Washington, DC – Following the resignation of Dr. Susan Wood from the FDA over concerns about the FDA’s process for considering the Plan B application for over the counter status, Senators Hillary Rodham Clinton (NY) and Patty Murray (WA), joined by 11 of their colleagues in the United States Senate, called on the United States Government Accountability Office (GAO) to release the findings of an investigation underway examining the FDA rejection of the Plan B application. In addition to Senators Murray and Clinton, the letter was signed by Senators Edward Kennedy (MA), Maria Cantwell (WA), Barbara Boxer (CA), Jon Corzine (NJ), James Jeffords (VT), Christopher Dodd (CT), Daniel Inouye (HI), Debbie Stabenow (MI), Tom Harkin (IA), Mark Dayton (MN) and Charles Schumer (NY).
“After more than two years of deliberation on the application, on Friday the FDA announced that the ‘available scientific data are sufficient to support the safe use of Plan B as an over the counter product’ but it still failed to approve Plan B, opting instead to invite public comment on whether the FDA has the authority to approve the application to make Plan B available over the counter. This turn of events leaves the strong impression that concerns about politics have overridden concerns about public health in this process,” the Senators wrote.
“Yours is the only independent investigation underway on this important matter of women’s health, and it has the potential to shed much-needed light on the FDA’s actions. We hope you will finish your work in the near future to allow policymakers and the public gain a full understanding of the FDA’s process.”
The Senators requested the investigation on June 15, 2004. The findings have not yet been released nor has an update been provided on the timeframe for release.
Senators Clinton and Murray have also urged Senate Health Education Labor and Pensions Committee Chairman Michael Enzi to uphold his promise to hold a Senate hearing to investigate the extended delays surrounding the over the counter application status of Plan B.
The text of the letter follows.
The Honorable David M. Walker
Comptroller General
U.S. General Accountability Office
441 G Street, NW
Washington, DC 20548
Dear Mr. Walker:
On June 15, 2004, we requested the General Accountability Office (GAO) commence an audit into the Food and Drug Administration’s (FDA) rejection of an application to make Plan B emergency contraception available without a prescription. We understand the investigation is underway and thank you for GAO’s commitment to a thorough review. We write to ask when you anticipate completing your report and to encourage you to release your findings as soon as possible.
As you may know, after more than two years of deliberation on the application, on Friday the FDA announced that the “the available scientific data are sufficient to support the safe use of Plan B as an over the counter product,” but it still failed to approve Plan B, opting instead to invite public comment on whether the FDA has the authority to approve the application to make Plan B available over the counter.
This turn of events leaves the strong impression that concerns about politics have overridden concerns about public health in this process. As we stated in our letter last June, the FDA’s own scientific advisory committee voted overwhelmingly in favor of the product being available over the counter. Over 70 major medical organizations including the American Medical Association, the American Academy of Pediatrics, and the American College of Obstretrics and Gynecologist have weighed in in support of Barr Laboratories application. Yet, the FDA has delayed action on the application time and again.
Yours is the only independent investigation underway on this important matter of women’s health, and it has the potential to shed much-needed light on the FDA’s actions. We hope you will finish your work in the near future to allow policymakers and the public gain a full understanding of the FDA’s process.
Thank you in advance for your cooperation.
Sincerely,
Senator Patty Murray
Senator Hillary Rodham Clinton
Senator Edward Kennedy
Senator Maria Cantwell
Senator Barbara Boxer
Senator Jon Corzine
Senator James Jeffords
Senator Chris Dodd
Senator Daniel Inouye
Senator Debbie Stabenow
Senator Tom Harkin
Senator Mark Dayton
Senator Charles Schumer
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