National Advertising Division Refers ViiV Healthcare’s DOVATO HIV Medication Claims to FDA and FTC for Review

New York, NY – April 27, 2023 – The National Advertising Division (NAD) of BBB National Programs has referred advertising claims made by ViiV Healthcare Company for its DOVATO® single-tablet HIV treatment medication to the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) after the company informed NAD that it would not participate in the NAD self-regulatory process with respect to the challenged claims.

ViiV’s claims about its DOVATO medication, which appeared in multichannel advertising, were challenged by Gilead Sciences, Inc., manufacturer of Biktarvy®, a competing HIV medication. 

Gilead challenged express and implied health-related claims that DOVATO is superior to Biktarvy because it contains less medicine, does not contain tenofovir alafenamide (TAF), and is less likely to adversely impact patients’ renal, lipid, and weight profiles.  

ViiV did not submit a substantive response, but instead informed NAD that it would not participate in NAD’s self-regulatory process because it believes FDA is best positioned to assess the appropriateness of these prescription drug claims. 

NAD frequently reviews advertising claims for FDA-regulated products, including pharmaceuticals.  

Considering ViiV’s decision to not participate in the NAD self-regulatory process, NAD has referred the matter to the FDA and FTC for review and possible enforcement action.

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