FDA Increases Study Of Generic Medications.

On the front of its Business Day section, the New York Times (11/1, B1, Thomas, Subscription Publication) reports, “The Food and Drug Administration said it was looking more closely at the way generic companies made extended-release drugs after it found one such medicine failed to work as well as its brand-name counterpart.” That “is a rare departure for the agency, which for years has insisted that generic drugs are just as effective as their brand-name versions.” So far, “regulators have said the episode appears to be limited to one dosage level of a single drug,” that is “a 300-milligram dose of bupropion…manufactured by Impax Laboratories.” Dr. Gregory P. Geba, director of the FDA’s Office of Generic Drugs, said, “This has actually prompted us to change our policy.” The change “has provided fodder to some longtime critics, who say the FDA and generic drug companies have been reluctant to acknowledge that sometimes generics don’t work as well as the brand-name originals.”

Related Links:

— “An Increase in Scrutiny for Generics,”Katie Thomas, The New York Times, October 31, 2012.

Posted in In The News.