New FDA Proposed Rule May Provide Better Drug Safety in the US

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The American Association of Justice (AAJ) recently announced their support of the US Food and Drug Administration’s (FDA) proposed rule to allow generic drug manufacturers to independently update their warning labels.

Currently, generic drug manufacturers cannot independently update their warning labels, even when new side effects are known. This creates two systems: one for patients who use name-brand drugs and one for patients who use the generic. As a result, thousands of Americans have had their court cases dismissed merely because they took the generic version of a drug.

The FDA’s new rulemaking would allow generic drug manufacturers to update their warning labels using the same process that brand name drug companies currently use. Since the FDA proposed this rule in November of last year, 20,500 consumers have called on the FDA to enact this rule through an online petition.

Sponsored by Koonz, McKenney, Johnson, DePaolis & Lightfoot, LLP, serving clients in Washington DC, Maryland and Virginia.