FDA Policy/General

‘False or Misleading’ Xeomin Promotion: FDA

The CDER Office of Prescription Drug Promotion (OPDP) says a Merz Pharmaceutical promotion for Xeomin (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use, featuring paid celebrity spokesman Nate Berkus, makes false or misleading representations and suggestions about the risks and efficacy of the drug. A 10/31 Notice of Violation says the violations are concerning because they create a misleading impression about the safety and effectiveness of Xeomin, a “drug with a number of serious and potentially life-threatening risks, including a Boxed Warning regarding the risk of distant spread of toxin effects.”

OPDP says Xeomin is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults. The labeling includes the Boxed Warning and additional Warnings and Precautions.

“We are concerned that Merz is not presenting the benefits and serious risks of the drug in a truthful and non-misleading manner, despite concerns previously expressed by OPDP,” the letter says.

OPDP faults Merz for failing to present information relating to side effects and contraindications associated with the drug with a prominence and readability reasonably comparable with the presentation of benefits information. It also says it is not aware of data to support the promotion’s suggestion that Xeomin can provide successful treatment as rapidly as suggested in the promotion.

Merz was told to respond with a list of promotions that contain representations like those cited in the letter and its plan for the timely discontinuation of such communications or for halting Xeomin distribution.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome