FDA’s Gottlieb Wants to Encourage Bioequivalence Clinical Trials

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Competition, transparency, and a bit of a nudge from the U.S. Food and Drug Administration (FDA) can help promote bioequivalence clinical trials, FDA Commissioner Dr. Scott Gottlieb told attendees of the Prescription Drug Delivery System conference on July 20 in Washington, D.C.

Citing what he called “gaming” by some branded drug developers, Gottlieb nevertheless stressed that they deserved a fair return on investment for the money they put into product development. Manufacturers of generics must also pay a fair price for the information they need to conduct a bioequivalence trial, Gottlieb added.

Meantime, Gottlieb touted FDA’s “Innovation Initiative” as one means of advancing use of technology and real-world data in trials. Specifically, Gottlieb drew attention to the agency’s encouragement of in silico tools in clinical trials. Such trials use computer models and simulations to develop and evaluate devices and drugs. “Modeling and simulation play a critical role in organizing diverse datasets and exploring alternate study designs,” Gottlieb says.

In silico is one way to enable advancement of safe and effective new therapeutics through various clinical trial stages, Gottlieb adds. FDA’s Center for Drug Evaluation and Research (CDER) is currently using modeling and simulation to predict clinical outcomes, inform clinical trial designs, support evidence of effectiveness, optimize dosing, predict product safety, and evaluate potential adverse event mechanisms.

Gottlieb also says FDA will put out updated and new guidances detailing how aspects of in silico trials can be “advanced and incorporated into different aspects of drug development.”

Author: Michael Causey