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BIO Statement on the Administration’s Drug Pricing Proposal

Biotechnology Innovation Organization (BIO) President & CEO James C. Greenwood issued the following statement after the Trump administration outlined proposed changes to the Medicare Part B program.

BIO Comments on National Institutes of Health (NIH) Office of Science Policy (OSP) Recombinant or Synthetic Nucleic Acid Research: Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

October 18, 2018

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BIO Comments on Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics

October 12, 2018

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BIO Applauds President Trump's Directive to Allow Sales of E15 Fuel Year-Round

The following statement may be attributed to Brent Erickson, BIO’s Executive Vice President, Industrial and Environmental Section, in response to President Donald Trump’s directive allowing the sale of E15 fuels year-round. 

BIO Comments on FDA Draft Guidance on Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.

October 8, 2018

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BIO Statement on the United States-Mexico-Canada Agreement

Washington, D.C. (October 4, 2018) – Biotechnology Innovation Organization (BIO) President & CEO James C. Greenwood today issued the following statement on the United States-Mexico-Canada...

BIO Joins Alliance to Protect Medical Innovation

"Innovation and bad public policy cannot coexist. That’s an important message often neglected in the debate about health care costs, and that’s precisely the message this organization will help deliver.”

BIO Submits Comments Re: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (OPPS) and Quality Reporting Programs Proposed Rule

On September 24, BIO submitted final comments in response to the CY 2019 Outpatient Prospective Payment System Proposed Rule. This year’s OPPS rule included a Request for Information (RFI) around the potential development of a new innovation model for delivery of Part B drugs, using CMS’ authority under the previously existing Competitive Acquisition Program (CAP) – of which the original iteration was discontinued in 2008 after failing to attract participants and costing more than the traditional reimbursement structure in Part B. BIO outlined the need for CMS to be thoughtful and measured in the development of models that are voluntary and support a competitive, market-driven approach, including that any models properly address: (1) adequate protections for patient access to clinically appropriate care and lowering costs to beneficiaries; (2) not creating interference that erodes the existing coverage and reimbursement structure, (3) encouraging robust competition and avoiding misaligned incentives; (4) ensuring workability for physicians who may choose to participate; (5) considering appropriate exemptions for certain drugs and biologicals; and (6) transparency in model design, development, and assessment processes.

BIO Applauds House Passage of the American Innovation Act

Bill reforms tax rules that currently penalize investment in job creation, innovation   Washington, DC (September 27, 2018) – The Biotechnology Innovation Organization (BIO) today applauded the House of Representatives for passing the American Innovation Act of 2018 (H.R. 6756), which includes a provision that would protect investments in start-ups from inadvertently triggering the net operating loss (NOL) limitations under Section 382 of the tax code. R&D-intensive biotech start-ups frequently accumulate substantial NOLs in their early, pre-revenue years, given their typical reliance on investor capital for more than a decade before realizing any product revenue.

RDOD: FDA Draft Guidance Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies

September 25, 2018

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