Health Care

Myths abound regarding data exclusivity and the ability of an innovator to extend the period of data exclusivity as provided in the health care reform bill passed by the U.S. House of Representatives and legislation currently under consideration in the Senate.

Dr. Targan explains how the biotech industry is using the biology of taste to create healthier sweeteners, block bitter tastes, and help make unpleasant-tasting medicines more palatable.

Youve probably heard the term pandemic a lot in the news today. What you might not know is that biotechnology researchers are working to create new vaccination options to help stop the next big pandemic before it starts.

What's a stem cell? Where does it come from? Learn more about how biotechnology is utilizing stem cells to create tomorrow's cures for today's diseases.

Personalized medicine will change the way patients are treated in the future - for the better. Learn more about personalized medicine - how it works, and why it could save consumers a lot of money.

This video provides a basic overview of biotechnology and its many applications in our daily lives.

Are biotech drugs really that different from traditional pharmaceuticals.  You bet they are.  Learn why here.

BIO President and CEO Jim Greenwood and BIO Board Chair Dr. Stephen Sherwin discuss the need to ensure that health care reform promotes and preserves innovation, particularly in a pathway for biosimilars and the use of comparative effectiveness data.

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The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the draft guidance issued by the Food and Drug Administration (FDA) on April 9, 2014, entitled “Draft Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff: Meetings with the Office of Orphan Products Development.”
May 27 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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway.
May 20 2014
The importance of supporting biomedical research and innovation and the development of new therapies cannot be overstated. Today, we face increasing competition around the globe to overtake U.S. world leadership in biomedical innovation. Even in this time of budgetary constraint, it is crucial that we not allow this to happen. We cannot afford to lose the next generation of discoveries that address one of the nation’s leading cost drivers – chronic and debilitating disease.
May 2 2014
As with the FDA’s previous Guidance on this topic (2009 Guidance),1 BIO continues to support FDA‘s clarification of its views on the dissemination of medical journal articles and medical or scientific reference publications that contain truthful and non-misleading information, including new information about the uses of approved drugs, biologics and medical devices. In addition, BIO supports FDA’s inclusion in this Revised Draft Guidance of recommendations regarding manufacturer provision of medical journals and texts, as well as Clinical Practice Guidelines (CPGs), that similarly contain truthful and non-misleading information, including new information, about the uses of approved drugs, biologics, and medical devices.
March 14 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the "Proposed Rule: Supplemental Applications Proposing Labelling Changes for Approved Drugs and Biological Products."
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. 
January 30 2014
Patients Should Be Informed if Doctor's Prescription Changed