GAO Questions FDA Decision on 'Morning-After' Pill

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A new government audit has found that the Food and Drug Administration may have decided to deny permission for the so-called "morning-after" pill to be sold without a prescription well before the scientific review was complete.

The Government Accountability Office launched its year-long investigation after lawmakers questioned whether politics, rather than science, dictated the FDA's May 2004 rejection of the application by Barr Laboratories to sell "Plan B" over-the-counter. Plan B is emergency contraception. Consisting of two high doses of regular birth control pills, the drug can prevent pregnancy if taken soon after unprotected intercourse.

The GAO's findings, released Monday, confirmed many lawmakers' charges. "They overruled the advice of the scientific panels and the medical staff," said Rep. Carolyn Maloney (D-NY), one of nearly 50 House members and senators who requested the study. "In fact, the report demonstrates that this decision was made before the scientific review of Plan B was even finished," she said.

But the GAO did not determine exactly when the decision was made. Two mid-level scientists told the GAO that superiors told them in late December 2003 or early January 2004 that the decision to deny the application had already been made. They said the decision had come directly from the office of the FDA commissioner. The scientific reviews were not completed until April 2004.

In an unusually angry rebuttal to the GAO, the FDA officials in question said the decision to reject Plan B wasn't made until months after the scientific review was complete. A spokesman for then-FDA Commissioner Mark McClellan said the commissioner neither made the decision, nor offered recommendations about Plan B. McClellan left the FDA in March of 2004. He now heads the Medicare and Medicaid programs.

The GAO also found other "unusual" processes involved with the Plan B application.

For example, over the past 10 years, FDA advisory committees recommended that 23 prescription drugs be switched to over-the-counter status. Plan B's application was the only one to be rejected by the agency.

Plan B was also the only medication whose "not approvable" letter to the manufacturer was signed by a high FDA official — in this case Steven Galson, acting director of the Center for Drug Evaluation and Research — rather than by the scientists who conducted the reviews.

The original draft of the GAO report said the reviewers declined to sign the letter. But the FDA said officials knew the reviewers disagreed with the decision, so they were never asked.

The GAO didn't examine whether anyone higher in the Bush administration participated in the decision about Plan B. But Rep. Maloney says she wouldn't be surprised, particularly given the pressure on the White House from conservative lawmakers and groups who claimed that easier access to the drug might encourage young teenagers to become sexually active.

"This is a White House that won't even say if the president supports birth control in general," she told NPR. "We've asked (Bush) and his representatives several times whether he supports birth control and they haven't answered."

Meanwhile, a revised application for Plan B is still pending at the FDA. It would allow the pills to be sold over-the-counter to women and older teens, but only with a doctor's order for those younger than 16.

Still, Sen. Patty Murray (D-WA) says the problems at the FDA uncovered by the GAO go beyond the availability of birth control.

"It is the one agency in the government that all of us rely on, on a daily basis," Murray said. "When we go to the store to buy a drug we need to know that it's safe and effective to use. If that credibility is not there, it undermines the gold standard that the FDA has not just in this country, but in the entire world."

FDA officials declined to be interviewed about the report, but the agency did release a sharply worded written statement.

"We question the integrity of the investigative process that results in such partial conclusions," said the statement from Julie Zawisza, acting assistant commissioner for public affairs. "The report mischaracterizes facts and does not appear to take into consideration the input provided by the FDA. We stand by the original decision to issue a Not Approvable letter to Barr Labs for OTC Plan B."



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