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Plan B Delay Draws Criticism From Congress, Academia, FDA Official

Executive Summary

FDA's handling of Barr's application to switch Plan B over the counter could elicit heightened external scrutiny of the agency's ability to make drug approval decisions based solely on science and public health

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Plan C? The Plan B Decision and Calls for a Third Class of Drugs

HHS Secretary Sebelius’ decision to overturn FDA’s approval of Plan B for widespread over-the-counter use was disappointing to many drug reviewers inside the agency. But FDA’s Office of New Drugs Director John Jenkins says the move should be used to reopen the debate over whether to create a third class of drugs. And Plan B, he says, might be a perfect place to start.

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