WASHINGTON — 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.
For The Record
Los Angeles Times Saturday May 27, 2006 Home Edition Main News Part A Page 2 National Desk 1 inches; 48 words Type of Material: Correction
'Morning-after' pill: An article in Thursday's Section A about the role two Food and Drug Administration commissioners played in blocking over-the-counter sales of the contraception drug marketed as Plan B said Wendy Wright was the senior policy director for Concerned Women for America. Wright is the group's president.
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.
