FDA Delays Decision on Nonprescription Sales of Plan B, Calls for Public Comment; Critics Say Decision Politically Motivated

Main Category: Public Health
Article Date: 30 Aug 2005 - 11:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

FDA Commissioner Lester Crawford on Friday 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 (Kaiser Daily Reproductive Health Report, 7/19). The Senate confirmed Crawford to head FDA on July 18 (Schuler, CQ Today, 8/26).

Crawford Comments, Barr Reaction
Crawford at a press conference on Friday said that science supported giving nonprescription access to Plan B to women 17 and older but added that the application presented FDA "with many difficult and novel policy and regulatory issues," including how to keep girls 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). Crawford added that through the public comment period will allow interested parties to "weigh in on the questions of whether a drug may be both prescription and over-the-counter based on uses by different subpopulations and whether the prescription and over-the-counter versions of the drug may be marketed in a single package" (FDA statement, 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, Murray Comments
Rodham Clinton said FDA "broke their promise to Senator 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).

Next Steps
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. However, 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 would 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).

NPR's "Weekend Edition Saturday" reported on FDA's delay of a ruling on Plan B. The segment includes comments from Crawford and Murray (Silberner, "Weekend Edition Saturday," NPR, 8/27). The complete segment is available online in RealPlayer.

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.