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Plan B Decision May Offer FDA Best Political Protection Available

 
• By Nielsen Hobbs

Assuming that sexually charged products such as Teva’s emergency contraceptive remain subject to political decision-making, the explicit heavy hand of the HHS secretary in the OTC switch ruling may be the best approach for FDA and the Rx industry, especially considering the alternatives.

The dust generated by the decision to reject the over-the-counter switch of Teva Pharmaceuticals USA Inc.’s emergency contraceptive Plan B One Step (levonorgestrel 1.5 mg) will take a long time to settle, but the good news for pharmaceutical companies is that process was about as clean as it could be from industry perspective.

To many, the decision by Department of Health and Human Services Secretary Kathleen Sebelius to overrule FDA Commissioner Margaret Hamburg and deny the switch application seems heavy-handed and politically motivated....

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