A row between Gilead Sciences and ViiV Healthcare over HIV drug ads has escalated. With ViiV declining to participate in a self-regulatory process, the National Advertising Division (NAD) has referred the case to a pair of federal agencies.
The dispute centers on ViiV’s multichannel promotion of Dovato, a fixed-dose antiretroviral combination that competes with Gilead’s Biktarvy for the HIV/AIDS market. Dovato is a two-drug regimen. Biktarvy is a combination of three molecules. That difference is at the heart of the row, according to the NAD, the self-regulatory body of the U.S. advertising industry.
“Gilead challenged express and implied health-related claims that Dovato is superior to Biktarvy because it contains less medicine, does not contain tenofovir alafenamide, and is less likely to adversely impact patients’ renal, lipid and weight profiles,” the NAD wrote in a statement.
The number of active ingredients in Dovato is central to ViiV’s promotion of the product. The Dovato website carries messages such as “no other complete HIV pill contains fewer medicines than Dovato” and “Dovato is as effective at helping you stay undetectable with fewer medicines in your body—today and tomorrow.” ViiV has pushed similar messages in TV ads.
Gilead’s challenge prompted the NAD to seek a response from ViiV as part of a self-regulatory process that can settle disputes without involving regulatory bodies. However, “ViiV did not submit a substantive response,” according to the NAD, and declined to participate in the process “because it believes FDA is best positioned to assess the appropriateness of these prescription drug claims.”
The NAD noted that it “frequently reviews advertising claims for FDA-regulated products, including pharmaceuticals” but, with ViiV refusing to engage, on this occasion it has needed to refer the matter to higher powers, namely the FDA and the Federal Trade Commission. The federal bodies will review the case and take enforcement action if necessary.