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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
Comments of the Biotechnology Innovation…
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…
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BIO Comments to FWS on Use of GMOs on National…
BIO comments on a proposed rule to restrict planting of GE organisms on national wildlife refuge lands. 
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BIO Comments to the Minnesota Department of…
BIO submits comments on the MDH’s proposed regulations regarding Drugs of Substantial Public Interest: Draft Methodology for Public Comment as required in statute by the Prescription Drug Price Transparency Act.    
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BIO Comments to the Senate Committee on Health, Education, Labor and Pensions on the Reauthorization of PAHPA
July 10, 2023
BIO provides detailed comments to the Committee on its draft of the 2023 Reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA), legislation that is critical to our national health security.
BIO comments to FDA on Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making
June 29, 2023
BIO submitted general comments and proposed changes to FDA (Docket No. FDA-2023-D-0026)
BIO Recommendations on PTAB patent invalidation proceedings
June 23, 2023
BIO comments on U.S. Patent & Trademark Office proposed reforms to PTAB patent invalidation proceedings.
BIO Comments on Biotech & Biomanufacturing Initiative
June 13, 2023
BIO comments to the Office of Management & Budget in response to the agency’s request for information on measuring and classifying the bioeconomy for potential inclusion in the North American Industry Classification System (NAICS) and North…
BIO testimony at the House Energy & Commerce Committee hearing, “Legislative Solutions to Bolster Preparedness and Response for All Hazards and Public Health Security Threats.”
June 13, 2023
Presented by Phyllis Arthur, MBA, BIO’s Senior Vice President of Infectious Disease and Emerging Science Policy.
BIO Comments to FDA on the agency’s Data and Technology Strategic Plan (Docket No. FDA–2023-N-1052)
June 12, 2023
BIO applauds FDA’s efforts to develop a plan consistent with PDUFA VII commitments and the FY23 Omnibus Bill and offers strategic recommendations.
BIO Testimony on Restoring R&D Tax Deduction
June 7, 2023
Biotechnology Innovation Organization statement for the record to the U.S. House Committee on Small Business Subcommittee on Economic Growth, Tax, and Capital Access hearing on "American Ingenuity: Promoting Innovation Through the Tax Code…
Testimony on Intellectual Property Protections in the Life Sciences
June 7, 2023
The global IP framework has enabled lifesaving innovation and provides a reliable legal foundation for companies to voluntarily license their IP to enhance research collaborations and provide timely, equitable global access to safe and effective…
Letter in support of U.S. Codex Office funding
May 30, 2023
BIO joined with more than 40 groups in calling on Congress to set 2024 funding for the U.S. Codex Office at or above the 2023 level. 
BIO Comments to FDA (Docket No. FDA-2023-N-0398) on Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products
May 26, 2023
In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.