One Year Later, Groups Press Sebelius To Backtrack On OTC Plan B Block
This article was originally published in The Tan Sheet
The Reproductive Health Technologies Project, plus 45 other organizations and 18 professionals, urge HHS Secretary Kathleen Sebelius to revisit her decision to overrule full OTC availability of Teva’s Plan B One-Step emergency contraceptive.
You may also be interested in...
The American College of Obstetricians and Gynecologists and the American Academy of Pediatrics recommend OTC availability of hormonal contraception, but pharmaceutical industry Rx-to-OTC switch sponsors remain elusive.
The re-election of Barack Obama injects some stability into a period of rapid change in regulatory and health policy. Most key health officials are expected to stay at least until 2014, and that is likely to include FDA Commissioner Margaret Hamburg. But there are plenty of big changes in key slots on Capitol Hill, and the implementation of health reform and PDUFA V will mean a lot is new even if the political lineups aren’t.
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.