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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
ohn’s One-Year Anniversary Letter to BIO…
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…
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BIO Comments on Office of Management and Budget …
Re: BIO Comments on Office of Management and Budget (OMB) Statistical Policy Directive No. 8 North American Industry Classification System (NAICS)-Request forComments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology…
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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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BIO Comments to the Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA)
September 29, 2023
BIO submitted comments to DoD, GSA, and NASA on the Proposed Rule to amend and restructure regulations on environmental and sustainability procurement (FAR Case 2022-006, Docket No. 2022-0006, Sequence No. 1 RIN 9000-AO43)
BIO's Comments on FTC Merger Guidelines
September 28, 2023
BIO Comments to FTC on Revised HSR Form
September 27, 2023
Comments on Revised HSR Premerger Notification and Report Form 16 CFR Parts 801-803—Hart-Scott-Rodino Coverage, Exemption, and Transmittal Rules, Project No. P239300
Testimony of John F. Crowley, Executive Chairman of Amicus Therapeautics, to the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations  for the hearing “How the IRA’s Price Setting Scheme Means Fewer Cures for Patients”
September 20, 2023
BIO Board Vice Chair and CEO of Amicus Therapeutics testified that the drug price controls in the Inflation Reduction Act harm drug research and development.
Coalition Letter Supporting Ag Research Funding
September 11, 2023
BIO joined with other groups in writing House and Senate Agriculture Committee leaders in support of agricultural research (FFAR) funding in the farm bill. 
BIO Comments to FDA on Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products
August 3, 2023
In response to the agency's request for information (Docket No. FDA-2023-N-0743-0002), BIO provides detailed comments.
BIO Comments on the NIH Technology Transfer Workshop
August 1, 2023
BIO provides detailed comments in advance of the July 31, 2023 NIH Workshop, “Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer.
BIO Comment on EU Compulsory Licensing Legislation
July 31, 2023
BIO Statement to the Senate 340B Bipartisan Working Group on Safeguarding and Strengthening 340B
July 28, 2023
In response to a Request for Information (RFI) from the Senate 340B Bipartisan Working Group, BIO submitted detailed comments on the current status of the program and suggestions for improvements.
BIO Comments to FDA on Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices
July 26, 2023
BIO submitted general comments and specific recommendations to the FDA in response to the agency's request for information. (Docket FDA-2022-D-2870)