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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October 15, 2021
BIO is pleased to join the undersigned food and agriculture organizations and companies in supporting the nomination of Elaine Trevino to serve as Chief Agricultural Negotiator at the Office of the U.S. Trade Representative.
October 8, 2021
As you know, several challenges facing the agriculture industry and our communities have emerged or intensified in recent years. Zoonotic disease, climate change, and a growing global population require us to consider new solutions to protect our…
September 30, 2021
The Biotechnology Innovation Organization (BIO) submits these comments in response to the U.S. Environmental Protection Agency’s (EPA) request for public input on the receipt of an application, 93167-EUP-2, from Oxitec Ltd requesting to amend and…
September 30, 2021
The undersigned organizations write to encourage policymakers to remove provisions in the Build Back Better Act that would curtail the effectiveness of Qualified Small Business Stock (QSBS) in incentivizing investment in innovative small businesses…
September 23, 2021
To meet the challenge of climate change, it is crucial to lead with science and U.S. innovation. We must incentivize the adoption of innovative, sustainable technologies and practices; and streamline and expedite regulatory pathways for breakthrough…
September 23, 2021
Safe, secure, affordable & accessible food supply Hundreds of millions of Americans and people around the world rely on safe and nutritious U.S. agricultural products and foods. Americans have access to one of the safest, most diverse, most…
September 14, 2021
The undersigned organizations and institutions, representing hundreds of thousands of individuals and entities working in science, technology, engineering, medicine, and mathematics would like to call your attention to the recent reintroduction of…
August 10, 2021
We want to commend you and your Administration for the global distribution of millions of doses of the COVID-19 vaccines. Our friends in recipient countries are truly grateful. Nonetheless, in order to gain control of the pandemic, a much more…
August 9, 2021
On Thursday, June 10th, 2021, the U.S. Food and Drug Administration (FDA) published a draft guidance, Core Patient-Reported Clinical Outcomes in Cancer Clinical Trials, providing recommendations to sponsors on the collection of a core set of patient…
August 6, 2021
BIO submitted comments to the United States Patent and Trademark Office in response to the USPTO's consideration of “the codification of its current policies and practices, or the modification thereof,” relating to the exercise of its discretion…