Health Care

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.

California’s Assembly and Senate have both overwhelmingly passed Senate Bill 598, legislation that creates a pathway for the substitution of interchangeable biologic medicines.

Meta-analysis is used to inform a wide array of questions ranging from pharmaceutical safety to the relative effectiveness of different medical interventions. Meta-analysis also can be used to generate new hypotheses and reflect on the nature and possible causes of heterogeneity between studies.

S.391 and H.R. 475 update the existing excise tax to cover newly approved season flu vaccines

Dr. Richard Mohs, Distinguished Research Fellow, Eli Lilly discusses the importance of early diagnosis in Alzheimer's at the 2013 BIO International Convention.

At the 2013 BIO International Convention, Mundel discusses biotech start-ups and how biotech and technology can help meet needs in developing countries. The Global Burden of Disease Study 2010 (GBD 2010) is the largest ever systematic effort to describe the global distribution and causes of a wide array of major diseases, injuries, and health risk factors. The results show that infectious diseases, maternal and child illness, and malnutrition now cause fewer deaths and less illness than they did twenty years ago.

Keynote speaker Josh Sommer was recently named one of Forbes 30 Under 30 in Life Sciences and Healthcare. He discusses his rare cancer diagnosis while in college and his subsequent journey to become the Executive Director of The Chordoma Foundation. He also explains his search for information, insight and connections at the BIO International Convention.

Kathleen Ruddy, CEO of the St. Baldricks Foundation, the world's largest funder of childhood cancer research grants outside of the federal government explains the type of relationships they hope to develop at the 2013 BIO International Convention.

Seth Ginsberg, President of the Global Healthy Living Foundation discusess their healthy biologics initiative to improve the quality of life for people with chronic illnesses at the 2013 BIO International Convention.

From the 15th Annual BIO CEO & Investor Conference at the Waldorf Astoria Hotel in New York on February 12th, 2013.

Congress created the 340B program in 1992 to help uninsured indigent patients gain better access to prescription medicines. This white paper examines the history and original intent of the program as well as highlights key findings to help policymakers ensure that the 340B program meets its stated purpose and to provide a roadmap for next steps to be considered.

The biosimilars pathway is critical for China's biotechnology industry – and this is evident in the investment the government is making in the manufacture of biotech products

Project BioShield seeks to expand the U.S. stockpile of medical countermeasures for potential chemical, biological, radiological and nuclear (CBRN) attacks.

Letters, Testimony & Comments

November 24 2015
In general, BIO is supportive of FDA’s effort to modernize regulatory oversight of drug quality and promotion of post-approval improvements, and of FDA’s quality metrics initiative overall. Assessing across organizations, programs, products, and processes can be a considerable challenge, and many factors, including where a particular product is in its lifecycle, may influence some measures. As a result, BIO is supportive of FDA’s intent to use the quality metrics gathered as a tool and in context with other sources of quality data and not as the sole way for FDA to determine the state of quality within sites or products. It would be helpful for FDA to more clearly state the intended use of the collected metrics and the benefits to industry. We understand that regulatory relief (e.g., less frequent inspections, post-approval manufacturing change categories) may be granted based on positive high-quality metrics; however, it is unclear whether FDA would use low-quality metrics as an indicator to increase inspections at a particular entity. We believe metrics can provide a valuable tool to quantify product quality and can assist the Agency in developing a risk-based inspection program. It will be important to view these metrics in their proper context and in the broader set of information and knowledge FDA possesses. BIO recommends that FDA clarify that the quality metrics data will be used as an input to the risk-based inspection model and for surveillance purposes only; FDA will not take compliance actions solely based on quality metrics data evaluation. In addition, BIO requests that clarity be provided regarding the extent to which CBER will implement this new approach for facilities it inspects.
July 10 2015
We applaud Chairman Fred Upton (R-MI), Ranking Member Frank Pallone (D-NJ) and Congresswoman Diana DeGette’s (D-CO) efforts on H.R. 6., which takes important steps toward placing patients at the center of the drug development process, and we believe will help spur the development of therapies for the most prevalent conditions, as well as encourage development of treatments focused on rare conditions and other unmet medical needs. We strongly support establishing a framework for incorporating patient views into the development and regulatory review processes in a more structured and transparent way, both with respect to patient input for benefit-risk assessments and use of patient experience data in regulatory decision-making.
June 5 2015
BIO submitted a letter to members of the Senate Judiciary Committee regarding the Managers Amendment to PATENT Act.
June 4 2015
BIO submitted a letter to members of the Senate Judiciary Committee regarding the Managers Amendment to PATENT Act.
February 23 2015
The Biotechnology Industry Organization (BIO) thanks you for the opportunity to provide our initial thoughts on your report Innovation for Healthier Americans. BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.

Press Releases

December 1 2015
Bill would extend a cost-saving JOBS Act provision
November 18 2015
BIO released a list of seven proposed topics for the November 20th U.S. Department of Health and Human Services (HHS) Forum on Pharmaceutical Innovation, Access, Affordability and Better Health. The consideration of these topics at the Forum will help to ensure that patients have access to the most innovative new treatments and cures.