DeLauro Requests Information on Drug & Device Approvals During Final Months of Bush Admin

Washington, DC – Congresswoman Rosa L. DeLauro (Conn. -3) wrote to the Food and Drug Administration Acting Commissioner, Frank M. Totti, M.D. to request information on drug and device approvals made in the final months of the Bush Administration. Below is the text of the letter.

February 12, 2009

Frank M. Torti, M.D.

Acting Commissioner

U.S. Food and Drug Administration

U.S. Department of Health and Human Services

5600 Fishers Lane

Rockville, MD 20857

Dear Dr. Torti:

As you know, I long have been concerned about the influence of industry and political interests in the approval process for drugs and devices at the FDA. I fear that this influence has permeated the culture of the agency and has resulted in the approval of a number of products that later were proven to be unsafe and/or ineffective

The transition period between Election Day in November and Inauguration Day in January often presents an opportunity for an outgoing Administration to impose their political will on agency decisions prior to their departure. In order to ensure that this situation did not occur during the recent transition period, please provide the following information:

· A list of all medical products (drugs, devices, or biologics) that were approved or cleared by the FDA in November 2008, December 2008, and January 2009.

· For each product approved, please provide the dates of when the product application was submitted and the dates for any previous non-approval or clearance decisions of those products.

· For food products, please provide information on any agency decisions regarding the generally regarded as safe (GRAS) designations during the same time period.

Please respond to this inquiry by February 26, 2009. Thank you very much for your attention to this matter.

Sincerely,

ROSA L. DeLAURO

Chairwoman

House Appropriations Subcommittee on Agriculture

Rural Development, Food and Drug Administration,

and Related Agencies