FDA's acts on Plan B faulted

WASHINGTON — WASHINGTON -- Top officials at the Food and Drug Administration told staff members they would reject over-the-counter sales of the "morning after" pill months before agency scientists finished safety reviews, congressional investigators said yesterday in a report that sparked renewed criticism that abortion politics is infecting government science.

The involvement of senior officials was among several "unusual" aspects of the FDA's handling of the Plan B application outlined in the 57-page report by investigators from the nonpartisan Government Accountability Office.


Early on, then-FDA Commissioner Dr. Mark McClellan expressed concerns about approving over-the-counter sales, according to agency minutes reviewed by investigators. Agency staff members told investigators that top officials decided to reject such sales at the direction of the commissioner's office.

Opponents say use of the pill by teenage girls could lead to the spread of sexually transmitted diseases. Supporters contend that abortion politics is taking priority over women's reproductive health and sound science.


Democrats critical

The GAO report rekindled accusations by Democrats in Congress that the Bush administration is sacrificing women's health to the culture wars.

Rep. Henry A. Waxman, a California Democrat, and 17 other lawmakers sent a letter urging Health and Human Services Secretary Michael O. Leavitt to guard against any "manipulation of science" and to consider over-the-counter sales of Plan B "based on the best available science instead of ideology."

Sen. Barbara A. Mikulski, a Maryland Democrat, said the FDA's decision illustrated the politicization of its decision-making.

"Regardless of how you feel about whether Plan B should be available in the community, the fact is the FDA decision should be based on science, not cultural controversy," she said in a statement.

The FDA issued a strongly worded statement dismissing the investigation as slipshod and its findings as incomplete.

"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. We stand by the original decision," the agency said.

The morning-after pill is essentially a high dosage of birth control for women to take after sex. In 1999, the FDA approved sales with a prescription. Four years later, the manufacturer asked the agency to allow over-the-counter sales. Usually, if the drug is deemed safe and effective, the agency agrees.


Outside advisers and agency staff recommended approval. But in May 2004, Steven Galson, then the acting director of the FDA's drug evaluation office, rejected the application, citing concern about the impact on the health of teenage girls.

Afterward, the drug's manufacturer, Barr Pharmaceuticals, asked the agency to allow it to sell the pill without a prescription to women 17 and older. The FDA has delayed a decision on the request. A 60-day period for public input ended Nov. 1 with more than 10,000 comments filed.

The GAO report

In their report, congressional investigators examined events leading to Galson's rejection. The Government Accountability Office is an independent agency that often researches on Congress' behalf. Mostly, Democrats asked for the Plan B review, which took 14 months.

The investigators found that the FDA departed from usual procedure in several respects.

The FDA's handling of the Plan B decision was "not typical" of 67 similar requests from 1994 through 2004, the GAO reported. Among the irregularities reported were top officials reaching a decision that differed from staff recommendations and offering a "novel" rationale for the rejection.


"High-level FDA management became more involved than usual," investigators wrote.

FDA staff members did not finish their review until April 2004, the report said, but as early as January 2004, agency staff documented being told that the decision against selling Plan B over the counter was final. That February, the report said, agency reviewers told top officials they had found no evidence that over-the-counter sales would harm teenage girls, but McClellan expressed doubts.

In a written comment, McClellan told investigators that his involvement was typical, and he said the agency's decision was made after he left. Galson told investigators he made the decision only weeks before the announcement, after consulting with top agency officials. Investigators said McClellan did not respond to written questions and that they were not able to arrange an interview.

James Trussell, a Princeton University professor and one of the outside advisers who voted 23-4 in favor of the FDA approving over-the-counter sales, called the GAO report a "damning indictment."

As a consequence of the FDA's decision, Trussell said, "there are more unintended pregnancies than there should have been, and an equally major problem has been an impact on morale at the FDA and among its scientists, who no longer believe the FDA is making scientifically based decisions."

But Dr. W. David Hager, one of the dissenting advisers, said legitimate questions remain over whether over-the-counter sales would discourage teens from receiving counseling and seeking regular tests for sexually transmitted diseases.


"These concerns need to be answered," said Hager, an obstetrician-gynecologist in Lexington, Ky., and part-time professor at the University of Kentucky.

A defender of the FDA's decision applauded senior agency officials for getting involved. Wendy Wright, senior policy director for Concerned Women for America, said approval of over-the-counter sales might have increased the spread of sexually transmitted diseases.

"So, the fact that the GAO report is finding that Plan B was handled differently is good news for women's health," she said.

Carol A. Cox, a spokeswoman for Barr Pharmaceuticals, expressed disappointment that the FDA hadn't approved sales of the pill without a prescription.

"We continue to believe that our Plan B emergency contraceptive product is safe and effective and should be approved for [over-the-counter] use," she said in a statement.