FDA Proposes Generic Drug Makers be Held Accountable for Labeling
The Food and Drug Administration has issued a proposal that generic drug makers be in charge of updating the labels of their products. This comes after years of petitioning by watchdog groups and in response to last week’s 5-4 Supreme Court decision that grants generic drug manufacturers further protection from lawsuits.
Generic Drug Makers Not Held Accountable
The FDA’s proposal responds to last week’s Supreme Court ruling that generic drug companies cannot be sued over harmful effects by any generic drug that has been approved by the FDA. This broadens the protection granted to generic drug makers two years ago which states inadequate labeling of a generic drug is not cause for a lawsuit against the drug maker.
Facts About Generic Drugs
- Currently, generic drugs must only update their label if ordered by the FDA or if a brand name equivalent makes an update.
- According to the Food and Drug Administration, approximately 80% of prescription drugs being filled in the United States considered generic drugs.
- Approximately 434 generic drugs do not have a “comparable brand-name product” on the market.
The FDA hopes to close the “regulatory gap” by holding generic drug makers to the same standards as those with a brand name.
Added Protection for Millions of Americans
“This proposed rule is a classic example of harm reduction, when finalized… it will provide added protection to the tens of millions of people who regularly use generic drugs.” Dr. Sidney Wolfe of Public Citizen
While the Generic Pharmaceutical Association would rather leave the regulation and labeling to the FDA, watchdog groups like the Public Citizen support the new proposal to hold generic drug makers accountable for inadequate labeling after FDA approval as drug makers often become aware of additional health risks after the drug is already on the market.
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