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Accuracy of Prescribing Information for Generic Drugs to Be Improved

The manufacturers of generic drugs are fighting an FDA proposal that would require them to update the prescribing information when new dangers come to light. This would level the playing field between brand name and generic firms when it comes to product liability.

Under current FDA regulations, generic drug companies are not permitted to make any changes in their labeling. (This is why the information doctors can read on Budeprion is identical to that for its brand-name counterpart, Wellbutrin, although taking them with food has a very different result.) As a result of a Supreme Court ruling in 2011, this exempts generic makers from liability for failure to warn of known hazards.

The new proposal would require generic drug companies to be responsible for monitoring safety data and updating their prescribing information. Because generic drugs now make up over 80 percent of all medications prescribed in the U.S., this new proposal should help patients and physicians become aware of newly discovered safety problems more promptly. 

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About the Author
Terry Graedon, PhD, is a medical anthropologist and co-host of The People’s Pharmacy radio show, co-author of The People’s Pharmacy syndicated newspaper columns and numerous books, and co-founder of The People’s Pharmacy website. Terry taught in the Duke University School of Nursing and was an adjunct assistant professor in the Department of Anthropology. She is a Fellow of the Society of Applied Anthropology. Terry is one of the country's leading authorities on the science behind folk remedies..
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