Since the COVID-19 pandemic began to intensify in March 2020, the Food and Drug Administration (FDA) has sent warning letters to 146 manufacturers of products claiming to prevent, treat, mitigate, diagnose or cure coronavirus. These products range from teas, tinctures, test kits, soaps, supplements, and CBD products. In January, the FDA’s Office of Criminal Investigations arrested a man for claiming to have a fraudulent COVID-19 vaccine and offering to inject it in paying customers for $400-$1000. While FDA has issued many COVID-related warning letters, the agency has issued far fewer warning letters for the more conventional misleading promotion of approved prescription drugs.
It was, therefore, notable, that last week, FDA issued a press release to accompany the warning letter to AcelRx Pharmaceuticals (the manufacturer of a powerful opioid named Dsuvia) for false and misleading promotional tactics. AcelRx promoted Dsuvia as easy to use, as patients just had to “Tongue and Done.” However, FDA imposed stringent conditions upon Dsuvia’s use; the opioid is indicated for acute pain management when there are no alternatives available or when adult patients cannot swallow oral medication or use IV-administered pain relief drugs.
FDA called out Dsuvia’s promotional materials for undermining “key prescribing conditions required for the safe use” of the drug. The promotion omitted important risk information such as the maximum daily dosage and its specialized administration instructions that required visually confirming tablet placement in a patient’s mouth. Failing to abide by these instructions could result in respiratory failure and death. Dsuvia was also approved with a Risk Evaluation and Mitigation Strategy which limits its distribution to certified, medically-supervised care settings (including emergency rooms, hospitals, and surgical centers) by trained professionals.
In addition to the usual instructions to cease violating the FDC Act and withdraw the misleading promotion, FDA also instructed AcelRx to submit a comprehensive action plan to distribute corrective communications.
FDA has issued very few warning or untitled letters for misleading prescription drug promotion in recent years – only six in all of 2020. While it is possible that a new Administration and leadership at FDA might signal increased scrutiny, overall, enforcement and policy development regarding prescription drug promotion have been on a downward trend for many years. FDA’s decision to send a warning letter to AcelRx was likely a signal that the agency will take a hard look at any promotions for opioids.