Los Angeles, CA (PRWEB) November 12, 2013
The Holistic Sanctuary announces its response to the guilty plea from Johnson & Johnson’s Janssen unit for misrepresenting the use and purpose of the anti-psychotic medication Risperdal. The company’s $2.2 billion settlement with U.S. prosecutors, the largest fine for a single drug, is a consequence of its deliberate marketing of Risperdal to elderly patients with dementia for uses not approved by the U.S. Food and Drug Administration.(1) According to U.S. District Judge Timothy Savage, who presided over the hearing and admission of guilt, the company acted in a “calculated manner” with the intent to “maximize profits with no regard to risk.”(2)
Judge Savage’s statement reflects the same concerns The Holistic Sanctuary has about Risperdal. U.S. Attorney General Eric Holder echoed these warnings by saying: “Put simply, this alleged conduct is shameful, and it is unacceptable. It displayed a reckless indifference to the safety of the American people. And it constituted a clear abuse of the public trust.”(3) Along with information compiled by the FDA, Johnson & Johnson’s actions violated FDA-approved regulations because “if a pharmaceutical manufacturer intends its drug to be used for a new use, not approved by the FDA, and introduces the drug into interstate commerce for that use, the drug is misbranded, and introduction of that misbranded drug into interstate commerce is a violation of the law.”(4)
The FDA’s formal announcement about this criminal abuse further includes a statement from John Roth, director of the FDA’s Office of Criminal Investigations: “Our investigators devoted considerable time and resources to this case, to help ensure that pharmaceutical companies do not mislead healthcare providers and the general public about the safety and efficacy of their me
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