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Letters, Testimony & Comments

BIO submits letters, testimony, and comments to government and regulatory bodies throughout the United States and around the world.

Featured Letters, Testimony, & Comments
Testimony of John F. Crowley President and CEO,…
Chairman Griffith, Chairman Guthrie, Ranking Member DeGette, Ranking Member Pallone, and distinguished members of the subcommittee, thank you for the opportunity to appear before you today on behalf of the Biotechnology Innovation Organization (BIO)…
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CSBA Letter to Congressional Leaders on PBM, PPRV…
Dear Congressional Leaders:On behalf of the Council of State Bioscience Associations (CSBA)—a national coalition of independent, state and territory-based organizations representing the full breadth of America’s biotechnology ecosystem—we write to…
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BIO's Comments on Advisory Committee on…
Re: Docket No. CDC-2025-0783; Advisory Committee on Immunization Practices (ACIP) MeetingDear Dr. Zadeh and Members of the ACIP:The Biotechnology Innovation Organization (BIO) appreciates the opportunity to provide comments to the Advisory Committee…
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BIO Statement for the Record: House Ways & Means Subcommittee on Health hearing on Examining Policies that Inhibit Innovation and Patient Access
May 10, 2023
BIO’s comments focus on two areas that threaten patient access to innovative medicines in Medicare: (1) the anti-innovation policies enacted as part of the Inflation Reduction Act, and (2) government policies that that are blocking patient access to…
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…
BIO - USITC Investigation - COVID-19 TRIPS Waiver - Post hearing Supplementary Submission
May 5, 2023
In this Post-hearing Supplementary Written Submission, BIO submits detailed comments to support the USITC investigation into the proposed WTO IP Waiver for COVID-19 therapeutics.
BIO Summary of Comments to USITC on COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities (ITC Investigation No. 332-596)
May 5, 2023
In this Post-hearing Supplementary Written Submission, BIO submits a 500-word summary of our position on the USITC investigation into the proposed WTO IP Waiver for COVID-19 therapeutics.
BIO Comments to FDA (No. FDA–2022-D-2983) Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products
May 2, 2023
BIO submitted comments and recommendations to FDA on their Draft Guidance on Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.
BIO Comments to FDA–2023-N-0487: Discussion Paper: Artificial Intelligence in Drug Manufacturing
May 1, 2023
In these comments to FDA, BIO supports FDA’s efforts to improve future guidance related to Artificial Intelligence in Drug Manufacturing and outlines recommendations for FDA’s review and further consideration.
BIO Statement for House Financial Services Subcommittee on Capital Markets Hearing: “A Roadmap for Growth: Reforms to Encourage Capital Formation and Investment Opportunities for All Americans”
April 23, 2023
BIO’s Chief Advocacy Officer Nick Shipley presents comments to the Committee as it considers reforms to encourage capital formation and investment opportunities for all Americans.
CSBA Comments to Centers for Medicare & Medicaid Services (CMS) on Medicare Drug Price Negotiation Program: Initial Memorandum, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2026
April 14, 2023
The CSBA Board of Directors endorses BIO’s formal comments on the Medicare Drug Price Negotiation Program, which are appended to this letter.  
BIO Comments to Centers for Medicare & Medicaid Services (CMS) on Medicare Drug Price Negotiation Program: Initial Memorandum, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2026
April 14, 2023
BIO comments on the initial guidance regarding the Drug Price Negotiation Program (Negotiation Program) under the Inflation Reduction Act of 2022 issued by CMS on March 15, 2023 (Initial Guidance)
BIO COMMENT LETTER OMB Race and Ethnicity OMB 2023
April 12, 2023
BIO provided detailed comments to the Office of Management and Budget (OMB) regarding the Initial Proposals For Updating OMB’s Race and Ethnicity Statistical Standards.