January 12, 2024
APC to FDA: Show your work (please?)
APC submitted comments this week on FDA’s Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act. In the letter, we indicate support for the policy, but we urge that FDA share evidence for its concerns about the safety of a substance. “It’s not enough for the agency to say it has concerns,” said APC’s Savannah Cunningham. “FDA needs to show its work. What’s the scientific basis for restricting nominated substances?”
FDA has responded to our October letter requesting detail on the safety risks FDA said it identified that led to the reclassification of numerous substances to Category 2. Their reply directs us to a new summary page that outlines generalized concerns with these substances but still fails to provide the evidence for FDA ruling the substance a safety risk to patients.
