FDA's Office of Prescription Drug Promotion ("OPDP") issued two warning letters regarding pharmaceutical product promotion in a two-week timeframe, most recently citing social media posts. On August 7, 2015, OPDP wrote a warning letter regarding claims made in a social media campaign by a reality TV star about a product intended to treat the nausea and vomiting associated with pregnancy in women who do not respond to conservative management. The celebrity had endorsed the product with descriptive posts on her Facebook, Instagram, and Twitter accounts. A complaint about the material was submitted to FDA via its Bad Ad Program, and in the warning letter, OPDP stated it considered the material false or misleading because it omitted risk information and material facts. In addition, on July 27, 2015, OPDP warned another company regarding a professional sales aid, which the agency asserts omits risk information, fails to adequately convey the product's indication, and makes unsubstantiated claims. In each letter, FDA has requested the companies issue corrective messaging, which should be distributed using the same media, and generally for the same duration and frequency as the original material. These actions follow a relatively quiet period from OPDP; while the office has issued several untitled letters in 2015, the last-posted warning letter was from September 2014.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
