Sanofi’s legal team was handed a double whammy this week (and may want a word with its marketing team) as two of the French pharma’s products have come under fire.
First up, Sanofi caught the ire of pharma giant and close rival Johnson & Johnson and the National Advertising Division (NAD), the overseer of self-regulation programs. Their beef is with Sanofi’s "#1 Doctor Recommended" claims for its heartburn drug Zantac 360°.
This claim has been challenged by Johnson & Johnson, which markets a competing Pepcid product. Zantac is an H2 blocker formulated with the active ingredient famotidine, the very same active ingredient used in Pepcid.
Sanofi based the marketing claim on a survey from IQVIA, which itself was based on doctors’ average weekly recommendations in the acid reducer category. But the NAD, siding with J&J’s challenge, said that “these facts were not a viable substitute for an affirmative active ingredient recommendation” and thus it “fell short of the evidence required to support a "#1 doctor recommended" claim.”
The NAD said Sanofi must cull any mention of these phrases from its marketing for the drug: Zantac 360° "contains the #1 doctor recommended medicine approved to both prevent and relieve heartburn"; "With the #1 doctor recommended heartburn medicine”; and “"#1 Doctor Recommended."
Sanofi was not happy with the NAD’s decision. The French drugmaker said it would appeal because it "disagrees with NAD's conclusions that the underlying IQVIA survey cannot substantiate doctor recommended ingredient claims" and because it "has concerns about the downstream industrywide ramifications" of this finding.
But Sanofi will “nevertheless take the NAD's recommendations with respect to this ruling into consideration in future advertising,” the company said, though it did not give the specifics on exactly how or when.
Pain patch plaintiffs
And there’s more trouble too as a District Court in California has told Sanofi U.S. in a separate case that it will have to face a proposed class action suit to argue that it did not deceptively market Icy Hot pain patches.
This comes after the French Big Pharma had hoped to have the case fully dismissed. Some elements were, including claims of outright fraud, but Sanofi will have to face accusations that its so-called Icy Hot pain patches and creams were marketed incorrectly.
Sanofi sold the products as “maximum strength,” but there are products on the market with more lidocaine, its active ingredient, the plaintiffs say, making that claim misleading. The plaintiffs say they would not have bought maximum strength Icy Hot—or would have paid less for it—had they not been misled.
"This was an initial decision without any factual development, and it narrowed the case from what was originally asserted," Sanofi said in a statement. "We will continue to defend the case through multiple additional stages and are confident that in the end, the claims will be rejected."