Fremont, Calif.-based Scios, a subsidiary of Johnson & Johnson, has pleaded guilty to misbranding its heart failure drug Natrecor and will pay an $85 million criminal fine, according to a news release from the Department of Justice.
Scios admitted that it intended the drug be used for purposes not approved by the FDA. The company admitted that the FDA-approved labeling for the drug did not contain any directions for scheduled, serial use to treat chronic, non-acute congestive heart failure patients — which is how Scios intended the drug be used.
Under the Food, Drug and Cosmetic Act, a company must specify the intended uses of a drug in its new drug application to the FDA. Before approval, the FDA must determine that the drug is safe and effective for the uses proposed by the company in its application. Once the drug is approved, if the manufacturer intends a different use and then introduces the drug into interstate commerce for that unapproved use, the drug becomes misbranded and the introduction into commerce is a criminal violation.
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Scios admitted that it intended the drug be used for purposes not approved by the FDA. The company admitted that the FDA-approved labeling for the drug did not contain any directions for scheduled, serial use to treat chronic, non-acute congestive heart failure patients — which is how Scios intended the drug be used.
Under the Food, Drug and Cosmetic Act, a company must specify the intended uses of a drug in its new drug application to the FDA. Before approval, the FDA must determine that the drug is safe and effective for the uses proposed by the company in its application. Once the drug is approved, if the manufacturer intends a different use and then introduces the drug into interstate commerce for that unapproved use, the drug becomes misbranded and the introduction into commerce is a criminal violation.
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