Bayer Contraceptives Win Advisory Committee Backing As Panel Rejects Call For Comparative Effectiveness
This article was originally published in The Pink Sheet Daily
In a 15-11 vote, FDA advisory panel members split on whether drugs containing progestin drospirenone should be judged on absolute risk, or whether their potentially higher risk than other birth control pills should be offset by benefits beyond those provided by alternatives.
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As Public Citizen presses to get J&J’s transdermal birth control pulled from the market, data suggest a higher risk of blood clots with the patch than with combination oral contraceptives, FDA says, but none of the studies provide a definitive answer on the drug’s relative safety.
FDA will seek advisory committee input Dec. 8 on whether and how to adjust labeling and to conduct further studies for contraceptives containing progestin drospirenone because of the drugs’ potential risk for venus thrombotic and thromboembolic events. The agency has a specific study design in mind that it wants sponsors to conduct.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.