Six Steps to Improve FDA Enforcement

FDA Acting Commissioner Margaret Hamburg outlined six steps to improve FDA enforcement in a speech given on August 6, eight weeks into her tenure.

Hamburg said that the current pathways for enforcement can be too long and arduous when the public’s health at risk. To improve the pathway, Hamburg outlined six key steps. Five of the six steps involve procedural activities and one involves the resolution of warning letters.

In one key new measure, the FDA will set post-inspection deadlines, giving firms a deadline of 15 working days to respond to inspection findings. “This will help FDA issue warning letters in a timely basis and facilitate prompt corrective action,” she said. The FDA will also prioritize enforcement follow-up, either through an inspection or an investigation, to assess whether the necessary changes have been made.

Also, the agency will no longer issue multiple warning letters before taking enforcement action. And in some cases, she said, the FDA may take immediate action to protect public health without the issuance of a formal warning letter. One additional step involves the development of a formal warning letter closeout process. Once a firm has fully corrected the violation raised in a warning letter, the agency will issue a “close-out” letter. The agency will also indicate on the web site that a close out has been issued.

Hamburg said that and effective enforcement strategy ultimately creates public confidence in FDA oversight, which in turn keeps trust in the safety of FDA-regulated products from eroding. “Such confidence is critical in the long-term interest of both consumers and industry,” she said.