French Regulators Launch New Prescription Drug Paradigm Aimed at Limiting Off-Label Use
Posted 08 October 2012 | By
In the wake of a drug safety scandal that brought down an entire regulatory agency, France's new healthcare product regulatory body, ANSM, is moving to fundamentally change the way it regulates the use and surveillance of off-label prescription drug products, reports the New England Journal of Medicine (NEJM).
France's previous regulatory agency, AFSSAPS, was reconstituted in May 2012 as the National Agency for the Safety of Medicines and Health Products (ANSM) after becoming embroiled in a huge scandal involving the anti-diabetes drug Mediator. Despite being pulled from other EU markets after safety concerns were raised, the drug, manufactured by France-based Servier, remained on the market for years. Authorities would later associate the drug with as many as 2,000 unnecessary deaths, and the fallout from the scandal would come to include one of the European Medicines Agency's (EMA) top drug regulatory officials, Eric Abadie, head of the influential Committee for Medicinal Products for Human Use (CHMP), who later resigned.
Writing in NEJM, three authors explained that in the wake of Mediator, French regulators and legislators have moved to implement a system that allows ANSM to more closely supervise the off-label use of otherwise licensed medicines. This will reportedly involve Temporary Recommendations for Use (TRU), a three-year window during which some medications may be prescribed for off-label purposes so long as they are closely monitored.
The new paradigm for off-label prescribing will reportedly revolve around unmet medical needs, such as patients suffering from rare diseases of subgroups of treatment populations with unique needs. Other uses will not be permitted, the authors report.
The TRU-based system is intended to allow for companies to have time to collect data to support an expanded marketing authorization. Products not given an expanded indication within three years will be presumed by regulators to not be safe for off-label prescribing and that indication will no longer be permitted.
It is hoped that the new rules will prevent another Mediator-like scandal from occurring. The drug was frequently prescribed for off-label purposes, most notably for weight-loss.
NEJM - France's New Framework for Regulating Off-Label Drug Use