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Ex-FDA Official Questions Plan B Decision
By JOHN J. LUMPKIN, Associated Press Writer
Mon Oct 17, 6:18 PM ET
The former top women's health official at the FDA said Monday that she believes the agency's refusal to approve over-the-counter sales of a morning-after contraception pill was on orders from above.
"I don't think FDA was acting independently," said Susan Wood, who resigned in August after the Food and Drug Administration issued its decision on the contraceptive, called Plan B.
Hers is a serious charge for an agency that was chartered to base its decisions on science, not politics. Both an independent advisory committee and the agency's scientific staff had recommended Plan B as safe for over-the-counter sales.
Plan B is opposed by religious conservatives who say it will promote promiscuity, particularly in young people. It uses a large dose of a common birth-control drug that can prevent conception up to 72 hours after unprotected sex. It is not an abortion pill.
Wood said she did not take part in the agency's decision and does not know for certain who made the call. The final authority rested with then-FDA Commissioner Lester Crawford, who resigned recently. The FDA reports to the Health and Human Services Department, which in turn reports to the White House.
Wood spoke to reporters after addressing the Center for American Progress, a Washington think tank.
Wood said Crawford's acting replacement, Andrew von Eschenbach, should quickly approve Plan B, which is now only available through prescription, making it more difficult to obtain in an emergency. If von Eschenbach doesn't, she said, "we'll know it isn't his decision. We'll know by his actions whether he is independent."
In an interview after his appointment last month, Von Eschenbach said he would review the Plan B issue but declined to discuss it further.
Wood, a biologist, joined FDA's women's health office in 2000, after directing women's health programs at its parent agency, the Health and Human Services Department. She has worked as a research scientist and a congressional adviser.
In 2004, the FDA announced it was rejecting Barr Pharmaceuticals' application for over-the-counter sales of Plan B, citing concern about young teens' use of the pills without a doctor's guidance.
The manufacturer reapplied, proposing the age limit that could be enforced just like drugstores enforce age limits on cigarette sales, but Crawford announced in August that any decision was on hold, saying that the agency didn't know how to enforce an age limit.
He opened the question to public comment for 60 days, but he wouldn't say how soon after that FDA would rule.
The original 2004 announcement sparked intense criticism from some in Congress who then sought an inquiry by the Government Accountability Office, Congress' investigative arm.
The GAO's report has not been issued, but some senators have been critical of the FDA after reviewing a draft.
"The draft GAO report appears to confirm what we have suspected for some time: science was compromised in the FDA's decision making process on Plan B," said Sen. Hillary Rodham Clinton, D-N.Y., in a statement. "It is essential that the FDA be the gold standard in drug approval, and science must come before politics or ideology."
The draft says that several senior FDA scientists refused to sign the letter rejecting Plan B, so their boss, Dr. Steven Galson, acting director of the Center for Drug Evaluation and Research, signed it, according to a congressional aide. It also notes unusual involvement from Crawford's office, the aide said.
The aide spoke on the condition of anonymity because the report has not been released.
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