The scandal surrounding Servier's Mediator drug in France has spawned a new approach to regulating pharma. Under pressure from an increasingly distrustful public, Health Minister Xavier Bertrand has proposed sweeping changes to France's regulatory framework, InPharm reports.
French regulators have been feeling the political heat from recent disclosures linking as many as 2,000 deaths with the now-withdrawn diabetes drug Mediator. The Servier drug was allowed to stay on the market in France after it had been withdrawn for safety reasons in other European markets. It was finally withdrawn there in November 2009. Some have blamed France-based Servier's close ties with doctors and regulators for Mediator's long stay on the market, InPharm notes.
The new regulations will require additional assessments of new drugs, mandate disclosures from industry and bar pharma funding of professional education. They'll also provide tighter controls on off-label prescribing. Mediator was often prescribed off-label in France for weight loss. Sales-rep visits to doctors would also be restricted. French lawmakers will begin considering the proposals this fall.
In the meantime, the ministry has begun reviewing 19,000 drugs currently approved in France. Bertrand predicts that many existing meds will be withdrawn because they can't demonstrate they're not inferior to other treatments.
- read the InPharm coverage