Generic drugs targeted by FDA after one fails

Published: Monday, Nov. 5 2012 10:49 p.m. MST

"In 2010, the FDA took the rare step of conducting its own study of the 300-milligram strength," wrote Thomas. "In early October, it announced that the drug did not, in fact, perform as well as the brand."

Some say concerns raised by the FDA's decision to look more closely at drug-making processes are overblown and that the science behind generics is sound. "There are approximately 10,000 FDA-approved interchangeable generics in the U.S. The recall by a single manufacturer of one strength of a generic drug should in no way cast doubt on the impeccable reputation of the generic industry or the FDA," Ralph Neas, CEO and president of the Generics Pharmaceutical Association, told CBS News.

"David Read, regulatory counsel for the FDA's office of generic drugs, isn't concerned," said an article in Forbes on the closer scrutiny. "According to Read, in the last five years the FDA has only had to correct itself on the equivalence of three drugs. Two cases involved drugs from Dr. Reddy's Laboratories: an antidepressant and an antifungal medication. The third case involved an anti-seizure drug from Upsher-Smith Laboratories."

EMAIL: lois@desnews.com Twitter: Loisco

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