Court Papers: Last Two FDA Directors Stopped Morning After Pill Sales
Posted by ssbg on May 29, 2006
by Steven Ertelt
May 25, 2006
Washington, DC (LifeNews.com) — Court papers from depositions given to a pro-abortion law firm that has sued the FDA over its delay in approving over the counter status for the morning after pill show the last two commissioners both intervened to halt or delay that status.The Center for Reproductive Rights, a New York-based pro-abortion law firm, has been deposing current and former FDA staff members in its quest to get the morning after pill approved for sale without a prescription.
Barr Laboratories, which makes the Plan B pill that can sometimes cause an abortion, originally asked the FDA to approve its request to sell the morning after pill to all women without a doctor's visit.
Although an FDA committee voted strongly in favor of granting the request, the papers show former FDA commissioner Mark McClellan stepped in and determined that the OTC status was inappropriate because the company didn't provide enough information about its effects on teenagers.
McClellan noted that Barr did not include many teenagers in its studies and worried that promoting the Plan B drugs to teens would encourage them in engaging in risky sexual behavior since the drug does not prevent STDs.
Dr. Janet Woodcock, the FDA's deputy commissioner for operations, testified in her deposition that this seemed like a reasonable concern.
"We did not have much data in the younger adolescent age group," she testified, according to a Los Angeles Times report.
"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," she told the pro-abortion law firm. "[We] have very proudly approved many drugs in the past that have become cult drugs in certain populations."
After the FDA rejected the request, it told Barr to resubmit its application and ask that women above the age of 16 be allowed to purchase the drug over the counter. Barr sent in a new application and the FDA delayed in rendering a decision on it.
Eventually, former FDA commissioner Lester Crawford indefinitely postponed a decision on the revised request.
The depositions show FDA staff members upset at the way in which Crawford unilaterally decided to postpone any decision on the application.
Dr. Steven Galson, head of the FDA division that reviews drugs, testified in his deposition that Crawford took the decision away from him, according to the Times report.
"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," Galson said.
Galson testified that it was the first time he had such a decision taken out of his hands.
Woodcock also testified on Crawford's involvement and said he gave her just a one day notice that he was going to have the agency put off the decision.
According to the Times, Crawford "was … going to take this decision himself, and that's what he told me," she testified.
Wendy Wright, of Concerned Women for America, told the Times that Crawford's decision made sense and that the agency kept saying it needed more time to review how to enforce a policy allowing most women to purchase the drug from prohibiting some women from doing so.
Crawford and McClellan "brought some basic common sense to the decision-making," Wright said.
She told the Los Angeles newspaper that the issue is not why the FDA has postponed selling the drug over the counter, but why abortion advocates are using the drug as a public relations ploy.
"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," Wright said.
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