Sept. 7, 2020 – A direct-to-consumer (DTC) television ad featuring an animated syringe yielded Xeris Pharmaceuticals Inc. an enforcement letter from the FDA’s Office of Prescription Drug Promotion (OPDP) for alleged violations related to the product’s risk profile that “create a misleading impression about its safety and effectiveness.”
In an Aug. 14 Untitled Letter, OPDP states that Xeris’ TV ad for GVOKE™ (glucagon) injection, which is indicated for the treatment of severe hypoglycemia, is misleading because “it includes efficacy claims for Gvoke but fails to include important risk information associated with the drug” and “fails to include the contraindication in patients with known hypersensitivity to glucagon or to any of the excipients in Gvoke.”
Although the ad, which was submitted to the agency via the Form FDA 2253 process, includes contraindications, it “fails to include material facts about the consequences that may result from the use of the drug,” as listed in the Warnings and Precautions section of the PI, which “misleadingly suggests that Gvoke is safer than has been demonstrated.”
The animated Gvoke pre-filled syringe states in the ad that the product is “Easy to use. Easy to know you did it right. Pretty easy, huh?” but these claims are deemed misleading because the Dosage and Administration section of the PI and its Instructions for Use describe multiple steps for administration and recommend that users become familiar with administration before an emergency occurs. Further, there is a “lack of signal” to users to know whether they “did it right,” according to OPDP, and, as such, these claims are “concerning from a public health perspective, especially in light of risks associated with prolonged hypoglycemia.”
Further, OPDP finds fault with the animated syringe making statements about some of the symptoms of low blood sugar (“You might start to sweat, panic, worry you might pass out. You may even feel like you’re falling.”), because “these 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 also cites Xeris for omitting information about when it is appropriate to administer Gvoke, and the need for administration by others.
The Xeris enforcement letter is the first Untitled Letter issued by OPDP in 2020; OPDP issued one Warning Letter in February, bringing the enforcement letter tally in 2020 to just two.