June 10, 2024

In a recent discussion at the Regulatory Education for Industry (REdI) meeting on May 30, Jill Furman, the director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research (CDER), provided crucial updates and addressed common misperceptions regarding FDA’s drug compliance actions. Furman highlighted several important points:

  1. New FDA Web Page: The FDA has launched a new web page aimed at clarifying misperceptions about its drug compliance actions. This resource provides detailed information on the agency’s efforts in monitoring drug manufacturers’ compliance with current good manufacturing practice (CGMP), including warning letters and post-inspection actions. It also links to the FDA data dashboard page, which outlines compliance actions.
  2. Use of Remote Tools: The FDA continues to utilize remote interactive evaluations and other remote tools as primary methods for compliance actions, especially since the COVID-19 pandemic. In fiscal year (FY) 2024, 75% of import alerts were based on remote tools, a significant increase from 5% in FY 2020. Similarly, 29% of warning letters in FY 2024 were prompted by remote tools compared to only 2% in FY 2020.
  3. Misconceptions: Furman addressed several misconceptions about the FDA’s authority and processes:
    • Recall Authority: Contrary to popular belief, the FDA does not have mandatory authority to recall drugs. It can request firms to remove violative drugs but cannot enforce a mandatory recall.
    • Drug Testing: Another common misperception is that the FDA tests all drugs on the market. In reality, the FDA employs a risk-based approach, prioritizing inspections for firms posing higher risks.
  4. Ongoing Education: Furman emphasized the need for continued education on the FDA’s inspection processes, Form 483 reports, and inspection classifications to mitigate misunderstandings in the industry.

The FDA’s proactive approach in utilizing remote tools and enhancing transparency through educational resources reflects its commitment to ensuring drug quality and compliance while adapting to modern challenges.