COMMENTARY

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

Marrecca Fiore; Margaret Hamburg, MD

Disclosures

October 17, 2013

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Editor's Note :
US Food and Drug Administration (FDA) Commissioner Margaret Hamburg, MD, spoke with Medscape during the recent National Health Research Forum in Washington, DC, and discussed clearing the hurdles to drug and device approvals, advancing personalized medicine, and smart spending to leverage scientific enterprise.

Medscape: Your panel today talked about "clearing the hurdles to a research and healthcare renaissance." Some researchers and clinicians see the FDA as a hurdle to getting new lifesaving medications and medical devices to patients. Can you discuss what the FDA is doing right now to streamline and speed up the drug and device approval process?

Dr. Hamburg: Sure. When you look at what is required to move an important discovery in science into a real-world product that patients and consumers want and need, obviously we play a critical role. We are responsible for reviewing the data to really examine critical questions about safety and efficacy. We see that as a clear value for patients and their families, and also for the industry sponsors of these products. Because if the product doesn't work, if it is going to cause problems, it is not in the industry's best interest either.

We need to all work together, and I think part of the discussion in the conference today was how important it is to have all the voices and perspectives represented around the table. FDA is one important player in that process, and we play a critical role because we sit in a position where we can look on one side and see what the unmet medical and public health needs are, and we can also see what is in the pipeline.

But we have an obligation to do our jobs as effectively and efficiently as possible. During my tenure as commissioner, I have worked hard to make sure that, number one, we are as engaged in the science as we can possibly be, and to make sure that we have people with the right scientific expertise and experience to appropriately review applications that come before us. More important, to engage with the scientific community early and often so that, as products are being developed, as new discoveries are moving through the pipeline, we help identify what kinds of data are going to be needed, what kinds of questions have to be asked and answered as part of the ultimate review process, and our ability to approve a drug to go into the marketplace. And we know that by working together in that way, we can actually speed the development process and the review process.

We also have to commit ourselves to making sure that our business processes are as efficient as possible so that we don't sit on applications, so that we return phone calls, so that we have the kind of mechanisms to hire the people that we need, train them properly, etc. We have focused very much on really strengthening our ability to do our job, but we see our job as part of a bigger mission to really advance biomedical product innovation.

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