Washington D.C.—Commissioner of Food and Drugs Margaret Hamburg 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 said in a speech sponsored by the Food and Drug Law Institute in Washington, D.C. “We must get the word out that the FDA is on the job.”
Commissioner 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, including: 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.”
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.”
The complete article is available at FDA; and the complete speech can be read at FDA Speeches.