The Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) focused its end-of-year enforcement efforts on drug manufacturers’ promotions on tv, social media ads, and electronic promotion efforts. The OPDP issued in December six of its eleven total enforcement letters for 2016. The eleven disciplinary letters represents a small spike from previous years’ letters – OPDP issued nine letters in 2015. Taken as a whole, these letters show drug companies that they must pay close attention to what their employees and consultants are saying about their products, regardless of where and how the message is being transmitted. In years’ past, FDA scrutinized ads placed on social media such as Instagram and Facebook and FDA is now also looking at email promotions and promotional messages on YouTube.
Two of the letters were aimed at two large drug manufacturers for their television advertisements that the FDA considered as false and misleading to viewers and consumers. For example, the FDA stated that one of the ads was misleading because of its fast paced and distracting visuals, all of which minimized the serious and life-threatening risks associated with the drug.
While the OPDP’s attention to television ads was expected, the latter batch of enforcement letters showed that OPDP is also scrutinizing electronic advertisements. OPDP focused on YouTube videos, emails, and manufacturer website videos. The claims raised by the OPDP in these letters generally focused on broad and misleading statements.
One untitled letter from the OPDP to a foreign drug manufacturer targeted the manufacturer’s YouTube video, which OPDP claimed to suggest that the drug was approved worldwide, when the drug is not actually approved by the FDA and is still considered investigational. The OPDP stated that language in the YouTube video, such as “world’s first,” with no other clarification statements about the drug’s actual approved use in the United States or in other countries was misleading. Additionally, the video made claims about the superior quality of the drug compared to competitor products and minimized the drug’s risks. The OPDP stated that these claims violate the Federal Food, Drug and Cosmetic Act since the drug was not even proven to be safe and effective in the United States. The letter called for the manufacturer to cease its use of the misleading language in the video and to submit a response letter to the FDA with a plan outlined for discontinuation of such language.
OPDP also focused on email promotions. One manufacturer received a Warning Letter because OPDP felt that the company’s promotional emails minimized the product’s risks – the email contained no mention of the drug’s risks, while including all of the drug’s benefits. Notably, the email included a link for the reader to access more information about the drug but the FDA found that the link was not enough to spare the manufacturer from an FDA enforcement action as the actual email text did not contain any mention of the drug’s risks. The Warning Letter requested that the manufacturer discontinue the misleading emails and any other similar promotions, as well as issue a corrective action plan to the FDA.
The latest OPDP letters are a sign to industry to review and monitor its promotional videos and messages on all media, as the new methods of drug promotion are coming under FDA scrutiny.