What is an FDA Drug Marketing Enforcement Letter?

Recent marketing enforcement letters the FDA sent to drug makers Eli Lilly, Bayer, Amylin Pharmaceuticals and Cephalon bring up the question: What is an FDA marketing enforcement letter and what does it really mean?

FDA Marketing Enforcement Letters

These are letters sent out as a warning by the FDA in order to rectify what the FDA views as a violation of the the Food, Drug, and Cosmetic Act. The warning letter affords firms the opportunity to voluntarily correct violations prior to the initiation of formal enforcement action. It is typically the first notification that a drug company gets that their drug marketing may be in violation.

The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the FDA is responsible for reviewing prescription drug advertising and promotional labeling to ensure that the information contained in these promotional materials is not false or misleading. They typically send out the warning letter. While the letters are not legally binding, they do allow the FDA to sue if the drug companies ignore the letters.

What Are Some Marketing Requirements of Drugs?

The Federal Food, Drug, and Cosmetic Act requires that all drug advertising contain information in brief summary relating to side effects, contraindications, and effectiveness. This includes ALL risk information of a drug. This is called the information disclosure requirement. Drug companies must also refrain from using claims of superiority, unless they have evidence to support the claim. Drug companies must submit their marketing to the FDA for review.

Related Resources:

• Database of FDA Drug Enforcement Reports (FDA)
• MedWatch: FDA Drug Safety Alerts (FDA)
• Division of Drug Marketing, Advertising, and Communications (DDMAC)
• Pharmaceutical Liability FAQ (provided by Fitts Zehl, LLP)
• Pharmaceutical Liability Resources (provided by Greenberg & Stone, P.A.)