Frank F. Weichold, MD, PhD, Director, Science and Innovation, U.S. FDA

How can the FDA help speed up the drug discovery process?


It is clear that we cannot necessarily continue to develop products the way we have been doing it for many years. The problem is that it costs more money and who's going to pay for that?

The mission of the FDA is significant, about a third of all consumer dollars spent on products are regulated. If we want health care and medical products, if you want them to be accessible, they have to be available at a price that they are affordable.

As such, we have to rethink how we develop drugs. We have to look very critically at the process. Beginning from the discovery process to the development process, the approval process, the marketing and even the post-marketing analysis and feedback that we get from patients and consumers, will critically guide what we're going to do in the future.

Regulatory process is not inhibiting innovation. It's rather the opposite. This opportunity is historically unique because our society and our economic situation force us in many ways to rethink and make innovation part of addressing the issue. The role of academia is significant. It is a vital source of innovation. Academia can benefit from interacting with the regulatory agency because at the regulatory agency we understand problems, gaps and shortcomings very well.

We need to find ways to illustrate that to the public and form strategic alliances to solve some of the challenges that we're facing particularly when we think of new technologies, emerging technologies. I think back to the times when I left the clinic to contribute to drug development and improve treatment options. New discoveries can go to the market much faster. That was unthinkable more than 20 years ago.