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U.S. Court of Appeals for the Second Circuit

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Second Circuit holds that manufacturers are not prohibited from adding supplemental warnings to drug labels under the Pregnancy Warning Regulation

July 13, 2026

Opinion

U.S. Chamber files amicus brief urging Second Circuit to hold that plaintiffs’ state-law claims are preempted by federal law, which does not permit state-by-state supplemental pregnancy warnings on over the counter drug labels that must include the FDA’s general pregnancy warning

November 14, 2024

U.S. Chamber Amicus Brief

Joshua J. Fougere and Madeleine Joseph of Sidley Austin LLP served as outside counsel.

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