Center of Excellence: Streamlining Drug Approvals

Leonard Lichtenfeld, MD: Recently, the FDA went into a new model—what they called the Oncology Center of Excellence—and they have agreed to do that, and they’re moving forward with it. I will say that I was involved in some of those discussions. The American Cancer Society supported it, and so did a number of other cancer advocacy organizations and influential individuals.

In the cancer space, most of us feel the FDA has tried to be as responsive as possible. I know everyone doesn’t agree with that, but they’ve tried to be as responsible as possible to get new drugs through the pipeline when appropriate, and they’ve revised their rules. They’re looking at smaller populations of patients. They’re not requiring randomized trials when there’s a clear unmet need and we have a drug that really works. They have really worked much quicker than was the case in the past.

Our hope is that, with this new Oncology Center of Excellence, the FDA is going to do even better, because when you talk to the folks at the FDA you learn that some experts are over here, some experts may be in a different place, and the lines of responsibility are getting blurred.

So, you may have a biologic medication that would be tested in lung cancer, but the tests to see if a patient is eligible for that medicine are over in a different department, and maybe a device needs to be approved and that’s in a different department. By bringing that together and hopefully streamlining the process, we’ll all be better off. Having said that—and I don’t mean this negatively—the reality is that it’s a government agency. So, making this happen is going to take a lot of effort on the part of a lot of people. But we, the American Cancer Society, think that it’s a step in the right direction.