Senate committee poised to pass bills on generics, PBMs, orphans
Generics bill seeks to ‘immunize’ FDA from litigation, attorneys say
A key Senate committee is slated to consider legislation Tuesday that aims to increase PBM transparency, speed generic drug approvals, and give FDA power to grant orphan drug approvals based on indications rather than diseases or conditions. Sen. Bernie Sanders (I-Vt.), chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee, and ranking committee member Sen. Bill Cassidy (R-La.), have reached agreement on the bills, so they are almost certain to be endorsed by the full committee.
Attorneys at Hyman, Phelps & McNamara, a Washington firm specializing in FDA law, are sounding the alarm about one of the bills, the “Ensuring Timely Access to Generics Act of 2023” (S. 1067). They said it “could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review.”...