Patient requests for access to drugs and biologics prior to their approval have long created a dilemma for biotechnology companies.

Although observers have been arguing for many years that conflicts of interest in medical research hurt patient care and diminish research integrity, the issue has lately become particularly salient to policy makers, researchers, institutions, and other stakeholders. The result is an environment with increased suspicion about the relationships between industry, research institutions, and physicians and greater regulation of these relationships.

BIO represents biotechnology companies, academic institutions, state biotechnology centers and related organizations throughout the United States and in many other countries.

The member companies of the Biotechnology Industry Organization (BIO) are committed to improving human health through the development of innovative therapies. We strongly support research that aims to improve human health through better drug development and recognize that responsibly sharing our clinical trial data can help to advance such research, while reinforcing public confidence in the safety and efficacy of our medicines.

While BIO does not comment on individual companies or their decision-making in regards to compassionate use, as the trade association representing the industry, we can comment on the issue of early access to experimental products that have not yet received FDA approval.

We will pursue applications of biotechnology that hold the promise of saving lives or improving the quality of life.

BIO has long supported responsible and ethical testing, protection of individual privacy and genetic information, and regulatory systems that best serve humanity and advance research into new treatments for patients, regardless of where research is conducted.

BIO is committed to the socially responsible use of biotechnology to save or improve lives, improve the quality and abundance of food, and protect our environment. Our board of directors has adopted a Statement of Ethical Principles, and we continue to refine a comprehensive vision of ways to ensure biotechnology is used for the betterment of humankind and not abused.

The public has a strong interest in protecting research and research participants. Federal policy must find the right balance in protecting participants while allowing critical research to continue.

The Brownback Bill (S. 1899) is Bad for American Science and Medical Progress

BIO opposes cloning to create a new human being (reproductive cloning) because it is unsafe and unethical. However, it is important to distinguish between that and other appropriate and important uses of the technology such as cloning specific human cells, genes and other tissues that do not and cannot lead to a human being (therapeutic cloning).

Research involving animals has been critical to understanding the fundamental processes of human biology that are so integral to modern medicine.

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.

Michael Werner, a partner at Holland & Knight, about the new stem cell guidelines issued by the NIH.

Letters, Testimony & Comments

November 20 2013
BIO welcomes the opportunity to provide the views of its members on facilitating access to genetic resources and traditional knowledge and the sharing of benefits from their use...
November 16 2011
Recent reports have raised concerns about how clinical trials are being performed in other countries, particularly in the developing world...
July 7 2009
 BIO thanks the National Institutes of Health (NIH) for the opportunity to submit comments on the advanced notice of proposed rulemaking regarding conflict of interest in federally funded medical research, published in the Federal Register on May 8, 2009...
May 27 2009
The Biotechnology Industry Organization (BIO) thanks the National Institutes of Health (NIH) for the opportunity to submit comments on the draft guidelines for human stem cell research, published in the Federal Register on April 23, 2009...
June 6 2007
As President & CEO of the Biotechnology Industry Organization (BIO), I am writing to express BIO’s support for S. 5, the Stem Cell Research Enhancement Act...

Press Releases

November 17 2011
A timely and consistent regulatory process will ultimately result in medical treatments and cures for some of the most devastating and life-threatening diseases... 
December 16 2010
Research and development in synthetic biology is an evolution of biotechnology innovation that should be supported and encouraged by federal regulatory policies... 
September 29 2010
BIO President and CEO Jim Greenwood released the following statement on action by the U.S. Circuit Court of Appeals last night to stay the lower court’s injunction on federally funded embryonic stem cell research...
August 24 2010
BIO President and CEO Jim Greenwood issued the following statement today regarding the injunction issued yesterday by a U.S. District Court prohibiting the use of federal funds to support embryonic stem cell research...
May 24 2010
Achievement of a milestone in creating synthetic life in the form of a self-replicating cell from synthesized DNA has focused attention on the field of synthetic biology...