FDA Rule Could Allow Suits Against Generic Drug Makers

On July 3, 2013, the New York Times published an article commenting on the recent announcement from the U.S. Food and Drug Administration (FDA).The FDA is considering publishing a new proposed rule which would allow the generic drug manufacturers to change a generic drug’s label without the necessity of the name brand drug doing so first.  Currently, generic drug manufacturers are barred from during this by FDA rule.  

This announcement comes on the heels of several U.S. Supreme Court rulings in the past several years barring individuals from bringing certain claims against generic drug manufacturers.  The U.S. Supreme Court has issued opinions that prevent injured individuals from suing generic drug manufacturers for failing to warn about the adverse reactions and side effects of a generic drug and for design defects in a generic drug.  The Supreme Court’s rulings have relied on the FDA regulations which bar a general drug manufacturer from unilaterally changing the warning label or the design of a generic drug.  The FDA’s rules currently require a generic drug manufacturer to manufacture the generic version of the drug with the same formulation, dosage and administration method as the name brand version.  The FDA rules also require the warning label on the generic drug to mirror the name brand drug’s warning label. As a result, the Supreme Court has stated that the generic drug manufacturer cannot be held liable for a failure to change the drug’s design or warning label.

This proposed rule, assuming it was put into effect, may allow consumers to bring lawsuits against generic drug manufacturers for failure to warn of adverse events and side effects.  According to the article, consumer advocates and attorneys who have represented patients negatively affected by generic drugs are encouraged by the FDA’s plans to propose such a rule. The FDA has indicated its intention to publish the proposed rule in September, 2013 for public comment.

See the New York Times article at:

See the F.D.A.’s proposed rule regarding generic drug labeling:


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