Review process 'unusual,' GAO says of contraceptive

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Originally published 12:34 a.m., November 15, 2005, updated 12:00 a.m., November 15, 2005

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Federal health officials used an "unusual" review process last year when they decided to continue requiring a prescription for an "emergency" birth-control product considered by some to be an abortion drug, a federal watchdog said yesterday.

The Government Accountability Office (GAO) findings lend credence to a former Food and Drug Administration (FDA) official who quit in August over the decision, saying scientific evidence on the Plan B drug was being "overruled."

The FDA's May 2004 decision to refuse to allow Plan B to be sold over the counter like aspirin or cold tablets "was not typical" of earlier FDA decisions, the GAO said in its 62-page report, which was requested by nearly 50 Democratic lawmakers.

Some of those Senate and House members said yesterday that the GAO report vindicates their claims that the agency's refusal was "a politically motivated decision" and a "subversion of science."

The GAO said it found several areas of "unusual" activity surrounding the FDA's decision to reject Plan B, such as the involvement of "high-level management" in the matter and "conflicting accounts" about when the May decision was made.

Susan F. Wood, FDA assistant commissioner for women's health, quit in August, saying upon her resignation that she was tired of seeing scientific evidence on Plan B "overruled," and that such decisions were causing "fairly widespread concern about FDA's credibility" on contraception.

Miss Wood could not be reached for comment yesterday.

An FDA spokeswoman questioned the integrity of the GAO report, saying it "mischaracterizes facts."

In its written response in the GAO report, the FDA said it is "fairly typical" for upper management to be involved in a high-profile decision like that involving Plan B. The agency also said its decision to reject Plan B's switch from being a prescription-only drug to an over-the-counter drug was made in a timely manner.

"We question the integrity of the investigative process that results in such partial conclusions by the GAO. The report mischaracterizes facts and does not appear to take into consideration the input provided by the FDA," an FDA spokeswoman said yesterday.

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