On February 21, 2020, the US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued a Warning Letter to Outlook Pharmaceuticals in reference to Outlook’s marketing of its attention deficit hyperactivity disorder (“ADHD”) drug, ProCentra, which is a schedule II controlled substance. Specifically, OPDP took issue with a sponsored link on Google.com which failed to include risk information about the drug.
The sponsored link in question was posted by Independence Pharmaceuticals, the company that distributes ProCentra. The link presented information about the benefits of ProCentra, including that is indicated for the treatment of ADHD in children, and that it has a “liquid treatment options” and is available in “sugar free” and “bubblegum flavor” formulations, which the FDA noted “could appeal to parents as desirable properties for pediatric administration.” The advertisement also noted that various forms of financial assistance are available, including online coupons and copay cards.
However, the advertisement failed to provide information about the risks associated with ProCentra, including that it is contraindicated in patients with advanced arteriosclerosis, cardiovascular disease, hypertension, hyperthyroidism and pre-existing psychosis. In addition, OPDP noted that the advertisement failed to include information from ProCentra’s Boxed Warning, which describes the “drug’s high potential for abuse,” as administration for prolonged periods of time may lead to dependence, and that “misuse may cause sudden death and serious cardiovascular adverse events.” OPDP noted that “[t]hese violations are especially concerning from a public health perspective because they create a misleading impression about the safety of ProCentra, a drug that is … used in the vulnerable pediatric population.”
OPDP concludes that this sponsored link misbrands ProCentra, because the failure to include any risk information renders the advertisement false or misleading with respect to risk. Accordingly, OPDP requests that Outlook “immediately cease misbranding ProCentra and/or cease introducing the misbranded drug into interstate commerce. “ The letter also asks Outlook to submit a written response indicating whether they intend to comply with this requirement, listing all ProCentra promotional materials that contain such violative statements, and explaining a plan for discontinuing use of the violative materials, or for ceasing distribution of ProCentra. In addition, OPDP requests that Outlook “include a comprehensive plan of action to disseminate truthful, non-misleading and complete corrective messages about the issues discussed … to the audience(s) that received the violative promotional materials.” The letter notes that the corrective messaging should be distributed, to the extent possible, using the same media, for the same duration of time, and with the same frequency as the violative materials.
OPDP gave Outlook two weeks to respond to the Warning Letter. The Google.com link has since been removed.