FDA Enforcement to Get Tougher

The agency charged with protecting U.S. consumers from defective <"https://www.yourlawyer.com/practice_areas/food_poisoning">foods, <"https://www.yourlawyer.com/practice_areas/defective_drugs">drugs, and <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">medical devices is getting tougher. Recently appointed Commissioner of Food and Drugs, Margaret A. Hamburg, M.D., just outlined her commitment “to prevent harm to the American people” through swift, aggressive, and effective enforcement of FDA laws and regulations, the U.S. Food and Drug Administration (FDA) just announced.

“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. “We must get the word out that the FDA is on the job.” Commissioner Hamburg noted 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: The FDA will establish a clear timeline for regulated industry 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.

Take responsible steps to speed the warning letter process: The 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.

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

Prioritize follow-up on warning letters and other enforcement actions: The 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.

Be prepared to take immediate action in response to public health risks: To better protect the public health, the agency 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.

Develop and implement a formal warning letter “close-out” process”: If the FDA can determine that a firm fully corrected violations raised in a warning letter, it will issue an official “close-out” notice and post this information on the FDA Web site. This will be an important motivator for corrective action by manufacturers.

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.”