William Tauzin: “when the Joint Statement of Managers was filed last night, it inadvertently omitted some important language concerning a…”

“when the Joint Statement of Managers was filed last night, it inadvertently omitted some important language concerning a Performance Goals Letter for the authorization of the Prescription Drug User Fee Act (PDUFA). Chairman Tauzin and Ranking Minority Member Dingell hereby submit the following additional statement which they view as authoritative legislative history on the provision in question. Performance Goals Letter Authorization of PDUFA is accompanied by a letter entitled ``PDUFA Reauthorization Performance Goals and Procedures.'' The goals letter is unique to PDUFA. It does not have force of law, but nonetheless the Agency views it as a statement of their obligations, and they issue a yearly report on their performance in meeting the goals specified in the letter. Title IX of the goals letter is entitled ``Independent Consultants for Biotechnology Clinical Trial Protocols.'' Contained in this title, as negotiated by the agency, is a paragraph ``D. Denial of Requests.'' As forwarded to the Congress, this paragraph previously read: ``except in the most unusual circumstances (for example, it is clearly premature) FDA will honor the request and engage the services of an independent consultant, of FDA's choosing, as soon as practicable. If the Agency denies the request, it will provide a written rationale to the requester within 14 days of receipt.'' Upon agreement of the Conferees, this paragraph shall now read ``D.…”