In her presentation to the Food and Drug Law Institute in August 2009, FDA Commissioner Margaret Hamburg announced her commitment to strengthen the agency’s enforcement efforts during her administration. Among the key initiatives identified to improve the agency’s ability to address potential violations of FDA law and regulations, Commissioner Hamburg noted that the agency would be taking a more active role in issuing enforcement letters to industry, which has been one of the FDA’s primary enforcement tools. As promised, FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) recently sent a number of Notice of Violation letters from December 2009 through February 2010, citing certain issues that the agency had with the advertising and marketing of the prescription drug products. Among other concerns raised by the FDA, direct-to-consumer (DTC) materials, oral statements, product websites, overstatements of product efficacy, presentation of risk information, pre-approval promotions, and insufficient disclaimers were highlighted.
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