Patient, consumer advocates call on FDA to restore generic drug manufacturer accountability

 – National Consumers League

November 5, 2013

Contact: NCL Communications, Ben Klein (202) 835-3323,

Washington, DC – Generic drugs account for more than 80 percent of all prescriptions filled in the United States, but generic manufacturers are not required to warn consumers about safety issues of the drugs they produce. A group of 15 patient and consumer advocates have sent a letter to Margaret Hamburg, M.D.,
Commissioner of the U.S. Food and Drug Administration (FDA), applauding the
 FDA’s announcement to revise its regulations to allow generic drug manufacturers to independently update their drug safety labels and to restore Americans’ right to quality drug safety information.

Due to a 2011 United States Supreme Court decision, Pliva v. Mensing, generic drug makers cannot be held legally accountable when they fail to adequately warn patients about the risk of their drugs. Patients who take generic drugs have their rights limited and justice denied, while patients who take brand name drugs do not.

“We believe it is critically important that all prescription drugs carry current and adequate safety warnings,” the groups (see list below) state in their letter. “Allowing generic drug manufacturers to update safety labeling is vital to ensuring that the public remains appropriately informed of drugs’ risks and benefits.”

The groups’ letter encourages the FDA to address this safety issue as quickly as possible and implement the new regulations to help diminish the risk that inadequately labeled generic drugs currently pose to consumers. Prescription medication can only be safe and effective if all manufacturers remain attentive to potential health hazards and accountable for warning patients of new potential risks.

Sally Greenberg, Executive Director of the National Consumers League, said, “NCL joins with other like-minded organizations in urging the FDA to level the playing field by allowing generic manufacturers to initiate changes to the safety warnings that appear on the labels of their prescription medication. All manufacturers, generic and brand, must be treated the same for the sake of patient safety and consumers must be warned about all potential risks.“

Cynthia Pearson, Executive Director of the National Women’s Health Network. “Women need to be warned of safety problems with a drug regardless of whether they take the brand name or generic version. We applaud the FDA for taking action to protect consumers.”

Signers of the letter include: AARP, Alpha-1 Association, Alpha-1
Foundation, American Autoimmune Related Diseases Association, Breast Cancer Action, COPD Foundation, Lupus Foundation of America, National Consumers League, National Eczema Association, National Multiple Sclerosis Society, National Psoriasis Foundation, National Women’s Health Network, Prevent Blindness America, Public Justice, P.C. and the Sjogren’s Syndrome Foundation.

To read the full letter, click here.


About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit