WASHINGTON – The United States has intervened in two whistleblower suits filed in the Northern District of Californiaagainst the drug manufacturer Scios Inc. and its parent company, Johnson & Johnson Inc., alleging that the companies marketed the cardiac drug Natrecor for a use not approved by the Food and Drug Administration (FDA) and caused false and fraudulent claims to be submitted to the federal health care programs, the Justice Department announced today. Such an unapproved use is also known as an "off-label" use because it is not included in the drug’s FDA approved product label.
Under the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to the FDA. Before approving a drug, the FDA must determine that the drug is safe and effective for the use proposed by the company. Once approved, the drug company may not market or promote the drug for off-label uses.
In August 2001, the FDA approved Natrecor for "the intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea [shortness of breath] at rest or with minimal activity." The study upon which this approval was based involved hospitalized patients who had severe heart failure and who received infusions of Natrecor over an average 36-hour period. The government’s investigation revealed that shortly after receiving this approval in 2001, Scios began an aggressive campaign to market Natrecor for scheduled, serial outpatient infusions for patients with less severe heart failure – a use not included in the FDA-approved label. These patients were prescribed Natrecor infusions for less than 6 hours on a scheduled basis over an extended period of time.
Medicare does not cover drugs used for off-label uses unless such off-label use is established to be medically necessary. The federal health care programs – in particular, Medicare – paid substantial amounts for the serial outpatient off-label use of Natrecor.
In mid-2005, a panel of leading cardiologists told Scios that it should stop promoting the scheduled, serial outpatient use of Natrecor. Scios subsequently sent a letter to healthcare providers in which it acknowledged that there was insufficient clinical evidence supporting the safety and efficacy for scheduled, serial outpatient use of the drug. In 2007, Scios released the results of a clinical study that showed no significant benefits of serial outpatient Natrecor infusions.
The two separate civil False Claims Act suits – called qui tam actions – were filed by former Scios sales managers against Scios and Johnson & Johnson in the Northern District of California. The False Claims Act allows for private persons to file whistleblower suits to provide the government information about wrongdoing. Under the statute, if it is established that a person has submitted or caused others to submit false or fraudulent claims to the United States, the government can recover treble damages and $5,500 to $11,000 for each false or fraudulent claim filed. If the government is successful in resolving or litigating its claims, the whistleblower who initiated the action can receive a share of between 15 percent to 25 percent of the amount recovered.
The qui tam or whistleblower actions contain additional allegations. However, the United States is only intervening with regard to allegations that Scios marketed the drug Natrecor for serial infusions in the outpatient setting.
The investigation was conducted by the Civil Division of the U.S. Department of Justice, the U.S. Attorney’s Office for the Northern District of California, the Federal Bureau of Investigation, and the Offices of Inspector General of the Department of Health and Human Services, the FDA, the Department of Veterans Affairs, the Office of Personnel Management, and the Department of Defense.