FDA Forms Senior-Level Generic Competition Working Group

August 11, 2017

The FDA created a new working group of senior staff members to develop ways to boost generic competition, according to Commissioner Scott Gottlieb.

On Capitol Hill last month, Gottlieb told members of Congress that he believed the FDA had “untapped authority” to increase competition, and that staffers are reviewing processes and regulatory requirements that could be “gamed” to slow the rate of generic approvals.

The group’s goal is to find new ideas for greater generic drug access and to end obstacles to otherwise expected competition, he said. It will also work to modernize the agency’s implementation of the Hatch-Waxman amendments that govern generic approvals.

In addition, about 150 complaints the agency has received from generic drugmakers have been passed on to the Federal Trade Commission, and were reviewed for antitrust implications.

The working group comes as a study highlights the declining number of U.S. generic drugmakers over the past decade. In addition, prices of generic drugs have risen over time, particularly following the implementations of the Affordable Care Act and GDUFA, the paper’s authors said.

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