Plan B Approval Is Good News for OTC Switch of Xenical
This article was originally published in RPM Report
Executive Summary
FDA's fitful handling of Barr's OTC switch application for the emergency contraceptive Plan B has provided great political theater. But for GSK and Roche, the issue was a complication for the OTC switch of the weight loss drug orlistat. Now the path looks clear.
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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.