Azurity Email Garners OPDP Enforcement Letter for False/Misleading Claims

Dec. 14, 2020 – In a recent Untitled Letter, the FDA’s Office of Prescription Drug Promotion (OPDP) states that claims made by Azurity Pharmaceuticals Inc. in a healthcare professional email for XATMEP® (methotrexate) oral solution indicate that Azurity “appears to be promoting Xatmep without presenting the serious risks of the drug in a truthful and non-misleading manner, despite concerns previously expressed.”

In the Nov. 24 enforcement letter, which is only the second OPDP Untitled Letter issued to date in 2020, OPDP states that Xatmep – a drug used in a vulnerable pediatric patient population to treat acute lymphoblastic leukemia as part of a multi-phase, combination chemotherapy maintenance regimen – bears a Boxed Warning due to the possibility of serious and life-threatening risks.

Although the email presents “numerous benefit claims” for Xatmep, and includes the Boxed Warning, it “completely omits other important warnings and precautions associated with the drug” and its dosing, the letter states. OPDP also takes issue with the email presenting information about the drug’s risks “with a prominence and readability reasonably comparable to the presentation of information relating to the benefits of the drug.”

The email does include click-through statements referring healthcare professionals to the full prescribing information and to the Xatmep website, but these links do not mitigate the email’s “failure to present the Boxed Warning with sufficient prominence or the omission of other risk information from the email,” OPDP asserts.

OPDP also takes issue with a claim made in the email stating: “I wanted to let you know that Xatmep … is available for your patients with Acute Lymphoblastic Leukemia.” OPDP states that this claim is misleading because it fails to adequately communicate the full approved indication for Xatmep. “This claim is particularly concerning because it suggests the drug is approved for use in patients of all ages without consideration for the necessity of other treatments as part of a combination therapy,” the letter states.

OPDP acknowledges that Xatmep’s full indication is presented at the bottom of the email, but after the signature block – which it notes typically signifies the end of correspondence – and states that this presentation “does not mitigate the misleading impression.”

In addition to the two Untitled Letters issued this year, OPDP also issued four Warning Letters, for a total of six enforcement letters in 2020; OPDP issued seven Untitled Letters and three Warning Letters in 2019.