Leahy Welcomes News That The FDA Will Move Forward With Proposed Rulemaking To Protect Consumers Using Generic Drugs

WASHINGTON – Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.) on Wednesday welcomed news that the Food and Drug Administration (FDA) will move forward with a Notice of Proposed Rulemaking to ensure that generic manufacturers of prescription drugs can update their warning labels to provide better  patient safety information to consumers.

Leahy has long championed this public safety issue, following two Supreme Court cases in which patients who were injured by a prescription drug were unable to seek relief from the drug manufacturer because they took the generic version of the drug.  Last month, Leahy joined with Senate HELP Committee Chairman Tom Harkin (D-Iowa) and Representatives Chris Van Hollen (D-Md.), Henry Waxman (D-Calif.), and other lawmakers in a letter to the FDA urging action in light of the Supreme Court’s recent decision in Mutual Pharmaceuticals v. Bartlett, involving a New Hampshire woman who received devastating injuries after taking the generic version of an anti-inflammatory drug.  Leahy, Harkin and Sen. Al Franken (D-Minn.) sent a similar letter in 2012.  Leahy also introduced related legislation last year.

“A consumer should not have her rights foreclosed simply because she takes the generic version of a prescription drug,” Leahy said.  “I welcome this first step by the Food and Drug Administration to address this troubling inconsistency in the law.  Responsible brand-name and generic manufacturers alike should have the ability, and the obligation, to give doctors and patients the information they need to avoid injuries.” 


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