regarding the Vice President's Council on Competitiveness and/or possible reforms of the drug approval process." The New York Democrat asked FDA to submit by Dec. 6 "all records written or received by FDA personnel since Nov. 13, 1991" documenting "communications to or from any drug manufacturer regarding any actions based on the reforms of the drug approval process announced by FDA on Nov. 13." The letter states that records submitted should include memoranda, notes, "draft Federal Register notices and other drafts, analyses and reports." In addition, Weiss requested FDA records of "communications to or from any drug manufacturer or trade association" that occurred in the period March 1-Nov. 13, 1991 with regard to the council or the approval process reforms. Weiss asked the agency to submit such records by Dec. 11. On Nov. 13, the House Intergovernmental Relations Subcommittee (chaired by Weiss) issued a subpoena to FDA to obtain all agency documents related to the Competitiveness Council. The subcommittee received the documents Nov. 21 and currently is reviewing them ("The Pink Sheet" Dec. 2, p. 15).

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