NEW YORK (MainStreet)—Many people opt for generic drugs over brand-name drugs to save money. In some cases, a brand name drug may not even be on the market, anymore. Either way, these consumers may not be aware that they could be buying trouble down the road.
Many possible risks aren't seen until a drug has been on the market for years. Reglan, for example, a drug used to treat gastrointestinal problems, was first approved in 1979. More than 30 years later, in 2009, it received a black-box warning from the U.S. Food and Drug Administration (FDA) after it was discovered that it could cause tardive dyskinesia, a serious irreversible and disfiguring movement disorder. By that time, more than 2 million people were taking products that contained the drug.
A recent report by the non-profit consumer rights advocacy group Public Citizen shows that at least 53 drugs that were approved by the FDA more than a decade ago have, in the past five years, required new black-box warnings, which alert patients to serious or life-threatening risks. Eleven of those drugs are currently only available as generics.
"Unlike brand-name drug manufacturers, generic drug manufacturers are not able to promptly make changes to the drug label when they become aware of important new safety information, such as new adverse event information," says Michael A. Carome, M.D., director of the Health Research Group at Public Citizen.
Generic drugs made up 80% of all prescriptions filled in 2011, according to the Generic Pharmaceutical Association.
Generic drug labels are required by law to match the label warnings of their brand-name counterparts.
A recent Public Citizen report lists 434 generic drugs without brand-name counterparts still on the market.
Public Citizen says that patients who are harmed by a generic drug that had inadequate labeling cannot sue generic drug manufacturers for injuries as they can with brand name drugs as a result of PLIVA, Inc. v. Mensing, which was decided by the U.S. Supreme Court in 2011. Generic drug manufacturers got further immunity from lawsuits in late June. In a closely watched case, Mutual Pharmaceutical Company v. Bartlett, the U.S. Supreme Court shielded generic drug manufacturers against liability from the design of a drug. The two rulings largely shut the door for consumers to sue generic drug manufacturers for injuries.
"Without such liability risks, there is not incentive for the generic company to conduct aggressive surveillance for new adverse event information that could be used to update the drug label or to reassess whether the risk-benefit ratio of the drug is still favorable," Carome says. "Thus, the FDA's restrictions on labeling revisions by generic drug manufacturers creates a gap that threatens patient health and safety," he says.
Public Citizen is calling for regulatory revisions to help ensure that generic drug labeling provides adequate warnings to patients after post-market risks are discovered. It submitted a citizen petition to the FDA in August 2011.
"The FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances," said an FDA spokesperson, noting there is no information on timing.
--Written by S.Z. Berg, author of College on the Cheap, for MainStreet
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