FDA has an impossible task, given the breadth of its scope and its limited resources. And given the accelerating emergence of promising new diagnostic and therapeutic capabilities, the challenge isn’t shrinking.
For example, the stimulus legislation provides NIH with $10 billion for new research to be spent over the next two years – presumably because NIH is “shovel ready.” Regardless, our science and our technological inventiveness, combined with our venture-based incentives, are producing more and more breakthroughs that will only strain FDA resources further.
In assessing the risks of new technology, rarely mentioned is the opportunity cost for patients of a regulatory process that is underfunded and therefore ill-equipped to manage approvals quickly. Given the public and political expectation of perfect outcomes, we err on the side of caution. Many argue this is as it should be.
Nevertheless, technology over the past 30 years has helped produce significant improvements in life expectancy, reductions in disabilities and shifts from more to less intensive care settings. In managing the advance of technology we must strike the right balance between risks and rewards.
In the end, a healthier society is more productive. Stimulating productivity through health is central to President Obama’s prescription. If we can get the balance between opportunities and cost right, FDA will play a vital and exciting role.