Sacre Bleu! European Agency Rebuffs French Regulator Over Bayer AG Acne Pill

Published: May 30, 2013

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Now what will French authorities do? After months of debate, the European agency that coordinates regulation of medicines on the continent has decided that the controversial Diane 35 acne pill sold by Bayer, which is also widely prescribed as a contraceptive, is safe to use so long as steps are taken to minimize the risk of blood clots. The decision was announced this morning. The overwhelming 26-to-1 vote by the Coordination Group for Mutual Recognition and Decentralised Procedures, which is overseen by the Heads of Medicines Agencies, endorsed the recent position taken by the European Medicines Agency (read statement here). Just the same, French regulators had rejected the EMA recommendation as part of a new get-tough stance toward medicines that may pose a safety risk.

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