Mark Mansour, Partner, Bryan Cave, LLP
In August, Commissioner of Food and Drugs Margaret A. Hamburg, M.D., outlined her commitment “to prevent harm to the American people” through swift, aggressive, and effective enforcement of FDA laws and regulations at a Food and Drug Law Institute (FDLI) meeting. Last week, FDA officials speaking at the FDLI meeting on enforcement reaffirmed that commitment, warning that “past performance is no measure for future performance” and that companies can expect a “flurry of warning letters.”
FDA staffers have indicated that the agency’s ramped up enforcement efforts will include a holistic and collaborative approach between the agency’s centers in such areas as advertisement enforcement; “blitzes” focused on undeclared allergens, label reviews and warehouse inspections; and data quality.
Among these initiatives, the Center for Drug Evaluation and Research (CDER) has indicated that its approach will include paying closer attention to compliance weaknesses and sloppiness as signs that other reporting could also be sloppy, ensuring proper monitoring of scientific research and data for new drug applications, and working with other centers on matching enforcement priorities.
The Division of Drug Marketing, Advertising and Communications (DDMAC) has also stated that it will dedicate more resources to identifying the most serious violations and getting more actions, through paying closer attention to promotions that could wield the greatest negative impact on public health. DDMAC will also be paying close attention to newly approved products, products with significant risks, or products cited in the past or currently subject to a complaint.
More information on the FDA’s increased enforcement efforts is available at here.
See also: Don’t Ignore 483s…it’s in Your Best Interest to Respond in Writing
See also: The Most Common Drug and Device GMP Items
Mark Mansour is a partner in the firm, Bryan Cave, LLP
