Plan C? The Plan B Decision and Calls for a Third Class of Drugs
This article was originally published in RPM Report
Executive Summary
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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Why Plan B Matters
While Barr's attempt to switch the emergency contraceptive Plan B to over-the-counter status is immaterial to the company, the rest of the drug industry can't afford to ignore the controversy, which could jeopardize the renewal of crucial legislation that supports fast and predictable reviews of all new drugs. Moreover, FDA may be reopening old controversies, like whether third parties can force an OTC switch against a brand company's wishes.