Former FDA Head: Agency Should Have Approved Morning After Pill

National   |   Steven Ertelt   |   Jun 14, 2006   |   9:00AM   |   WASHINGTON, DC

Former FDA Head: Agency Should Have Approved Morning After Pill Email this article
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by Steven Ertelt Editor
June 14, 2006

Washington, DC ( — Former Food and Drug Administration commissioner Lester Crawford said in a sworn statement in a legal case that the federal agency should have approved the morning after pill for over the counter sales by now. He said the delay in approving that request was because of the unique enforcement issues involved.

An FDA advisory committee urged the agency to approve Barr Pharmaceuticals’ request to sell the morning after pill without a prescription, but the agency denied the request saying the company failed to provide enough information on how the drug affects teenagers.

Barr came back with a revised proposal to only allow the drug to be sold to women above the age of 16, but the FDA has postponed a final decision saying such a request presents unusual enforcement issues.

Crawford issued his comments in a sworn statement he gave in a lawsuit he is involved in about his resignation as the head of the agency. The lawsuit regards the morning after pill but also covers unrelated personal issues.

Crawford said he reserved the right to determine how the drug could be sold to women 17 and older but said the delay in tackling that issue should have been resolved by now. His testimony confirmed the statements of former FDA officials who said Crawford chose to unilaterally make the decision about the morning after pill, which can sometimes cause an abortion.

According to an AP report, he added that the decision to delay was not meant to be a denial.

"There was no — no talk of denial, there was talk of trying to get straight what the enforcement procedures would be," Crawford said in a May 24 deposition, according to AP. "What I could not decide on is whether or not I could stand before the American people and say this will be successfully enforced. That I could not decide."

He indicated he thought the agency would take no more than six to nine months to resolve the enforcement issues.

Crawford abruptly resigned from the agency the next month due to personal reasons and the FDA has not made a final determination on the drug.

The Center for Reproductive Rights, a pro-abortion law firm that has filed suit against the FDA to allow over the counter sales of the Plan B drug, released Crawford’s statement.

The pro-abortion lawyers are planning to depose Crawford’s predecessor, former FDA commissioner Mark McClellan, on Tuesday, according to AP.

Meanwhile, pro-abortion Democratic Sens. Patty Murray of Washington and Hillary Rodham Clinton of New York have placed a hold on Crawford’s successor, Dr. Andrew von Eschenbach, until the FDA makes its final decision on over the counter sales.