Here's a good post by Stewart Lyman in Xconomy. It points out the folly of blaming primarily (or solely) the FDA for the pharmaceutical industry's lack of recent drug approval success and innovation. It also reminds us that the FDA's chief responsibility is to ensure safety and efficacy. This is good counterpoint given the prevailing winds that sometimes like to blame the FDA (regulation) for lack of innovation (see Viehbacher and Lechleiter comments at PhRMA yesterday as an example).
I recommend that you give this a read and reflect on a history of bad company behavior's in the past and not so distant past that led to the foundation of the FDA and its regulatory role in ensuring safety and efficacy. There is a good reason that it exists -- to protect you and me from charlatans and bad science. KInd of reminds me of people who rail against Unions -- but there is a very legitimate set of reasons why they came into existence - of course institutions do need to continue to evolve and the FDA is no different in that respect.
Lyman finishes his article:
The problem facing the pharma and biotech industry isn't excessive regulation; it's a lack of inducements in the midst of a drought (ed note: self-inflicted I might add) of innovation. Let's create significant new incentives that will reward companies for generating new drugs to combat the problem. Among the possibilities are significant tax breaks, longer patents, and guaranteed pricing tied to effectiveness.
I tend to back tax incentives and particularly pricing premiums for drugs that actually work and provide real patient benefit. I'm much less enthused about extended patent lives. But that's me.
Posted by Bruce Lehr April 15th 2011.