New French Regulatory Agency Announces Transition of Leadership
France's newly-formed National Agency for the Safety of Medicines and Health Products (MSNA), which will ostensibly replace Afssaps, announced 5 May that it will retain its existing leader, Dominique Maraninchi, for the new agency.
Maraninchi will lead the new agency, established 1 May by decree, after only having been at Afssaps since February 2011.
The agency has been under fire for a number of scandals, including the revelations that the agency allowed Servier's diabetes drug Mediator to remain on the French market even after safety concerns were raised and that the agency was unaware that now-defunct French implant manufacturer Poly Implant Prothese was manufacturing breast implant products using industrial-grade silicone.
The scandals eventually contributed to the resignation of Scientific Advisor Eric Abadie, who also served as Chair of the European Medicines Agency's influential Committee for Medicinal Products for Human Use (CHMP). A statement provided to the Reuters news service at the time of his resignation indicated his departure was a result of his role in the Mediator scandal.
MSNA said in a statement Maraninchi will continue to oversee a number of projects aiming to reorganize the agency to prevent further scandals from occurring and improve its efficiency. Of particular note, Maraninchi will continue a program to reassess the benefit:risk assessments of many drugs in light of the Mediator scandal.
Other initiatives under way include projects to manage conflicts of interest, the public declaration of interests, the promotion of independent research on the safety of health products and improved transparency.
MSNA also said in a statement that Maraninchi plans to deliver a new strategic plan to its Board of Directors in July, which will reportedly include a host of new operating rules for its advisory committees.
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Regulatory Focus - France: New Agency to Soon Replace AFSSAPS
Regulatory Focus - UPDATED (2): EMA's Abadie Resigns as Chair of CHMP