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RDOD: FDA Draft Guidance Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for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


Biosimilars: Facilitating Competition and Innovation in the Biological Products Marketplace

September 21, 2018


BIO/Food Value Chain letter to Senate and House Appropriations Committee leadership in support of legislative language ensuring consistency under the National Bioengineered Food Disclosure Law

September 21, 2018


BIO Praises Passage of Small Business Innovation Protection Act

Washington, D.C. (September 26, 2018) – The Biotechnology Innovation Organization applauds the House and Senate’s bipartisan passage of the Small Business Innovation Protection Act. The bill...

BIO Applauds House Passage of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018

Legislation will strengthen pipeline of medical countermeasures against serious public health threats   Washington, DC (September 25, 2018) – The Biotechnology Innovation Organization (BIO) today applauds the House of Representatives for passing the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 (H.R. 6378). The legislation would re-authorize critical federal biodefense programs and agencies, including the BioShield Special Reserve Fund (SRF), the Biomedical Advanced Research and Development Authority (BARDA), and the Strategic National Stockpile (SNS).  

BIO/Coalition for Safe, Affordable Food letter for Senate and House Ag Committee leadership in support of biotech education provision

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 express our support for Section 7608 in the House-passed H.R. 2, the Agriculture Improvement Act of 2018, regarding public education on agricultural biotechnology. We believe these provisions will support the U.S. Department of Agriculture (USDA) and other relevant federal agencies in providing consumers with education materials on the National Bioengineered Food Disclosure Law (NBFDL) and its implementing regulations – the National Bioengineered Food Disclosure Standard (NBFDS). Such education materials can assist in explaining how the NBFDS provides consumers with information on the ingredients of the foods they eat, one overriding purpose of the NBFDL...

BIO Applauds Release of New National Biodefense Strategy

“I applaud the Administration for recognizing the importance of strengthening our national biodefense and preparedness efforts. Our nation continues to face a wide range of biological threats, and this strategy is an important step in the right direction."