Celgene Corp. has agreed to pay $280 million to settle claims that it marketed the cancer drugs Thalomid and Revlimid for unapproved uses, the company said in a press statement yesterday.
The lawsuit filed by a whistle-blower — a former sales representative at Celgene — will see the company paying $259.3 million to the United States and $20.7 million to 28 states and the District of Columbia. Celgene denied wrongdoing and settled to avoid uncertainty, distraction and expensive litigation, the company said in the statement.
“Patients deserve to know their doctors are prescribing drugs that are likely to provide effective treatment, rather than drugs marketed aggressively by pharmaceutical companies,” said Acting U.S. Attorney Sandra R. Brown.
The lawsuit filed by Beverly Brown was brought on behalf of the U.S. government under a federal whistleblower law. She could receive as much as $84 million as her share of the settlement.
Brown was an “immunology specialist” trained by Celgene to promote Thalomid and Revlimid drugs for cancer treatments that had not been approved by the FDA. Thalomid, another name for thalidomide, a drug prescribed for morning sickness in the 1950s and 1960s that caused severe birth defects, was approved by the agency in 1998 for treating leprosy. And
because Thalomid would only be useful to a fraction of the few hundred leprosy cases diagnosed in the U.S. each year, the company developed a plan to promote the drug for cancer, the lawsuit said.Sales of Thalomid quickly took off, in part because — as Ms. Brown claimed in her complaint — Celgene “flooded the country” with sales representatives who were under heavy pressure to pitch the drug to oncologists for a variety of cancers.
Ms. Brown’s complaint also claimed that the company’s inappropriate marketing of Thalomid exposed patients to heightened risks that included potentially fatal blood clots and other side effects.
Cancer drugs are seen as more difficult to pursue in so-called off-label marketing cases in part because oncologists often prescribe drugs for unapproved uses in an effort to combat a deadly and still mysterious disease.
“The company got the idea that it could be fast and loose with what it was saying about its drug because it was selling to cancer patients who might be in need,” said Reuben A. Guttman, who represented the whistle-blower. “At the end of the day, what this is about is that even when you’re on life’s edge,” he added, a company “can’t break the law by off-label marketing a drug.”
The payment is equivalent to about two weeks worth of sales of Revlimid, which generated $6.97 billion in revenue for Celgene last year, according to an analysis. Celgene fell 1 percent to $136.44 at 4 p.m. in New York.
The settlement was reached after federal prosecutors declined to intervene in the case. Under the federal False Claims Act, private citizens like Ms. Brown can bring a suit against companies in the United States and share in any recovery.
