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RyanSongSecondPaper 10 - 06 Jul 2010 - Main.RyanSong
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| META TOPICPARENT | name="SecondPaper" |
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Pfizer Reformed, Again | |
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< | 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 drug for an unapproved purpose. Such practice is so customary that the failure to prescribe a drug for a specific off-label use may expose a doctor to medical malpractice. Unlike doctors, who appear to have good intentions when prescribing off-label uses, drug manufacturers are subject to suspicion of malicious motives when they promote any off label use. Therefore, the law generally permits doctors to practice off-label use while forbidding off-label use promotion by manufacturers. In 2004, the government fined Warner-Lambert (a Pfizer subsidiary) $430 million for promoting the off label use of Neurotin. In response, Pfizer pledged to reform. Yet, In 2009, the government fined Pfizer $2.3 billion for its off-label promotion of Bextra. And of course, Pfizer “reformed,” again. | >
> | When a drug manufacturer applies to the Food and Drug Administration (“FDA”) for approval of a new drug, it must indicate the drug's specific usages on the application. If a doctor prescribes a drug for an usage which did not receive FDA approval, he engages in the practice of prescribing off-label use. Such practice is so prevalent in the medical community that the failure to prescribe the off-label use of certain drugs may expose a doctor to medical malpractice. Unlike doctors, who may act in good faith, drug manufacturers are often suspected of malicious motives when they promote any off label uses. Therefore, on the one hand, the law generally permits doctors to practice off-label use, but on the other land, forbids any promotion of off-label use by manufacturers. In 2004, the government fined Warner-Lambert (a Pfizer subsidiary) $430 million for promoting the off label use of Neurotin. In response, Pfizer pledged to reform. Yet, In 2009, the government fined Pfizer $2.3 billion for its off-label promotion of Bextra. And of course, according to Pfizer representative, Pfizer will “reform,” again. | | | Off-Label Settlement of Bextra |
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| Revision 10 | r10 - 06 Jul 2010 - 04:11:20 - RyanSong |
| Revision 9 | r9 - 16 Jun 2010 - 01:25:07 - RobLaser |
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