Expert Recall

FDA Commissioner Margaret Hamburg, M.D. today spoke to the Food and Drug Law Institute (FDLI) about the Agency’s use of law enforcement to promote public health. The Commissioner presented the “get tough on violators” side of FDA that appears to be what Congress and the public expect but haven’t always seen. According to the Commissioner, the goal of the FDA is for all companies to stay in compliance with federal regulations in order to prevent harm to the American people. Ensuring this result requires effective enforcement against violations.

Dr. Hamburg listed benefits of effective enforcement to public health, including preventing harm, deterring other violative actions, providing clear guidance about products presenting potential dangers, creating public confidence in the FDA, and leveling the playing field in industry.

So why should you care? It is clear from the Commissioner’s presentation that FDA enforcement is to be strengthened in all areas, including recalls. In fact, one of the six steps the FDA will take to strengthen enforcement is to see that major product recalls are followed up promptly with an “inspection or investigation”. The industry can not only expect to have an inspection of its facility, but should expect to have a FDA investigator in the production facility “promptly”. The inspections usually do not focus on the recall itself but rather on the reason for the recall. Rather than having an FDA investigator conducting a detailed investigation into all areas of Good Manufacturing Practice (GMP) Regulations, it is in the best interest of the recalling firm to have the reason for the recall determined through its own completed investigation before FDA even arrives.

The Investigator is charged with identifying the root cause for the recall and assuring that steps have been taken to prevent it from reoccurring. If the recalling firm has done this in advance – determining the how, when, where and why – it will be a matter of verifying that the firm’s findings reflect the correct conclusions about both the problem and the correction.