Commissioner of Food and Drugs Margaret Hamburg, M.D., today outlined her commitment “to prevent harm to the American people” through swift, aggressive, and effective enforcement of FDA laws and regulations.
“The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible,” Commissioner Hamburg told a group of industry representatives, attorneys, consumers, and others attending a speech sponsored by the Food and Drug Law Institute in Washington, D.C.
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.”
Commissioner Hamburg highlighted six initial steps designed to hone the effectiveness and timeliness of the FDA’s regulatory and enforcement system:
- Set post-inspection deadlines.
- Take responsible steps to speed the warning letter process.
- Work more closely with FDA’s regulatory partners.
- Prioritize follow-up on warning letters and other enforcement actions.
- Be prepared to take immediate action in response to public health risks.
- Develop and implement a formal warning letter “close-out” process.”