The US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said that FDA is taking several initial steps to enforce the laws and regulations that govern the safety of drugs, medical devices and much of the US food supply. FDA must be vigilant, strategic, quick and visible, she told the audience in a speech to the Food and Drug Law Institute in Washington D.C.
The FDA has outlined six steps to make its enforcement more effective and timely, including setting timelines for industry to respond to inspection findings and streamlining warning letter reviews.
First step, the FDA will set post-inspection deadlines. When the FDA finds that a firm is significantly out of compliance, FDA expect a prompt response to our findings. Once the FDA provides inspection findings identifying a serious problem, the firm will generally have no more than fifteen working days in which to respond before the FDA moves ahead with a warning letter or enforcement action. This will help FDA issue warning letters on a timely basis and facilitate prompt corrective action.
Second, the FDA will take responsible steps to speed the issuance of warning letters.
Third, the FDA will seek to work more closely with our regulatory partners to develop effective risk control and enforcement strategies.
Fourth, the FDA will prioritize enforcement follow-up. After a warning letter is issued or a major product recall occurs, FDA will make it a priority to follow up promptly with appropriate action, such as an inspection or investigation to assess whether or not a company has made required changes in its practices.
Fifth, the FDA will be prepared to act swiftly and aggressively to protect the public. The FDA will no longer issue multiple warning letters to noncompliant firms before taking enforcement action. If FDA find that we must move quickly to address significant health concerns or egregious violations, FDA will consider immediate action – even before we have issued a formal warning letter.
These five procedural changes will help to ensure that violations are taken seriously, 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.
A sixth new practice is a little different from the others. It relates to our response to firms after they have made necessary corrections.
At Margaret Hamburg direction, the FDA is developing a formal warning letter “close-out” process. If the FDA can determine, usually based on a re-inspection, that a firm has fully corrected the violations raised in a warning letter, FDA will provide to the firm a “close-out” letter, indicating that the issues in the warning letter have been successfully addressed. To keep the public informed, we will indicate on our website when a firm has received a “close-out” letter.
Not every type of warning letter will be eligible for a “close-out” letter. But for ongoing violations, it could play an important motivating role in spurring corrective action.
These six changes are significant steps in the right direction. The FDA is fortunate to have received significant funding increases for the current and next fiscal year that will be devoted to additional inspection and compliance activities that will support the elements of an effective enforcement strategy.