Califf Seeks Insurers’ Help In Ensuring Accelerated Approval Studies Done

FDA Commissioner Robert Califf on Thursday (March 16) called on health insurers to play a role in ensuring drug companies complete follow-up studies confirming clinical benefit of drugs cleared for market under FDA’s accelerated approval pathway. He suggested insurers could help generate evidence by making it easier for physicians to participate in trials. Califf’s comments came during the last day of health insurance lobby AHIP’s three-day annual conference. FDA’s accelerated approval pathway allows for earlier approval of drugs that treat...