releases: http://franken.senate.gov/?p=press_release&id=2607
Data license: MIT · Data source: dwillis/congress-press
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| http://franken.senate.gov/?p=press_release&id=2607 | At Urging of Sen. Franken, FDA Proposes Fix to Protect Consumers Relying on Generic Prescriptions | 2013-11-08 | 2013 | 2013-11 | Democrat | House | MN | Al Franken | F000457 | franken.senate.gov | legacy | Today, U.S. Sen. Al Franken (D-Minn.) said he is pleased that the Food and Drug Administration (FDA) has proposed a rule to give manufacturers of generic prescription drugs the ability to update their warning labels to improve consumer safety. Sen. Franken pushed the FDA to take this action and helped author legislation that would make this fix. As a result of the U.S. Supreme Court ruling in Mutual Pharmaceuticals v. Bartlett-involving a New Hampshire woman who became permanently disabled after using an inadequately labeled generic drug-Sen. Franken and several of his colleagues urged the FDA to take action and help prevent consumers from facing serious injuries. You can read Sen. Franken's letter to the FDA here. "A senior in Minnesota may have no idea that a prescription drug they're taking could cause devastating complications, because generic drug manufacturers aren't allowed to update their labels to accurately reflect all side effects or risks," said Sen. Franken. "Last year, I introduced a bill with the help of my colleagues to fix this problem. And today, after our urging, the FDA took a critical step forward to right this wrong. I'll be pushing to get the FDA's labeling fix implemented as soon as possible." Last year, Sen. Franken introduced legislation with his colleagues to protect consumers using generic drugs. The Patient Safety and Generic Labeling Improvement Act was introduced to address another Supreme Court case, PLIVA v. Mensing, which held that patients cannot hold generic drug manufacturers accountable for failure to warn of injuries associated with their products. As a result, consumers who are injured by the generic version of a prescription drug may be foreclosed from seeking any remedy, even though consumers who take the brand-name version of the drug can seek recourse for their injury. | 1 | 2026-03-30T12:14:52Z | 2026-03-30T12:14:52Z |