FDA, NIH Aim to Push New Breakthroughs, but the Budget's Tight
The intiative aims to integrate good science with safety, efficacy, and quality regulations -- ensuring that biomedical research follows regulations from an early stage, and that the latest innovation is part of the regulatory review process. The NIH, which has long supported and facilitated new discoveries, and the FDA, which has long regulated the approval of drugs, biologics, and medical devices, say that they have collaborated for more than two decades -- but also that this collaboration is the first of its kind.
"We've all been following the remarkable advances in biomedical sciences led by the NIH with great enthusiasm for years," said Kathleen Sebelius, Secretary of Health and Human Services, in a statement. "Collaboration between the NIH and the FDA, including support for regulatory science, will go a long way towards fostering access to the safest and most effective therapies for the American people."
Big Initiative, Small Budget
Naturally, there's a catch: money. The NIH and FDA will apportion only $6.75 million over three years to fund regulatory science research on new methods, models, and technologies for evaluating safety and efficacy in developing medical products. Officials plan to solicit input from the public, starting this spring.
This is a commendable initiative. I've heard of several medical breakthroughs supported by the NIH, such as the work on HIV and cocaine vaccines. But it's hard to understand why creating this initiative took so long -- or what exactly can be done on a three-year shoestring budget of $6.75 million.