The General Accounting Office released a report criticizing the review process the FDA employed when it looked at Barr Laboratories' application to sell the controversial Plan B "morning after" pill on an over-the-counter basis. The "non-decision" on the matter this year created a political firestorm at the agency and is believed to have played a role in former chairman Lester Crawford's decision to step down last month. The GAO report released Monday calls some aspects of the approval process "unusual" and suggests that high-ranking officials at the agency may have intervened. Following the report's release, a group of lawmakers led by Rep. Henry Waxman (D-CA) issued a formal protest to HHS Secretary Mike Leavitt, asking him to force the FDA to issue a decision on the drug.
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