FDA increases scrutiny of some generic drugs

Akos Stiller/Bloomberg Teva Pharmaceutical Industries, the world's largest generic-drug maker, pulled a copy of the antidepressant Wellbutrin XL from the U.S. market after regulators said it failed to work properly.

Regulation Problem with antidepressant renews debate over knock-offs effectiveness.

The Food and Drug Administration said it is looking more closely at the way generic companies make extended-release drugs after it found one such medicine failed to work as well as its brand-name counterpart.

The finding is a rare departure for the agency, which for years has insisted that generic drugs are just as effective as their brand-name versions.

The drug, a 300-milligram dose of bupropion, was manufactured by Impax Laboratories and was intended to mimic the popular antidepressant, Wellbutrin XL. But soon after it was introduced in 2006, patients who switched to it from Wellbutrin began complaining that their depression had returned. Impax and Teva Pharmaceuticals, which marketed the drug, have stopped selling the 300-milligram dose.

Although regulators have said the episode appears to be limited to one dosage level of a single drug, an FDA official said in October that the agency was now looking more closely at the techniques generic drugmakers use to make the extended-release drugs.

"This has actually prompted us to change our policy," Dr. Gregory Geba, the director of the FDAs office of generic drugs, said in an interview.

Generic drugs now account for the overwhelming majority of medicines prescribed in the United States, and extended-release drugs are a rapidly growing segment of the generic market. But they can be tricky to make. While the active ingredient is the same as the brand-name version, the mechanism for gradually releasing the drug into a persons body can vary.

The unusual decision by the FDA that a generic was not the equivalent of the brand has provided fodder to some longtime critics, who say the FDA and generic drug companies have been reluctant to acknowledge that sometimes generics dont work as well as the brand-name originals.

Others dismissed such arguments, saying the recent criticism is just the latest effort in a longstanding campaign to unfairly discredit generics.

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FDA increases scrutiny of some generic drugs