New FDA Yaz, Yasmin Hearing Sought Amid Conflict-of-Interest Concerns

A public advocacy group wants the U.S. Food & Drug Administration (FDA) to convene another advisory panel hearing on the safety of Yaz, Yasmin and other birth control pills containing the synthetic progestin, drospirenone. The Project on Government Oversight (POGO) asked for the new hearing after it was revealed that several panelists who sat on a similar advisory panel in December had ties to Bayer AG, the maker of Yaz and Yasmin.

On December 8, that FDA advisory panel voted 15-11 that the benefits of the Yaz, Yasmin and other drospirenone birth control pills outweighed their risks. As we previously reported, three of those who backed Bayer had research or financial ties to Bayer. According to a Reuters report, another FDA adviser had a connection to Barr Laboratories, now part of Teva Pharmaceuticals, which makes a generic version of Yaz. The panel was convened to assess the contraceptives’ association with dangerous blood clots.

In a letter to FDA Commissioner Margaret Hamburg, POGO writes that:

“Because of the industry ties of these members, the joint committee’s conclusion—which amounted to an endorsement of the safety of these oral contraceptives—should be disregarded. A new advisory committee—without questionable impartiality or any conflicts of interest—should re-evaluate the safety of Yaz and Yasmin.”

The letter further asserts that “if a reasonable person would have questions about the impartiality of any member of an advisory committee regarding a matter before the committee, the FDA should not allow that member to participate in the matter and should make public the relevant information about that committee member.”

According to a report from The Wall Street Journal, the FDA requires its advisory committee members to declare any financial relationships to the relevant drug maker; however, the agency is prohibited from giving the public any information contained in a financial disclosure. The same Journal article also pointed out that while the FDA allowed all four advisors with Bayer ties to vote on the Yaz/Yasmin question, a frequent critic of the drugs – Dr. Sidney Wolfe of the group Public Citizen – was barred from doing so by the agency.

A number of studies have linked oral contraceptives made with drospirenone to an increased risk of blood clots compared to other birth control pills. Currently, more than 10,000 lawsuits claiming the drugs caused young women to suffer dangerous blood clots and other serious side effects are pending in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) in federal court in Illinois. Plaintiffs’ lawyers have cited reports of at least 50 deaths tied to the pills from 2004 to 2008.

This entry was posted in Pharmaceuticals, Yaz / Yasmin. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.