Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Bayer Contraceptives Win Advisory Committee Backing As Panel Rejects Call For Comparative Effectiveness

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

You may also be interested in...

Ortho Evra’s First Hurdle Is Advisory Panel; Second Is Withdrawal Petition

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.

Non-Contraceptive Use Could Confound Safety Evaluation Of Drospirenone-Containing Products

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.

Rx Misbranding Penalties Should Be Stronger To Stop Counterfeiting, FDA Says

Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.


Related Companies




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts