In recent news, a drug maker is being accused of making false claims about a vaccine, which gives consumers yet another valid reason to question Big Pharma and their reasonings.
Novartis AG falsely implied that its Menveo® meningitis vaccine was approved in a manner consistent with guidelines from an influential U.S. advisory group, health regulators said in a letter to the Swiss drugmaker.
Novartis was created in 1996 through the merger of Ciba-Geigy and Sandoz, two companies with a rich and diverse corporate history. Throughout the years, Novartis and its predecessor companies have discovered and developed many innovative products for patients and consumers worldwide.
Menveo® , a meningococcal vaccine, is the latest vaccine from Novartis Vaccines that helps provide important protection for your child against meningococcal disease. It is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menveo® does not prevent N meningitidis serogroup B infections.
In a letter dated June 24, written by Robert A. Sausville, Director Division of Case Management, Office of Compliance and Biologics Quality for the Center for Biologics Evaluation and Research for The U.S. Food and Drug Administration, said some statements in a recorded phone call and professional slides from March 2011 were “false and misleading.”
The FDA also said the promotional materials falsely imply that FDA-approved use of Menveo® is consistent with published recommendations by the U.S. Advisory Committee on Immunization Practices, a panel of federal vaccine experts that advises the U.S. Centers for Disease Control and Prevention.
The FDA requested that Novartis “immediately cease the dissemination of this violative promotional material for MENVEO®, as well as promotional materials with the same or similar claims and representations. Please submit a written response within ten (10) business days of the date of this letter, stating whether you intend to comply with this request, listing all violative promotional materials for MENVEO® and explaining your plan for discontinuing use of such materials.”
The company’s spokeswoman, Brandi Robinson, said the vaccine unit has already done that. “(The unit) takes this communication very seriously and has immediately ceased the dissemination of the material in question,” said Robinson. “We are committed to addressing the FDA’s concerns adequately and expeditiously.”
Earlier this month, the FDA accepted Novartis’ application to broaden the use of Menveo® in infants and toddlers from 2 months of age. The vaccine, which protects against strains of the meningococcal disease that causes potentially deadly meningitis, is approved in the United States for people aged between 2 and 55.
Novartis has three types of meningitis vaccines and it is optimistic that its meningitis franchise will be a blockbuster. The company is also hoping its meningitis franchise will help the unit reduce its dependency on sales from pandemic vaccines.
It is tactics like these used by pharmaceutical companies that have consumers concerned with vaccines. It is the public’s right to know the truth about each and every vaccine and the FDA forcing Novartis to be held accountable for these actions can truly be considered a step in the right direction.
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