FDA’s Role in Blocking ‘Morning-After’ Pill Cited

The last two appointees to head the FDA were closely involved in decisions to overrule the agency’s medical reviewers and block the “morning-after” birth control pill from being sold without a prescription, according to court transcripts to be released today.

Last year, Lester M. Crawford personally took the decision away from his top subordinates, according to depositions of two senior Food and Drug Administration officials. And at an earlier stage in the process, his immediate predecessor as FDA commissioner, Mark B. McClellan, raised objections that formed the basis for overruling medical reviewers.

The transcripts provide the most detailed look yet at an internal review that some critics say has been tainted by politics. The dispute over the drug, marketed as Plan B, has pitted Christian conservatives against liberal women’s groups and raised concerns in academic circles that the FDA had compromised its scientific principles.

The depositions were released by the Center for Reproductive Rights, a New York-based advocacy group that has filed suit against the FDA for delaying the decision on Plan B. It seeks to force the agency to approve over-the-counter sales. Similar lawsuits have been dismissed in the past, but a federal judge in New York has allowed this one to proceed.

Crawford was scheduled to give a deposition in the case Wednesday. McClellan is to be deposed next month.

As the FDA’s top political appointee, the commissioner sets broad policies and rarely casts the deciding vote on such narrow issues as switching a drug from prescription to over-the-counter status. The Government Accountability Office, in a report, has called the agency’s handling of the case unusual.

Because of the controversy over Plan B, prominent Democratic senators are blocking confirmation of the FDA’s current acting commissioner, Andrew C. von Eschenbach. The dispute also played a role in delaying Crawford’s confirmation. He became acting commissioner in February 2004, after McClellan was named head of the Medicare program, but was not confirmed until July 2005. He resigned abruptly two months later.

According to the FDA officials’ testimony in their depositions, Crawford took control of the Plan B review early in 2005, after it became evident that senior FDA staff members were going to recommend that women 17 and older be allowed to obtain the drug without a prescription. Crawford shut top managers out of the process and in August announced an indefinite postponement of the decision.

“Dr. Crawford ... told me that he was concerned about where we were heading because he knew that I was heading toward this recommendation, and he told me that he was going to make the decision on what to do with the application,” Dr. Steven Galson, head of the FDA division that reviews drugs, testified.

Galson testified that never before had such a decision been taken away from him.

Dr. Janet Woodcock, the FDA’s deputy commissioner for operations, testified that Crawford gave her about a day’s notice of his August announcement. As a top-ranking official, Woodcock was accustomed to being consulted by the commissioner on key matters. But Crawford “was

Neither the FDA nor the Department of Health and Human Services offered a response Wednesday when asked about Galson’s and Woodcock’s testimony.

In an interview, the head of obstetrics and gynecology at Yale University’s medical school, Dr. Charles J. Lockwood, called Crawford’s actions “amazing” and “sad.”

“This provides illumination on what has long been suspected, that political -- rather than scientific or health -- concerns drove the decision by the commissioner,” said Lockwood, who serves as an outside advisor to the FDA. “It sets an ominous precedent for political and potentially theological control over scientific [entities].”

But Wendy Wright, senior policy director for Concerned Women for America, a conservative public policy group, said the FDA had no authority to promulgate such an age restriction and no way to enforce it.

The involvement of the two commissioners “brought some basic common sense to the decision-making,” said Wright, whose group opposes over-the-counter status for the drug.

“What this is really all about is the abortion lobby has been losing on the issue of abortion, and they are now diverting attention to something they can win on -- the ‘morning-after’ pill,” she said.

Available only by prescription, Plan B is a high dose of a common contraceptive that, if taken within 72 hours of unprotected sex, works primarily by preventing a woman’s ovary from releasing an egg. It also may prevent fertilization of an egg or prevent a fertilized egg from implanting in the uterus. The FDA does not consider Plan B to be an abortion drug, Woodcock and Galson testified.

Crawford’s predecessor as commissioner, McClellan, also had opposed approving over-the-counter access for Plan B in 2003 and 2004, the two officials testified.

But McClellan raised specific objections about whether the youngest teenage girls could safely use the drug, noting that its manufacturer, Barr Laboratories, had enrolled few young teens in its studies.

Woodcock, the mother of two teenage daughters, testified that McClellan’s argument had struck her as reasonable: The easy availability of a “morning-after” pill might prompt some young teens to engage in risky sexual behavior.

“We did not have much data in the younger adolescent age group,” she testified. “I discussed [with FDA staff] our inability as basically middle-aged health professionals ... to really get into the minds of young teenagers and their behaviors. [We] have very proudly approved many drugs in the past that have become cult drugs in certain populations.”