FDA Commissioner Outlines Six-Step Plan for Improved Enforcement

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ePT--the Electronic Newsletter of Pharmaceutical Technology

US Food and Drug Administration Commissioner Margaret Hamburg outlined last week six initial steps designed to improve the effectiveness and timeliness of FDA's regulatory and enforcement system.

US Food and Drug Administration Commissioner Margaret Hamburg outlined last week six initial steps designed to improve the effectiveness and timeliness of FDA’s regulatory and enforcement system. Hamburg outlined the measures to a group of industry representatives, attorneys, consumers, and others attending a speech sponsored by the Food and Drug Law Institute in Washington DC, and in an agency press release.

Hamburg said that 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.” To address these problems, she outlined the following steps to improve FDA’s enforcement activities:


  • Setting postinspection deadlines. FDA will establish a clear timeline for regulated industries 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.

  • Taking responsible steps to speed the Warning-Letter process. 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.

  • Working more closely with FDA’s regulatory partners. In some cases, such as food-safety issues, state, local, and international officials can act more quickly than FDA, according to the FDA press release. When public health is at risk, the agency will coordinate with its regulatory partners to take rapid action.

  • Prioritizing follow-up on Warning Letters and other enforcement actions. FDA will work quickly to assess and follow up on corrective action taken by industry after a warning letter is issued or a major product recall occurs.

  • Being prepared to take immediate action in response to public-health risks. To better protect the public health, FDA says it 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.

  • Developing and implement a formaling 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 website. FDA says this move will be an important motivator for corrective action by manufacturers.

By taking these steps, Hamburg says 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.”