Federal Government Relations

Congress created the 340B program in 1992 to help uninsured indigent patients gain better access to prescription medicines. This white paper examines the history and original intent of the program as well as highlights key findings to help policymakers ensure that the 340B program meets its stated purpose and to provide a roadmap for next steps to be considered.

Brent Del Monte, BIO’s Vice President of Federal Government Relations, discusses the 113th Congress and BIO’s 2013 legislative priorities.

LtGen John "Glad" Castellaw explains how the U.S. military will validate the use of biofuels in military exercises. Terrabon CEO Gary Luce discusses the benefits to commercial aviation of large-scale biofuel production.

Capital formation challenges in the industry have forced many biotech companies to halt projects, lay off staff or shutdown all together. Our analysis shows that the industry is approximately one-quarter smaller than it was in 2008.

BIO believes that the level of support provided by the TDP simply cannot meet the needs of the growing biotech field. As evidence of the project's popularity suggests, Congress should consider extending or expanding the project in order to support American innovation and speed the development of life-saving cures.

The biotech industry is a thriving sector employing 1.3 million Americans in high quality, high paying jobs.

Acorda Therapeutics' Ron Cohen presented testimony on the importance of federal policies to support the biotechnology industry at a House Committee on Science, Space and Technology, Subcommittee on Technology and Innovation hearing on March 27, a summary of his testimony is presented here

The House and Senate passed H.R. 3606, the Jumpstart Our Business Startups (JOBS) Act. It is now headed to the White House for President Obama’s signature.

William D. Waddill, Senior Vice President and Chief Financial Officer of OncoMed Pharmaceuticals, highlights the importance of capital formation to encourage investment in the biotechnology industry and spur job growth. Mr. Waddill provided testimony today on behalf of BIO at a Senate Committee on Banking, Housing, and Urban Affairs hearing.

BIO President & CEO Jim Greenwood and Tom Watkins, President & CEO of Human Genome Sciences and Chair of BIO’s Board of Directors, recently hosted a media briefing to recap our advocacy accomplishments in 2011 and lay out BIO’s policy priorities for 2012.

BIO President & CEO Jim Greenwood and Tom Watkins, President & CEO of Human Genome Sciences and Chair of BIO’s Board of Directors, recently hosted a media briefing to recap our advocacy accomplishments in 2011 and lay out BIO’s policy priorities for 2012.

BIOtech-NOW's Tracy Cooley discusses the legislative year ahead with Brent Del Monte, BIO's Vice President of Federal Government Relations.

Biotechnology continues to hold the greatest promise to address many of the most critical issues facing our world.

BIOtech-NOW's Tracy Cooley discusses the legislative year ahead with Brent Del Monte, BIO's Vice President of Federal Government Relations. In this two part series, Del Monte discusses the outlook for 2012 and legislative priorities.

April 29 2014
Chairperson Mikulski, Ranking Member Shelby, Members of the Committee, thank you for the opportunity to provide you with written testimony on the extremely important topic of driving innovation through federal investments.
March 27 2014
February 25, 2013     Marilyn Tavenner, B.S.N., M.H.A. Administrator Centers for Medicare & Medicaid Services Room 445–G, Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC 20201   Re: Draft 2015 Letter to Issuers on Federally-facilitated Marketplaces   Dear Ms. Tavenner:             The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the draft letter related to the Patient Protection and Affordable Care Act’s (ACA) health insurance Marketplaces that the Centers for Medicare & Medicaid Services (CMS) issued on February 4, 2014, entitled “Draft 2015 Letter to Issuers on Federally-facilitated Marketplaces” (the “Draft Letter”).[1]             BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO's members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, including productivity and quality of life, but also have reduced health care expenditures due to fewer physician office visits, hospitalizations, and surgical interventions. [1] Center for Consumer Information and Insurance Oversight (CCIIO), Centers for Medicare & Medicaid Services (CMS), Draft 2015 Letter to Issuers in the Federally-facilitated Marketplaces (FFM) (Feb. 4, 2014). Available at: http://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/draft-issuer-letter-2-4-2014.pdf (hereinafter “Draft Letter to Issuers”).   
March 27 2014
VIA ELECTRONIC SUBMISSION   March 1, 2014     Patrick Conway, M.D. Deputy Administrator for Innovation and Quality Chief Medical Officer Centers for Medicare & Medicaid Services Center for Medicare and Medicaid Innovation 7500 Security Boulevard Baltimore, MD 21244   RE: Request for Information: Evolution of ACO Initiatives at CMS   Dear Dr. Conway:   The Biotechnology Industry Organization (BIO) is pleased to submit the following comments regarding the Request for Information (RFI) on the “Evolution of ACO Initiatives at CMS” released by the Center for Medicare and Medicaid Innovation (CMMI) on December 20, 2013.[1]  BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations.  BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place.  In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions. [1]           Center for Medicare and Medicaid Innovation, Request for Information: Evolution of ACO Initiatives at CMS (Dec. 20, 2013), available at: http://innovation.cms.gov/Files/x/Pioneer-RFI.pdf.   
December 18 2012
BIO President and CEO Jim Greenwood wrote a letter in support of H.R. 6672, the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2012, sponsored and championed by Chairman Mike Rogers (R-MI).
October 18 2012
A keynote Address by James C. Greenwood, President & CEO of BIO, to RETECH 2012 in Washington, DC on October 18, 2012.
September 25 2014
Washington, DC, September 25, 2014 – Today, the Biotechnology Industry Organization (BIO) issued the following response to the recent Treasury Department notice of its intent to propose rules to limit corporate inversions, urging Congress and the Administration to reform the corporate tax system in order to maintain America’s global competitiveness, sustain and create American jobs, and encourage investments in the United States.  
September 17 2014
Legislation aimed at enhancing capital access and creating jobs
July 31 2014
Washington, D.C. (July 31, 2014) – The Biotechnology Industry Organization (BIO) today encourages support for the Competitiveness and Opportunity by Modernizing and Permanently Extending the Tax Credit for Experimentation (COMPETE) Act, introduced today by Senator Tom Carper (D-DE). 
April 9 2014
Consumer-focused legislation will enhance transparency and advance food safety Washington, D.C. (April 9, 2014) – The Biotechnology Industry Organization (BIO), applauds today’s introduction of the Safe and Accurate Food Labeling Act, which would establish a federal standard for the safety and labeling of food and beverage products made with genetically modified ingredients (GMOs).
March 11 2014
BIO commended the Centers for Medicare & Medicaid Services (CMS) for announcing their decision to halt movement on several proposals in their Medicare Part D draft rule.