Senator Clinton, Colleagues Call for “Plan B” ProbeSenators Seek Oversight Hearings and a Formal Investigation Washington, DC – Senator Hillary Rodham Clinton (NY) and several of her Senate colleagues called, today, for a thorough investigation of the Food and Drug Administration's (FDA) denial of Barr Laboratory's application to designate "Plan B" an emergency contraceptive that would be available without a prescription. The Senators are demanding oversight hearings and a review by the General Accounting Office (GAO), Congress' independent investigative arm. This denial came despite the determination by the FDA's Advisory Board that the drug is effective and should be distributed over the counter. Furthermore, more than 70 organizations, including the American Academy of Pediatrics, the American Association of Family Physicians and the American Medical Association supported Barr Lab's application. "This appears to be an unfortunate triumph of politics over science," said Senator Clinton. She called the FDA decision "a sad example of the Administration pandering to its conservative base at the expense of women's health." In a virtually unprecedented move, the final decision was made by Acting Center Director Dr. Steven Galson rather than the scientific reviewers who usually issue such decisions. Senator Clinton and her colleagues sent a letter, today, to Senator Judd Gregg (R-NH), Chairman of the Health, Education, Labor and Pensions Committee, calling for oversight hearings into the FDA's action. A second letter has been sent to the GAO seeking an investigation. "Through hearings and an investigation by the GAO we should be able to determine whether the FDA violated protocol and ignored scientific evidence to arrive at its decision. We also want to know if there was any intervention by the White House in this process," said Senator Clinton. Copies of the Senators' letters to Senator Gregg and the GAO are attached below:
The Honorable Judd Gregg Dear Chairman Gregg: We write to request that the Committee on Health, Education, Labor and Pensions schedule an oversight hearing about the Food and Drug Administration's (FDA) recent refusal to approve the over-the-counter application for Plan B, an emergency contraceptive. The refusal came after the FDA's own joint advisory committee voted overwhelmingly to recommend approval of the application. Reports have indicated that there may have been irregularities in the decision and the process by which it was arrived, and we find the reports troubling enough to believe the issue merits oversight by the committee. In particular, we would like to hear expert testimony from the FDA acting commisioner and other experts on the following points: • Who, specifically, made the decision that Plan B's application was nonapprovable, and on what specific grounds? • What was the role of the Acting Commissioner in this decision? • Are there other examples of cases in which professional agency staff and overwhelming, near-unanimous votes of advisory committees were overridden by more senior-level staff in the agency? • Has the FDA ever approved over-the-counter switches without requiring data on adolescent use such as those the agency required of Plan B? • What communication did the Acting Center Director have with political appointees at FDA, Department of Health and Human Services, or White House on this matter? • Finally, the nonapprovable letter claims that the FDA did not conduct a complete review of the application. Yet the ostensible purpose of the 90-day delay in the application's consideration announced by the FDA in February was to allow agency staff sufficient time for review. If the application was still not fully reviewed by May, why was another delay not suggested – instead of ruling the application altogether nonapprovable? We believe these questions are important and worthy of the committee's time and resources. We stand ready to work with you, should you decide to organize such a hearing, and look forward to what we hope will be a favorable response to our request. Sincerely, - - - - -
The Honorable David M. Walker On May 6th, 2004, the Food and Drug Administration (FDA) rejected Barr Laboratories application to allow the "Plan B" emergency contraception pill to be sold over-the-counter (OTC). This decision was made in spite of the overwhelming support of an FDA advisory panel, which voted 23-4 in December of 2003 to approve Plan B for over-the-counter status. The panel also unanimously agreed that Plan B is safe for use in the non-prescription setting and unanimously rejected the claim (voting 0-28) that use of Plan B leads to substitution of emergency contraception for the regular use of other methods of contraception. More than 70 organizations—including the American Academy of Pediatrics, the American Association of Family Physicians, and the American Medical Association—submitted testimony in support of making Plan B available without a prescription. Dr. Julie Johnson, a member of the Nonprescription Drug Advisory Committee concluded, "I've been on this committee…for almost four years, and I would task this to be the safest product that we have seen brought before us." We have grave concerns that the FDA's decision to deny Plan B OTC status was based on politics rather than scientific evidence. In January, a group of forty-nine conservative members of Congress sent a letter to President Bush urging him to prevent the FDA from granting Plan B over-the-counter status. After this letter was sent, the FDA announced in February that it would delay its decision on Plan B by an additional 90 days. Experts and former FDA officials have spoken out about the Plan B decision, saying that they cannot recall a time where an FDA Director had overruled the recommendations of an advisory panel and FDA staff. Furthermore, in a virtually unprecedented move, the final decision on Plan B's OTC status was made by the Acting Center Director, Dr. Steven Galson, rather than by the scientific reviewers who usually issue a decision. In interviews with The New York Times, Dr. Raymond Lipicky, who was with the agency for 18 years and retired in 2002, said "I can't ever remember the center director ever signing a nonapprovable letter,'' while Dr. Robert R. Fenichel, who was with the FDA for 12 years said, "This is simply unheard of." Even the rationale used by the FDA to reject the application seems to be unfounded based on scientific evidence. Hundreds of studies reviewed by the panel showed that emergency contraception is safe for teenagers and that its use is not associated with increased risk for future sexually transmitted infections or pregnancy. According to Dr. Hewitt, a member of the advisory panel, "we have lots of information in the medical literature that shows that [emergency contraception] would be completely safe for teenagers to use… and I see no reason that medically a young, adolescent woman would not use Plan B safely." Plan B prevents 95% of pregnancies if taken within 24 hours of unprotected sex. Since half of all pregnancies in this country are unintended, making emergency contraception available without a prescription could significantly cut health care costs and the number of abortions performed. We write to request that the General Accounting Office (GAO) review key issues concerning the process by which FDA considered this evidence and subsequently rejected the Plan B's OTC application. Accordingly, we would like GAO to commence an audit that would answer the following questions: 1. In the past twenty years, has the Center for Drug Evaluation and Research (CDER) director ever overridden staff and advisory committee recommendations, in particular ones that received votes of more than three-quarters of the advisory panel? If so, what were those specific instances and why did they occur? 2. In the past twenty years, what has been FDA's practice with respect to data on adolescents when reviewing OTC switches? If that practice has changed, describe and assess those changes. How does FDA's use of adolescent data when reviewing the Plan B OTC switch compare with its use of adolescent data in other, recent OTC switches? 3. Who made the decision that Barr Laboratory's application is nonapprovable and why? Is there written documentation of the decision? If so, we would like to see a copy of this decision. 4. Was the Acting Center Director alone in making the decision? Is there written documentation of this? If so, we would like a copy and we would also like to know how many times this has happened in the past. If there was not written documentation, please explain why. 5. What communication did the Acting Center Director have with political appointees at FDA, HHS or White House on this matter? Please provide any and all copies of this correspondence, including emails, phone logs, etc. 6. What was the role of the Acting Commissioner in this decision? Is it documented? If not, why not? As you proceed with this request, we would appreciate you keeping us informed of your progress. Thank you in advance for your cooperation. Sincerely,
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