When the FDA’s panel advisory meeting handed down its decision about the fate of Bayer’s oral contraceptives Yaz and Yasmin, its decision was met with controversy after it was discovered that four of the panel members had financial ties to Bayer. Now four women’s health groups have decided to band together to show how disappointed they are that the panel opted to keep the pills on the market.
The panel was originally put together to address the concerns that Yaz and Yasmin cause serious side effects, including blood clots, which has been repeatedly proven with research. The four women’s groups assert that the FDA committee’s decision was “rife with irregularities that prevented voters from fully evaluating the risks of Yaz side effects.” Those side effects have caused thousands of women and their families to file lawsuits.
On March 9, 2012, the women’s groups mailed a letter to Margaret Hamburg, FDA commissioner, that expressed their concern over the members of the voting panel. Their main point of concern is the fact that practicing OB/GYNs were omitted from being a part of the vote because of a perceived conflict of interest, but other members who had financial ties to Bayer were included. The facts about the questionable panelists were made public soon after the vote was taken, but the FDA opted to follow through with the panel’s recommendations anyway.
As more than 10,000 Yaz lawsuits have been filed already, it looks as if Bayer is finally preparing to concede to the dangers of Yaz dangers; the company recently agreed to settle 500 cases to the tune of $110 million, which amounts to about $220,000 per plaintiff. Bayer is also in settlement negotiations in the Illinois MDL cases being presided over by Judge David R. Herndon, which has caused another stay in the proceedings. RD Legal has even agreed to offer up the settlement funds should an agreement be reached.
So far, there is no knowledge as to how the FDA commissioner will respond to the letter sent by the four groups, but if the past provides any insight, Yaz and Yasmin will stay on the market and the panel’s decision will continue to be upheld.