El acuerdo incluyó 1.300 millones de dólares por cargos criminales sobre formas de venta del antiartrítico ya retirado del mercado en el 2005, Bextra (Valdecoxib), como así también 1.000 millones de dólares por cargos civiles respecto a promoción por fuera de prospecto, y no autorizados por la FDA, del mismo Bextra, el antipsicótico atípico Geodon (Ziprasidone), el antibiótico Zyvox (Linezolid) y la droga para dolor neuropático y epilepsia, Lyrica (Pregabalin).
Con excepción de Bextra, los demás medicamentos tienen estatus blockbuster, con ventas en el 2008 por 1.007 millones de dólares para Geodon, 1.115 millones de dólares para Zyvox y 2.602 millones de dólares para Lyrica, la segunda especialidad en ventas de la compañía neoyorquina. (Ver...)
Pfizer Inc., the world's largest drug maker, will pay a record $2.3 billion civil and criminal penalty over unlawful prescription drug promotions, the Justice Department announced Wednesday.
The department said the $2.3 billion settlement included a $1.2 billion criminal fine, the largest criminal fine in U.S. history. The agreement also included a criminal forfeiture of $105 million.
"Combating health care fraud is one of this administration's top priorities," Associate Attorney General Thomas Perelli said in announcing the settlement. He said it illustrates ways the department "can help the American public at a time when budgets are tight and health care costs are rising."
The overall settlement is the largest ever paid by a drug company for alleged violations of federal drug rules.
The government said the company promoted four prescription drugs, including the pain killer Bextra, as treatments for medical conditions different than those the drugs had been approved for by federal regulators.
Use of drugs for so-called "off-label" medical conditions is not uncommon, but drug manufacturers are prohibited from marketing drugs for uses that have not been approved by the Food and Drug Administration. (Ver...)
1 comentario:
Y todavía Pfizer tiene que enfrentarse a juicios por Vioxx en todo el mundo!
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