“Drug Facts” Box Not Ready For Prime Time, FDA Advisory Cmte. Says
FDA's Risk Communication Advisory Committee likes the concept of a standardized format in drug promotional labeling and print advertising, but remains concerned that different risk levels for different populations could negate its utility.
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FDA’s Risk Communication Advisory Committee will delve into research on communicating uncertainty and how individuals perceive risk and seek information when confronted with multiple risks, during a June 29 meeting.
Uncertainty remained the dominant opinion about the risk for blood clots with the four Bayer contraceptives at the conclusion of a Dec. 8 joint meeting of the Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committees. One thing panelists were sure of was that they didn’t want a summary conclusion about the risks in labeling. But they didn’t want a lengthy discussion of data, either.
With an eye toward keeping the contraceptive patch as an alternative to birth control pills, the Reproductive Health Drugs and Drug Safety and Risk Management Committees voted 19-5 on Dec. 9 that the benefits of the contraceptive patch outweigh its risks.