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FDA Delays Rule on Generic Drug Labels Until 2017

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The Food and Drug Administration (FDA) has again delayed a decision on whether generic drug makers will be held responsible for warning patients about the risks of their medications. This comes as a disappointment to trial lawyers and consumer groups who want to eliminate the legal loophole which prevents patients from suing generic drug manufacturers for dangerous generic drugs.

The majority of prescription drugs dispensed in the U.S. are generic drugs, and the companies that market them are not subject to the same warning label rules as their name brand counterparts. To get a generic drug approved for sale in the U.S., the generic drug manufacturer must prove that their generic is chemically identical to the name brand, and the label on the generic drug is identical to the one on the name brand drug. Generic drug manufacturers are not required to do any testing on the drug or update the use, safety and warning information as new medical and scientific information is learned unless the brand name drug manufacturer first updates the label information.

This regulatory scheme creates very serious health dangers to consumers using generic drugs.  First, if the brand name drug is defective, then the generic equivalent is also defective, but most courts hold that only the name brand drug manufacturer can be sued and held responsible. So, the patients taking the generic equivalents have no lawsuit when harmed by the defective generic.

Second, when a brand name drug is no longer made and sold, the brand name drug company is no longer responsible for researching and updating safety information. This means that if the drug is still available as a generic only, there is no company doing the research and updating the safety information. So if new dangers about the drug are learned, this information is not provided to the consumer by any manufacturer.

The FDA’s decision is troubling. Dr. Michael Carome, speaking as director of the Public Citizen’s Health Research Group, said, “The F.D.A. is plainly bowing to industry pressure and, in the process, prioritizing industry profits over patient health and safety.” Dr. Carome is one of many consumer advocates who had hoped the FDA would fix this safety and accountability gap.

Generic drug manufacturers object to a change in the industry standard, saying that it would create confusion as equivalent drugs could have different warning labels. Manufacturers have proposed an alternative in which the FDA would be responsible for making decisions regarding label changes. However, consumer advocates have pointed out that the agency does not test drugs and does not have the resources to monitor new developments in drug safety information.

Please join Cory Watson Attorneys in supporting safer drug labeling.

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