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
John F. Crowley, President and CEO of the…
“Most favored nation is a deeply flawed proposal that would devastate our nation’s small- and mid-size biotech companies – the very companies that are the leading drivers of medical innovation in the United States and the cornerstone of America’s…
CSBA Letter to Congressional Leadership on Most…
CSBA Letter to Congressional Leadership on…
The Council of State Bioscience Associations (CSBA) is a coalition of independent state and territory-based non-profit trade associations, each of which advocates for public policies that support responsible development and delivery of innovative…
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May 12, 2025
“Most favored nation is a deeply flawed proposal that would devastate our nation’s small- and mid-size biotech companies – the very companies that are the leading drivers of medical innovation in the United States and the cornerstone of America’s…
May 7, 2025
The Biotechnology Innovation Organization (BIO) offers this submission in response to the request by the Department of Commerce for comments on section 232 national security investigation of imports of pharmaceuticals and pharmaceutical ingredients…
May 7, 2025
The Council of State Bioscience Associations (CSBA) is a coalition of independent state and territory-based non-profit trade associations, each of which advocates for public policies that support responsible development and delivery of innovative…
March 7, 2025
One thing that we can all agree on is the need to give our children a fighting chance so they can lead long and productive lives. That is why it is critical to pass the bipartisan Give Kids a Chance Act and ensure the Pediatric Priority Review…
March 4, 2025
Dear Colleagues, This month marks my one-year anniversary as BIO's CEO. Like most of us in biotech, this post has been a labor of love. At no time in my 25-year career in this industry have I ever witnessed such awe-inspiring science. Today, we…
February 28, 2025
Re: BIO Comments on Office of Management and Budget (OMB) Statistical Policy Directive No. 8 North American Industry Classification System (NAICS)-Request for Comments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology…
October 10, 2024
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…
May 15, 2024
On behalf of its member organizations, Biotechnology Innovation Organization (“BIO”) respectfully submits this Comment in response to the United States Patent and Trademark Office’s (the “Patent Office” or “PTO”) February 13, 2024 Request for…