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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 BIO President & CEO John F. Crowley…
Chairman Cassidy, Ranking Member Sanders, and distinguished Members of the Committee:Thank you for the opportunity to appear before you today on behalf of the Biotechnology Innovation Organization (BIO), which represents more than 1,000…
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BIO Statement on Vaccines and Autism
Phyllis Arthur, EVP, Health Policy and Programs, “Vaccines are one of the most important and effective innovations for the defense of public health. They have saved millions of lives and drastically reduced or eliminated deadly and debilitating…
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BIO's Comments to CDC’s Advisory Committee on…
Re: Docket No. CDC-2025-0454; Advisory Committee on Immunization Practices (ACIP)The Biotechnology Innovation Organization (BIO) is appreciative of the opportunity to provide comments to the Advisory Committee on Immunization Practices (ACIP) in…
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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).
BIO Comments to the U.S. Senate Committee on Health, Education, Labor, and Pensions on Improving and Protecting Access to Gene Therapies
January 22, 2024
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the U.S. Senate Committee on Health, Education, Labor, and Pensions’ (Committee’s) Request for Information on Improving and Protecting Access to Gene Therapies…
BIO Comments to FDA on Enhancing Adoption of Innovative Clinical Trial Approaches (FDA-2023-N-4489)
January 19, 2024
In advance of the Agency's public workshop on Enhancing Adoption of Innovative Clinical Trial Approaches, BIO outlined specific considerations and plans to participate in the workshop.
BIO-ASTA Comments on Movement of Organisms Modified or Produced through Genetic Engineering
January 18, 2024
BIO and the American Seed Trade Association submitted comments on USDA-APHIS' proposed exemptions of five types of genetic modifications a plant can contain and be exempt from regulations for the movement of organisms modified or produced through…