National Association of Attorneys General
Attorneys General Support Federal Legislation Giving Generic Drug Makers the Ability to Correct Label Warnings
Washington, DC---The National Association of Attorneys General (NAAG) supports U.S. Senate bill, “Patient Safety and Generic Labeling Improvement Act” (S.2295) that would give generic drug manufacturers the same ability to correct label warnings as brand-name manufacturers. The legislation would overturn a 2011 U.S. Supreme Court decision, in PLIVA, Inc. v. Mensing, which held that state laws requiring generic manufacturers to adequately warn consumers of dangerous side effects are preempted because current federal law permits only brand-name manufacturers to independently change label warnings. The adverse consequences of this decision are magnified by the fact that over 70 percent of U.S. prescriptions are filled with generic drugs.
“Consumers whose prescriptions happen to be filled with the brand-name version of a drug are protected by state law from inadequate warnings, but consumers whose pharmacists fill their prescriptions with the generic versions are now denied this protection,” reads the May 11NAAG letter signed by 41 state and territorial Attorneys General and sent to bill sponsors Sens. Patrick Leahy and Al Franken. “…Congress can readily cure this problem by amending federal law.”
A copy of the NAAG letter can be found here: http://www.naag.org/sign-on_archive.php
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The National Association of Attorneys General (NAAG), www.naag.org, was founded in 1907 to help Attorneys General fulfill the responsibilities of their office and to assist in the delivery of high quality legal services to the states and territorial jurisdictions.