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FDA proposal could hold generic drug makers liable in health risk suits

A generic photo of prescription drugs taken March 20, 2009.
A generic photo of prescription drugs taken March 20, 2009.

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A new proposal from the FDA may require generic drug makers to update the labeling and health risks on their packaging as new information becomes available. Currently, generic companies rely on brand name versions of their drugs to update consumers on relevant new health information and are not allowed to update their own labels right away.

Because generic companies have had less responsibility to to provide information about health risks associated with their drugs, the Supreme Court ruled in 2011 and 2013 that businesses that make generic pharmaceuticals aren’t legally liable for injuries sustained after using generic medications.

Consumer advocates argue that this leaves consumers who take generic medication without legal recourse. The FDA’s new proposal would level the playing field, but the Generic Pharmaceutical Association is skeptical -- according to a study they sponsored, the proposed requirements would inflate the cost of generic drugs by $4 billion, pricing some generic drug makers out of the market and raising prices.

Should generic drug companies be held to the same standards as brand name groups? What kinds of legal protections should consumers have when it comes to generic medication?


Allison Zieve, Director, Public Citizen Litigation Group where she focuses on public health litigation, regulatory law, open government, the First Amendment and more; Public Citizen is a nonprofit advocacy group that focuses on citizen rights and consumer safety; Zieve will testify on this issue before Congressional lawmakers

Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association

Planned testimony from the Generic Pharmaceutical Association and Public Citizen available here