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BIO Submits Comments Re: CMS Innovation Center New Direction Request for Information

BIO submitted comments in response to the CMS Innovation Center New Direction Request for Information (RFI). BIO represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we have closely monitored the Innovation Center’s development and delivery of demonstration models and their potential impact on patient access to treatment and innovation. BIO applauds CMS for engaging in the collection of broad stakeholder feedback through this RFI, and not only for seeking input on the model focus areas, but also on the overarching principles that guide the Innovation Center’s activities (guiding principles). We support the Center for Medicare and Medicaid Innovation’s (CMMI’s) broader goal to improve quality of care and reduce overall healthcare expenditures, and believe appropriate access to, and utilization of, medicines can contribute to both goals. Innovative therapies have the potential to improve patient health outcomes and reduce healthcare spending in the short- and long-term. Thus, a prominent theme of our comments on this RFI center on the ideal that all demonstrations should not only maintain, but improve access to necessary therapies.

BIO Comments to FDA on “Agricultural Biotechnology Education and Outreach Initiative; Public Meetings; Request for Comments” (FDA-2017-N-5991; November 17, 2017)

Re: FDA-2017-N-5991: “Agricultural Biotechnology Education and Outreach Initiative; Public Meetings; Request for Comments” To whom it may concern: The Biotechnology Innovation Organization (BIO) appreciates this opportunity to provide comments to the Food and Drug Administration (FDA) on its proposed Agricultural Biotechnology Education and Outreach Initiative (FDA-2017-N-5991). BIO is the world's largest biotechnology trade association, representing small and large companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of agricultural, healthcare, industrial and environmental biotechnology products. BIO represents its members in a number of matters related to the uses of biology-based technologies in agriculture, animal health and human health.

BIO Applauds Sens. Tillis and Peters for Introducing the Fostering Innovation Act

Washington, DC (November 15, 2017) – Today, the Biotechnology Innovation Organization (BIO) applauds Sens. Thom Tillis (R-NC) and Gary Peters (D-MI) for introducing the Fostering Innovation Act.  This vital legislation would build on the success of the JOBS Act and further reduce regulatory costs for biotech small businesses.

Benefit-Risk: BIO Comments on Benefit-Risk Assessments in Drug Regulatory Decision-Making

Dear Sir/Madam: ...

BIO Statement on Senate GOP Tax Reform Proposal

Washington, DC (November 10, 2017) – Biotechnology Innovation Organization (BIO) Senior Vice President of Communications Kenneth Lisaius released the following statement regarding the Senate GOP tax reform proposal.

BIO Submits Comments Re: HHS Draft Strategic Plan FY 2018-2022

BIO submitted comments in response to the Health and Human Services (HHS/the Agency) Draft Strategic Plan for Fiscal Years 2018-2022. BIO strongly supports HHS’ mission to enhance the health and well-being of Americans, by providing for effective health and human services and by fostering sound, sustained advances in the science of underlying medicine, public health, and social services; and the associated strategic planning process.

BIO Submits Comments Re: USP Drug Classification System, Second Round of Public Comments

BIO submitted comments to the U.S. Pharmacopeial Convention (USP) Healthcare Quality and Safety Expert Committee (Expert Committee) in response to the second round of public comment on the USP Drug Classification System (USP DC), released September 25, 2017. In response to the USP DC, BIO offers comments consistent with our comprehensive comments on the draft Version 7.0 Medicare Model Guidelines (MMG) and comments on last year’s draft USP DC, both of which are included as appendices for the Expert Committee’s reference. Our comments, as follows, also correspond to the call for additional feedback on how to make the USP DC more user friendly as expressed on the open-mic web meeting.

BIO Statement on USDA Withdrawal of 340 Biotech Rules

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) today announced its intention to withdraw its proposed revisions to regulations (7 CFR part 340) governing agricultural biotechnology.  The Biotechnology Innovation Organization (BIO) issued the following statement in response:

BIO Releases Plan to Unleash Innovation in Fight against Opioid Abuse and Addiction

Washington, DC (November 2, 2017) – The Biotechnology Innovation Organization (BIO) today released a set of priorities for unleashing the power of innovation to develop solutions to prescription opioid abuse and addiction. Many of BIO’s priorities align with recommendations put forth yesterday by the President’s Commission on Combating Drug Addiction and the Opioid Crisis, including proposals to ensure that patients have comprehensive access to appropriate treatments, and increasing support for basic research to improve our understanding of the biology of pain and addiction. 

BIO Statement on House GOP Tax Reform Bill

Washington, DC (November 2, 2017) – Biotechnology Innovation Organization (BIO) Jim Greenwood released the following statement today regarding the Tax Cuts and Jobs Act: “BIO applauds Chairman Brady and the House Ways & Means Committee for their dedication to pro-growth tax reform. Tax reform presents a unique, historic opportunity to stimulate American investment, support job creation, and promote life-saving innovation. The Tax Cuts and Jobs Act would lower America’s corporate tax rate, maintain the R&D Tax Credit, and move the U.S. to a territorial tax system, which will make the U.S. more competitive on the world stage and support domestic manufacturing and job creation. This reform is vital to maintaining American leadership in biotechnology innovation.