Baxter Recovery and FDA Actions

The FDA announced additional actions “to increase access to and supply of IV and peritoneal dialysis (PD) solutions following Hurricane Helene-related damage to Baxter International Inc.’s North Cove facility in Marion, North Carolina.”  The FDA performed assessments to enable import of IV solutions and PD solutions from seven different Baxter sites around the world.  In addition, the Agency has evaluated data to permit extending expiration dates on some existing Baxter products to ease supply shortages (see data on products, lot numbers, and new expirations dates here).  This evaluation will provide some time for recovery of the Baxter facilities impacted by the disaster and creates a buffer period before the FDA needs to take additional regulatory flexibility to ensure continued supply of these critical products.

REMS Modification to Require Mail-Back Envelopes for Unused Portions of Opioid Prescriptions

The FDA has also taken action to modify the risk evaluation and mitigation strategy (REMS) to the existing Opioid Analgesic REMS program.  “[C]ompanies participating in the OA REMS Program have been notified that they will be required to begin providing pre-paid drug mail-back envelopes upon request to outpatient pharmacies and other dispensers of opioid analgesics by March 31, 2025.”

The FDA notice indicates that “[o]nce fully implemented, FDA intends for patients and caregivers to be provided a free, pre-paid drug mail-back envelope (MBE) by outpatient pharmacies or other dispensers of opioid analgesics that order MBEs from the OA REMS.  Other changes to the OA REMS enacted by this approval include:

  • updates to the related Patient Guide to include information about the risk of unused OAs and the importance of safe disposal;
  • a new Patient Education Sheet explaining the risk of unused OAs and the importance of safe disposal to be included with each pre-paid drug MBE.”

See more information on the new modification to this REMS here.

OMUFA Reauthorization Public Meeting

The FDA announced a second public meeting on the reauthorization of the Over-the-Counter Monograph User Fee Amendments.  “OMUFA II to be held on November 20, 2024, to discuss the new commitment letter and related recommendations for reauthorization.”  Further details about the meeting and the issues discussed at the previous meeting can be found here.

We plan to issue these briefs when the FDA has a flurry of important announcements in an effort to keep you aware of issues that may affect your firm’s ability to comply with applicable regulations.