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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 on SEC Proposed Proxy Amendments
February 3, 2020
In comments to the Securities and Exchange Commission (SEC), BIO applauds the SEC for taking a proactive approach in amending the exemptions from the proxy rules for proxy voting. If adopted, the proposal will significantly improve proxy firm…
Office of New Drugs: BIO Comments on Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs
January 10, 2020
January 7, 2020 Re: Docket No. FDA–2019-N-3453: Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs Dear Sir/Madam: The Biotechnology Innovation Organization (BIO…
Clinical Outcomes and Endpoints: BIO Comments on Standard Core Sets: Clinical Outcome Assessments (COAs) and Endpoints Grant Program
January 10, 2020
January 4, 2020 Re: Docket No. FDA–2019-N-5157: 2019 Public Meeting on Center for Drug Evaluation and Research Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program. Dear Sir/Madam: The Biotechnology Innovation Organization…
Select Committee on Climate Crisis: BIO Comments on Public Policies Needed to Help Biotech Address Climate Change
December 20, 2019
The Biotechnology Innovation Organization (BIO) is pleased to respond to the Select Committee's Request for Information (RFI) on how supportive public policy can help biotechnology reduce greenhouse gas emissions, enhance carbon sequestration,…
BIO Comments on FDA Guidance - IVD Device Studies Frequently Asked Questions
December 17, 2019
On December 16, 2019, the Biotechnology Innovation Organization (BIO) provided comments on the Food and Drug Administration’s (FDA’s) Notice to Public of Website Location of CDRH Fiscal Year 2020 Proposed Guidance Development; In Vitro…
BIO Comments on CMS National Coverage Decision Memo for Advanced Cancer Next Generation Sequencing
December 17, 2019
On November 27, 2019, the Biotechnology Innovation Organization (BIO) provided comments on the Centers for Medicare and Medicaid Services’ (CMS’) National Coverage Determination for Diagnostic Laboratory Tests using Next Generation Sequencing (NGS)…
More than 135 Emerging Biotech Leaders Urge Congress to Reject H.R. 3
December 5, 2019
In a letter addressed to House Speaker Nancy Pelosi (D-CA) and House Republican Leader Kevin McCarthy (R-CA), 138 emerging biotech leaders warn that H.R. 3, the Lower Drug Cost Now Act, will “shatter the dreams” of patients and families who stand to…
BIO Comments on FDA docket Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction
November 18, 2019
Biotechnology Innovation Organization (BIO) comments on the FDA docket, Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction. BIO also believes that risks associated with opioid…
BIO Comments on Proposed Section 382(h) Regulations
November 13, 2019
The Biotechnology Innovation Organization provided comments to the Treasury Department and Internal Revenue Service on proposed regulations under Section 382 with respect to the built-in gain and built-in loss rules of Section 382(h).
BIO Comments on SEC Proposal to Amend the Accelerated Filer and Large Accelerated Filer Definitions
November 11, 2019
In a recent letter, BIO applauded the Securities and Exchange Commission (SEC) for taking a proactive approach in amending its accelerated and large accelerated filer definitions. “If adopted as proposed, these amendments will benefit startups and…