MONDAY, JUNE 25, 2018

FDA alleges Swiss co. making false statements about its meningitis vaccine

The U.S. Food and Drug Administration recently alleged that the Swiss biopharmaceutical company Novartis AG falsely implied that its Menveo meningitis vaccine was approved according to guidelines from a major U.S. advisory group.

The FDA said that the promotional materials relating to Menveo falsely imply that FDA-approved use of the drug is consistent with recommendations by the U.S. Advisory Committee on Immunization Practices, a panel of experts that advises the U.S. Centers for Disease Control and Prevention, according to Reuters.

In a June 24 letter, the FDA requested that Novartis immediately stop using the promotional materials in question. A Novartis spokeswoman said that the company has already complied to the request.

"(The unit) takes this communication very seriously and has immediately ceased the dissemination of the material in question," Novartis spokeswoman Brandi Robinson said, according to Reuters. "We are committed to addressing the FDA's concerns adequately and expeditiously.”

Novartis currently produces three types of meningitis vaccines and is hopeful that its meningitis franchise will be a major success that helps the company reduce its dependence on the sale of pandemic vaccines.

Earlier this month, the FDA accepted Novartis’ application to increase the use of Menveo to infants and toddlers from two months of age. Menveo is currently approved for use against strains of the meningococcal disease that causes meningitis for people in the United States between the ages of two and 55.