Sanofi's CEO Chris Viehbacher, speaking in his role as leader of PhRMA, says the FDA needs to clearly state what drug makers have to meet when it comes to risk-benefit analysis with new drugs. The uncertainty of FDA rulings is making it unattractive for Big Pharma to develop products for the primary care diseases, like obesity and diabetes, according to Viehbacher. Both obesity and diabetes treatments have taken more than their share of lumps in recently agency rulings leading to a lot more work to get these treatments approved. See Fierce Biotech.
Clearly, I think it is fair for the industry to get transparent guidance on what it is going to take to get certain types of therapies approved. Everyone working on a project should know what "success looks like". I think we all expect that in our daily lives. Why not drug makers too?
I would think that the FDA and the US Goverment would want to provide this -- and I'm not saying they don't. Diseases like obesity and diabetes have to cost US taxpayers and patients billions in treatment costs. These are diseases that have a major impact on the health of our citizen's and healthcare costs. There should be ample motivation to get treatments out there that work (although eating better and exercise wouldn't hurt either).
These are important areas of health where we do want to see continued improvement with treatments because of the high social and economic impact. These would seem to be areas that are ripe for the FDA and drug makers to work together to come up with expectations on future therapies that are reasonable and safe. The US governement also has a vested interest in helping to reach such a conclusion.
Posted by Bruce Lehr Jan 23rd 2012.