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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 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. | >
> | 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. | | | Off-Label Settlement of Bextra | |
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< | The story of Bextra began in 2001 when Pharmacia & UpJohn? Company (“P&U”), a Pfizer subsidiary, received approval from FDA for three indications of Bextra: osteoarthritis, adult rheumatoid arthritis, and primary dysmennorrhea. Due to safety concern, FDA rejected approving Bextra for general acute pain. Displaying complete disregard for patients’ safety, from 2002 through 2005, P&U promoted Bextra for general acute pain to physicians under false claims of safety. It used so-called advisory boards, consultant meetings, and paid vacation at lavish resorts to promote Bextra to, as one local manager claimed, "anyone that use[d] a scalpel for a living." | >
> | The story of Bextra began in 2001 when Pharmacia & UpJohn? Company (“P&U”), a Pfizer subsidiary, received approval from FDA for three indications of Bextra: osteoarthritis, adult rheumatoid arthritis, and primary dysmennorrhea. Due to safety concerns, the FDA did not approve Bextra for general acute pain. Displaying complete disregard for patients’ safety, P&U promoted Bextra for general acute pain to physicians claiming it was safe. From 2002 to 2005, Pfizer used so-called advisory boards, consultant meetings, and paid vacation at lavish resorts to promote Bextra to, as one local manager claimed, "anyone that use[d] a scalpel for a living." | | | | |
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< | In 2005, Pfizer withdrew Bextra from the market on recommendation by the FDA, citing an increased risk of heart attack, stroke, and a serious, sometimes fatal, skin reaction. In September 2009, P&U pled guilty to a felony violation of the Food, Drug & Cosmetic Act, for misbranding Bextra with the intent to defraud or mislead. In the plea agreement, it agreed to pay a criminal fine of $1.195 billion. Furthermore, Pfizer paid an additional $1 billion to settle civil allegations that it induced physician with kickbacks to market four drugs, including Bextra. | >
> | In 2005, Pfizer withdrew Bextra from the market on recommendation by the FDA, citing an increased risk of heart attack, stroke, and a sometimes fatal skin reaction. In September 2009, P&U pled guilty to a felony violation of the Food, Drug & Cosmetic Act, for misbranding Bextra with the intent to defraud or mislead. In the plea agreement, it agreed to pay a criminal fine of $1.195 billion. Furthermore, Pfizer paid an additional $1 billion to settle civil allegations that it induced physicians using kickbacks to market Bextra and three other drugs. | | |
Why manufacturers will forego FDA approval and risk civil and criminal sanctions? | |
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< | Manufacturers forego FDA approval and risk civil and criminal sanctions for many reasons: FDA approval process is expensive and takes a long time; in the case of Bextra, FDA may decline to approve; and FDA approval will expand the scope of generic competition once the patent expires. More importantly, manufacturers are motivated by profits. After realizing that the approved uses of a drug fail to generate enough revenue, manufacturers promote off-label uses to grab more profit. Bextra is 20 times more expensive than ibuprofen, but not shown to be more effective. Another reason for manufacturers to promote off-label use is that everyone else does it. Eli Lilly pled guilty to criminal misbranding of Evista, Serono paid 704 milion to resolve charges relating to its marketing of Serostim, and the list goes on. | >
> | Manufacturers forego FDA approval and risk civil and criminal sanctions for many reasons: FDA approval process is expensive and takes a long time; the FDA may decline to grant its approval at all; and FDA approval will expand the scope of generic competition once their patent expires. Most importantly, manufacturers are motivated by profits. After realizing that the approved uses of a drug fail to generate enough revenue, manufacturers promote off-label uses to grab more profit. Bextra is 20 times more expensive than ibuprofen, but not shown to be more effective. These massive profits explain why companies promote off label use even in the face of huge sanctions. Pfizer is not alone in promoting off label use. Eli Lilly pled guilty to criminal misbranding of Evista, Serono paid 704 milion to resolve charges relating to its marketing of Serostim, and the list goes on. | | |
too big to fail? |
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