FDA To Revisit Rule Blocking Lawsuits Against Generic Drug Makers

The U.S. Food & Drug Administration has indicated it might allow generic drug manufacturers to revise their products’ safety labels independent of their name brand counterparts. If this change is made, consumers harmed by generic drugs would be able to enforce their legal rights and hold drug manufacturers accountable for their injuries.

Currently, lawsuits against generic drug manufacturers are blocked as a result of the Plivia v Mensing Supreme Court Decision two years ago. The decision stated generic manufacturers of known dangerous drugs cannot be held accountable for injuries suffered by their products because, by law, they are required to have the same label as their name brand name counterparts.

As a result, thousands of people injured by dangerous and defective generic drugs have been unable to pursue litigation against the generic drug companies. Meanwhile, individuals who took the name brand version of the drug have been able to seek compensation for the same injuries.

I applaud the FDA’s decision to revisit the ruling. I’ve seen thousands of people go without justice because they were injured by a generic drug. The current law is unfair to those injured by generic drug manufacturers and it is encouraging to see the FDA taking responsibility to change it.

The proposed rule revision will be posted in September and open for public comment. It needs to include the steps necessary to ensure all drug makers be held to the same reporting standards. All pharmaceutical companies should be allowed to update their warning labels. Doing this will restore the original intent of the FDA label requirements to keep consumers safe and ensure everyone receives fair treatment within the court system.

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