FDA's Hamburg on Research Investment and Clearing the Hurdles to Drug Approvals

Marrecca Fiore; Margaret Hamburg, MD


October 17, 2013

In This Article

Record Numbers of Drug and Device Approvals

Medscape: Correct me if I am wrong, but I believe you said that the FDA has actually been approving more drugs and devices than in the past.

Dr. Hamburg: In the past couple of years, we have had record numbers of new medical product approvals and, more important, we approve more drugs first. If you compare us with other countries, we approve new drugs more quickly. I think we are providing a critical and unique service to the American people.

We can always do better. We must do better, but I think one of the lessons from our panel today -- and certainly a lesson from my experience at FDA and working as a bench scientist and a healthcare provider -- is that we have to always recognize that real, sustainable progress doesn't happen by operating in a silo. We need this kind of partnership and coordination across all of the components and all of the stakeholders [in the approval process] to really make the difference we want to make.

Medscape: Turning to clinical trials, there are some who believe that the randomized, placebo-controlled trial is somewhat antiquated and not always the best method of gauging real-world results when it comes to new drugs and devices. How is the FDA working to improve the way it tests new products?

Dr. Hamburg: We are so far down that path that this question is almost irrelevant, to be honest. Obviously, the randomized controlled clinical trial is the absolute gold standard in terms of rigorous science and getting really solid answers. But there are lots of other ways to get robust scientific answers without using that, and there are many circumstances where you simply can't do a randomized controlled clinical trial for ethnical reasons or practical reasons. We look at [this kind of trial] as one tool in our toolbox, and we use many other strategies in terms of the kinds of clinical data that we will use for review.

We have also funded a lot of work in this area to really look at innovative clinical trial design, working with our academic partners and in some cases with industry. We see it as an area ripe for continuing collaboration and development of new strategies and approaches. But it is critically important, as we learn more and do more, that we become increasingly flexible and innovative in our approaches.


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