This year has been a very slow year for enforcement letters from the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP), with only two letters being issued. The first letter, which we wrote about earlier this year, was a Warning Letter to Outlook Pharmaceuticals over its omission of risk information in a sponsored link on Google.
The second letter was the first Untitled Letter from OPDP this year, and it was sent to Xeris Pharmaceuticals on August 14, 2020. The letter took issue with claims Xeris made it a television advertisement for its Gvoke pre-filled syringe used to treat low blood sugar/hypoglycemia.
According to the OPDP, Xeris made “false or misleading claims and representations” about the safety and efficacy of Gvoke and omitted information about its risks, including that the drug is contraindicated in “patients with a known hypersensitivity to glucagon or to any of the excipients in Gvoke.” The letter also indicates that the television ad omits information concerning allergic reactions that is found in the WARNINGS and PRECAUTIONS, as well as the PATIENT COUNSELING INFORMATION sections of the product information.
The letter does appreciate that the ad acknowledges some contraindications for Gvoke (such as pheochromocytoma and insulinoma) but takes issue with Xeris’ failure to “include material facts about the consequences that may result from the use of the drug.” OPDP wrote that, “By omitting these serious risks associated with Gvoke and material facts pertaining to these risks for Gvoke, the TV ad misleadingly suggests that Gvoke is safer than has been demonstrated.”
In addition to the false/misleading claims in the ad, OPDP also did not like some of the voiceover statements that were made in the ad about how easy Gvoke is to use, such as, “Easy to use. Easy to know you did it right. Pretty easy, huh?”. In the letter, OPDP indicates that, “With regard to ease of use, FDA notes that the DOSAGE AND ADMINISTRATION section of the PI and the Instructions for Use describe multiple steps involved in the preparation and administration of the Gvoke pre-filled syringe and recommends that users become familiar with these instructions before an emergency happens.” OPDP also noted that Gvoke does not actually give any signal to users that they “did it right” or correctly administered the prescription. Therefore, OPDP belives that the mislading claims are concerning from a public health perspective, especially when considering the risks associated with prolonged hypoglycemia.
Last, OPDP believes that the ad minimizes the risk of severe hypoglycemia as it only focuses on early, mild symptoms of the condition while leaving out symptoms of severe hypoglycemia, which is what the drug is intended to treat (not the more mild version). For example, the advertisement voiceover includes the following, “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,” while the Instructions for Use show the seriousness of severe hypoglycemia, stating, “If not treated, the patient may progress to severe hypoglycemia, which can include: confusion, seizures, unconsciousness, death.”
At the close of the letter, FDA and OPDP requested that Xeris immediately stop using any promotional materials for Gvoke that violate the letter and provide a list of its promotional materials with similar violations to the FDA.