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Pharmaceuticals / Regulatory Affairs

Gottlieb Flags FDA’s ‘Untapped’ Authority to Fight High Prices and REMS Abuses

Aug. 2, 2017

FDA Commissioner Scott Gottlieb updated lawmakers Thursday on the agency’s plan to help lower drug prices using its “untapped authority” to increase competition and streamline generic drug approvals.

Testifying alongside Markus Meier, the acting director of the Federal Trade Commission’s bureau of competition, Gottlieb told the House judiciary antitrust subcommittee that the FDA is gathering information on abuses of REMS requirements and limited distribution systems, pay-for-delay agreements and citizen petitions, as well as price hikes of older, off-patent drugs.

In addition, the FDA sent the FTC a list of the approximately 150 complaints received from generics companies, regarding brand-name manufacturers denying access to samples of REMS-covered products.

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