Last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted two more warning letters for 2020, bringing the tally to five warning and untitled letters for the year. These letters, to Nalpropion and Nephron, rebuke drug sponsors for failing to communicate safety risk information. And, the Nephron letter cites emails that claim budesonide can treat COVID-19 symptoms, which is notable because it is one of the first OPDP warning letters in recent years to cite promotion of an unapproved use.
First, a warning letter to Nalpropion cites a sponsored link for Contrave, pointing out that Orexigen, a prior sponsor of Contrave, also received an untitled letter in 2017 for a television advertisement, which OPDP said created a misleading impression about the safety of Contrave. Similarly, OPDP said Nalpropion’s sponsored link “fails to communicate any risk information.” Although the sponsored link includes the statement “View Important Safety Info & Boxed Warning,” OPDP concluded that this statement fails to mitigate the misleading omission of risk information. Contrave has been associated with serious and potentially life-threatening risks, including the risk of suicidal thoughts and behaviors, OPDP noted.
In addition to the omission of safety information, OPDP said Nalpropion’s sponsored link is misleading with respect to efficacy because it “fails to provide material information from the full FDA-approved indication regarding the use of the drug product as an adjunct to diet and exercise, the minimum initial BMI for which treatment with Contrave is indicated, the requisite presence of weight-related comorbid condition(s) in patients with an initial BMI of greater than or equal to 27 kg/m2 and the limitations of use.” Furthermore, the sponsored link was said to create a misleading impression regarding the efficacy of Contrave by “selectively presenting more favorable data.”
The second warning letter, to Nephron, cites emails sent by CEO Lou Kennedy and a sales representative claiming that their generic inhaled asthma medication budesonide product, which is subject to an ANDA, can treat COVID-19 symptoms. Again, OPDP said the emails “fail to include any risk information about the drug.” The sales representative’s email also included a link to a YouTube video purporting to show a physician successfully treating a COVID-19 patient with budesonide and an antibiotic.
OPDP noted that budesonide is not approved as a treatment for symptoms associated with COVID-19, and that its labeling does not contain adequate directions for such use. As noted above, this is one of the first OPDP warning letters in recent years that cites promotion of an unapproved use, likely because of the focus FDA is currently giving to Covid-19. It is also notable that this warning letter cited promotional material found on YouTube, continuing FDA’s trend toward monitoring nontraditional communications vehicles to assure prescription drugs are not being misbranded on newer platforms, which we discussed here.
Both of these latest warning letters mentioned that OPDP had received complaints about the promotional materials through the FDA Bad Ad Program.
With these warning letters, OPDP has now published five warning and untitled letters in 2020, down from the 10 letters it sent last year. These provide useful guidance on web-based promotion and social media, both of which continue to be hot topics in the promotional world. We will continue to monitor these enforcement actions, and keep you informed on FDA’s focus on promotional materials that OPDP concludes are unlawfully misbranded pursuant to the Federal Food, Drug, and Cosmetic Act.
[View source.]
