Road not taken: the unrecognized harm of excessive regulation

American Enterprise Institute ^ | 1-30-2012 | David Shaywitz

[Dysart]

The difficulty of creating new and better medicines has been the subject of extensive – at times excessive – soul searching, a process that’s 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 “don’t 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 it’s a cop-out; while there is clearly a measure of shared responsibility, it’s 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 world’s most vibrant drug development ecosystem.

It’s not that other factors (such as the complexity of science) aren’t important – in fact, it’s precisely because developing new drugs is challenging, so inherently difficult, that’s it’s 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 it’s especially frustrating – it’s 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 isn’t so much the sentiment as the way it’s reduced to practice.