Abstract
JOHNSON & JOHNSON IS THE latest major drug firm-along with Eli Lilly, Abbott Laboratories, and Schering-Plough—to come under regulatory scrutiny. FDA is investigating allegations of falsified documents at J&J's Ortho Biologics plant in Puerto Rico. Meanwhile, agency and French health authorities representing European Union have been looking into cases of pure red blood cell aplasia (PRCA) in patients using J&J's erythropoietin (EPO) product, Eprex, which stimulates production of red blood cells. J&J makes Eprex for non-U.S. markets at its Puerto Rico facility. However, company says its own investigation confirms that the integrity of our product has never been compromised and there is no connection between allegations and occurrence of PRCA. The probes started after a former Ortho Biologics employee sued J&J in March 2000, claiming in part that his supervisors directed him to falsify documents. The employee was a utilities worker with no manufacturing responsibilities. He was ...
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