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FDA Pushing for More Information Disclosure on Generic Drugs

Updated: 02/18/2014 2:02 PM
Created: 02/18/2014 6:15 AM KSTP.com
By: Megan Stewart

Generic drug companies are fighting back against the Food and Drug Administration.

For the first time, the FDA wants all drugmakers to warn patients of all known health risks of the generic drugs they sell. Currently, only brand names have to disclose that information.

The FDA would enforce this by requiring generic drugmakers to update warning labels when problems not previously known arise.

But the president of the Generic Pharmaceutical Association says the new rule would raise costs. He also said it could "create dangerous confusion" for patients and doctors.

Previous Supreme Court rulings created a loop-hole for generic drugmakers by distinguishing a difference between brand-name drugs and lower-cost generics.

The high court ruled in 2009 that drugmakers could be sued if they did not warn patients that a drug caused health problems, but they also ruled in a later case that this did not apply to generic drugs.

A chemist
Photo: Generic Pharmaceutical Association

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