In 2013, the US Food and Drug Administration (FDA) issued 26 enforcement letters targeting the promotion and advertising of prescription drugs, including biologic products.1 More than 90% (24/26) of these Warning Letters and Notice of Violation Letters (also popularly known as “Untitled Letters”) were issued by FDA’s Office of Prescription Drug Promotion (OPDP), with the remainder issued by the Office of Compliance and Biologics Quality (OCBQ).2 Just 15% (4/26) of the letters were issued as Warning Letters, a designation reserved “only for violations of regulatory significance”— meaning they “may lead to enforcement action if not promptly and adequately corrected.”3 Compared to recent years, the number of enforcement letters issued in 2013 targeting the promotion and advertising of prescription drugs has continued to decline. See Table 1.

Last year's enforcement letters identified various types of promotional materials as violative, amounting to 38 different promotional pieces.  The majority (74%) of these materials targeted health care professional audiences, while the rest were aimed at consumers, investors, or nonspecific audiences.  See Table 2.

The promotional materials identified by FDA included sales aids, letters, emails, brochures, print advertisements, and websites, among others.  More than 75% of these were print promotional labeling or advertising materials, and approximately 18% consisted of internet communications.  The remainder were less traditional forms of promotional communication, including a video news release and statements made on a CNBC talk show.  See Table 3.

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