[ti:Illegal Marketing of Drugs: Pfizer's Record Fine ] [ar:Bob Doughty] [al:Economics Report] [by:51VOA.COM] [00:00.00]This is the VOA Special English [00:04.14]Economics Report. [00:06.26]The world's largest drug company has agreed [00:09.90]to pay almost two and a half billion dollars [00:13.30]for illegal marketing of medicines. [00:16.45]The settlement between Pfizer [00:18.96]and the United States Justice Department [00:21.37]was announced last week. [00:23.46]The settlement is the nation's largest ever [00:26.61]in a case of health care fraud. [00:29.61]It also includes the largest criminal fine ever [00:33.55] in any case in the United States, [00:36.36]more than one billion dollars. [00:40.89]Pfizer agreed to pay another billion [00:44.19]for violations of a civil law, [00:47.53]the False Claims Act. [00:49.88]Pfizer, based in New York, [00:52.22]had sales last year of forty-eight billion dollars. [00:56.82]A Pfizer division, Pharmacia & Upjohn, [01:01.31]agreed to plead guilty to a criminal violation [01:05.21]over the painkiller Bextra. [01:07.94]Pfizer pushed sales of Bextra [01:11.38]for several uses unapproved [01:13.72]by the government because of safety concerns. [01:17.61]It also pushed for use in unapproved amounts. [01:21.59]Pfizer withdrew Bextra from the market [01:24.58]in two thousand five because of links [01:28.11]to heart attacks and other problems. [01:31.50]Pfizer also faced civil charges over Bextra [01:36.28]as well as an anti-psychotic drug, Geodon; [01:39.91]an antibiotic, Zyvox; [01:43.00]and an anti-epilepsy drug, Lyrica. [01:46.73]Officials said Pfizer paid health care providers [01:51.01]to prescribe these medicines [01:53.31]for conditions other than the ones [01:56.05]for which they are approved. [01:58.44]This is called "off-label" use of a drug. [02:02.57]Doctors are permitted to try off-label uses [02:06.61]to treat their patients. [02:09.05]The idea is that a doctor might [02:11.83]find other ways that a drug is effective. [02:15.27]But federal law bars drug companies [02:18.41]from marketing their products [02:20.45]for unapproved uses. [02:22.74]Kathleen Sebelius is the secretary [02:26.24]of health and human services. [02:29.03]KATHLEEN SEBELIUS: "This settlement is historic [02:31.17]not only because it's the most money taxpayers [02:34.37]have ever recovered from a drug company, [02:36.21]but also because it includes the most [02:38.51]comprehensive corporate integrity agreement [02:40.75]that a drug company has ever signed [02:42.89]in the United States." [02:44.58]Under the agreement, doctors will have a way [02:48.27]to report abuses by Pfizer sales representatives. [02:52.37]And officials said Pfizer will have [02:55.97]to make "detailed disclosures" on its Web site. [02:59.70]Pfizer announced a plan in February [03:03.38]to publicly disclose its financial relationships [03:07.41]with doctors, medical organizations [03:10.90]and patient groups. [03:13.18]Yet this is not the company's [03:16.32]first corporate integrity agreement [03:19.01]with the government. [03:20.80]Pfizer has now been fined [03:23.50]for illegal marketing four times [03:26.33]since two thousand two. [03:28.94]Prescription drugs represent only [03:32.43]about one-tenth of all health care spending [03:35.98]in the United States. [03:38.71]But fast-growing demand and prices [03:42.00]have made them part of the debate over health reform. [03:46.54]And that's the VOA Special English [03:50.73]Economics Report, written by Mario Ritter. [03:54.76]I'm Bob Doughty.