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Lawmakers Seek Briefing on FDA’s Tracking of Withdrawn Generics

March 18, 2020

Members of the House Energy and Commerce Committee said drugmakers are using temporary generic drug market withdrawals to stifle competition and have asked the FDA for a briefing on how the agency monitors the practice.

In a letter to FDA Commissioner Stephen Hahn, the committee called for a briefing on the agency’s implementation of the market status reporting requirements under the FDA Reauthorization Act (FDARA).

The lawmakers pointed to a May 2019 complaint filed by 45 states alleging that Sandoz withdrew ten products that overlapped with Taro Pharmaceuticals products so Taro could raise the prices on those drugs and Sandoz could then re-enter the market at a higher price.

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