New court documents in a lawsuit against the Food and Drug Administration allege that decisions about whether to allow over-the-counter sales of the morning-after birth-control pill were made according to political, rather than scientific, considerations.
The depositions released Thursday are part of a lawsuit filed in January 2005 by the Center for Reproductive Rights. At issue is a request by Barr Pharmaceuticals to sell its emergency contraceptive, known as Plan B, without a doctor's prescription.
The company originally applied for over-the-counter status for the drug in April 2003. In December, two FDA advisory committees voted overwhelmingly to grant the request -- for all age groups.
But in April 2004, Steven Galson, head of the FDA Center for Drug Evaluation and Research, rejected the application. He suggested that the company reapply for a "split approval" -- allowing over-the-counter sales to older teens and adults, while retaining prescription-only status for younger teens. The company submitted that request three months later.
The FDA, however, missed the January 2005 deadline to decide on the revised request, prompting the filing of the lawsuit. That application is still pending.
The latest depositions in the lawsuit come from former FDA Commissioner Mark McClellan, and two lower-level FDA officials involved in reviewing the application, Florence Houn, M.D., and Curtis Rosebraugh, M.D.
McClellan said in his deposition that he was not involved in the decision to reject the initial Plan B application for non-prescription sales; he left the FDA in February 2004 to head the agency that runs Medicare and Medicaid. He also said that he was never told by anyone higher up in the Bush administration what to do about the application, although he did say that he "briefed" two White House domestic-policy advisors, Jay Lefkowitz and Kristen Silverberg.
Rosebraugh, however, said it was clear to him that the decision to deny the initial request was made much earlier than 2004.
"As early as August (2003), we were being directed that we needed to talk to the sponsor about a distribution restriction plan, and that's highly unusual," he testified.
And Houn said that she was called at home by FDA Deputy Commissioner Janet Woodcock in January 2004, and told, in effect, that the only way the application would ever be approved was with an age restriction.
"She conveyed to me her assurance that this was the only way to go, to issue a non-approval letter to appease the administration's constituents, and then later this could be approved," Houn testified.
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