Who Is Now Responsible for Discovering and Warning About Adverse Effects of Generic Drugs?

Changes to drug warnings are needed to assure that patients are protected from adverse effects of generic drugs.

The Issue:
Generic drugs account for 80 percent of U.S. prescriptions but, because of their lower cost, just 20 percent of drug spending. Generics and brand-name drugs also are distinctive legally.

These key findings show some issues that were involved in three recent Supreme Court cases.

Key Findings

  • Brand-name drug manufacturers are responsible for monitoring adverse effects and updating labels or be subject to substantial fines.

  • Generic manufacturers must use the same warnings that are approved for their identical brand drug, even if the brand has been neglected and new adverse effects are known.

  • To help address this discrepancy, the Food and Drug Administration (FDA) intends to propose a rule that would allow generics to update safety information.

Next Steps:
An independent organization (and mechanism to fund it) could provide systematic adverse-effects data to the FDA, which could then decide whether generic drug labels need to be adjusted or, in extreme cases, drugs taken off the market.

About the Study:
The Supreme Court decisions cited in this “Viewpoint” article are Wyeth v Levine (2009), PLIVA v Mensing (2011), and Mutual Pharmaceutical Co. v Bartlett (2013).