In a speech yesterday, new FDA Commissioner Margaret A. Hamburg set forth the enforcement philosophy of the new administration. Unlike many such speeches by an agency head, this one was not just platitudes about enforcement. Commissioner Hamburg described a number of specific initiatives and the agency’s new enforcement paradigm.

As the backdrop to her remarks, she lamented the perceived decline and slower pace of FDA enforcement over the past several years. She attributed much of this to resource limitations within FDA which have now been addressed by increased Congressional appropriations.

To start, she reviewed four key “elements” in FDA’s new enforcement paradigm.

  • FDA must be vigilant
    • More robust and focused inspections
    • Earlier intervention and enforcement
  • Enforcement must be strategic
    • Focus on significant issues, particularly those involving a risk to public health
    • Imposition of “meaningful” (i.e. large) penalties
  • Enforcement must be fast
  • Enforcement must be visible
    • Industry and the public need to see concrete examples of significant enforcement actions and penalties

Commissioner Hamburg also announced six steps the agency will take in its reinvigorated enforcement program.

  1. FDA will impose stricter post-inspection deadlines. Companies will have 15 working days to provide FDA with a substantive and complete response to inspectional observations. In the absence of a substantive and complete response, FDA will promptly escalate to warning letters or other enforcement actions.
  2. FDA will issue warning letters faster. Fewer warning letters will be reviewed by FDA's Office of Chief Counsel than in recent years. Now, there will be legal review only of warning letters that raise “significant legal issues”. (The Commissioner declined to define “significant legal issues”.) As a result of this streamlined process, warning letters will be issued faster and without the level of legal review that was the norm under the prior administration.
  3. FDA will develop more effective cooperative enforcement strategies with other federal, state and international agencies.
  4. FDA will prioritize enforcement and recall follow up, focusing on public health and safety issues and situations of significant non-compliance.
  5. FDA will take aggressive action faster. The agency may initiate enforcement action before a formal warning letter is issued in instances of significant public health concern. In addition, there may not be multiple warning letters before escalation to a more severe enforcement action. This is likely to result in a more frequent use of corporate wide warning letters and an increase in seizures, injunctions and civil monetary penalties.
  6. Finally, FDA will implement a formal warning letter close out process. Once FDA confirms that a company has completed the necessary corrective actions under a warning letter, FDA will issue and publicly post a close out letter confirming that the corrective actions have been completed. The Commissioner expressed her hope that industry will strive for fast close out letters. Implicit in her approach is the hope that customers, physicians, shareholders and others will demand prompt close out letters.

In summary, Commissioner Hamburg expressed strong support for a more aggressive and robust enforcement process. She directly linked enforcement to the protection of public health. A complete copy of her speech can be found at http://www.fda.gov/NewsEvents/Speeches/ucm175983.htm.

Industry is now on notice of this enhanced scrutiny, FDA’s willingness to escalate issues faster and the use of public pressure to drive compliance. FDA expects companies to effectively implement robust compliance systems and to respond quickly to any issue. Once a company is targeted by FDA it will be under a microscope and subject to substantial FDA oversight. Companies should make compliance a priority to avoid being such a target.