US Pharm. 2016;41(6):10.
Silver Spring, MD—The FDA has decided to delay until next year a decision about whether to require generic drug manufacturers to update warning labels to reflect new risks. In 2011, the Supreme Court ruled that generic drug manufacturers could not be held liable for failing to warn patients about the risks of their products because they had no control over warning label content. However, in 2013, the FDA proposed changing the rules to create parity between brand and generic drug manufacturers for how they update their labels, exposing generic companies to legal liability. This postponement has dismayed consumer groups, but the Generic Pharmaceutical Association said they were pleased with the FDA’s careful approach.
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