FDA Warns Opioid Manufacturer That Drug Marketing Material Violates Federal Law

The U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) has written to AcelRx Pharmaceuticals, Inc. (AcelRx) to notify the company that a banner advertisement and tabletop display for its oral opioid Dsuvia, are out of compliance with the Federal Food, Drug and Cosmetic Act (FD&C Act). Last week’s letter contended that certain Dsuvia promotional materials presented risk and benefit information in a false or misleading manner.

The letter explained the labels’ faults and what AcelRx must do to comply with the FD&C Act. Specifically, the OPDP took issue with AcelRx’s oversimplified administration instructions, “Tongue and Done.” The letter claimed that this presentation misleads users because it implies that the drug’s under-the-tongue administration consists of a one-step process, when in fact a patient must also visually confirm that the tablet is correctly placed under his or her tongue. The OPDP noted that this is especially important in light of the tablet’s small size and high potency. 

In addition, Dsuvia’s banner omits part of the product labeling section stating “Do not exceed 12 tablets in 24 hours.” According to the OPDP, this creates a confusing impression about the drug’s safe maximum daily dosage. The OPDP further explained that “[t]hese omissions are concerning from a public health perspective due to the serious risks associated with overdose with Dsuvia, including respiratory depression and death…”.

The OPDP also challenged aspects of the banner’s “important safety information” section, including its format and font. The letter claimed that compared to the benefits section, the safety information section appears to be lesser, and only available if viewers “scroll” down the banner. Finally, and similarly, the OPDP argued that the banner and display do not present warning information “with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of Dsuvia.”

The OPDP requested a response within 15 days from the date of AcelRx’s receipt of the letter, including a proposed plan to disseminate corrective information. In the event that AcelRx does not timely respond, it may be subject to regulatory action, the letter cautioned.