A top official at FDA’s Center for Biologics Evaluation and Research (CBER) says the lack of an exemption under the Inflation Reduction Act (IRA) drug negotiation program for drugs approved for multiple rare diseases is shifting drug developers’ focus and could result in less investment in the rare disease space, in an unusual FDA comment on one of the Biden administration’s chief legislative achievements and a favorite target of Republicans and the pharmaceutical industry. Julie Tierney, who previously served as...