Federal Government Relations

BIO will be co-hosting an event with the United States Patent and Trademark Office (USPTO) to celebrate the 30th anniversary of the issuance of U.S. patent 4,259,444 to Ananda Chakrabarty following the Supreme Court case, Diamond v. Chakrabarty, which held that Chakrabarty’s bioengineered bacterium was eligible for patenting.

A new report analyzing FDA-approved monoclonal antibodies (mAbs) produced by a select group of leading biotechnology companies shows that clinical development times – specifically the duration of Phase II and Phase III trials – are lengthening, while FDA review times have remained constant.

Current rules resulting from a 2003 Office of Hearings and Appeals decision have inhibited and interfered with the growth and survival of small private biotechnology companies and the development of promising technologies and products

The Agriculture Department has announced additional money for loan guarantees to support construction of new advanced biofuel biorefineries.

As we celebrate World Health Day today, it is an opportunity to remember that vaccines represent one of the most important global health investments.

President’s call for more funding comes as Congress focuses on reducing budget deficits.

The Patent Reform Act of 2011 would strengthen and improve our nation’s patent system, spurring innovation and job creation.

Industry leaders point out that biotech-enabled advanced biofuels spur job growth and reduce U.S. dependence on imported oil.

The government’s Qualifying Therapeutic Discovery Project Program is doing what it was intended to do, according to a recent survey of senior executives at small biotechnology companies.

Agency issues partial deregulation of Roundup Ready sugar beets while it prepares an environmental impact statement.

This report presents the estimates of the significant financial contributions of the biotechnology industry to the U.S. economy and to revenues collected by the federal, state and local governments.

In 2010, a lessening of the regulatory burden on biotech startups looks promising.

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 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.
February 12 2014
Bill would spur capital formation for small public companies