News Releases

Murray, Clinton: Dr. Wood's Resignation Tremendous Loss to FDA, Scientific Integrity,and Women's Health

Aug 31 2005

Call for Senate Hearing on Plan B in Letter to HELP Committee Chairman Enzi

(WASHINGTON, D.C.) – Senators Patty Murray (D-WA) and Hillary Rodham Clinton (D-NY) were dismayed to learn that Dr. Susan Wood, Assistant Commissioner for Women’s Health and Director of the Office of Women’s Health, resigned from the FDA today citing concerns about the FDA's process for considering the Plan B application for over-the-counter status.

"The FDA and the American people lost a strong voice for scientific integrity in Dr. Wood. It is deeply disturbing that an agency long recognized for making decisions based on sound science has become so politicized that one of its most widely respected, long-serving veterans would feel disillusioned enough to quit in protest," they said.

Dr. Wood's statement of resignation confirms what Senators Murray and Clinton have contended for two years -- that the science has taken a backseat to politics in the FDA's decisionmaking process for Plan B. "I have spent the last 15 years working to ensure that science informs good health policy decisions. I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," said Dr. Wood in a statement released today.

"Unfortunately this is just the latest in a long list of examples of the Bush Administration suppressing science when it doesn't fit their political agenda," said the Senators.

Senators Clinton and Murray underscored that today’s resignation only intensifies the need for the Senate to examine the extended delays surrounding the over-the-counter application status of Plan B emergency contraceptives. The Senators sent the following letter to Senate Health Education Labor and Pensions Committee Chairman Michael Enzi again urging him to uphold his promise to hold a hearing and calling on him to ensure that the work of the HELP Committee and Congress are not undermined by politics and ideology at the FDA.

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August 31, 2005

The Honorable Michael Enzi
Chairman, Committee on Health, Education, Labor and Pension
Washington, D.C. 20510


Dear Chairman Enzi, In light of the FDA’s recently broken promise to issue a decision on the over-the-counter application of Plan B by September 1st, we write to ask that you fulfill the commitment you made in July to investigate the source of the agency’s continued delays.

As U.S. Senators we make a commitment to protect the safety and well-being of the American public and we take this responsibility seriously. It is both disappointing and frustrating that our job has been hindered by the disingenuous actions of HHS and the FDA with regard to Plan B emergency contraceptives.

In a July 13th letter, HHS Secretary Michael Leavitt gave you his word that a decision on Plan B’s over-the-counter application would be made by September 1:

“I have spoken to the FDA, and, based on the feedback I have received, the FDA will act on this application by September 1, 2005.”


Based on Secretary Leavitt’s promise to you that the FDA would deliver a yes or no answer by September 1, we lifted our hold on the President’s nominee to head the agency.

The President now has his FDA administrator, but the American public still does not have an answer on Plan B.

Mr. Chairman, the Secretary has not only broken a promise to you and to Congress, but he broke his promise to the American people.

This process has raised fundamental questions about the FDA’s drug approval practices and the future independence and credibility of the agency.

The Senate HELP Committee has worked diligently to provide the FDA with the resources necessary to review pharmaceutical applications in a timely fashion while still ensuring the safety of the American public. Our Committee has taken seriously our responsibility to write and enact laws like the Prescription Drug Marketing Act to eliminate unnecessary bureaucratic delays in bringing safe, effective drugs to consumers. It is critical to the future of the drug approval process that the laws Congress has worked so hard to pass not be undermined by politics and ideology.

Mr. Chairman, you have been very fair and respectful in working with us on our concerns over Plan B. You also made a commitment to us that you would hold bring leaders of the FDA before our Committee if the agency dug in its heels and continued to further delay this application process.

A delay is not a decision, and no amount of semantics can change that. The Secretary can play word games all he wants, but it is time for the FDA to stop playing games with the health and well being of millions of American women.

We ask you now to fulfill your commitment to hold a hearing of the HELP Committee to look into the serious issues of independence and credibility that FDA Administrator Lester Crawford’s continued delays on Plan B have raised about the agency as a whole.

The FDA has known since last July that the application under consideration only allowed over-the-counter access for girls 16 and older. Yet, it waited a year and one month to start a process for determining how to implement such an age restriction. These concerns should have been dealt with within the normal FDA review process, not at the eleventh hour.

The FDA’s only criteria for approval of Plan B should be safety and efficacy, not politics or ideology.

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 urge you to honor your promise to hold a hearing and insist that action be brought swiftly on Plan B’s application.

Sincerely,

U.S. Senator Patty Murray
U.S. Senator Hillary Rodham Clinton
Cc: The Honorable Edward M. Kennedy, Ranking Member