The new Commissioner of the US Food and Drug Administration has been laying out her vision for the agency and is promising to speed up enforcement actions and warning letters.
Speaking to the Food and Drug Law Institute, Margaret Homburg who has been in the post for eight weeks, said that a strong FDA “has credibility with the public” and is “transparent in explaining its decisions”. However much of her speech focused on enforcing the law effectively. Saying that “ultimately, an effective enforcement strategy creates public confidence in FDA oversight… which in turn keeps trust in the safety of FDA-regulated products from eroding”.
Such a strategy depends on several key elements, Dr Hamburg said, noting that the agency must be vigilant. She said that “our expectation is that companies will work to quickly and thoroughly correct deficiencies and ensure safety”. However, they need to know that “if they are crossing the line, they will be caught, and that if they fail to act… we will”.
The Commissioner went on to say that the agency must use “meaningful penalties to send a strong message to discourage future offences” and “respond rapidly to egregious violations or violations that jeopardise public health”. It also needs to be visible and “show industry and consumers that we are on the job. We must publicise our enforcement actions – and the rationale for those actions – widely and effectively”.
She acknowledged that in recent years, “the Government Accountability Office and others have suggested that the FDA’s enforcement efforts may not have always lived up to these principles”. Dr Hamburg added that “serious violations have gone unaddressed for far too long”, involving product quality, adulteration and misbranding, as well as unlawful labelling and misleading advertising”.
The problem, she says, has not been a lack of commitment by FDA career staff but rather, “the pathways for enforcement action can be too long and arduous”. To combat this, Dr Hamburg outlined a six-point plan.
First, the FDA will set post-inspection deadlines, so that when a serious problem is identified, the firm will generally have no more than fifteen working days in which to respond before the agency moves ahead with a warning letter or enforcement action. It will also 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” while prompt enforcement follow-up will be a priority. Fifthly, the FDA “will be prepared to act swiftly and aggressively to protect the public”, Dr Hamburg said. It will “no longer issue multiple warning letters to noncompliant firms before taking enforcement action”. Also, “we will consider immediate action – even before we have issued a formal warning letter”.
Finally, if a company has fully corrected violations raised in a warning letter, it will receive a ‘close-out’ letter, indicating that the problems have been successfully addressed. To keep the public informed, “we will indicate on our website when a firm has received a ‘close-out’ letter, she added.
Dr Hamburg noted that the FDA “is fortunate to have received significant funding increases” for the next two years or so that will be “devoted to additional inspection and compliance activities” that will support an effective enforcement strategy.
She concluded by saying that “ultimately, the FDA’s success should be measured not by the number of warning letters or injunctions or seizures … but by our impact on the health and welfare of the public”. Enforcement of the law “is not simply an end in itself… enforcement is critical to the agency’s public health mission”.
