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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
BIO Letter to HRSA on 340B Rebate Model
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…
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CSBA Letter to Congressional Leadership on…
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BIO Comments to the USPTO’s MAY 10, 2024 Proposed…
BIO submitted these comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting.
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BIO Comments to HHS on Medicare Prescription Payment Plan: Draft Part Two Guidance on Implementation of Section 1860D-2 of the Social Security Act for 2025
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,…
BIO Request for Information to U.S. House Committee on Education and the Workforce on ERISA’s 50th Anniversary: Reforms to Increase Affordability and Quality in Employer-Sponsored Health Coverage
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…
BIO Comments to FDA on their Advanced Manufacturing Technologies Designation Program
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to submit comments regarding the request and comments on the Advanced Manufacturing Technologies Designation Program Draft Guidance.
BIO Comments to FDA on their Draft Report and Plan on Best Practices for 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…
BIO Comments to HHS Centers for Medicare & Medicaid Services’ Draft CY 2025 Part D Redesign Program Instructions
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.
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…