FDA launches department to oversee drug quality control

The FDA announced the creation of a new Office of Pharmaceutical Quality tasked with reducing lapses in quality control at pharmaceutical manufacturing facilities. Janet Woodcock, director of the agency's Center for Drug Evaluation and Research, said the initiative is designed in part to establish consistent quality standards for all drugs, whether brand name or generic.

The regulator noted that the move isn't in response to recent problems from generic versions of some extended-release medicines, but is designed to make its focus on manufacturing more systematic. However, Lawrence Yu, deputy director of the Office of Pharmaceutical Quality, commented "modified release is a high-risk area, so we're going to put a lot of emphasis on it." Yu indicated that the FDA is collaborating with researchers to change the standards for testing how extended-release drugs are absorbed by the body.

Last year, Dr. Reddy's Laboratories and Wockhardt recalled more than 100 000 bottles of the extended-release heart drug metoprolol succinate, a generic version of AstraZeneca's Toprol XL, because their products weren't dissolving properly. Meanwhile, in 2012, the FDA concluded that Teva's generic extended-release version of GlaxoSmithKline's antidepressant Wellbutrin wasn't therapeutically equivalent to the branded product.

According to Woodcock, the FDA has only previously had a general sense of the state of manufacturing quality, while the new project will provide it with quantitative information. She indicated that drugmakers can expect a more integrated review and greater communication with the agency. Woodcock noted that the FDA will propose a set of quality metrics, and after a public comment period, produce a final rule. She added that medicines currently being evaluated for approval will remain with their existing review team at the FDA, with new applications being filed with the new office beginning immediately.

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