FDA Indefinitely Defers Decision on Emergency Contraceptive Plan B
FDA Commissioner Lester Crawford on Aug. 26 said the agency is indefinitely deferring Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B and opening a 60-day public comment period on the application, sparking charges that the decision was motivated by politics rather than science, Reuters reports (Richwine, Reuters, 8/26). FDA in May 2004 issued a "not approvable" letter in response to Barr's original application to allow Plan B -- which can prevent pregnancy if taken within 72 hours of sexual intercourse -- to be sold without a doctor's prescription and in January delayed a ruling on Barr's revised application, which would allow EC to be sold without a doctor's prescription only to women ages 17 and older.
During a confirmation hearing in March, Crawford told the Senate health committee that FDA would approve the application "within weeks." As a result of the delay, Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) in June blocked a full Senate vote on Crawford's nomination and said they would maintain the hold until FDA made a decision on Barr's Plan B application. However, the senators in July agreed to lift their holds after HHS Secretary Mike Leavitt in a letter to Sen. Mike Enzi (R-Wyo.), who chairs the Senate Committee on Health, Education, Labor and Pensions, said that FDA would make a decision on Barr's application by Sept. 1 (California Healthline, 7/19). The Senate confirmed Crawford to head FDA on July 18 (Schuler, CQ Today, 8/26).
Crawford at a press conference said that science supported giving nonprescription access to Plan B to women ages 17 and older but added that the application presented FDA "with many difficult and novel policy and regulatory issues," including how to keep girls ages 16 and younger from obtaining the drug. "FDA cannot have an inspector in every pharmacy in the U.S.," he said (Harris, New York Times, 8/27). Crawford also said that because FDA decided nonprescription access to the drug was safe for women ages 17 and older but Barr's application specified that women must show proof that they are age 16 or older to purchase the drug, the agency was unable to come to a conclusion. Crawford said FDA had to consider at "what age do they have the ability to interpret the instructions" on how to take the prescription (CQ Today, 8/26).
Barr CEO Bruce Downey said he was "very disappointed" in the ruling and frustrated that there is no definite timetable for ruling on the application. "I thought we'd done everything that had been asked of us," Downey said (Wilde Mathews/Abboud, Wall Street Journal, 8/29). He added, "[W]e provided a detailed legal analysis supporting approval of a dual-label product and continue to believe that a dual-label status can and should be approved for Plan B" (Kaufman, Washington Post, 8/27).
However, Crawford said FDA would be making an "unprecedented" move if it distinguished how women of different ages could buy a drug with the same dosage, packaging and use (Rockoff, Baltimore Sun, 8/27).
Rodham Clinton said FDA "broke [its] promise to Sen. Murray and me, to the Congress and to the American people" by delaying the ruling on Plan B (New York Times, 8/27). Murray said she was "stunned and outraged and furious" by FDA's decision, adding, "This is not only a broken promise to us, but another frightening example of politics trumping science at the FDA" (Washington Post, 8/27).
The two senators called on Enzi to "promptly schedule a hearing to look into FDA's approval process for this drug and to ensure that American patients are receiving access to safe and effective treatments in a timely manner" (CQ Today, 8/26). Enzi spokesperson Craig Orfield said that Enzi is reviewing the request and will consider holding a hearing (CQ HealthBeat, 8/31). Orfield said Enzi had expected "a firm decision" by FDA on Plan B, not further delays (Los Angeles Times, 9/1).
FDA first approved Plan B as a prescription contraceptive in 1999, the New York Times reports (Harris, New York Times, 8/28). Barr's application for nonprescription sales of the drug have been delayed several times since December 2003, when an FDA panel of outside reviewers voted 23-4 to recommend reclassifying the contraceptive from prescription to nonprescription status. FDA rejected that recommendation in May 2004 (Reuters, 8/26). Eve Slater, assistant secretary of health from 2001 to 2003, said, "At some point the statute requires that [FDA] make a decision," adding that the Plan B application has become "overly politicized, and it shouldn't be." Kirsten Moore, president of the Reproductive Health Technologies Project, said she and other abortion-rights advocates would like Barr to withdraw its present application -- which uses data from its original application -- perform a new study on comprehension of Plan B labels for women of all ages and resubmit a new application.
Downey said the company is considering a new label-comprehension study and added that it will provide comments to FDA during the next 60 days (New York Times, 8/28). Downey said that although Barr has concentrated its efforts on FDA approval of nonprescription Plan B, the company might now push for nonprescription access at the state level. Seven states -- Alaska, California, Hawaii, Maine, New Hampshire, New Mexico and Washington -- allow pharmacists to collaborate with physicians to distribute EC through "pharmacy access" programs (Rubin, USA Today, 8/29).
Leavitt on Monday defended FDA's action, saying that he promised senators that the agency would act by Sept. 1 but never guaranteed a "yes or no" decision, Reuters reports (Heavey, Reuters, 8/29). Leavitt on Monday said, "FDA made their commitment to me, and I made my commitment to the senators. The commitment was they would act. They did." He added, "Sometimes action isn't always yes and no. Sometimes it requires additional thought."
However, Rodham Clinton and Murray in a joint statement said that Leavitt was playing "word games," adding, "A delay is not a decision, and no amount of semantics can change that" (Heavey, Reuters, 8/29). Leavitt said that in considering Barr's application, FDA found that "the science revealed significant policy questions that needed to be dealt with." He declined to speculate when FDA would issue a final decision on the application, CQ HealthBeat reports (Reichard, CQ HealthBeat, 8/29).
FDA Assistant Commissioner for Women's Health Susan Wood on Wednesday resigned from the agency in protest of its deferment on Barr's application for OTC status of Plan B, the AP/ABC News reports (Neergaard, AP/ABC News, 8/31). Wood, a biologist, had served as assistant FDA commissioner since 2000 (Rockoff, Baltimore Sun, 9/1). Wood wrote, "I can no longer serve ... when scientific and clinical evidence, fully evaluated and recommended for approval by professional staff here, has been overruled" (Alonso-Zaldivar, Los Angeles Times, 9/1).
Wood said Crawford's decision to delay Barr's current application "was not made in consultation with the normal people who are involved with the decision-making at the agency," adding, "Even in the commissioner's office, it seems there was very little awareness about what the decision would be. It seemed to be very closely held and not at all transparent to the professional staff" (Rubin, USA Today, 9/1). She said the decision on Plan B "shouldn't be about abortion politics," adding, "This is a way to prevent unwanted pregnancy and thereby prevent abortion."
Wood said she "doesn't find persuasive" Crawford's arguments for delaying the Plan B application, adding that it is unlikely FDA will make a decision on it "in the foreseeable future" (Harris, New York Times, 9/1). "I admire and respect FDA as an institution, and I worry about its credibility," Wood said, adding, "I couldn't stand there and be the face of women's health at the agency during such a decision" (Wilde Mathews, Wall Street Journal, 9/1). Wood said she does not know where she will work next (McCullough, Philadelphia Inquirer, 9/1).
FDA in a statement said Wood's resignation "is unfortunate as we work toward solving the complex policy and regulatory issues related to Plan B," adding, "The FDA is committed to protecting and advancing women's health, and under Susan Wood's leadership, the agency has made significant strides" (Kaufman, Washington Post, 9/1).
Meanwhile, Wood's resignation "ramped up the political tension" surrounding the Plan B application, the Wall Street Journal reports (Wall Street Journal, 9/1). A group of House Democrats, including House Minority Leader Nancy Pelosi (D-Calif.), has sent a letter to President Bush concerning the issue of "political influence" on scientific decisions, the Journal reports (Wall Street Journal, 9/1).