Health Care

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

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.

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

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.

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.

Biotechnology companies must have some certainty that they can protect their investment in the development of new breakthrough therapies for a substantial period of time.

September 2 2014
 The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Current Good Manufacturing Practices—Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and Cosmetic Act.”
August 26 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products – Recommended Practices (Draft Guidance).
July 31 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “The Food and Drug Administration Fiscal Year 2014-2018 Strategic Priorities.”
July 22 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions; Draft Guidance for Industry and Food and Drug Administration Staff.”
June 9 2014
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the draft guidance issued by the Food and Drug Administration (FDA) on April 9, 2014, entitled “Draft Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff: Meetings with the Office of Orphan Products Development.”
September 22 2014
Washington, D.C. (September 22, 2014) – BIO President and CEO James Greenwood joined AdvaMed President and CEO Stephen Ubl and PhRMA President and CEO John Castellani in a letter to CMS Administrator Marilyn Tavenner highlighting ongoing concerns about a potential lack of necessary context around the Sunshine data release.  
April 7 2014
The EXPIRE Act would extend tax credits that expired at the end of 2013, including several of importance to the biotechnology industry.
March 25 2014
The Biotechnology Industry Organization (BIO) and the Indiana Health Industry Forum (IHIF) commend Indiana Governor Mike Pence for signing legislation today 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.