Oct. 12, 2020 – The FDA’s Office of Prescription Drug Promotion (OPDP) enforcement efforts are picking up steam following a slow start – just one enforcement letter issued between January 2020 and July 2020 – with two recent Warning Letters resulting from complaints through the agency’s Bad Ad Program.
In a Sept. 22 Warning Letter to Nalpropion Pharmaceuticals LLC, OPDP cited the company for making promotional claims for CONTRAVE® in a sponsored link on Google, stating that the link is misleading because “it presents efficacy claims for Contrave but fails to communicate any risk information” (emphasis original). The FDA reviewed the link and also received a Bad Ad Program complaint about it.
OPDP states that the sponsored link makes misleading claims about the efficacy of Contrave, which is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with specific body mass index (BMI) numbers, “because it fails to provide material information from the full FDA-approved indication.”
Although the sponsored link includes the statement “View Important Safety Info & Boxed Warning,” this statement “does not mitigate the misleading omission of risk information,” and, accordingly, “fails to communicate that Contrave is associated with serious and potentially life-threatening risks, such as … the risk of suicidal thoughts and behaviors.”
OPDP also cites Nalpropion for creating a misleading impression about the FDA-approved indication for Contrave (statements in the sponsored link imply that patients with any BMI can achieve “average” results), and about the efficacy of Contrave (statements in the sponsored link selectively present more favorable data from the clinical studies section of the PI).
The Warning Letter also states that OPDP had expressed concerns regarding Contrave promotional materials in a 2017 Untitled Letter when its application holder was Orexigen Therapeutics Inc. “We are concerned that Nalpropion is continuing promotion of Contrave in a manner that similarly fails to adequately convey risk information,” OPDP said in its recent letter.
In a Sept. 22 Warning Letter to Nephron Pharmaceuticals Corp., OPDP cited emails from the company and its sales representatives about the use of Budesonide inhalers for the treatment of symptoms associated with COVID-19. These emails were brought to the agency’s attention through complaints to the Bad AD Program.
According to OPDP, Budesonide is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to eight years of age, and is not indicated for the relief of acute bronchospasm. The emails cited in the Warning Letter “include claims and representations about the use and/or benefits of Budesonide as a treatment for symptoms associated with COVID-19,” which is “a new use for which it lacks approval and for which its labeling does not provide adequate directions for use.”
Further, the Warning Letter states that these emails “fail to communicate any risk information about the product” (emphasis original).
These claims and representations “are particularly alarming from a public health perspective because COVID-19 has caused significant morbidity and mortality, and because there is currently no FDA-approved treatment for symptoms associated with COVID-19.”
These two Warning Letters bring OPDP’s 2020 enforcement tally to four Warning Letters and one Untitled Letter thus far. OPDP issued three Warning Letters and seven Untitled Letters in 2019.