Scios, a subsidiary of Johnson & Johnson, has pleaded guilty to charges by the FDA that alleged Scios introduced its heart failure drug, Natrecor (nesiritide), to the market for an indication that was not approved by the FDA, violating the Food, Drug and Cosmetic Act (FDCA). Scios will be forced to pay an $85 million criminal fine, according to the Department of Justice (DoJ).
Under the FDCA, a company must specify the intended use of a drug in its new drug application to the FDA, which Scios failed to do. Prior to approval, FDA must approve the drug for its indended uses. If the manufacturer decided to market that drug with an unapproved use, this then becomes misbranded and its introduction to the market is a criminal violation.
FDA approved Natrecor for use in 2001 with the indication to treat patients with acutely decompensated congestive heart failure (CHF) and dyspnea at rest or with minimal activity. The FDA did not approve the drug for any other use.
During the case, Scios admitted that it intended Natrecor to be used off-label for infusing chronic CHF patients on a scheduled, serial basis, which was not approved by FDA. The drug’s FDA-approved labeling did not contain this scheduled, serial use.
“Putting misbranded drugs into interstate commerce is serious because it undercuts the FDA’s role in keeping our medicines safe and effective,” said Tony West, assistant attorney general for the Civil Division of the DoJ. “This criminal plea by a major pharmaceutical company and the significant criminal fine imposed demonstrate the Justice Department’s commitment to fighting healthcare fraud wherever we find it.”
In a related civil case, the U.S. has sued Scios and its parent company Johnson & Johnson under the False Claims Act. The U.S. has alleged that the companies promoted the scheduled and serial use of the drug for non-acute heart failure patients, which caused false claims to be submitted to Medicare and Medicaid. The case was prosecuted by the DoJ’s Civil Division and the U.S. Attorney’s Office for the Northern District of California, along with the FDA’s Office of Chief Counsel.
A recent study published in the New England Journal of Medicine questioned whether nesiritide should be recommended for use at all, particularly after the drug was found to be associated with hypotension in acute HF patients. O'Connor et al concluded from the ASCEND-HF trial that "the use of nesiritide in patients with acute decompensated heart failure neither increased nor decreased the incidence of death or rehospitalization for heart failure at 30 days."