DeLauro Calls for Timeline on Naming New FDA Head

Date: Sept. 27, 2005
Location: Washington, DC
Issues: Science


DeLauro Calls for Timeline on Naming New FDA Head

- Problems Plaguing Agency Need Attention of Full-Time, Permanent Commissioner -

WASHINGTON, D.C. - Congresswoman Rosa L. DeLauro (Conn.-3) today called on President Bush to provide a timeline to Congress on when he will name a permanent commissioner for the Food and Drug Administration (FDA). Last week, the president named National Cancer Institute Director Dr. Andrew von Eschenbach to be the agency's acting commissioner following the resignation of Dr. Lester Crawford. Von Eschenbach will serve as Commissioner to the FDA while still serving as director of the National Cancer Institute - splitting his time between the agencies for an undetermined amount of time.

DeLauro, who is ranking member of the House subcommittee with jurisdiction over the FDA budget, has previously raised concerns over the flu vaccine shortages, the delayed withdrawal of medicines such as Vioxx and ongoing safety concerns regarding medical devices such as defibrillators.

"Now is clearly not the time for a part-time director at FDA with another prolonged period of temporary leadership," said DeLauro. "Irrespective of Dr. Von Eschenbach's qualifications, such an arrangement would undoubtedly compromise the distinct missions of both the FDA and the NCI, which performs the bulk of our nation's most important and innovative cancer research. We cannot afford to weaken these two agencies."

The full text of the letter follows.

September 27, 2005

President George W. Bush

The White House

1600 Pennsylvania Avenue

Washington DC 20500

Dear Mr. President:

I am writing to express my concerns with the appointment of a part-time commissioner to the Food and Drug Administration (FDA) and comments made by Department of Health and Human Services Secretary Michael O. Leavitt that "there is no timetable" for nominating a permanent commissioner following Lester M. Crawford's resignation Friday. I respectfully request that you provide the Congress with a timetable for naming a permanent director to this important agency.

As the agency entrusted with ensuring the safety of our food and drug supply and to protect the public health, the FDA requires strong and permanent leadership. For too long the leadership of this agency has been in transition, with Dr. Crawford having served two periods as interim commissioner, resulting in serious scientific and management challenges. The past year has been particularly difficult - from flu vaccine shortages caused by inept manufacturing oversight to delayed withdrawal of medicines such as Vioxx that have resulted in thousands of unreported deaths to ongoing safety concerns regarding medical devices such as defibrillators.

Given these missteps, now is clearly not the time for a part-time director at FDA with another prolonged period of temporary leadership. Irrespective of Dr. Von Eschenbach's qualifications, such an arrangement would undoubtedly compromise the distinct missions of both the FDA and the NCI, which performs the bulk of our nation's most important and innovative cancer research. We cannot afford to weaken these two agencies - nor do we need to.

Restoring public confidence in FDA must be our highest priority. Without immediately appointing a full-time, permanent commissioner, I believe we will continue to see a diminished focus of FDA leadership at this critical time, to say nothing of the impact it will have on the live-saving work conducted at NCI. The work of these two agencies is too important to operate without full-time stewardship.

I look forward to your response and to reviewing your timetable for appointing permanent leadership at FDA.

Sincerely,

Rosa L. DeLauro
Member of Congress

Cc: HHS Secretary Michael O. Leavitt

http://www.house.gov/delauro/press/2005/September/FDA_timeline_09_27_05.html

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