GOA Report Calls FDA’s Handling Of Plan B Application ‘Unusual’

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The New York Sun

The Food and Drug Administration’s handling of an application for the emergency contraception pill, Plan B, was “unusual,” a new government study has found. The report prompted harsh criticism of the agency from abortion-rights advocates, who said yesterday that the FDA had allowed “politics to trump science.”


The FDA has long delayed a decision on whether to make Plan B, currently a prescription drug, available over the counter, leading House and Senate members to demand a review of its handling of the “morning-after” pill.


The report released yesterday by the Government Accountability Office said the FDA had strayed from its typical decision-making process, and that it was the first time in more than a decade that the agency did not follow recommendations from its advisory committees to make a prescription drug available over the counter. The FDA disputes the conclusion of the GAO report, saying it followed standard procedures.


“Politics infected what should have been a medical decision,” Rep. Carolyn Maloney, a Democrat of New York, told reporters yesterday outside City Hall. Ms. Maloney, who has sponsored a bill to force the FDA to decide on Plan B, said she would push for congressional hearings on the topic. The FDA yesterday defended its decision not to approve Plan B and said the GAO “mischaracterized facts” in its report. “We question the integrity of the investigative process that results in such partial conclusions by the GAO,” an agency spokesman, Yier Shi, said in a statement.


In a response to a draft of the GAO report, the FDA had disputed findings that its decision-making process for Plan B was atypical. The GAO had questioned the involvement of high-ranking agency officials in the decision, but the FDA said that was the norm for “high profile, controversial applications.”


The agency also took issue with the GAO’s suggestion that the FDA may have decided not to approve Plan B before the scientific review had been completed.


A spokeswoman for Planned Parenthood said “anti-choice fingerprints” were all over the FDA decision, and the head of the National Organization for Women’s New York branch called it “an outrage” that the agency had not approved Plan B’s over-the-counter status.


Plan B, known as the “morning-after” pill, is more potent than regular birth control and must be taken within 72 hours to effectively prevent pregnancy. It is most effective if taken within the first 24 hours after intercourse.


Some social conservative groups have opposed making Plan B available over the counter, especially to teenage women. They contend it would make younger women more likely to engage in risky sexual activity if an emergency contraceptive were so easily available.


The GAO report is the latest hiccup for the regulatory agency, whose former commissioner, Lester Crawford, resigned in September, just two months after his much-delayed confirmation by the Senate. The FDA first approved Plan B as a prescription drug for emergency contraception in 1999. Four years later, the agency said it would review an application to change the drug’s status to over-the-counter.


In December 2003, a scientific advisory panel overwhelmingly recommended that the FDA approve a status change for Plan B. But six months later, the agency deemed the drug “not approvable” for over-the-counter access, citing concerns about safe use by younger adolescent women.


The FDA’s action on Plan B triggered a backlash within the agency and among Democrats on Capitol Hill, where Senator Clinton threatened to hold up the nomination of Mr. Crawford, then acting commissioner, until a decision was made on the drug. Mr. Crawford promised to act by September 2005, but in late August he announced another delay, this time for a public comment period on a revised request for the drug to be available without a prescription only to women over 16. He resigned less than a month later.


The repeated delays also prompted the FDA’s top women’s health official, Susan Wood, to resign in protest, Ms. Wood said. An FDA official said yesterday the agency was reviewing thousands of comments on Plan B, and a decision did not appear imminent. In a joint statement yesterday, Mrs. Clinton and Senator Murray, a Democrat of Washington, said the GAO report confirmed their suspicions that the FDA’s handling of Plan B was politically motivated.


“How can American consumers regain confidence in the FDA if science is so clearly overlooked by its leading officials?” the senators said. “Despite overwhelming evidence that Plan B is safe and effective, politics trumped science in this case.”


The New York Sun

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