FDA Encourages Innovative Clinical Trial Design to Fight High Drug Prices

FDA Commissioner Scott Gottlieb, MD

FDA Commissioner Scott Gottlieb, MD

Two new guidances from the U.S. Food and Drug Administration (FDA) demonstrate the agency’s increasing attempts to inspire clinical trial innovations and the use of advanced trial techniques to help drive down drug costs and bolster consumer choice.

A 36-page draft guidance on adaptive design replaces a 2010 document and is broad in scope. A separate guidance on master protocols focuses on cancer trials.

“By modernizing our approach to the design of clinical trials, we can make drug development more efficient and less costly while also increasing the amount of information we can learn about a new product’s safety and benefits,” said FDA Commissioner Scott Gottlieb, MD.

FDA’s actions are driven, in part, because the agency believes it’s taking “much longer after a new drug is approved to get a second or third drug to the market that’s in the same class as the original medicine,” Gottlieb said as the agency released the guidances.

Part of the problem is that new drugs are holding monopolies for longer periods of time, and consumers aren’t benefiting from price competition, Gottlieb said. In addition, patients aren’t getting the benefits from a choice between different drugs in a new class of medicines, where each drug is similar but might have slightly different profiles, and where one drug may work better for an individual patient, he said.

“One of the most promising ways to make drug development more efficient—while enabling providers and patients to get better information about how a new medicine works—is through the use of more modern approaches to the design of clinical trials,” Gottlieb said.

Author: Michael Causey