Recently, the US Food and Drug Administration Office of Prescription Drug Promotion (“OPDP”) sent a warning letter to Metuchen Pharmaceuticals for several false or misleading advertisements in conjunction with is erectile dysfunction (“ED”) drug Stendra. OPDP requested that Metuchen “immediately cease misbranding Stendra,” as well as provide a written response to the warning letter.
The ads, which were published in print and online formats, ran in trade publications, such as the American College of Cardiology magazine, as well as consumer-oriented publications, including adult websites. The OPDP cited the following deficiencies in the warning letter:
Lack of Adequate Directions for Use: A print ad claimed that Stendra can be used to “reduce risk of heart failure.” OPDP noted that Stendra has not been approved for that indication, and further that “its labeling does not contain adequate directions for such use.” In addition to being an unapproved use, OPDP is particularly concerned about this claim as the prescribing information actually contains a warning and precaution regarding cardiovascular risks, and specifically states that Stendra should not be use in patients with congestive heart failure.
False or Misleading Risk Presentations: While the ads contain claims and representations about the uses and/or benefits of Stendra, they “fail to include important risk information associated with the drug.” For example, the ads include a statement that Stendra can be taken “with or without food and alcohol,” but fail to disclose that drinking too much alcohol while taking Stendra can result in “headache, dizziness, increased heart rate, or lowered blood pressure.”
False or Misleading Claims About Efficacy: The ads fail to specify that the Stendra is only to be used by patients experiencing ED, as opposed to healthy individuals. The OPDP notes that this omission “is particularly concerning from a public health perspective due to the serious health risks associated with Stendra.”
The OPDP concluded the warning letter by requesting that Metuchen “immediately cease misbranding Stendra and/or cease introducing the misbranded drug into interstate commerce.” In addition, the OPDP requested that Metuchen submit a written response to the warning letter addressing a number of things, including whether the company intends to comply with the OPDP request, listing all promotional materials that contain the violative representations, providing a plan for discontinuing those materials, or, in the alternative, “ceasing distribution of Stendra.” The OPDP also requested that Metuchen submit a comprehensive plan to disseminate “truthful, non-misleading” corrective messaging.
A reminder to companies to read their FDA approved label when creating promotional pieces. Making claims without backup evidence is a bad idea. Also, the pharmaceutical industry even if your drug is not reimbursed such as Stendra, should still avoid advertising on adult websites.