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Group Seeks New FDA Vote on Birth Control Safety Risks After Industry Ties Surface

Group Seeks New FDA Vote on Birth Control Safety Risks After Industry Ties Surface

January 17, 2011 — The Project on Government Oversight, a consumer watchdog group, in a letter last week called for an FDA advisory committee to reassess safety warnings for certain birth control pills because some panel members have ties to the drugs' makers, Reuters reports (Yukhananov, Reuters, 1/12).

On Dec. 8, 2011, the advisory panel recommended additional safety warnings on the risk of blood clots from newer birth control pills that contain the hormone drospirenone. Drospirenone is a form of progestin found in Bayer's Yaz, Yasmin, Beyaz and Safyral, as well as other birth control pills.

After spending nine hours debating inconsistent data from studies on the risk of blood clots, the panel voted 21-5 in favor of altering the labels. However, the panel voted 15-11 to affirm that the benefits of the drugs for preventing pregnancy outweigh their risks. FDA did not set a schedule for making any changes to the labels (Women's Health Policy Report, 12/9/11).

According to POGO, court and public documents show that three members of the 26-member advisory committee had research or financial connections to Bayer, while a fourth member had ties to Barr Laboratories, which makes a generic version of Yaz. POGO said the four members voted in favor of keeping the pills on the market, arguing that their benefits outweighed their risks.

In its letter, POGO calls on FDA Commissioner Margaret Hamburg to dismiss the panel's vote and assemble a new advisory panel to reexamine the pills' safety. Three of the panel members told POGO that their votes were not influenced by their connections, while the fourth declined to comment.

According to Reuters, it is not clear whether FDA knew about the advisers' connections. The agency can issue waivers to panelists who have financial ties with the industry, but past ties are not usually considered and no waivers were issued in this case (Reuters, 1/12).