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…
CSBA Letter to Congressional Leadership on…
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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April 28, 2022
BIO supports public policies centered on innovation to incentivize the adoption of cutting-edge technologies and practices and benefit rural economies. Further, it is crucial that the government establishes risk-proportionate, transparent…
April 28, 2022
The Biotechnology Innovation Organization (BIO) is the largest biotechnology trade association, representing approximately 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United…
April 28, 2022
BIO represents 1,000 members in a biotech ecosystem with a central mission – to advance public policy that supports a wide range of companies and academic research centers that are working to apply biology and technology in the energy, agriculture,…
April 28, 2022
The Biotechnology Innovation Organization (BIO) is the largest biotechnology trade association, representing approximately 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United…
April 27, 2022
On Wednesday, April 27th, BIO submitted comments regarding an upcoming meeting of ODAC’s Pediatric Oncology Subcommittee on PREA Waivers for Same-in-Class Drugs. In particular, the subcommittee will meet to discuss the development of a conceptual…
April 26, 2022
As a diverse set of stakeholders dedicated to building a cleaner, more resilient aviation industry, we write today to urge your committees to prioritize funding for federal programs that will help develop and scale up the sustainable aviation fuel …
April 22, 2022
As a broad coalition of aviation industry stakeholders—including passenger and cargo carriers, clean fuel producers, engine and aircraft manufacturers, labor unions, airports, business and general aviation, airline passengers, trade…
April 21, 2022
The Biotechnology Innovation Organization (BIO) welcomes the opportunity to provide comments on the proposed Rules for the Implementation of Regulations on Management of Human Genetic Resources (HGR). BIO acknowledges the efforts of the Division of…
April 19, 2022
The farmers, cooperatives, researchers, retailers, seed producers, scientists, and technology developers represented by the organizations below write to express our strong support for the inclusion of language in the Fiscal Year 2023 (FY 2023)…
April 11, 2022
On Monday, April 11th, BIO also submitted comments in response to the CDC’s recently published Clinical Practice Guideline for Prescribing Opioids. In the comments submitted, BIO primarily requested that the CDC revise its language referencing…