How Fast Should a Generic Drug Maker Update Labeling With new Safety Info? – Pharmalot – WSJ
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Should a generic drug maker be held responsible for failing to immediately update its product labeling to match the equivalent brand-name medicine?
The question has been raised in connection with a lawsuit filed by a consumer who claims she suffered harm because risk information for a generic medicine she was prescribed was allegedly insufficient. But the timeliness of the warning has become a central issue in the case, which U.S. Supreme Court has been asked to review. Moreover, the court asked the U.S. Solicitor General to offer its views.
At stake is yet another contentious effort to interpret federal and state laws governing liability for medicines, a topic that has embroiled the pharmaceutical industry, regulators and the courts for the last several years. And as with a controversial Supreme Court ruling three years ago, the fortunes of the generic drug industry may once again be in play.
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