Public Policy

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.

What happens in Washington influences biotechnology progress every bit as much as what happens on Wall Street or in the lab.

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.