OPDP Issues Second Untitled Letter of 2020

J.W. Schomisch
December 4, 2020 at 12:23 PM EST
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The FDA’s Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter of 2020 to Azurity Pharmaceuticals Inc. over a health care professional email the company had submitted to OPDP for review.

The Untitled Letter, which is the agency’s sixth promotion-related enforcement letter of the year, alleged the email for Xatmep® (methotrexate) oral solution made false or misleading claims and/or representations about the risks and efficacy associated with the drug, which is indicated for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen.

“These violations are especially concerning from a public health perspective because they create a misleading impression about the safety and effectiveness of Xatmep, a drug used in a vulnerable pediatric patient population and that bears a Boxed Warning due to the possibility of serious and life-threatening risks,” the letter said.

“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 by OPDP” in June 2017 advisory comments.

“The email presents numerous benefit claims regarding Xatmep for the treatment of ALL,” the Untitled Letter said. “Although the presentation includes the Boxed Warning for Xatmep, the email completely omits other important warnings and precautions associated with the drug,” such as the warning and precaution regarding the risk of improper dosing.

The section on the risk of improper dosing “warns that a household teaspoon is not an accurate measuring device and could lead to overdosage.”

The letter also noted the “email prominently presents benefit claims for Xatmep in the body of the email in a bulleted list. In contrast, the limited risk information (i.e., the Boxed Warning) included in the email is presented after the signature block, which typically signals the close or end of a correspondence. As such, the email fails to also present the limited risk information included in the email with a prominence and readability reasonably comparable to the presentation of information relating to the benefits of the drug.”

OPDP said links to full prescribing information and the Xatmep website 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. By minimizing the Boxed Warning and omitting the other material information related to the serious risks associated with Xatmep, the email misleadingly suggests that Xatmep is safer than has been demonstrated.”

The letter also objected to the email’s statement that Xatmep “is available for your patients with Acute Lymphoblastic Leukemia.” “This claim is misleading because it fails to adequately communicate the full approved indication for Xatmep,” which is for the treatment of pediatric ALL patients as part of a multi-phase, combination chemotherapy maintenance regimen.

“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 said. “We acknowledge that the full indication is presented at the bottom of the email, after the signature block. … However, this does not mitigate the misleading impression.”

OPDP requested a written response that addressed the Untitled Letter’s concerns, a list of all promotional materials (with the form 2253 submission date) for Xatmep that contained similar representations and the company’s plan for discontinuing use of such materials.

Editor’s note: All FDA Warning and Untitled Letters are available in Thompson Information Services’ FDA Enforcement Letter Database, which is available to subscribers of Thompson's FDA Compliance Expert.

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