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FDA Decision To Reject Plan B Made Under Political Pressure: Officials

The U.S. Food and Drug Administration's decision on whether to approve the emergency contraceptive Plan B was taken before the scientists submitted their recommendations// , according to two FDA officials who made sworn statements before court.

Dr. John Jenkins, director of the FDA's Office of New Drugs, said in a sworn statement in June that he was aware of the fact that then-FDA Commissioner Mark McClellan had made the decision to reject Plan B before scientists made their findings.

"I think many of us were very concerned that there were policy or political issues that came to play in the decision," Jenkins said. He deposed in a suit brought by Center for Reproductive Rights, which wants easier access for Plan B.

Dr. Florence Houn, another FDA official also said that she was told by Deputy Commissioner Dr. Janet Woodcock that "Plan B needed to be rejected to appease the administration's constituents"

FDA spokeswoman Susan Bro decided not to comment on the issue and said that it was important to see where the agency stood today. Last Monday the FDA decided to reconsider approving Plan B for OTC sales.


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