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Bill gives generic drug makers ability to alter safety information

Filed April 19th, 2012 Laurie

Several Democrats in Congress are set to introduce legislation allowing generic prescription drug makers to update their own safety labels when they find studies suggesting they carry certain risks of serious side effects.

Currently, the makers of generic prescription drugs are barred from updating the safety labels on their drugs, hamstrung by the makers of the brand-name version, which must apply to the Food and Drug Administration to do so. Even if a generic drug maker is well aware of the dangers of their drug, they are unable to force any action and compel the maker of the name brand drug to change its label.

This limitation makes them almost indefensible if a person taking the drug suffers an unexpected side effect, one not mentioned on any safety information.

According to, several Democrats in Congress have drafted the Patient Safety and Generic Labeling Improvement Act that would allow generic drug makers to alter safety labels through the same process as name-brand makers. The legislation is lead by Reps. Chris Van Hollen (D-Md.), and Bruce Braley (D-Iowa) in the House, and Sens. Patrick Leahy (D-Vt.), Jeff Bingaman (D-N.M.), Richard Blumenthal (D-Conn.), Sherrod Brown (D-Ohio), Christopher Coons (D-Del.), Al Franken (D-Minn.), and Sheldon Whitehouse (D-R.I.).

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