Public Policy

In the biotech industry’s early days, the benchmark for success for any early-stage company was the nurturing of a biological discovery made in the lab through to market approval.

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

When business and academia team up on cutting-edge initiatives, the combination can generate serious revenue and spur the economy.

The biotechnology industry’s endeavor to transform science into therapy for a previously untreatable disease is the subject of a new movie, “Extraordinary Measures.”

Biosimilars, also known as follow-on biologics, may eventually expand access and provide patients a more affordable alternative to innovative, lifesaving medicines. 

Biofuels have the potential to play a critical role in addressing climate change

BIO hosted a successful special session on August 20th where the first public presentation was made of the BIO Guidance on Genetically Engineered (GE) Animal Stewardship with 100 international scientists and government officials in the audience of the 7th Transgenic Animal Conference, Tahoe, Calif.

Today’s program at the 7th Transgenic Animal Research Conference in Tahoe, Calif., hit the “hot science”, as one researcher from Germany noted during lunch. The research on genetically engineered (GE) animals will reap huge dividends in societal benefits to solve the world’s most pressing challenges.

In this interview, BIO President and CEO Jim Greenwood explains the promise of stem cell research and why it is an important first step in bringing new therapies to patients.

Total job creation, accounting for economic multiplier effects, could reach 123,000 in 2012, 383,000 in 2016, and 807,000 by 2022.

We have used the biological processes of microorganisms for 6,000 years to make useful food products, such as bread and cheese, and to preserve dairy products.

Today, the biotechnology industry is enjoying more success and influence than ever before. Our industry’s innovations continue to improve the lives of people worldwide, and the advancement of these innovations is supported by the work of BIO.

States and regions throughout the United States are investing to create a business climate that supports the specific needs of the biosciences sector.

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.