France’s health minister has promised sweeping changes to improve safety checks on medicines in the wake of a damning report over the weight-control pill Mediator, which is suspected of killing more than 500 people.
The report, compiled by state inspectors, revealed that the pill made by French company Servier should have been pulled off the shelves far earlier than the withdrawal date of November 2009 after hundreds were affected by exposure to benfluorex, the pills’ main ingredient.
Health Minister Xavier Bertrand said that France needed to move to a more transparent system where drug safety approval deliberations were recorded, debates published and public hearings organised when needed.
The minister called for the national agency responsible for drug safety, Afssaps, to be assured of sufficient state funds to reduce its reliance on the drug industry, which it is supposed to oversee.
Afssaps has also been asked to accelerate checks on 76 other products that are on a watchlist and report back within 15 days.
Five million diabetics and dieters are believed to have received Mediator between 1976 and November 2009, years after it was rejected as unsafe by Spain and Italy.
Servier, which made sales of €3.7bn in its last financial year, has previously stated that estimates do not reflect historical safety reports but has said it is willing to look into the matter with the authorities.