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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 Comments to HHS on Advance Notice of Methodological Changes for Calendar Year (CY) 2025 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (Docket CMS-2024-0006)
March 1, 2024
CMS proposes updates to the RxHCC to reflect the impact of the new 2025 Part D benefit structure per the Inflation Reduction Act (IRA).
Biotech Companies Urge Congress to Pass Bipartisan ORPHAN Cures Act
February 26, 2024
We are writing to express our strong support for the bipartisan Optimizing Research Progress Hope and New Cures (ORPHAN Cures Act). The legislation, which was introduced by Reps. John Joyce (R-PA) and Wiley Nickel (D-NC) in September,1 corrects a…
Joint statement from pharmaceutical trade bodies on the WTO TRIPS Waiver and upcoming WTO 13th Ministerial Conference
February 23, 2024
The meeting of global trade ministers at the World Trade Organization’s 13th Ministerial Conference in Abu Dhabi offers an important opportunity to build on and strengthen the open and rules-based international trading system to support better…
Congressional Letter on use of Bayh-Dole Act to Control Drug Prices
February 22, 2024
A letter signed by 28 members of Congress urging President Biden to reconsider a NIST proposal to use the Bayh-Dole Act to "march in," weaken patents and exert federal control over prescription drug prices. 
Joint letter to Secretary of State Blinken, Commerce Secretary Raimondo, USTR Ambassador Tai and White House Chief of Staff Jeffrey Zients on the WTO TRIPS Waiver and upcoming WTO 13th Ministerial Conference
February 21, 2024
The companies and workers represented by the undersigned organizations stepped up to combat the COVID-19 pandemic, investing in and creating hundreds of partnerships at an unprecedented speed and scale to leverage U.S. innovation and manufacturing…
Comments to Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights
February 7, 2024
On behalf of its member companies and organizations, the Biotechnology Innovation Organization (“BIO”) extends its appreciation to NIST for considering these comments in response to the agency’s Draft Interagency Guidance Framework for Considering…
BIO Comments to Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (NIST–2023–0008), 88 Fed. Reg. 85593
February 7, 2024
On behalf of its member companies and organizations, the Biotechnology Innovation Organization (“BIO”) extends its appreciation to NIST for considering these comments in response to the agency’s Draft Interagency Guidance Framework for Considering…
BIO Comment - USPTO FRN on WIPO IGC DIPCON
January 30, 2024
BIO provides comments to the Office of Policy and International Affairs, U. S. Patent and Trademark Office (Docket ID: PTO-C-2023-0019)
BIO Comments to USTR as part of the 2024 Special 301 Review, Highlighting Global IP Challenges Around the World
January 30, 2024
BIO provides detailed comments to USTR RE: 2024 Special 301 Review: Identification of Countries under Section 182 of the Trade Act of 1974 (Docket ID: USTR-2023-0014)  
BIO Comments to FDA on their Workshop to Enhance Clinical Study Diversity
January 29, 2024
Following the FDA Workshop to Enhance Clinical Study Diversity on November 29-30, 2023, BIO submits specific comments per the request for information (FDA-2023-N-2462).