An independent watchdog group has asked the Food and Drug Administration to disregard a safety panel’s recommendation to keep the popular birth control drugs Yaz and Yasmin on the market. Evidence was cited that several panel members operated under conflicts of interest. Danielle Brian, Executive Director of the Project of Government Oversight, stated in a letter to the FDA:
Because of the [pharmaceutical] 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.
The Jan. 11 open letter was e-mailed to FDA Commissioner Margaret Hamburg and addressed concerns over the outcome of the December joint meeting of two federal advisory panels to address the safety of drospirenone-containing oral contraceptives like Bayer’s Yaz and Yasmin. The FDA sponsored the meeting of the agency’s Reproductive Health Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. The joint panel voted 15 to 11 against a Yaz and Yasmin recall, but also voted 21-5 in favor of increased information on the potential risk of blood clots on the labeling of Bayer’s popular birth control pills.
Recent studies have found that drospirenone causes a greater risk of blood clots than similar ingredients used in previous types of birth control pills. Thousands of lawsuits are pending across the country alleging that Yaz, its predecessor, Yasmin, and the generic Ocella cause heart attacks, strokes and gallbladder failure. According to the watchdog’s letter, at least four members of the committee either were paid as consultants by Bayer or received research funding from the drug company or one of its subsidiaries. It was stated in the letter:
In the future, 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.
In light of the evidence concerning Bayer’s financial ties to committee members, the watchdog’s letter stated that a “new advisory committee – without questionable impartiality or any conflicts of interest – should re-evaluate the safety of Yaz and Yasmin.
Source: Lawyers USA Online
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.