March 8, 2022
Life Sciences
  • House Energy and Commerce Chair Frank Pallone introduced a bill that would dramatically rein in the FDA’s accelerated approval program. Under accelerated approval pathway, the FDA can approve drugs without clear evidence that they actually prolong patients’ lives, so long as drug companies complete follow-up studies and demonstrate that the therapies actually do have a “clinical benefit.” The bill would set a five-year expiration on licenses granted under the pathway to streamline the process for taking products off the market if no benefit is shown, making it easier for the FDA to crack down on drug companies that do not complete those follow-up studies. (Article here)