November 29,2004

Chairman Grassley questions acting FDA Commissioner about allegations of FDA actions against drug safety official

November 29, 2004

VIA FACSIMILE: (301) 827-1960

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

Dear Dr. Crawford:

As Chairman of the Committee on Finance (Committee), I have made it clear to you that I expect that Dr. David Graham’s rights as a federal employee will be fully respected by the Food and Drug Administration (FDA). Last Wednesday, November 24, 2004, I requested that theOffice of Inspector General (OIG), Department of Health and Human Services conduct acomplete and thorough investigation into the facts, events, persons, policies, regulations and lawsrelating to allegations that a number of management level employees at the FDA may have acted“to discredit an outspoken agency safety officer who was challenging the FDA’s drug safetypolicies.” I referred to the attached article from the Washington Post entitled, “Attempt toDiscredit Whistle-Blower Alleged.”

To reiterate my own expectations, in a letter dated October 7, 2004, I stated, “I sincerelyhope that no allegations of retaliation or other prohibited personnel practices arise from anythingrelating to this Committee’s inquiry.” On November 18, 2004, in my opening comments at theCommittee’s hearing related to Vioxx, I stated:

Before the testimony begins, I want to respond to comments issued last night bythe Food and Drug Administration’s Acting Administrator, Dr. Crawford, aboutDr. Graham, our first witness. News reports today say that the FDA is calling him“a maverick who did not follow agency protocols.” . . . [T]he clarificationsprovided last night by Dr. Crawford appear intended to intimidate a witness on theeve of a hearing. . . . Dr. Crawford knows there’s a problem and would betterserve the FDA by spending time on the problem, rather than going aftercongressional witnesses who helped identify the problem in the first place.

In addition, I also stated to Dr. Sandra Kweder at the hearing: “I’d like to reiterate what Ihave repeatedly stated in writing and have verbally communicated to your agency, namely thatthis Committee takes its responsibility to protect witnesses and particularly government witnessesvery seriously, and that holds particularly true for Dr. Graham.”

The article in the Washington Post raises substantive questions about whether a number ofFDA employees “used deceptive practices against [Dr. David] Graham” and whether thoseemployees acted within the spirit and intent of all applicable laws, including, among others, lawsgoverning whistleblowers and prohibited personnel practices. As Chairman of the Committee, Irequest that the FDA cooperate fully with the OIG’s investigation. Further, I request that youadvise all FDA employees about this investigation and notify them that all records and documentsrelating in any manner whatsoever to this investigation, either directly or indirectly, must bepreserved immediately.

I understand that retaliatory action against dissident employees can come under manyguises. Therefore, I also request that you address allegations that administrative action may betaken against Dr. Graham, including that he may be terminated or transferred against his wishes toa job other than conducting scientific research. Please advise me whether there is any truth tothese allegations and, if so, explain what actions are being taken to transfer Dr. Graham from hispresent position and duties at FDA.

Beyond that, I request that you address another matter that remains outstanding. On atleast 6 separate occasions—3 by letter and 3 in meetings with FDA staff—I have requested thatFDA employees be advised that they may come to Congress and speak freely without fear ofreprisal. Do you believe that FDA employees are free to speak to members of Congress withoutadvising FDA’s Office of Legislation? If so, when are you going to act on this request?

Thank you in advance for having your staff coordinate with my staff about theseoutstanding matters by no later than December 1, 2004. Any questions or concerns should bedirected to Emilia DiSanto or Dan Donovan at (202) 224-4515. All formal correspondenceshould be sent via facsimile to (202) 228-2131 and original by U.S. mail. Please do not hesitateto contact me if you have any concerns.


Charles E. Grassley