"It is a simple, if not seductive, pitch," Gottlieb writes. "New medicines should demonstrate that they offer clear advantages over older, often cheaper drugs. But if fails to take into account the costs this requirement would impose, the weakness of the clinical information it would ultimately generate, and the existing regulatory authorities and market forces that already compel drug companies to undertake these "active comparator" trials when the information that can be generated is important to clinical decision making."
The French debate could have international repercussions because of the size of the drug market there — $38.8 billion in 2009 — and the industry's clout (France is home to the world's sixth largest pharmaceutical company by revenue, Sanofi-Aventis, with $42 billion in revenues in 2009).
The proposed overhaul comes as France is dealing with the fallout over the diabetes drug Mediator, which has been linked to the deaths of some 500 people. The Servier company drug, also known as benfluorex, was prescribed to more than 5 million people between 1976 and 2009, when it was banned after regulators questioned its safety and efficacy.
French health minister Xavier Bertrand, who outlined the proposal last Thursday, has vowed that there would be "a before and after Mediator."
"I want to provoke a cultural shift in the healthcare system," he told the newspaper Le Monde. "We are going to conduct a complete review of the national drug formulary: the French consume too many prescription drugs and there are too many products on the market."
Other proposed reforms include stronger restrictions on pharmaceutical salespeople — they'd be required to see teams of hospital physicians instead of having one-on-one access — and requiring more public disclosure of payments to researchers, physicians and specialty societies. The government is expected to introduce its legislative proposal by early August.