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Generic-Drug Makers Can Speed Safety Changes in FDA Plan

Nov. 8 (Bloomberg) -- Generic drug companies will be able to publicize new safety information on a product on their own instead of waiting for their brand-name counterparts to release the information under a plan from U.S. regulators.

The Food and Drug Administration proposed a rule today that allows generic drugmakers such as Teva Pharmaceutical Industries Ltd and Mylan Inc. to makes changes to their labels the same way as brand-name pharmaceutical companies. Current rules allow brand manufacturers to update their labels to acknowledge new safety information before an FDA review of the change.

“This proposal will help ensure that health care professionals and consumers have access to the latest safety information for the medications they use,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “More than 80 percent of prescriptions filled in the U.S. are for generics, so we want to make sure that generic drug companies actively participate with the FDA to ensure that product safety information is accurate and up to date.”

Under current law, generic companies must wait to change product safety information until the label for the corresponding brand medicine has been updated by its drugmaker and received FDA approval for the revision. The agency said that policy may have delayed relaying information to health-care professionals.

To contact the reporter on this story: Anna Edney in Washington at

To contact the editor responsible for this story: Reg Gale at

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