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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/Coalition for Safe, Affordable Food letter for Senate and House Ag Committee leadership in support of biotech education provision
September 20, 2018
Dear Chairman Roberts, Chairman Conaway, Ranking Member Stabenow, and Ranking Member Peterson:As representatives of the U.S. food and agricultural value chain and members of the Coalition for Safe, Affordable Food (the Coalition), we write to…
Re: Docket No. FDA-2018-D-1895: Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and Format
September 14, 2018
Re: Docket No. FDA-2018-D-1895: Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and FormatDear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration …
BIO Submits Comments Re: CY 2019 Medicare Physician Fee Schedule and Other Revisions to Part B
September 14, 2018
BIO represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we closely monitor changes to Medicare’s reimbursement rates and payment policies for their potential impact on innovation and…
BIO Comments on FDA Draft Guidance on Patient-Focused Drug Development: Collecting Comprehensive and Representative Input
September 11, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input. In the comments, BIO applauds the FDA’s initiative to advance the use of patient…
BIO Comments on RFS Standards for 2019 and Biomass-Based Diesel Volumes for 2020
August 17, 2018
The Biotechnology Innovation Organization (BIO) is pleased to provide comment on the U.S. Environmental Protection Agency’s (EPA’s) proposed rule on the Renewable Fuel Standard Program: Standards for 2019 and Biomass-Based Diesel Volume for 2020 …
BIO Submits Comments on FDA Draft Guidance: Limited Population Pathway for Antibacterial and Antifungal Drugs
August 14, 2018
Re: Docket No. FDA-2018-D-2032: The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments on the Food and Drug Administration (FDA) Draft Guidance, “Limited Population Pathway for Antibacterial and Antifungal Drugs …
BIO Comments on FDA Draft Guidance on Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials
August 3, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials. The draft guidance is an important step towards ensuring stakeholders…
BIO Led Coalition Letter in Support of Cellulosic Biofuel Technologies
July 31, 2018
As the U.S. Environmental Protection Agency (EPA) begins its work to develop the proposed 2019 Renewable Fuel Standard (RFS) Renewable Volume Obligation (RVO), we encourage the agency to take a renewed look at commercial-ready cellulosic biofuels.
Letter to Rep. Barbara Comstock in Support of SUCCESS Act of 2018
July 26, 2018
BIO sent the following letter to Representative Barbara Comstock following her introduction of H.R. 6390, the “Study of Underrepresented Classes Chasing Engineering and Science Success Act of 2018” or the SUCCESS Act  
BIO Submits Comments Re: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs
July 16, 2018
First and foremost, this is an extraordinary time for biotechnology. The therapies in development and coming to the market are unlike any we have seen in the history of medicine. We have entered into a new era of medicine, and BIO members are making…