Tuesday, November 15, 2005

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.

Plan B is a prescription-only set of high-dose birth-control pills that can prevent pregnancy if taken within 72 hours of sexual intercourse. Plan B marketers want their pills to be sold without a prescription so women can get it more easily in an “emergency.”

Conservative lawmakers and traditional-values groups say Plan B should not be sold like aspirin because of the health risks to women, especially teenage girls. Some religious leaders oppose Plan B altogether, indicating its effects are tantamount to abortion.

In its May 2004 rejection letter to Barr Pharmaceuticals Inc., Plan B’s marketer, the FDA said the product application was “not approvable at this time” because there was insufficient data on how young teens would use Plan B safely without parental or medical supervision.

Barr reapplied with a plan to sell Plan B over the counter to those 16 or older, and to younger teens only if they had prescriptions.

However, in August, the FDA’s then-commissioner, Lester M. Crawford, responded to the new Plan B request with a 60-day comment period, saying it was not clear how the FDA would enforce an age limit.

Plan B supporters were galvanized by yesterday’s GAO report.

“The GAO report confirms what our lawsuit has argued all along — the FDA broke its own rules … and women have suffered the consequences,” said Nancy Northup, president of the Center for Reproductive Rights in New York.

In January, the center filed a lawsuit asking a federal court to order the FDA to make Plan B available, without a prescription, for women of all ages.

“The GAO has confirmed what we have always suspected, that this was a politically motivated decision that came down from the highest levels at the FDA,” Democratic Sens. Patty Murray of Washington and Hillary Rodham Clinton of New York said in a joint statement.

“We are deeply opposed to this subversion of science,” Rep. Henry A. Waxman, California Democrat, and 17 other lawmakers wrote to Health and Human Services Secretary Michael O. Leavitt yesterday. “It appears that the decision … was preordained.”

However, Wendy Wright of Concerned Women for America praised the FDA’s “great caution.”

“Thankfully, the FDA’s leadership did what others refused to do — consider whether a drug’s easy availability would present unique health risks to women and girls,” she said.

• This article is based in part on wire service reports.

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