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RyanSongSecondPaper 7 - 03 Jun 2010 - Main.RyanSong
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Pfizer Reformed, Again | |
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< | Off-label use is the practice of prescribing drugs for an indication unapproved by the FDA. In the medical community, off-label use is so prevalent that the failure to do so may amount to medical malpractice, especially in treatment against HIV, cancer and etc. Contrary to the legal protection which doctors receive for prescribing off-label use, drug manufacturers are forbidden to promote it. In 2004, the government fined Warner-Lambert, a Pfizer subsidiary, $430 million for its off-label promotion of Neurotin. According to Pfizer, it reformed after this. In 2009, the government fined Pfizer $2.3 billion for its off-label promotion of Bextra. And of course, Pfizer “reformed,” again. | >
> | When the Food and Drug Administration (“FDA”) approves a new drug, it only approves its usage for a specific reason. Off-label use is the practice of prescribing patients a certain drug for a reason unapproved by the FDA. In the medical community, such practice is so prevalent that, in limited circumstances such as cancer treatment, the failure to prescribe patients a certain drug for its off-label use may expose a doctor to medical malpractice; thus the law generally permits physicians to prescribe drugs for off label use. Unlike doctors, who may have a good faith belief to prescribe off-label uses, drug manufacturers are much more suspicious of malicious motive when they promote any off label use. Therefore the law forbids any off label promotion by manufacturers. In 2004, the government fined Warner-Lambert, a Pfizer subsidiary, $430 million for its off-label promotion of Neurotin. Pfizer pledged to reform. In 2009, the government fined Pfizer $2.3 billion for its off-label promotion of Bextra. And of course, Pfizer “reformed,” again. | | | Off-Label Settlement of Bextra |
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| Revision 7 | r7 - 03 Jun 2010 - 04:08:44 - RyanSong |
| Revision 6 | r6 - 17 Apr 2010 - 01:05:22 - RyanSong |
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