Public Policy

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Citizen Petition with the Food and Drug Administration (FDA), requesting that the agency refrain from (1) publishing a draft guidance document setting forth standards for so-called follow-on or "generic" biotechnology-derived products, and (2) approving an application filed under section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?

At BIO’s recent Focus on Compliance workshop, participants learned about the responsible use of plant biotechnology during R&D.

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 2013
Therapeutic biologics are an opportunity to address unmet patient needs, drive innovation, and assist China's transformation into a knowledge-intensive economy.
July 10 2013
A healthy public market is key to the success of the biotech industry, as growing innovators often turn to an IPO to fund late-stage clinical trials.
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. 
March 5 2014
Many of the provisions included in this budget proposal would jeopardize the continued biotech research and development that is necessary to find cures and breakthrough medicines for patients living with debilitating and life-threatening diseases. 
January 30 2014
Patients Should Be Informed if Doctor's Prescription Changed
January 14 2014
Spending plan would enable the FDA to access $85 million in sequestered user fees
November 18 2013
BIO commends the Senate for approving H.R. 3204, the Drug Quality and Security Act.