After Maze Therapeutics opted not to participate in the National Advertising Division’s (NAD’s) self-regulatory process for monitoring promotional claims, a case brought by competitor Vertex Pharmaceuticals is being escalated to federal authorities.
According to a Wednesday release from the NAD, Vertex initiated the challenge over “express and implied claims” that Maze made in investor presentations, press releases and public filings about MZE829, a small molecule APOL1 inhibitor that Maze is currently developing as a treatment for APOL1-mediated kidney disease (AMKD).
Specifically, Vertex took issue with instances where Maze compared the efficacy of MZE829 to that of inaxaplin, Vertex’s own candidate for AMKD.
According to the U.S. marketing watchdog, Maze noted in its response to a NAD inquiry that it doesn’t currently sell any products and doesn’t formally advertise MZE829 and therefore declined to participate in the self-regulatory process.
For that “failure to submit a substantive response,” the NAD said it will now refer the case to regulators for “review and possible enforcement action.” Though it didn’t specify which agencies it will involve in the case, past escalations have gone before the FDA and the Federal Trade Commission.
In a statement sent to Fierce Pharma Marketing, Maze maintained its stance that because it doesn’t formally market or sell any products, including MZE829, its messaging isn’t subject to the NAD’s oversight.
The NAD “provides a voluntary forum for reviewing national advertising, which it defines as paid commercial messaging,” the company said. “As a development-stage company, Maze does not currently sell MZE829 and has not engaged in any paid national advertising for the investigational product.”
This is the first such escalation that the NAD has made in a case concerning the biopharma industry this year. Back in 2023, it referred a challenge from Gilead Sciences over certain claims made in ViiV Healthcare’s advertisements for HIV treatment Dovato to the FDA and FTC.
In that case, ViiV said it opted out of the self-regulatory process because it “believes FDA is best positioned to assess the appropriateness of these prescription drug claims.”
About a year later, the FTC resolved the matter in a letter (PDF) stating that it would not be investigating the matter further or levying any disciplinary actions against ViiV. At the same time, the FTC noted that the decision didn’t equate to a ruling in either direction regarding ViiV's potential violation of marketing regulations.