Dear Dr. Crawford:
The United States Senate, Committee on Finance (Committee) has been conducting oversight of theFood and Drug Administration (FDA) since last spring. Over these past months, many problems,concerns, and new drug safety controversies have been brought to light.
On Thursday, Nov. 18, 2004, the Committee held a hearing entitled, “FDA, Merck and Vioxx: Putting Patient Safety First?" At the hearing, Dr. David Graham testified that the problemsassociated with the worldwide withdrawal of Vioxx were symptomatic of systemic problems withinFDA. Among other concerns, Dr. Graham stated that there were a number of drugs on the marketthat needed to be looked at seriously, including a drug manufactured by Pfizer Inc. and marketedunder the brand name Bextra. As chairman of the Committee, I request the following informationfrom the FDA related to Bextra, in accordance with attached general definitions.
1. Provide the Committee with a copy of the administrative file and related documents on labelingchanges related to cardiovascular risk and Bextra.
2. Provide all documents relating to communications between the FDA and Pfizer, including but notlimited to emails, teleconference minutes, and meeting notes on labeling changes related tocardiovascular risk and Bextra.
3. Provide the Committee with a briefing for each of the following drugs: Meridia, Crestor,Accutane, Bextra and Serevent. Please make the lead medical review officer for each drug availableto attend the briefing as well.
Thank you in advance for having your staff coordinate with my staff about this letter by no later thanthe close of business on Dec. 13, 2004. Please provide the requested documents by Jan. 3,2005, unless they are available sooner.
Sincerely,
Charles E. Grassley Chairman
Source: Ranking Member’s News
