Skip to comments.Road not taken: the unrecognized harm of excessive regulation
Posted on 01/30/2012 6:29:25 PM PST by Dysart
The difficulty of creating new and better medicines has been the subject of extensive at times excessive soul searching, a process thats intensified as high-profile patents expire, along with their associated revenue streams, traditionally relied upon to support future R&D. As a result, both biopharma companies and patients awaiting new treatments find themselves struggling for viable solutions.
Predictably, industry (where I obviously reside) attributes excessive regulation, regulators say dont blame us, and considered reporters and observers typically try to split the different maybe everyone is a little bit at fault.
The problem with this resolution is that its a cop-out; while there is clearly a measure of shared responsibility, its willful blindness not to recognize the extent to which a deliberate and very conscious regulatory policy is putting a damper on what has traditionally been the worlds most vibrant drug development ecosystem.
Its not that other factors (such as the complexity of science) arent important in fact, its precisely because developing new drugs is challenging, so inherently difficult, thats its crucial to do everything within our control to work together and create an environment, an ecosystem, that stimulates and enables meaningful innovation.
The most significant and potentially, most correctable (which is why its especially frustrating its explicitly of our own making) problem is that regulators, as others have astutely observed, seem to have misapplied the precautionary principle, colloquially understood as first, do no harm. The problem isnt so much the sentiment as the way its reduced to practice.
(Excerpt) Read more at aei.org ...