A proposed rule that would allow generic drug companies to quickly update safety labeling without FDA approval is under consideration by the agency and stakeholders, with a decision due in early Fall 2015. The FDA rule essentially amends their current regulations by allowing generic drug companies to have the same power to quickly update safety labeling as brand name drug companies already have the power to do. Although under federal law, generic drugs must have the basically the same labeling as their branded counterparts, the 2011 Pliva v. Mensing decision remains a point of contention for the industry. In that case, the U.S. Supreme Court concluded that a generic company cannot be found liable when its labeling fails to include warnings about an adverse event, as long as the label matches brand name labeling – even if a company is aware of potential problems. The Generic Pharmaceutical Association is arguing for an entirely different solution, saying that both their members and brand name companies should need to secure FDA approval for label updates. It is unclear how rapidly updating labeling and additional FDA approvals could affect rising generic drug prices.
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