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Congressional Hearing on Proposed FDA Rule Change


Yesterday afternoon, Congress’s Subcommittee on Health held a hearing to examine the FDA’s proposal to change the rules of generic drug labeling.

Under the current law, enacted in 1984, warning labels for particular drug formulations are created by the brand-name manufacturers, and generic manufacturers are legally prevented from altering them. This is fine so long as the original manufacturer updates the label; however, these companies typically stop active marketing of their product once generic versions enter the market. Once the original producer stops marketing, they are no longer responsible for updating the label. When the brand-name manufacturer is not obligated to update the label, and the generic manufacturers are legally prevented from doing so, the result is a label that fails to reflect any new risks or side-effects that come to light.


80% of all filled prescriptions in the United States are generic.

Another consequence of the current law is that, according to a 2011 ruling by the Supreme Court, the makers of generic drugs cannot be held liable for failing to warn consumers of these new dangers. When brand-name manufacturers fail to warn patients, they can be sued to compensate patients for the injuries their products have caused. However, when a patient is harmed by the generic version of a drug, they can sue neither the brand-name nor the generic manufacturers. These patients, sometimes suffering from debilitating injuries, have no recourse to seek justice under our legal system.

The FDA’s proposed rule change would authorize generic drug manufacturers to update the warning labels and keep patients informed. Generic manufacturers oppose the rule, as they do not wish to become liable for the drugs they copy. They argue that being open to lawsuits will drive up their costs, and that generic labels that differ from the original will cause confusion for consumers.

In my legal practice I represent dozens of individuals who have had the misfortune of being seriously hurt by generic versions of prescription drugs. In the case of one generic drug meant to treat gastroesophageal reflux, the label had not been updated since the original manufacturer stopped promoting the drug in the early 1970s. If the generic drug makers would have been permitted to update the warning label as information developed over time about the significantly increased risk of drug-induced movement disorders, I believe that most of my clients would have never have been prescribed the medication and would not have suffered the catastrophic injuries that they now face today.

I applaud the FDA for their proposal, and I am hopeful that Congress will see the common sense of these changes that will result in safer drugs, greater accountability of generic drug manufacturers, and justice for injured patients

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