Teva Plan B OTC Application Fails Political Test After Clearing FDA Hurdle
This article was originally published in The Tan Sheet
HHS Secretary Sebelius says Teva must show more evidence of how young adolescent females would use Plan B One-Step as an OTC. But obtaining such clinical data for the emergency contraceptive – in excess of what FDA already needed to approve it – appears nearly impossible, experts say.
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Guidelines list preventive services for women, including FDA-approved contraceptives, that must be covered by private health plans with no cost-sharing.
Teva Pharmaceutical Industries asks FDA to allow over-the-counter sales of Plan B One-Step, starting the likely final leg of the emergency contraceptive's journey toward OTC status.
FDA does not plan to look at allowing wider access to nonprescription emergency contraceptive Plan B until Teva Pharmaceuticals files an application, despite a complaint accusing the agency of ignoring a court order to reconsider age restrictions on the product.