France has taken a very large step to address scandals that have plagued its key drug and device regulator: It is replacing the agency.
According to a translated release, the government is dissolving the Food Safety Agency of Health Products (AFSSAPS) and replacing it with the National Security Agency of Medicines and Health Products (MSNA). The move implements one of the key measures of legislation passed at the end of last year intended to strengthen drug and health safety.
The new agency is being invested in a number of ways to remove it from the issues that have plagued AFSSAPS. It will have the authority to do independent research on drug and product safety and be able to mandate certain clinical studies, points out Regulatory Focus. It also will have a more money to do its job. Instead of coming from taxes or fees on manufacturers, it will come from a government allotment.
The move follows repeated issues at the predecessor agency. It was highly criticized for allowing the diabetes drug Mediator, developed by a French company, to remain on the market for years even when it was linked an estimated 2,000 deaths and thousands of cases of heart valve damage. It was often used as a weight-loss drug. There was also an outcry last year when it was learned that a breast-implant maker in France had been using industrial-grade silicone, which was rupturing and causing lots of medical issues.
People with voting power on decisions about medical products in France have served as consultants to drug companies, and regulators in the country failed to act on early warning signs about the risks of taking Mediator.
Last month, a top regulator resigned from the European Medicines Agency because of concern over his ties to the AFSSAPS. Eric Abadie, who chaired the EMA's Committee for Medicinal Products for Human Use since 2007, was also the scientific adviser to the AFSSAPS director general, a relationship some in the EMA found untenable.
While the new agency is effective today, RF points out a release from France's Official Journal explains it is still being developed and it will be a few months before it is operating.
- here's RF's take
- read the untranslated press release