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

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. Four deaths have been linked to its use. Just last week, France’s National Security Agency for Medicines and Health, or ANSM, announced it would continue a suspension on all sales of the pill and that all available product had to be recalled. Rather than accept the EMA recommendation, French regulators decided to instead wait for  a decision by the European Commission (back story). But once the EC adopts the recommendation, members states are required to follow its position. UPDATE: ANSM officials tell Reuters they will comply with any final European Commission once it is issued, but for now, the suspension will remain intact]  The HMA recommendation is a blow to French regulators in the wake of the Me...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs