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Author: Admin | 2025-04-28
The Food and Drug Administration (FDA) approved gabapentin only for treatment of seizures. Warner–Lambert, which merged with Pfizer in 2000, used continuing medical education and medical research, sponsored articles about the drug for the medical literature, and alleged suppression of unfavorable study results, to promote gabapentin. Within five years, the drug was being widely used for off-label uses such as treatment of pain and psychiatric conditions. Warner–Lambert admitted to violating FDA regulations by promoting the drug for pain, psychiatric conditions, migraine, and other unapproved uses.[183] In 2004, the company paid $430 million in one of the largest settlements to resolve criminal and civil health care liability charges. It was the first off-label promotion case successfully brought under the False Claims Act.[184] A Cochrane review concluded that gabapentin is ineffective in migraine prophylaxis.[185] The American Academy of Neurology rates it as having unproven efficacy, while the Canadian Headache Society and the European Federation of Neurological Societies rate its use as being supported by moderate and low-quality evidence.[186]In September 2009, Pfizer pleaded guilty to the illegal marketing of arthritis drug valdecoxib (Bextra) and agreed to a $2.3 billion settlement, the largest health care fraud settlement at that time.[187] Pfizer promoted the sale of the drug for several uses and dosages that the Food and Drug Administration specifically declined to approve due to safety concerns. The drug was pulled from the market in 2005.[188] It was Pfizer's fourth such settlement in a decade.[189][190][191] The payment included $1.195 billion in criminal penalties for felony violations of the Federal Food, Drug, and Cosmetic Act, and $1.0 billion to settle allegations it had illegally promoted the drugs for uses that were not approved by the Food and Drug Administration (FDA) leading to violations under the False Claims Act as reimbursements were requested from Federal and State programs. The criminal fine was the largest ever assessed in the United States to date.[189][190][191] Pfizer entered a corporate integrity agreement with the Office of Inspector General that required it to make substantial structural reforms within the company, and publish to its website its post approval commitments and a searchable database of all payments to physicians made by the company.[192]Termination of Peter RostPeter Rost was vice president in charge of the endocrinology division at Pharmacia before its acquisition by Pfizer. During that time he raised concerns internally about kickbacks and off-label marketing of Genotropin, Pharmacia's human growth hormone drug. Pfizer reported the Pharmacia marketing practices to the FDA and Department of Justice; Rost was unaware of this and filed an FCA lawsuit against Pfizer. Pfizer kept him employed, but isolated him until the FCA suit was unsealed in 2005. The Justice Department declined to intervene, and Pfizer fired him, and he filed a wrongful termination suit against Pfizer. Pfizer won a summary dismissal of the case, with the court ruling that the evidence showed Pfizer had decided to fire Rost prior to learning of his whistleblower activities.[193][194]2014 Illegal marketing of Rapamune settlementA "whistleblower suit" was filed in 2005 against Wyeth,
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