Date: Fri, 31 Mar 2000 21:34:27 -0700

To: Recipient List Suppressed:;

(posted on alt.support.breast-implant)

March 17, 2000

The Honorable Jane Henney, M.D.

Commissioner

Food and Drug Administration

Room 14-71 (HF-1)

5600 Fishers Lane

Rockville, Maryland 20857

Dear Dr. Henney:

On March 1-3, 2000, the FDA convened an Advisory Committee meeting to consider the approvability of data submissions from several sponsors for saline-filled breast implants. The Advisory Committee concluded that the data submissions for two sponsors were sufficient to show safety and effectiveness.

Since the March 2000 Advisory Committee meeting, the FDA staff has confirmed to Committee staff that the FDA's Office of Criminal Investigations has an open investigation initiated in 1998 concerning allegations related to one of the sponsors. I note that an open investigation does not necessarily reflect the credibility of the allegations. Nevertheless, I question why the FDA proceeded to the Advisory Committee under these circumstances. Therefore, pursuant to Rules X and XI of the U.S. House of Representatives, I request that the FDA explain why the agency proceeded to panel under the circumstances and to provide all records relating to the FDA's decision to proceed to panel with the submission from the sponsor in question. I would appreciate a response by March 31, 2000.

Please note that, for the purpose of responding to these requests, the terms "records" and "relating" should be interpreted in accordance with the Attachment to this letter.

Thank you for your assistance. If you have any questions, please contact Alan Slobodin of the Committee staff at (202) 225-2927.

Sincerely,

Tom Bliley

Chairman

cc: The Honorable John D. Dingell, Ranking Member The Honorable Fred Upton, Chairman, Subcommittee on Oversight and Investigations

The Honorable Ron Klink, Ranking Member, Subcommittee on Oversight and Investigations

ATTACHMENT

1. The term "records" is to be construed in the broadest sense and shall mean any written or graphic material, however produced or reproduced, of any kind or description, consisting of the original and any non-identical copy (whether different from the original because of notes made on or attached to such copy or otherwise) and drafts and both sides thereof, whether printed or recorded electronically or magnetically or stored in any type of data bank, including, but not limited to, the following: correspondence, memoranda, records, summaries of personal conversations or interviews, minutes or records of meetings or conferences, opinions or reports of consultants, projections, statistical statements, drafts, contracts, agreements, purchase orders, invoices, confirmations, telegraphs, telexes, agendas, books, notes, pamphlets, periodicals, reports, studies, evaluations, opinions, logs, diaries, desk calendars, appointment books, tape recordings, video recordings, e-mails, voice mails, computer tapes, or other computer stored matter, magnetic tapes, microfilm, microfiche, punch cards, all other records kept by electronic, photographic, or mechanical means, charts, photographs, notebooks (including laboratory notebooks), drawings, plans, inter-office communications, intra-office and intra-departmental communications, transcripts, checks and canceled checks, bank statements, ledgers, books, records or statements of accounts, and papers and things similar to any of the foregoing, however denominated.

2. The terms "relating," "relate," or "regarding" as to any given subject means anything that constitutes, contains, embodies, identifies, deals with, or is in any manner whatsoever pertinent to that subject, including but not limited to records concerning the preparation of other records.