Public Policy

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.

Scientific American will release the third annual Worldview: A Global Biotechnology Perspective at this year’s BIO International Convention.  Created in partnership with BIO, the publication explores the diverse economic regions of the world, highlighting success stories, policy achievements, cutting-edge science and the unique challenges that lie ahead. This year’s report focuses on BRIC (Brazil, Russia, India and China) country efforts to build local biotechnology hubs. 

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

Biotech research holds a great deal of promise for future innovation in the treatment of previously untreatable diseases. But how long does it take for a biotech therapy to come to market?

On April 8, 2004, Genentech, Inc. filed a Citizen Petition with the Food and Drug Administration (FDA), requesting that the agency refrain from (1) publishing a draft guidance document setting forth standards for so-called follow-on or "generic" biotechnology-derived products, and (2) approving an application filed under section 505(b)(2) of the Food, Drug and Cosmetic Act (FDCA) with respect to a biotechnology product that relies, directly or indirectly, on trade secret and confidential commercial data and information of an innovator.

The following expresses the agricultural values of the Biotechnology Industry Organization, and its more than 1,000 member companies located across the United States and in 33 countries.

Biotechnology is all around us and is already a big part of our lives, providing breakthrough products and technologies to combat disease, reduce our environmental footprint, feed the hungry, and make useful products.

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.

Ohio is a national leader in terms of both bioscience employment and establishments. In fact the industry accounts for about 15 percent of the state’s total economic output.

A new federal recommendation could hinder innovations from biotechnology R&D by limiting gene patents and licenses.

Disease resistant animals, environmentally friendly livestock, pharmaceuticals produced by goats - are these really possible?

July 14 2014
Dear Chairman Terry and Ranking Member Schakowsky: On behalf of the Biotechnology Industry Organization (BIO), I write in support of H.R. ___, the Targeting Rogue and Opaque Letters (TROL) Act of 2014, and urge the Subcommittee to pass this legislation. It is critical that legislation that seeks to reign in abuses by patent trolls does so in a way that preserves and enhances the incentives necessary to sustain our nation’s global leadership in biotechnology innovation and to spur the creation of high-wage, high-value jobs throughout the country. Improving our patent system can help America retain its global competitive advantage in biotechnology and other innovative industries, and will spur more investment and job creation at a time when both are sorely needed. We commend Chairman Terry and Members of the Subcommittee on Commerce, Manufacturing, and Trade for creating a balanced approach that will address the issue of false or deceptive patent demand letters without impeding the ability of legitimate patent owners to enforce their patents by sending patent-related communications made in good faith.
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.   
November 6 2013
On behalf of the BIO and its 1,100 members, I am writing in strong support of your Start-up Jobs and Innovation Act. I want to thank you for introducing this important legislation, which will spur investment in small biotech companies and other innovative businesses.
July 10 2014
The International Council of Biotechnology Associations has been established with the expressed purpose of advocating for public policies that support the growth of the innovative biotechnology industry worldwide.
June 24 2014
Bioscience industry a bright spot among the technology sector
May 29 2014
Delaware Governor Markell signed legislation designed to create a pathway for the substitution of interchangeable biologic medicines.
May 16 2014
BIO and Delaware Bio call upon Governor Markell to sign critical legislation to create a pathway for the substitution of interchangeable biologic medicines.
April 10 2014
BIO and Delaware Bio commend the Delaware State Senate for unanimously passing legislation yesterday designed to create a pathway for the substitution of interchangeable biologic medicines.