September 10,2004

Grassley Seeks Complete Information from Food and Drug Administration

WASHINGTON — Sen. Chuck Grassley is keeping pressure on the Food and DrugAdministration to respond fully to requests he has made during the last five months fordocuments related to the safety of pediatric use of antidepressants.

The senator said that the public health and safety agency has provided some informationbut that other important information has not yet been delivered, even after a long period of time,or it has been delivered in an incomplete form. Grassley met on July 6 with the Food and DrugAdministration's acting commissioner, who provided assurances that the agency would cooperatefully with Congress.

The text of Grassley's most recent letter to the Secretary of Health and Human Servicesand the Acting Commissioner of the Food and Drug Administration follows here. Grassley hasbeen conducting oversight of the Food and Drug Administration from his position as Chairmanof the Senate Committee on Finance.

September 7, 2004

The Honorable Tommy G. Thompson
Department of Health and Human Services
Hubert Humphrey Building, Room 416 G
200 Independence Avenue, SW
Washington, D.C. 20201

Mr. Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane, Room 1547
Rockville, MD 20857

Dear Secretary Thompson and Dr. Crawford:

Since May 4, 2004, the Food and Drug Administration (FDA) has respondedincompletely to my requests for information related to whether the FDA is effectively addressingdrug safety concerns, and protecting the public health at the level expected by the Americanpeople. Specifically, for several months now my Committee staff has reviewed, among otherconcerns, whether the FDA suppressed an analysis completed by Dr. Andy Mosholder about thepossible link between antidepressants and suicide among children and adolescents. While someinformation has been provided on a timely basis, quite a number of requests remain outstandingand deadlines have long ago passed.

Dr. Crawford, when we met awhile ago, you assured me that the FDA would respondcompletely and cooperate fully with the Committee on these matters. Further, my Committeestaff reached an agreement with FDA staff that information and documents would be providedconsistently on a “rolling basis.” However, as I have stated previously, the FDA continues todelay and provide incomplete information and responses. Accordingly, I would appreciate yourimmediate attention to these outstanding requests:

1. On May 18, 2004, I requested that the FDA supply a number of documents regardingDr. Mosholder’s report on antidepressants. The FDA responded to this request on July 12th andJuly 28th. However, the FDA did not respond to question #6 in my letter dated May 18th.Specifically, I requested all e-mails regarding the contents and findings of Dr. Mosholder’s reporton SSRIs. I asked that the FDA include all e-mails written by Drs. Mosholder, Seligman,Trontell, Avigan, Temple, Jenkins, Katz, and Laughren. This response was due on May28th—more than three months ago.

2. On June 1, 2004, I asked that the FDA advise its employees that they have the right tospeak directly to Congress or to a Committee of Congress without interference. After the FDAfailed to address this request, I asked again in a July 2nd letter. It is now September and I havenot yet heard from the FDA whether it will notify its employees that they are free to speak to me,to my staff members and to Members of Congress without fear of reprisal.

3. On June 3, 2004, I requested that the FDA provide all documents and correspondencebetween the Office of Drug Safety and GlaxoSmithKline (GSK) regarding the antidepressants,Paxil. In addition, I requested all documents and correspondence between Dr. Mosholder andGSK regarding the data GSK submitted to the FDA on Paxil. The FDA has failed to respond toeither of these requests that were due on June 14th.

4. On July 23, 2004, I sent the FDA a detailed list of questions and documentationrequests regarding the following:

a) the Columbia University Reclassification Study;

b) FDA’s July 2nd response to my May 11th letter;

c) the organizational structure of the Office of New Drugs and the Office of Drug Safety;

d) potential conflicts of interest in the Office of the Chief Counsel;

e) FDA’s Independent Validation and Verification process for clinical trial data; and

f) recent news reports regarding the alleged concealment of safety data by drug manufacturers.My letter dated July 23rd set a deadline of July 30th and the FDA has failed to respond tothis inquiry entirely. In addition, some of these questions are repeated from my letter dated May11th, which was due in full on June 7, 2004. My letter dated July 2, 2004, also brought up theissue of outstanding document requests and long overdue deadlines.

In closing, I request the aforementioned documentation immediately. While some delaymay be unavoidable and even understandable, months of delay and a pattern of incompleteresponses and information is not consistent with your personal assurances to me. Reasonableextensions of time may be appropriate at times, but the FDA cannot simply side-step itsresponsibilities to Congress. FDA’s response to date and further delay is simply unacceptable.

Please have your staff coordinate with my staff regarding this letter by Friday, September10th. Thank you in advance for your written response by September 17, 2004, unless it isavailable sooner. In responding to my requests, please repeat each numbered request, followed byits accompanying response. In the event that documents or other materials are requested, pleasebe sure to mark them accordingly.


Charles E. Grassley