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BIO Members Letter to Congress Re R&D Amortization

May 5, 2023

The Biotechnology Innovation Organization (BIO) and BIO members urge immediate legislative action to repeal the harmful R&D amortization provision that went into effect in 2022 and urge Congress to swiftly pass S. 866/H.R. 2673, also known as the American Innovation and Jobs Act in the Senate and the American Innovation and R&D Competitiveness Act in the House.

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In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.
BIO joined with more than 40 groups in calling on Congress to set 2024 funding for the U.S. Codex Office at or above the 2023 level. 
BIO’s comments support accelerated approval as an important regulatory pathway that allows patients with serious and life-threatening illnesses such as cancer to have earlier access to promising therapies.