Not all business travel is arduous. I’ve just returned from the 11th annual France-USA Conference on pharmaceuticals and health policy. The meeting was in Paris. Sometimes being a policy wonk has its perks.
My role was to debate NYU professor, Dr. Victor Rodwin on “The Current State of Obama’s Health Reforms.” It was fun and feisty – especially the parts where we both spoke in French. (Shout out to my high school French teacher, Linda Diaz!)
Dr. Rodwin regularly cited Commonwealth Fund research, ‘Nuff said. I focused on the legality of the individual mandate, the growing “idealism gap” of those who want to improve our healthcare system – but not via the approaches of the Affordable Care Act, the increasing (and increasingly contradictory) roles of comparative effectiveness and patient-centered outcomes research, IPAB (and the creeping fear of Uncle Sam, MD), the dangerous vagaries of academic detailing, and the war against medical innovation (personified by President Obama’s call for a roll-back of biologics patent life from 12 to 7) and the issue of data exclusivity.
My summation – “L’audace, l’audace. Toujours l’audace.”
Another fascinating presentation was offered by Dominique Maraninchi, the relatively new (since the end of February 2011) General Manager of AFSSAPS. That means he’s the French equivalent of the Commissioner of the FDA.
France is going through it’s own “Vioxx Moment,” having recently rescinded the market license for Mediator (a diabetes drug that was widely used off label as a weight loss treatment). “L’Affaire Mediator” is a big deal and has created a public outcry for change and reform. Sound familiar? (FYI – for more detailed information on the Mediator issue, see here.)
Much of what Dr. Maraninchi had to say will sound very familiar to FDA watchers:
AFSSAPS must:
· Reestablish trust
· Enhance pharmacovigilance and do a better job analyzing data and drawing conclusions
· Be more transparent (a truly radical concept for the French bureaucracy)
· Be more accountable
· Offer more information and explanations about its decisions via “bon usage” (safe use)
These might sound rather derivative to a US audience, they are not. While they certainly do share much of what the FDA is trying to accomplish, (1) the French system is very different and these initiatives will require different strategies and tactics, (2) as such, their efforts will deliver different results, and (3) there will be much for the Wizards of White Oak to learn from the AFSSAPS experience.
Another echo of FDA came from Yves Burr (a member of France's National Assembly and chair of that body’s working group on medicines and health products), who asked, “Do we have the courage to put the patient in a role where they can be heard?”
Dr. Maraninchi ended his presentation with a statement of principle that should be widely discussed inside the FDA:
“It is better to make a decision than to have no decision at all.”
Perhaps he should testify at the upcoming Congressional hearings on PDUFA?
