FDA Wants Generic Drugs To Disclose Health Risks
ByThe makers of generic aspirin and other drugs are fighting a regulation proposed by the Food and Drug Administration that would require them to warn patients of all known health risks, The Los Angeles Times reported.
The proposed federal rule would close a legal loophole and allow patients to sue generic drug makers by requiring them to warn patients of all the known risks of the products they sell. Currently, only brand names have to disclose that information, The Los Angeles Times reported.
"In the current marketplace, approximately 80% of drugs dispensed are generic drugs," the agency said according to The Los Angeles Times. "Accordingly, there is a need for [generic drug producers] to able to independently update product labeling to reflect certain newly acquired safety information."
Ralph Neas, president of the Generic Pharmaceutical Association - an industry trade group - released a statement saying the rule change would be "nothing short of catastrophic," and could raise healthcare costs and "create dangerous confusion" for doctors and patients.
"Flooding the marketplace with multiple versions of labels for the same medicines would not only seriously jeopardize patient safety, but also would burden consumers, taxpayers, large and small businesses, and state and federal governments with billions of dollars in increased costs for generic medicines," Neas said.
The Los Angeles Times reported that closing a legal loophole created by a Supreme Court ruling that drew a sharp distinction between brand-name drugs and lower-cost drugs is the reason for the proposed federal regulation.
In 2009, the high court ruled that brand name drug makers could be sued if they failed to warn patients that a product carried a serious potential health risk, but "flipped," when faced with a similar case involving a generic drug last year.
The rule shielded generic drug makers from lawsuits from patients.