Washington Watch: FDA fails to rule on EC OTC status . . . again
FDA fails to rule on EC OTC status . . . again
By Cynthia Dailard
Senior Public Policy Associate
Guttmacher Institute
Washington, DC
(Editor’s note: About 86% of the 2005 Contraception Survey respondents say their facility prescribes emergency contraception on site and provides the method at any time. About 57% say they now include advance emergency contraception provision in their practice.)
On Aug. 26, the U.S. Food and Drug Administration (FDA) announced that it would indefinitely postpone its decision to allow nonprescription status for the emergency contraceptive pill Plan B — popularly known as the "morning-after pill." The agency explained it would delay any action to make the product available over-the-counter (OTC) while it gathers public comments on the legality and feasibility of a regulatory scheme that the agency recommended the manufacturer, Barr Laboratories, pursue.
The move — which came more than a year and a half after two of the agency’s expert advisory panels voted overwhelmingly to recommend OTC status for the drug — prompted a fierce outcry among women’s health advocates, scientists, and key members of Congress, who denounced it as another example of the Bush administration putting politics before science. In fact, an editorial in the New England Journal of Medicine deemed the announcement "a sad day for science at the FDA" and said the "decision — or nondecision — deserves serious scrutiny, since it appears to reflect political meddling in the drug-approval process."1
Plan B’s journey to OTC status has been long and torturous. In response to Barr’s April 2003 application for OTC status, an FDA expert advisory panel in December of that year unanimously deemed the drug safe for OTC use and voted overwhelmingly that the drug should be made available OTC. When asked specifically about whether the product should be available to adolescents OTC, only three of the panel’s 28 members objected and claimed that the evidence did not adequately assess the impact of wider access on adolescent sexual behavior, especially among younger adolescents. These objections came even though the committee had before it scientific studies showing that the drug is safe for young teen-agers and that advanced access to emergency contraception did not increase unprotected sex.
Under enormous political pressure from social conservatives to reject the recommendations of its own advisory panel, the FDA announced in February 2004 that it would delay a decision for 90 days while it reviewed the data on adolescents. In May, the agency officially rejected the application. At that time, it encouraged Barr to resubmit an application pursuing a dual marketing plan that would permit the OTC sale of Plan B without a prescription for women aged 16 and older, while maintaining the prescription status for women aged 15 and younger.
Barr’s application for dual status, however, would languish at the agency for months with no response. In fact, the agency’s failure to act prompted two influential members of Congress — Sens. Hillary Clinton (D-NY) and Patty Murray (D-WA) — to prevent Lester Crawford’s nomination to head the FDA from moving forward until they were assured by Health and Human Services Secretary Michael Leavitt that the FDA would render a yes or no decision by Sept. 1.
Back to the future
Yet only days before that Sept. 1 deadline, the agency announced that it might not in fact have the legal authority to grant the dual status scheme that it had recommended Barr pursue. It stated that it would postpone any decision on Barr’s application, and it opened a 60-day comment period. It invited public input on the feasibility and legality of the dual-status and related enforcement issues.
This turnabout infuriated Sens. Clinton and Murray. Angered by what they perceived to be a personal betrayal and political double-cross, the senators have urged Michael Enzi (R-WY), chairman of the Senate Health, Education, Labor, and Pensions Committee, to hold a hearing on the FDA’s decision-making process. Thirteen senators also sent a letter urging the Government Accountability Office (GAO) to quickly conclude the investigation they requested in June 2004 into why the FDA rejected the application to make Plan B available OTC to women of all ages. The GAO responded within a week that it would release those findings by October.
Another casualty of the FDA announcement was Susan Wood, assistant commissioner for women’s health and director of the FDA Office of Women’s Health, who resigned in protest over how the FDA has handled the Plan B application for OTC status. In an interview with the Chicago Tribune, Wood explained her decision. "I couldn’t stand quietly as head of women’s health while this decision, which is contrary to women’s health, was made," she said.2
What will happen after the conclusion of the 60-day public comment period remains to be seen. As each day goes by, it is looking more and more dubious that Plan B will ever be available over-the-counter to U.S. women — of any age. This represents both a great loss for American women and a significant blemish on the record of the FDA.
References
- Wood AJ, Drazen JM, Greene MF. A sad day for science at the FDA. New Engl J Med 2005; Sept. 1 [Epub ahead of print]. Accessed at: content.nejm.org/cgi/content/abstract/NEJMp058222.
- Lara AN. Dismay over delay spurred FDA officer. Chicago Tribune, Sept. 7, 2005: Accessed at: www.chicagotribune.com/features/printedition/chi-0509070010sep07,1,1821274.story.
Resources
To submit an on-line comment regarding Plan B to the Food and Drug Administration, go to the web site www.fda.gov. Next to "More FDA News," click on "Press Releases." Next, under the heading "Press Releases," click on "August 2005." Click on "FDA Takes Action on Plan B: Statement by FDA Commissioner Lester M. Crawford." Click on "Online Comment Form." Comment deadline is Nov. 1, 2005.
On Aug. 26, the U.S. Food and Drug Administration (FDA) announced that it would indefinitely postpone its decision to allow nonprescription status for the emergency contraceptive pill Plan B popularly known as the morning-after pill.Subscribe Now for Access
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