The biotechnology giant Amgen marketed its anemia drug Aranesp for unapproved uses even after the Food and Drug Administration explicitly ruled them out, federal prosecutors said on Tuesday.
The federal charges were made public as Amgen pleaded guilty to illegally marketing the drug and agreed to pay $762 million in criminal penalties and settlements of whistle-blower lawsuits.
Amgen was "pursuing profits at the risk of patient safety," Marshall L. Miller, acting United States attorneyin Brooklyn, said in a telephone news briefing on Tuesday.
David J. Scott, Amgen's general counsel, entered the guilty plea at the United States District Court in Brooklyn to a single misdemeanor count of misbranding the drug, Aranesp, meaning selling it for uses not approved by the F.D.A.
Amgen agreed to pay $136 million in criminal fines and forfeit $14 million, with about $612 million going to settle civil litigation.
The presiding judge, Sterling Johnson Jr., scheduled a hearing for Wednesday to announce whether he will accept the agreement. If he does, a broader settlement and as many as 11 whistle-blower lawsuits would be made public, some containing accusations beyond those to which Amgen pleaded guilty.
In court on Tuesday, prosecutors charged that Amgen had promoted the use of Aranesp to treat anemia in cancer patients who were not undergoing chemotherapy, even though the drug's approval was only for patients receiving chemotherapy.
A subsequent study sponsored by Amgen showed that use of Aranesp by those nonchemotherapy cancer patients had actually increased the risk of death, and the off-label use diminished.
The federal charges also say Amgen promoted using larger but less frequent injection of Aranesp than stated in the label as a way of making the drug more attractive to doctors and patients than Procrit, a rival anemia drug from Johnson & Johnson.
Amgen eventually tried to obtain approval for the less frequent dose, but the F.D.A. turned down its requests, saying the company's studies were inadequate. Nonetheless, according to the federal charges, Amgen continued to promote the off-label dosing, relying on the same studies the F.D.A. had deemed inadequate.
Roger Burlingame, a federal prosecutor, told the judge Tuesday that "in certain instances, Amgen employees were so thoroughly indoctrinated to sell the drug for off-label uses that they did not, in fact, know that the drug had not been approved for the use for which they were selling it."
A document summarizing the charges says that while sales representatives were not supposed to initiate discussions of off-label uses, they were trained to elicit questions from doctors. Such questions would provide the "necessary cover" for the sales representatives to provide the doctor with studies supporting the off-label use. Amgen referred to this as "reactive" marketing, the document said.
Amgen also managed to list the unapproved uses in a reference called a compendium. Medicare is required to pay for off-label uses of cancer drugs listed in an approved compendium. The compendium system is intended to make drugs more easily available to cancer patients, but critics say the compendiums do not adequately review the evidence.
Amgen issued a statement Tuesday acknowledging the guilty plea and noting that 14 months ago the company announced that it had set aside $780 million for the settlement of federal, state and whistle-blower complaints. Amgen's stock fell 21 cents, to $89.29.
While doctors are allowed to use drugs for unapproved uses, companies are not supposed to promote such uses. The government has collected billions of dollars from pharmaceutical companies in recent years for off-label marketing.
The Amgen settlement is fairly large, but several have exceeded $1 billion. In July, GlaxoSmithKline agreed to pay $3 billion, in part for promoting antidepressants and other drugs for unapproved uses.
Critics say that fines alone do not deter such behavior because executives are not held personally responsible.
Mr. Miller said that the evidence in the Amgen case was not sufficient to charge individuals. However, he said, Amgen agreed to sign a corporate integrity agreement that requires executives and board members to personally certify compliance with regulations. That would make it easier to prosecute individuals should violations occur again, he said.
A decision two weeks ago by the Court of Appeals for the Second Circuit in Manhattan held some off-label promotion was protected as free speech. That ruling could make it harder for the government to pursue such cases in the future. But Mr. Miller said that case involved speech by a sales representative while the Amgen case involved a plan by a company. "It's a very different type of prosecution," he said.
Aranesp was once Amgen's biggest product, with sales of more than $4 billion a year. Sales have declined since 2007 because studies show that high doses can lead to blood clots and the worsening of cancer. Global sales of Aranesp in the first nine months of this year were $1.55 billion, down 12 percent from the first nine months of 2011.
Anda sedang membaca artikel tentang
Amgen Agrees to Pay $762 Million in Drug Marketing Case
Dengan url
http://healtybodyguard.blogspot.com/2012/12/amgen-agrees-to-pay-762-million-in-drug.html
Anda boleh menyebar luaskannya atau mengcopy paste-nya
Amgen Agrees to Pay $762 Million in Drug Marketing Case
namun jangan lupa untuk meletakkan link
Amgen Agrees to Pay $762 Million in Drug Marketing Case
sebagai sumbernya
0 komentar:
Posting Komentar