WASHINGTON—In a special session arranged by the Food and Drug Law Institute (FDLI), FDA Commissioner Margaret A. Hamburg, M.D., spoke about FDA’s reinvigorated plans to protect the American public, namely in improving certain areas of its policies on effective enforcement of FDA laws.
She said effective enforcement helps FDA intercept unsafe or fraudulent products promptly, thereby preventing additional harm; it also helps the agency hold violators accountable, which deters other companies from putting the public at risk. “Visible and clearly explained enforcement actions inform the public about potential dangers,” she noted. “It also helps regulated industries; by maintaining a level playing field for safe products, holding violators legally accountable prevents companies from having to choose between doing the right thing and staying competitive.” She further stressed the importance of effective enforcement in building public confidence in FDA oversight, which would help keep trust in the safety of FDA-regulated products from eroding. “This confidence is critical to long-term interest of both consumers and industry.”
FDA’s goal is to be more vigilant, strategic and quick in its actions, according to Hamburg. “FDA must be vigilant thru regular inspections and follow-up on signals indicating problems,” she said. Noting the agency must work to identify and solve problems early. “Companies must have a realistic expectation that if they are crossing the line, they will be caught; if they fail to act, we will.” On becoming more strategic, she said FDA must place greater emphasis on significant risks of violation and levy meaningful penalties to send strong messages that discourage future offenses.
Hamburg said some FDA enforcement actions over the past several years “have been hampered by unreasonable delays” and “in some cases, serious violations have gone unaddressed for far too long.” She added that the pathways for enforcement actions “can be too long and arduous when the public’s health is in jeopardy.”
In her speech, Hamburg detailed six initial steps that target the effectiveness and timeliness of the FDA’s regulatory and enforcement system:
– Set post-inspection deadlines. The FDA will establish a clear timeline for regulated industry to respond to significant FDA inspection findings, generally giving no more than 15 days to respond to such findings before the agency issues a warning letter or takes other enforcement action.
– Take responsible steps to speed the warning letter process. The FDA will streamline the warning letter process by limiting review of warning letters by the Office of Chief Counsel to those that present significant legal issues.
– Work more closely with FDA’s regulatory partners. In some cases, such as with food safety issues, state, local, and international officials can act more quickly than the FDA. When public health is at risk, the agency will coordinate with its regulatory partners to take rapid action.
– Prioritize follow-up on warning letters and other enforcement actions. The FDA will work quickly to assess and follow up on corrective action taken by industry after a warning letter is issued or major product recall occurs.
– Be prepared to take immediate action in response to public health risks. To better protect the public health, the agency is prepared to act more quickly and aggressively to deal with significant public health concerns and violations. Such actions may occur before a formal warning letter is issued.
– Develop and implement a formal warning letter “close-out” process.” If the agency can determine that a firm has fully corrected violations raised in a warning letter the agency will issue an official “close-out” notice and post this information on the FDA Web site. This will be an important motivator for corrective action by manufacturers.
By taking these steps, Commissioner Hamburg said, the FDA will ensure that “violative inspection results 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.”
Hamburg revealed FDA has received significant funding increases for the current and next fiscal years, noting the funds will be used for additional inspection and compliance activities, as well as to support the elements of effective enforcement strategy.
She further praised the House for recently passing a food safety bill that “would greatly enhance our ability to prevent food born illness and inspections, and would give FDA mandatory recall authority for tainted foods.”
Among the many other ways FDA intends to strengthen its reach is increasing its work with national and international partners to find ways to ensure global and domestic companies secure increasingly complex and ever-growing supply chains.