Senators urge investigation into Hager memo to FDA on Plan B

Drug News -- May 12, 2005

Senators urge investigation into Hager memo to FDA acting commissioner on Plan B contraceptive

WASHINGTON, D.C., May 12, 2005 -- Senators Patty Murray (D-WA) and Hillary Rodham Clinton (D-NY) 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
Secretary
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.

Sincerely,

Patty Murray
Hillary Rodham Clinton

Source: Sen. Murray's Press office

TIMELINE: FDA Approval Process for Plan B Emergency Contraceptive

July 1999
The FDA approved "on label" use of Plan B as an emergency contraceptive available by prescription.

April 2003
The manufacturer submitted an application to the FDA requesting that Plan B be approved for over-the-counter (OTC) use.

8 months pass

December 2003
The FDA Advisory Committee overwhelmingly recommends the OTC approval (24-3)

February 2004
The FDA postpones its decision on the Plan B for 90 days.

3 months pass

May 2004
FDA rejects the application, stating concerns about the safe use of the drug by women under age 16.

July 2004
The manufacturer submits a response to FDA asking for OTC with age restrictions.

6 months pass

January 2005
The FDA delays its decision on Plan B again, indicating to the manufacturer that it will complete its review of the application in the near future.

2 months pass

March 17, 2005
At a HELP Committee hearing on the confirmation of FDA Nominee Lester Crawford, Senator Murray pressed Crawford to explain the delays in approving Plan B for over-the-counter use. Crawford agreed to brief Murray and other HELP Committee members before his confirmation hearing.

April 6, 2005
Nominee Crawford meets with Senator Murray and other HELP Committee members in Murray's Washington, D.C. office.

Source: Prepared by Senator Murray's Office 4/6/05

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Posted: May 2005


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