New US FDA Leadership to Focus on Enforcement of the Law
By Rochelle Runas, ISPE Technical Writer
US FDA Commissioner Margaret Hamburg announced that “enforcement of the law” will be the overriding objective of the FDA under her leadership.
In a presentation to the Food and Drug Law Institute on 6 August in Washington, D.C., Hamburg set the tone for the new administration, emphasizing the Agency’s renewed focus on “effective” enforcement and outlining specific steps toward strengthening that enforcement.
“Reports have been 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. These include violations involving product quality, adulteration, and misbranding; false, misleading, or otherwise unlawful labeling; and misleading advertising.”
Hamburg said these delays are not a reflection on the lack of commitment by FDA staff, rather the pathways
for enforcement action can be too long and arduous when the public’s health is in jeopardy.
In an effort to fix these pathways to improve the effectiveness of the FDA’s enforcement system, the Agency will take these six initial steps:
- The FDA will set post-inspection deadlines. Once the FDA provides inspection findings identifying a serious problem, a firm will generally have no more than 15 working days in which to respond before the FDA moves ahead with a warning letter or enforcement action.
- The FDA will take responsible steps to speed the issuance of warning letters. Under a new policy from the FDA’s Chief Counsel, warning letter reviews will be limited to significant legal issues. As a result, most enforcement letters will be able to move through a more streamlined process.
- The FDA will seek to work more closely with regulatory partners (local, state, international officials) to develop effective risk control and enforcement strategies. Because these partners have more authority to take action quicker than the FDA, when the public health is at risk, the FDA will reach out to its partners to take rapid action, while the FDA alerts the public and prepares longer-term responses.
- The FDA will prioritize enforcement follow-up. After a warning letter is issued or a major product recall occurs, the FDA will make it a priority to follow up promptly with appropriate action (e.g. inspection, investigation) to assess whether a company has made required changes in its practices.
- The FDA will be prepared to act swiftly and aggressively to protect the public. Gone are the days of the FDA issuing multiple warning letters to noncompliant firms before taking enforcement action. “If we find that we must move quickly to address significant health concerns or egregious violations, we will consider immediate action – even before we have issued a formal warning letter,” said Hamburg.
- 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, the FDA will provide the firm with a “close-out” letter, indicating that the issues in the warning letter have been successfully addressed. The public will be kept informed through the FDA Web site when a firm has received a “close-out” letter.
Also in her presentation, Hamburg highlighted recent successful FDA enforcement actions in response to Web sites promoting products fraudulently claiming to diagnose, prevent, and treat the H1N1 influenza virus, as well as companies selling anabolic steroids under the guise of dietary supplements. A good portion of her presentation was dedicated to these issues, indicating increasing FDA vigilance on dietary supplements and H1N1-related fraud.
“When you fail to meet the standards that the FDA has set to prevent harm, then you are putting the public at risk,” said Hamburg. “You are also jeopardizing the public’s confidence in your industry. The solution is a commitment to compliance backed by a strong compliance program. Now is a good time to reassess whether you have such an effort in place.”