In a speech last week at the Food and Drug Law Institute in Washington, D.C., FDA Commissioner Margaret A. Hamburg outlined a six-step strategy to make the agency's regulatory and enforcement efforts more efficient.
The commissioner lamented the fact that over the last several years the perception has become prevalent that the FDA has failed to live up to its enforcement responsibilities.
“Reports have noted that there has been a steep decline in the FDA’s enforcement activity over the past several years,” said Hamburg. “At the same time, many of the enforcement actions that the FDA has undertaken have been hampered by unreasonable delays. In some cases, serious violations have gone unaddressed for far too long.”
The steps FDA plans to take include:
- Establishing post-inspection deadlines of no more than 15 days before the agency issues a warning letter or initiates an enforcement action;
- Make the warning letter process more efficient by limiting review by the Office of Chief Counsel to only those letters of legal significance;
- Work more closely with regulatory partners at the local, state and international level;
- Expedite follow-up on warning letters and other enforcement actions;
- Prepare for quicker action in response to possible health risks, even before formal warning letters are issued; and
- Develop a warning letter “close-out” process.
These steps will allow the FDA to ensure that “violative inspection results are taken seriously,” Hamburg said, “that warning letters and enforcement actions occur in a timely manner and that steps are taken to protect consumers in cases where immediate enforcement action is not possible.”