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."

BIO Applauds Senate Passage of Opioid Crisis Response Act of 2018

“BIO’s member companies are committed to unleashing the power of scientific innovation to develop solutions that will lead to an America free of prescription opioid addiction. Today’s vote advances vital legislation that will help get new innovations to patients suffering from pain and addiction, by ensuring that our research and regulatory environments keep pace with our accelerating scientific knowledge and capabilities."

Re: Docket No. FDA-2018-D-1895: Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and Format

Re: Docket No. FDA-2018-D-1895: Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and Format Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Draft Guidance titled Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and Format.

BIO Submits Comments Re: CY 2019 Medicare Physician Fee Schedule and Other Revisions to Part B

BIO represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we closely monitor changes to Medicare’s reimbursement rates and payment policies for their potential impact on innovation and patient access to drugs and biologicals. As a threshold matter, we raise our concern with the implementation of a policy that can have such impacts in limiting access for beneficiaries in MA via the application of step therapy, as detailed in the Administration’s August 7th memo.2 As detailed in our letter to the Administration, we are particularly concerned with the lack of specificity or detail in this memo around critical patient protections and appropriate implementation, including ensuring: sufficient oversight by CMS; clear clinical criteria for step therapy policies; transparency into, and communication of, step therapy policies to beneficiaries and robust beneficiary protections; timely exceptions and appeals processes; sufficient protections for those on existing therapies; and protection for beneficiaries from higher cost-sharing.

BIO Applauds Legislation to Spur Investment in Start-ups

Washington, DC (September 12, 2018) – The Biotechnology Innovation Organization (BIO) today applauded the introduction of 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.

PFDD: BIO Comments on FDA Draft Guidance Patient-Focused Drug Development: Collecting Comprehensive and Representative Input

September 11, 2018


BIO Announces Programming for the 17th Annual BIO Investor Forum

Amidst a healthy investment climate for biotech companies, BIO announces programming for the 17th annual BIO Investor Forum