publication date: Sep. 15, 2017

Gottlieb: Oncology center shows how FDA can improve regulation, lower development costs

FDA has a legitimate role to play in slowing down the cost of developing drugs, and it can do so by relying on good regulatory science, the agency’s commissioner Scott Gottlieb said.

Speaking at a Washington event sponsored by Friends of Cancer Research and focused on precision medicine, Gottlieb said the agency’s Oncology Center of Excellence demonstrates what the agency can do to streamline the drug development process.

“There are a lot of scientific opportunities to modernize our approach to drug regulation and also make it more rigorous. We’ve seen this, in particular, in oncology,” Gottlieb said.

The center has “thought about things like seamless trials, master protocols, site-agnostic clinical trials, and other ways to try to develop drugs through methodologies that not only could be more efficient and potentially lower-cost, but will yield a lot more information about how those drugs can work in clinical practice,” he said.

A partial transcript of Gottlieb’s remarks at the FOCR meeting Sept. 13 follows:

We’ve talked a lot about my concern about drug prices as a public health issue, because we do concern ourselves at FDA with issues of access, and to the extent that patients don’t have access to the medications they need because of the way they are priced that is something that … Continue reading Gottlieb: Oncology center shows how FDA can improve regulation, lower development costs

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