Novartis

FDA: Novartis AG distributing 'false and misleading' marketing materials for meningitis vaccine

Tuesday, July 12, 2011 by: Jonathan Benson, staff writer
Tags: Novartis, vaccines, health news

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(NaturalNews) In a rare example of a federal agency holding a drug company responsible for its actions, the US Food and Drug Administration (FDA) recently notified pharmaceutical giant Novartis AG that certain statements it made in a recorded phone call, on professional slides, and in company marketing material were "false and misleading." The FDA says the claims made about Novartis AG's Menveo meningitis vaccine are not in accordance with the agency's guidelines, and thus cannot be made.

In a letter to Novartis AG dated June 24, 2011, the FDA points out that some of the company's dose and schedule statements for Menveo are not FDA-approved, as is implied by the company's materials. Such unapproved recommendations include "routine vaccination of adolescents, preferably at age 11 or 12 years, with a booster dose at age 16 years." The agency has requested that the company remove these claims.

The issue stems from discrepancies between recommendations made by the US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP), and those made by the FDA, concerning Menveo's usage. Novartis AG allegedly implied that the FDA's approval specifications for Menveo were in accordance with ACIP, when in fact they are not.

The FDA recently, however, complied with requests by Novartis AG to expand the use of Menveo to children as young as two months of age, despite the fact that the vaccine is known to increase risk of seizures and Guillain-Barre Syndrome, not to mention a whole slew of other harmful side effects including headache, nausea and muscle pain (http://www.drugs.com/pro/menveo.html).

Novartis AG is banking on its meningitis vaccines to be the company's next big blockbuster drugs.

Sources for this story include:

http://www.reuters.com/article/2011/07/01/us...

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