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Another FDA Expert Resigns in Protest over Plan B Non-Decision; Legislators Urge Acting FDA Commissioner to Approve Over-the-Counter Status

Dr. Frank Davidoff recently joined the ranks of those who have resigned in protest of the U.S. Food and Drug Administration's (FDA) handling of the decision on whether to gramt over-the-counter status to emergency contraception pills. The FDA has indefinitely postponed a decision on Barr Laboratories' application for nonprescription sales of its emergency contraceptive (EC) Plan B. In late August, the FDA's top women's health official, Assistant Commissioner for Women's Health Susan Wood, also resigned in protest.

In his short, five-paragraph letter to the FDA resigning as a consultant and former member of the FDA's influential Nonprescription Drugs Advisory Committee, Davidoff wrote, “I can no longer associate myself with an organization that is capable of making such an important decision so flagrantly on the basis of political influence, rather than the scientific and clinical evidence… I'm truly sorry it has come to this, since the agency serves an extraordinarily important function, and I generally respect the staff and the work they do.”1

Davidoff, editor emeritus of the Annals of Internal Medicine, was a member of the advisory panel that voted to recommend the approval of Plan B for nonprescription sales in 2003. Since the panel's recommendation that EC be made available over the counter—a move supported by a broad range of professional medical groups, two FDA advisory panels, and the agency's own expert staff—the FDA has continued to postpone an official decision, employing one political stall tactic after another. Davidoff's resignation stems from his disappointment over the FDA's foot-dragging since the 2003 positive recommendation.

Davidoff had considered resigning in May 2004, when the FDA issued a “not approvable” letter in response to Barr's original application to allow Plan B to be sold without a doctor's prescription. In its letter, the FDA expressed concerns regarding over the counter (OTC) access for teens 16 and under and suggested that Barr Laboratories could submit a new application under which Plan B would be available OTC for women 17 and over but younger teens would still be required to obtain a prescription. Although distressed with the decision, Davidoff felt strongly that he might be more effective continuing to work with the agency.

He abandoned this line of thinking, however, when Former FDA Commissioner Lester Crawford delayed action for the third time this past August. Crawford explained that the FDA had concerns over whether or not a product could be sold both over the counter (OTC) and with a prescription in the same packaging. He issued an Advance Notice of Proposed Rulemaking (ANPR) to request comment on whether the FDA has the authority to approve a drug in both prescription and OTC form and whether such a limitation would be enforceable.2 Consequently, Davidoff said that the FDA is favoring politics over science in delaying approval of the drug for nonprescription sales. “There wasn't any observable scientific or procedural reason for them to first decline and then further delay the decision… [I]t seemed to me that [this] was unacceptable,” said Davidoff.3

Davidoff not only feels that the “Plan B meltdown” at the FDA has taken its toll on millions of women because of “a compromised federal agency [that] has failed to serve,” but also feels that the agency itself is in disarray and worries about how long it will take for the agency to recover its reputation. “I can tell you quite definitely that the FDA staff is more than upset,” he said. “I got an e-mail today from a prominent FDA official saying that the staff is demoralized and depressed. It's quite a benefit that the American people have, trusting the reliability and safety of their drugs. But for that to continue, people have to believe in the FDA's science. The record of decisions on Plan B could well shred that credibility.”4

William Smith, vice president for public policy at SIECUS, said of Davidoff's resignation, “it is a shame that the FDA has lost another unbiased doctor who felt that his scientific integrity was compromised due to the politicization of the agency. Dr. Davidoff's resignation is yet another stain on the reputation of the agency. The FDA needs to stop playing politics and make the sound medical decision to allow emergency contraception to be available without a prescription.”

Legislators Urge Approval of Plan B

Following on the heels of Davidoff's and Wood's resignations, as well as the third non-decision by the agency, a bipartisan group of 62 U.S. lawmakers called on the new acting head of the FDA to approve Barr Pharmaceuticals' application to make Plan B available over the counter. In a letter to Acting FDA Commissioner Dr. Andrew von Eschenbach, who has temporarily replaced Former FDA Commissioner Lester Crawford who stepped down last month, the members of Congress stopped just short of accusing the agency of making its decisions thus far on the basis of politics and chided officials for ignoring evidence.

In a letter dated October 7, 2005, the lawmakers wrote, “we believe this new delay does not truly reflect valid scientific or regulatory concerns…We find it contradictory and disconcerting that the FDA's concerns are a direct result of the agency's own recommendations last May.” The group of lawmakers, which included six Republicans and one Independent, wrote that, “by further delaying the FDA's decision to expand access to emergency contraception, you are seriously hindering efforts to reduce abortions across the U.S. ” The lawmakers called on von Eschenbach to approve Plan B “without further delay.”5

References

  1. Rinker Buck, “Plan B Casualties,” Hartford Courant, 2 October 2005, accessed 12 October 2005, <www.courant.com>.
  2. Ibid.
  3. “FDA Adviser Resigns Over Plan B Handling,” AP/San Jose Mercury News, 6 October 2005, accessed 12 October 2005, <www.mercurynews.com>.
  4. Buck.
  5. U.S. Lawmakers Call for Morning-After Pill Approval,” Reuters, 11 October 2005, accessed 12 October 2005, <msnbc.msn.com>.

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