August 10th, 2009
Margaret A. Hamburg M.D., commissioner of the US FDA recently announced her obligation to “prevent harm to the American people” through immediate, dynamic, potent administration of FDA laws and rules.
Commissioner Hamburg while speaking to a crowd of industry representatives, attorneys and consumers who all attended the speech funded by the Food and Drug Law Institute in Washington, D.C., declared that the FDA must be “vigilant, the FDA must be quick, the FDA must be visible.”
Commissioner Hamburg stated that over the past years, some FDA enforcement “have been hampered by unreasonable delays” and “in some cases, serious violations have gone unaddressed for far too long.” Resulting in what she calls “long” and “arduous” routes for enforcement operations.
She focused on six preliminary steps that have been created to improve the authoritativeness and expediency of the FDA’s command and enforcement system:
1. Set post-inspection deadlines. The FDA will institute a precise timeline for regulated officials to react to crucial FDA inspection findings. No more than 15 days will be given to react to such findings, before the agency communicates a warning letter or takes alternative enforcement action.
2. Take responsible steps to speed the warning letter process. The FDA will efficiently manage the warning letter procedure by regulating review of warning letters by the Office of Chief Counsel to those that present notable legal matters.
3. Work more closely with FDA’s regulatory partners. When it comes to food safety issues, state, local, and international agents can act more quickly than the FDA. When public health is in jeopardy, the FDA will collaborate with its regulatory partners to ensure rapid action is taken.
4. Prioritize follow-up on warning letters and other enforcement action. The FDA will work swiftly to evaluate and follow up on reparative effort taken by industry once a warning letter has been communicated or a major product recall arises.
5. Be prepared to take immediate action in response to public health risks. In the effort to best safeguard public health, the FDA is committed to acting more swiftly and boldly when confronted with public health issues and violations. Such actions may materialize before the written letter is communicated.
6. Develop and implement a formal warning letter “close-out” process. A “close-out” notice will be posted on the FDA web site, should a firm correct violations that were previously raised in their warning letter. This effort will motivate reparative action by manufacturers.
