Drug Quality Concerns Spur New U.S. FDA Oversight Effort

Drug quality concerns, such as those that have banned U.S. sales of generic medicines from several Indian manufacturing plants, have spurred regulators to create a new unit to sharpen their oversight.

The Food and Drug Administration is establishing an Office of Pharmaceutical Quality to improve the agency’s scrutiny of brand-name, generic and over-the-counter drugs, Janet Woodcock, director of the Food and Drug Administration’s Center for Drug Evaluation and Research, said today at the Bloomberg health-care summit. The FDA is talking with the industry to develop data that may signal which manufacturing plants are straying from standards and need inspection, she said.