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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A survey with 2,026 women and 513 teens showed they are willing to pay out-of-pocket for the convenience of OTC access to an oral contraceptive but not to pay as much as they were four years earlier, according to a study led by Daniel Grossman, University of California-San Francisco, and Kate Grindlay, Ibis Reproductive Health.