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
Biotech Companies Express Concern With Proposed…
We, the undersigned, are writing to express our strong concern with a proposed update to the Medicaid Drug Rebate Program. If finalized in its current form, the proposed rule (CMS-2434-P) would impose significant costs to the government and industry…
BIO Statement to the Senate 340B Bipartisan…
In response to the 340B Request for Information issued by the Senate 340B Bipartisan Working Group, BIO submits detailed comments.
BIO Comments to the U.S. Senate Committee on…
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…
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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. 
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…
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…
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…
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)
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)  
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).
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…
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.
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…