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Pharmaceutical firms not only have to worry about counterfeiters taking a chunk out of their bottom lines, but they must also protect themselves from being held liable for those bogus products, according to an expert on the counterfeit drug trade.
Brand drugmaker King Pharmaceuticals announced last month that it intends to restate its earnings for 2002, 2003 and the first six months of 2004 — an action that could prompt Mylan Laboratories to terminate its pending merger with King without having to pay an $85 million penalty fee.
The recall of brand giant’s Merck’s top-selling arthritis drug, Vioxx (rofecoxib), has led the Indian Health Ministry to ban pharmaceutical firms in that country from manufacturing and marketing generic versions of Vioxx.
Failing to comply with FDA GMPs can have serious financial ramifications for a pharmaceutical firm — a reality that needs to be reflected in the priorities and actions of drug manufacturers’ boardrooms, according to a compliance and quality management expert.