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.
All Letters, Testimony & Comments
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July 30, 2021
BIO regularly publishes reports that help us assess the health of the biopharmaceutical pipeline across different diseases so that we can identify and remove barriers to providing next generation cures and treatments to patients and their families…
July 27, 2021
COVID-19 will not be our last public health emergency.  We face numerous bio-threats from natural and bioterror threats.  Strong support for medical countermeasures R&D is critical to protecting our national security. Today I will…
July 27, 2021
Chairman Wyden, Ranking Member Crapo, Members of the Committee, my name is Dr. Michelle McMurry-Heath. I am the President and CEO of the Biotechnology Innovation Organization (BIO). I am honored to testify before you for today’s hearing,…
July 22, 2021
The Biotechnology Innovation Organization (BIO) is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30…
July 21, 2021
BIO appreciates FDA’s commitment to harmonization of regulatory concepts across regional Health Authorities through the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Harmonization of…
July 20, 2021
We write to express our support for the nomination of Robert Bonnie to serve as the U.S. Department of Agriculture’s Under Secretary for Farm Production and Conservation. The Under Secretary position is critical in overseeing the administration of a…
July 16, 2021
On Wednesday, July 14th, BIO submitted comments on FDA’s Guidances: 1) Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance; 2) Updated Manufacturing, Supply…
July 16, 2021
We, the undersigned organizations, representing a broad and diverse group of the agriculture industry are pleased to support the consideration for Jenny Lester Moffitt, who currently serves as Undersecretary of the California Department of Food and…
July 15, 2021
As you prepare for Chancellor Merkel’s visit to Washington, we, the representatives of America’s biotechnology sector thought that you and your government might benefit from an update on all that our sector is doing globally to address the ongoing…
June 30, 2021
We would like to provide you some updates on the U.S. and global biotechnology industry’s efforts to scale-up global vaccine production to address the global imbalance in access to COVID vaccines, and to request a close working relationship with…