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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April 11, 2024
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…
April 1, 2024
In response to the 340B Request for Information issued by the Senate 340B Bipartisan Working Group, BIO submits detailed comments.
March 16, 2024
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the Center for Medicare and Medicaid Services’ (CMS’s/the Agency’s) Medicare Prescription Payment Plan: Draft Part Two Guidance on Select Topics,…
March 15, 2024
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the U.S. Committee on Education and the Workforce’s (Committee’s) Request for Information on Reforms to Increase Affordability and Quality in Employer…
March 12, 2024
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding the request and comments on the Advanced Manufacturing Technologies Designation Program Draft Guidance.
March 4, 2024
The Biotechnology Innovation Organization thanks the Food and Drug Administration for the opportunity to submit comments regarding the request for information and comments on the Food and Drug Administration's Draft Report and Plan on Best Practices…
March 1, 2024
We are writing on behalf of the Biotechnology Innovation Organization (BIO) to provide comments on the Centers for Medicare & Medicaid Services’ Draft CY 2025 Part D Redesign Program Instructions.
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).
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…
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…