Bill Would Give FDA New Tools to Prevent Drug Shortages

New legislation introduced in the Senate would require drugmakers to notify the FDA six months in advance of discontinuing, interrupting or adjusting the manufacture of “medically necessary” prescription drugs in order to avert shortages that could compromise patient care. Companies would be expected to apprise the agency of unanticipated drug shortages as soon as possible, the Preserving Access to Life-Saving Medications Act (S. 296) says. The bill would also require the FDA to post information about actual drug shortages on its website, along with steps the agency planned to address the shortage, and to disseminate information to provider and patient groups.
Drug Industry Daily