This bill increases transparency in the generic drug approval process by requiring the Food and Drug Administration to provide more detailed information to companies developing generic drugs. Specifically, when a generic drug manufacturer asks, the FDA must tell them whether their proposed drug has the same active and inactive ingredients in the same amounts as the original brand-name drug. If the drugs don't match, the FDA must identify which ingredient or ingredients are different and specify the amount of any deviation. The bill protects brand-name drug makers' trade secrets by preventing the FDA from disclosing detailed formulation information, while still helping generic manufacturers understand approval requirements. The FDA must issue guidance within one year on how it will make these comparisons, and the requirements take effect immediately upon enactment rather than waiting for the guidance to be finalized. The bill has no specific funding allocated and was introduced by Senators Hassan, Paul, Hickenlooper, and Lee in April 2025.
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