October 11, 2024
Lots of letters
The FDA’s inbox is getting quite a workout lately. Here’s a rundown of what the agency has received lately just on compounding-related issues:
- Our letter to Gail Bormel, director of the Office of Compounding Quality and Compliance, urging “that FDA immediately implement an ‘off-ramp’ period of at least 60 days after a GLP-1 drug [comes] off shortage.”
- A joint APC-NCPA letter to Commissioner Califf and others explaining our concern for patient continuity of care with tirzepatide coming off shortage. We reiterated our request for a 60-day off-ramp, and we also asked for clearer guidance on 503A pharmacies sourcing tirzepatide from 503B facilities.
- A bipartisan letter to FDA Commissioner Robert Califf from members of the House Energy and Commerce Committee expressing concern “about counterfeit Ozempic entering through illegal channels.” Of note is that the letter is clear about the distinction between legitimate compounding pharmacies and illegal, counterfeit-drug operations.
- A letter from four Republican members of Congress to Commissioner Califf asking for FDA to make its oversight of 503B facilities clearer and less burdensome so those facilities can better fill the gaps during drug shortages, as well as “take steps to improve the drug shortage list, including better utilization of drug shortage information provided to the agency by health care providers, including both 503B outsourcing facilities and 503A state licensed compounding pharmacies.”
