Federal Government Relations

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.

Letters, Testimony & Comments

June 5 2015
BIO submitted a letter to members of the Senate Judiciary Committee regarding the Managers Amendment to PATENT Act.
June 4 2015
BIO submitted a letter to members of the Senate Judiciary Committee regarding the Managers Amendment to PATENT Act.
January 22 2015
BIO, as part of a broad coalition of the nation's patent holders and inventors, sent a letter to the ranking members of the House and Senate Judiciary Committees on patent litigation reform. 
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”).   

Press Releases

August 3 2015
BIO announced the appointment of Jeanne Haggerty as Senior Vice President of Federal Government Relations.
July 10 2015
We praise the House of Representatives for today’s vote to pass 21st Century Cures legislation that recognizes the critical link between research, development and reimbursement to expedite the delivery of breakthrough treatments and cures to patients suffering from life-threatening and debilitating diseases.  
June 11 2015
BIO continues its continued opposition to The Innovation Act (H.R.9) as amended and reported by the House Judiciary Committee today.
June 5 2015
BIO issued the following statement regarding the mark-up of The Protecting American Talent and Entrepreneurship (PATENT) Act