France investigates its own drug regulator for involuntary manslaughter
In a move bound to get the notice of drug regulators around the world, France is investigating its own agency for involuntary manslaughter.
The probe is looking into why the ANSM failed for years to remove the diabetes drug Mediator from the market, when other jurisdictions had already yanked it over health concerns. Authorities told The Wall Street Journal they are acting on complaints filed by relatives of people who allegedly died from taking Mediator and complaints from hundreds of patients who say they have had serious health effects.
Many countries, including the U.S., generally protect their federal agencies from criminal prosecutions. The manslaughter probe by France of its drug-safety agency ANSM raises some prickly questions about the conflicts that can arise among drugmakers and the experts and regulators who recommend, approve and oversee their products, some of which come with dangerous side effects.
For 10 years after the U.S. and other countries had withdrawn the diabetes drug from the market, authorities in France permitted the French company Servier to continue selling Mediator there. Many doctors prescribed it off-label for weight loss. The WSJ points out Mediator's makeup is similar to amphetamine-based compounds, which can kill appetite but come with dangerous side effects. Studies tied Mediator to heart-valve issues but France didn't act for years.
France pulled the drug in 2009 and company founder, Louis Servier, is now facing manslaughter charges. But by then public outrage had built up over the relationship between the company and regulators. Public sentiment turned even darker against France's regulators last year when it was discovered that a French maker of breast implants had been using industrial-grade silicone. Some of the implants ruptured, causing serious health problems in patients. The country has since completely overhauled its drug approval and oversight process.
- here's the WSJ story
French drug exec charged with manslaughter over drug safety
France replaces drug regulator with new agency
Mediator probe rolls on with searches at Afssaps, executives' homes
Europe's substandard breast implants may signal bigger regulatory problem