FDA Warning Against False MAT Advertising

Summary and Analysis

This article covers the latest in a long history of misrepresentations by the industry about opioid-related drugs. It is well known that the pharmaceutical industry contributed materially to the current opioid crisis and has routinely engaged in problematic marketing practices. For example, see:

This FDA warning highlights the need for health care, local and state planners to take into account industry marketing practices when making decisions about how to respond to the opioid crisis -- and to include the range of non-drug-based responses needed to fully address the crisis. 

Excerpted from U.S. Food and Drug Administration

@gettyimages

The U.S. Food and Drug Administration today posted a warning letter to Alkermes, Inc. of Massachusetts, for misbranding the drug Vivitrol (an extended-release injection formulation of naltrexone) by omitting warnings about the most serious risks associated with the drug from promotional materials. Vivitrol is approved for the prevention of relapse to opioid dependence, following opioid detoxification and should be part of a comprehensive management program that includes psychosocial support. Known as medication-assisted treatment, the use of medications like Vivitrol, in combination with counseling and behavioral therapies, is effective in the treatment of opioid use disorder (OUD) and can help some people to sustain recovery. The warning letter was issued in relation to a print advertisement about Vivitrol. While the print advertisement contains claims and representations about the drug’s benefits, it fails to adequately communicate important warnings and precautions listed in the product labeling, including vulnerability to opioid overdose, a potentially fatal risk.

The FDA is requesting the company immediately cease advertising practices that misbrand Vivitrol. In addition, because the violations described in the warning letter are serious, the FDA is also requesting the company include a comprehensive plan of action to disseminate truthful, non-misleading and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials.

Health care professionals and consumers should report any adverse events related to these and other drugs to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.