(Washington, DC) -- Senators Patty Murray (D-WA) and Hillary Rodham Clinton (D-NY) today sent the following letter to Secretary of Health and Human Services Michael Leavitt urging him to launch an investigation into a memo sent by Dr. David Hager to Acting Commissioner Lester Crawford on Plan B. The Senators reiterated their concern that FDA decision-making process was being driven by personal beliefs and ideology over science.
May 12, 2005
The Honorable Michael O. Leavitt
United States Department of Health and Human Services
Washington, D.C., 20201
Dear Secretary Leavitt:
We write to urge you to immediately initiate an investigation into reports in this morning’s Washington Post and The Nation that W. David Hager was asked to write a memo to the FDA commissioner about Plan B. According to the reports, Dr. Hager was requested to write the memo after an FDA Advisory panel voted in favor of making Plan B available over-the-counter. If substantiated, these allegations seem to leave little doubt that the process for considering Barr Laboratories’ application was based not on science, but on personal beliefs.
Both The Washington Post and the Nation report that Dr. Hager stated in a videotaped sermon that he was asked to write a “minority report” outlining why over-the-counter sales of Plan B should be rejected. It is unclear whether the FDA asked Dr. Hager to write a report, with the Washington Post reporting that he has given conflicting accounts to reporters.
On the taped sermon itself, Dr. Hager states that “I was asked to write a minority opinion that was sent to the commissioner of the FDA. For the second time in five decades, the FDA did not abide by its advisory committee opinion, and the measure was rejected… I argued from a scientific perspective, and God took that information, and he used it through this minority report to influence the decision. Once again, what Satan meant for evil, God turned into good.”
As we have previously stated, we are concerned that the FDA’s decision-making process is placing personal beliefs over science. And Dr. Hager’s statements only add to our deep concern. The FDA should never let political considerations interfere with scientific treatment decisions.
Day-by-day, the public’s confidence in the FDA’s ability to make decisions based on scientific evidence of safety and efficacy is eroding. We asked Acting Commissioner Crawford weeks ago to make a decision about Plan B – yes or no. Unfortunately, the American people have yet to hear from Dr. Crawford and the FDA.
We urge you to commence an investigation into the serious issues that this memo has raised and make your findings available to the public as soon as possible. As part of your investigation, we also request that the videotape be made available to allow Members of Congress and the American people to hear first-hand Dr. Hager’s complete explanation about the memo.
Hillary Rodham Clinton