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Did Suspected Advisory Panel Bias Affect Safyral et al Vote?

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Washington, DCGiven that the new-age contraceptive Safyral contains drospirenone (DRSP) and estradiol (EE), it is not surprising to see that the Bayer-manufactured product was tagged with the same concerns—and label updates—as other products in the Bayer family containing that specific formulation.

Critics have commented that label changes should be specific to individual products, as opposed to the formulations and ingredients inherent with each. Nonetheless, a joint advisory panel reporting to the US Food and Drug Administration (FDA), while narrowly voting in favor of allowing DRSP and EE-containing products to continue on the market, overwhelmingly recommended to the FDA that labels be updated to provide more specific details and guidance with regard to Safyral blood clots and other side effects.

Of course, when the committee references Safyral side effects, it means all products formulated with DRSP and EE in the class.

New-age contraceptives such as Safyral have been the subject of much debate given suspected links to blood clots. Bayer argues that Safyral and other products it manufactures in the class carry no greater risk of blood clot than older, more traditional contraceptive products.

In December, in comments made at the joint gathering of the Reproductive Health Drugs Advisory Committee, and the Drug Safety and Risk Management Advisory Committee, it appeared as if those who voted against leaving Safyral and other DRSP-based contraceptives on the market were of the opinion that there are insufficient unique benefits inherent with drospirenone-based products that cannot be provided by other hormonal contraceptives, according to the official transcript of the meeting.

Not to mention other drospirenone side effects that include Safyral blood clots.

The vote to allow Safyral—and others—to continue was 15 to 11. Were two of those voting "YES" to change their vote to "NO," would have resulted in a 13-13 deadlock. The foregoing is an interesting observation, given recent revelations that certain individuals who participated in the voting are alleged to have had industry ties: this, according to a report published in the Washington Monthly (1/9/12) and the Project on Government Oversight (1/11/12).

Critics wonder as to the outcome, had the joint meeting participants been completely free of bias.

Had the joint panel voted to remove Safyral from the market (and other drospirenone-based products such as Yaz and Yasmin due to concerns including Safyral blood clot), the vote constitutes a recommendation to the FDA, which then proceeds to act based upon its own merits. In the past the FDA usually follows the lead of its expert panels. However, the agency is not bound by such outcomes.

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