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FDA Proposes New Rule for Safety Warning Labels on Generic Drugs

Separate Guidelines On the Way for Generic Drug Safety Warning Labels

After urging from consumer advocates, the U.S. Food and Drug Administration is on track to issue a new guideline for separate safety warning labels on generic drugs. According to The New York Times, current legislation requires generic drug manufacturers to use the same safety labels as their name-brand counterparts.

Although generic drugs may differ from the brand-name product in certain respects, generic drug makers cannot change their safety labels until the brand and the FDA agree the label should be altered. According to the FDA, the proposed guideline would allow generic drug manufacturers to propose labeling changes as well, creating separate labels for the products. 

Custom Product Labels in the Works for Increased Safety
The New York Times reported the custom product labels will help consumers receive compensation if they have experienced adverse side effects after taking generic drugs. Under the current system, consumer lawsuits are dismissed.

Dr. Sidney Wolfe, senior advisor to the Health Research Group at Public Citizen, told the newspaper the new rule would aid consumers in receiving reparation for injuries caused by the drugs. 

"It's common sense," Wolfe said. "It will obviously end this situation where people are being harmed physically and yet, although they are harmed, they have no right to go into court and get redress for serious damages."