Leahy Introduces Generic Drug Label Legislation

The measure, which was introduced in the Senate and has a House companion, would permit generic drug companies to update safety information about the drugs they manufacture, enabling patients to sue the companies for failing to issue warnings about risks. It aims to address a gap in the law that allows people to sue brand-name drug makers for insufficient warnings, but not generics manufacturers.

The New York Times: Bills Seek To Change Rule On Generic Drug Labels
Democrats in the Senate and House introduced companion bills Wednesday that would permit generic drug companies to update warning information about the drugs they manufacture, a change that could allow patients to sue the companies for failing to warn about the risks of taking their drugs (Thomas, 4/18).

CQ HealthBeat: Leahy Offers Bill To Ease Recovery Of Damages From Generic Drugmakers
Sen. Patrick J. Leahy announced Wednesday that he has introduced legislation to ensure that generic drugmakers can add safety information for their products to the prescribing instructions doctors receive. The legislation aims to address a gap in the law that allows consumers to sue brand name drug manufacturers for the failure to warn consumers against hazards but not the maker of the generic equivalents. The U.S. Supreme Court held in a 2011 ruling, Pliva v. Mansing, that generic drug makers cannot be held liable under state tort law for failure to warn consumers about drug hazards even if they know their labeling is inadequate, Leahy noted (Reichard, 4/18).

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