A friendly animated syringe is in the FDA ad police crosshairs. The Office of Prescription Drug Promotion sent Xeris Pharmaceuticals an untitled letter last week over "false or misleading claims" in a TV ad for its new Gvoke pre-filled syringe.
OPDP takes issue with several statements the animated glucagon syringe says in the 60-second ad. The commercial begins: “If you have diabetes and take insulin, you know low blood sugar can be scary. You might start to sweat, panic, worry you might pass out. You may even feel like you’re falling.”
That's a no-no, OPDP says. Its letter to Xeris points those “claims are misleading and minimize the seriousness of the condition because they include some of the early, mild symptoms of hypoglycemia, but fail to present the symptoms of severe hypoglycemia for which Gvoke is indicated."
OPDP goes on to take issue with several other remarks made by the affable Gvoke syringe, including when it says, “I can be used even before passing out.”
Not detailed enough, OPDP complained. The ad fails to discuss that help from other people is needed and describe when it’s appropriate to administer Gvoke. The device's approved instructions state that the syringe is prescribed so that relatives or caregivers can give the injection when a diabetic becomes hypoglycemic and can’t take sugar by mouth.
Xeris downplayed the letter to analysts at Mizuho Securities. Summarizing its discussion with Xeris management, Mizuho noted the OPDP missive is an untitled letter, not a more-serious warning letter, and should have no “regulatory or commercial impact.”
The company also noted the ad stopped running in March.
Xeris told Mizuho it disagrees with OPDP's assessment and will challenge the letter in its response. Either OPDP will agree with Xeris or the company will have to modify the language in the ad if it wants to run it again, the company said.
The Xeris letter is the second sent by the FDA’s ad police this year, and 2020's first untitled one. The first was a warning letter to Outlook Pharmaceutical for “false or misleading” sponsored links on Google for ADHD med ProCentra.
The slow flow of OPDP warning letters is an ongoing trend, though the rate has been even slower in 2020. That may be in part because of the COVID-19 pandemic, but it’s also a sign of FDA shifting priorities, said Eye on FDA blogger Mark Senak last month. Misleading drug marketing can be problematic, but the overall risk to consumers is low as prescription meds aren’t consumer products.