Generic Drugs

Nearly 80 percent of all prescriptions in the U.S. are filled with the generic version of a drug.  The price tag can be appealing to consumers and health care providers, but taking a generic drug can also have dangerous consequences because patients who take generics inadvertently give up their right to justice.

Accountability is the key incentive to ensure drug companies monitor and adequately warn patients about the safety of drugs.  Despite what many may think, the FDA does not test drugs, but instead relies on testing provided by the drug companies.  Thus FDA approval of a drug does not guarantee its safety.  Until recently, patients were protected because manufacturers knew if they failed to warn the public about harmful and deadly side-effects, they could be held accountable in court.  

However, a recent U.S. Supreme Court decision took away access to justice for patients who take generic drugs and left millions at risk of injury from undisclosed, dangerous side-effects.

The Court held that, unlike name-brand manufacturers, generic manufacturers are not responsible for updating the labels on the drugs they sell and cannot be held accountable in court for failing to warn consumers about side-effects – even if it can be proven that the manufacturer knew the drugs were dangerous and patients could die.  This means generic drug manufacturers no longer have an incentive to monitor side-effects and disclose newly discovered risks of the drugs they sell.  

This ruling created 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 instead of the brand name drug.  

The Facts

  • Generic drug corporations are off the hook from legal accountability due to the U.S. Supreme Court case Pliva v. Mensing.  [U.S. Supreme Court]
  • Nearly 80 percent of all prescriptions in the U.S. are filled with the generic version of a drug.  [U.S. Food and Drug Administration]
  • Half of all black box warnings on drugs introduced after 1975 were added after the drug had received FDA approval and been on the market for seven years.  [The Journal of American Medical Association]

Federal Legislation

The Patient Safety and Generic Labeling Act (S.2295 / H.R.4384), as considered in the 112th Congress, would fix the current discrepancy between holding generic and brand name manufacturers accountable for the safety of their drugs.

This legislation would amend U.S. Food and Drug Administration (FDA) regulations to allow generic manufacturers to make changes to their labels to reflect current health and safety information. 

This would ensure that brand and generic manufacturers have the same responsibility to adequately warn the public of their drugs’ risks.

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