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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 Written Testimony for House Financial Services Hearing on Legislative Proposals to Help Fuel Capital and Growth on Main Street
May 23, 2018
Good morning Chairman Huizenga, Ranking Member Maloney, and Members of the Capital Markets, Securities, and Investment Subcommittee. My name is Brian Hahn, and I am the Chief Financial Officer of GlycoMimetics, Inc., a 48-employee public biotech…
BIO Leads Letter on Need for Biostimulants Regulatory Clarity in Farm Bill
May 9, 2018
On behalf of the U.S. Biostimulant Coalition (USBC), the Biological Products Industry Alliance (BPIA), the American Seed Trade Association (ASTA), the Biotechnology Innovation Organization (BIO), and the Humic Products Trade Association, we are…
BIO Submission to the China Section 301 Investigation - September 28, 2017
April 4, 2018
BIO submitted comments to the Office of the United States Trade Representative (USTR) and the inter-agency Section 301 Committee regarding the investigation, initiated on August 18, 2017, by USTR under section 302(b) of the Trade Act of…
BIO Comments on FDA Draft Guidance on Formal Meetings Between the FDA and Sponsors or Applicants of Prescription Drug User Fee Act Products
March 27, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products. The Prescription Drug User Fee Act …
BIO Comments on Proposed Settlement Agreement Between EPA and Philadelphia Energy Solutions on RFS Obligations
March 26, 2018
BIO is greatly concerned by the Department of Justice's and Environmental Protection Agency's proposed Settlement Agreement to resolve a dispute about the PES Holdings' obligations under the Renewable Fuel Standard.
BIO Comments on FDA Draft Guidance on Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products
March 22, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products. BIO supports the FDA’s efforts to update and replace the 1997…
BIO Comments on Promoting the Use of Complex Innovative Designs in Clinical Trials
March 20, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) public meeting on Promoting the Use of Complex Innovative Designs in Clinical Trials. BIO supports the development and launch of this initiative. BIO shares the FDA’s goals for the…
BIO Submits Comments to House Ways and Means on Expired Tax Provisions
March 14, 2018
BIO supports a seamless multi-year extension for the Second Generation Biofuel Producer Tax Credit; Special Depreciation Allowance for Second Generation Biofuel Plant Property; Biodiesel and Renewable Diesel Fuels Credit; and the …
BIO Submits Comments Re: CY 2019 Medicare Advantage and Part D Call Letter
March 7, 2018
BIO supports CMS’s commitment to improving the quality and delivery of care in the MA and Part D programs. We believe it is critically important to ensure that policies in these programs advance patient access to timely and appropriate treatment,…
BIO Comments on FDA Public Workshop on Patient-Focused Drug Development: Guidance 1
February 16, 2018
BIO submitted comments after the Food and Drug Administration’s (FDA) public hearings on Patient-Focused Drug Development: Guidance 1 – Collecting Comprehensive and Representative Input. BIO commends the FDA’s efforts to facilitate the use of…