Janssen was fined more than $1.6 billion by the United States for over marketing of risperidone

Source: DXY on November 4, 2013, the U.S Department of justice, on behalf of the U.S Food and Drug Administration (FDA), announced a plea agreement with Janssen Pharmaceutical Company (JPI), based in taitesville, New Jersey JPI was fined $400 million for introducing risperidone, a mislabeled drug, into interstate trade Janssen, a subsidiary of Johnson & Johnson, also has to pay $1.25 billion under separate civil settlements for the same drugs The total cost of criminal defense and civil settlement agreements related to risperidone after the merger is more than US $1.67 billion Other costs related to JPI medical fraud and other federal agencies can be found on the website The Eastern District Court of Pennsylvania oversees the agreement "When pharmaceutical companies ignore FDA requirements, they not only put the public's health at risk, but also hurt patients' trust in their doctors and the drugs they use," said Margaret A Hamburg, director of FDA and doctor of medicine "FDA relies on rigorous scientific research data to determine and approve an application of a drug that has been shown to be safe and effective Today's announcement confirms that drug manufacturers who ignore the FDA's regulatory authority are also neglecting that they are in danger of making their own products " The FDA approved risperidone in 2002 for schizophrenia, in 2003 for short-term treatment of acute mania and for mixed episodes related to bipolar disorder However, JPI launched the drug in March 2002 for agitation related to Alzheimer's disease, indicating that risperidone is safe and effective for this unapproved indication and patient subgroup FDA believes that doctors can use the drug to treat patients' symptoms or diseases in medical practice, even if the drug has not been approved by FDA for such use However, if a pharmaceutical company intends to use its drug for a new indication that has not been approved by FDA, and introduce the drug into interstate trade for the indication, then the drug is considered to be mislabeled, and it is a violation of law to introduce the mislabeled drug into interstate trade The US Department of justice's action also shows that JPI and Johnson & Johnson know that risperidone brings serious health risks to the elderly, including increasing the risk of stroke, but the company does not pay attention to these risks, but combines the negative data with other studies to support a perceived risk reduction of the drug The company has received repeated warnings from the FDA about the misleading information JPI has brought to physicians on the market After the whistleblower filed a complaint, the FDA criminal investigation office launched a criminal investigation into JPI's actions "For this case, our investigators spent a lot of time and resources to help ensure that pharmaceutical companies cannot mislead healthcare institutions and the public about their drug safety and effectiveness," said John Roth, director of the FDA's criminal investigation office "In order to protect public health, we are ready to take similar actions in the future if necessary." JPI listed risperidone is also used in children's behavioral challenges, although they know the drug has health risks for children and adolescents Until the end of 2006, risperidone was not approved for use in children with this indication, and the FDA repeatedly recommended that the company sell risperidone to children for this indication is problematic and may be an illegal act Under a corporate integrity agreement with the U.S Department of health and Human Services Oversight Office, JPI and Johnson & Johnson will also be subject to strict requirements The agreement aims to enhance the operational responsibility and transparency of pharmaceutical companies and prevent future fraud and abuse.