Keeping you updated on the latest Medicare and Part D news

FDA Labeling Proposal to Increase Generic Drug Safety

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Currently, only brand name drug manufacturers can change labels, while generic drugs must carry the same warning labels as their brand name counterparts. Earlier this year, and in 2011, the Supreme Court heard cases in which defendants were suing generic drug manufacturers for adverse side effects. The Court ruled that generic drug manufacturers could not be sued under state law because the superseding federal law already approved the generic drug and its label.  Essentially, unless the generic manufacturer has introduced new problems into the drug, it is not liable for inadequate safety labels. Critics of the decision argued that it disincentives generic drug manufacturers to monitor the safety of their products and warn consumers since only brand name manufacturers can be held accountable. This presents an especially frightening situation given that generic companies sell over 80% of the prescription drugs in the nation.

Last month, the FDA proposed allowing generic drug manufacturers to change drug labels through the same process followed by brand name manufacturers. The proposal will undergo a 60-day commenting period, and if finalized, could be an important step towards increasing the responsibility and legal liability of the generic drugs industry.


Supreme Court Decision

12/18/2013: The FDA extended the commenting period for this proposal by an additional 60 days- read more.


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