Health Care

From genetic testing to earlier cancer diagnosis, to rapid result strep tests and diagnostic tools that can be used outside of a traditional hospital environment, biotechnology researchers are making great strides in the field of ddiagnostic tools.

On April 8, 2004, Genentech, Inc. filed a Citizen Petition with the Food and Drug Administration (FDA), requesting that the agency refrain from (1) publishing a draft guidance document setting forth standards for so-called follow-on or "generic" biotechnology-derived products, and (2) approving an application filed under section 505(b)(2) of the Food, Drug and Cosmetic Act (FDCA) with respect to a biotechnology product that relies, directly or indirectly, on trade secret and confidential commercial data and information of an innovator.

The European Medicines Agency (EMEA), the European equivalent to the Food and Drug Administration (FDA), has implemented an approval scheme that specifically distinguishes between biosimilars (follow-on biologics) and generic drugs.

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

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).

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

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.

By utilizing DNA, scientists are able to create a genetic finger print that is unique to each individual to help find and prosecute crime suspects and identify remains.

By utilizing DNA, scientists are able to create a genetic finger print that is unique to each individual to help find and prosecute crime suspects and identify remains.

Every 70 seconds someone develops Alzheimer's. By 2029 there will be 70 million retired baby boomers. If we dont find a way to treat the disease we are going to have a public health disaster.

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.

Ohio is a national leader in terms of both bioscience employment and establishments. In fact the industry accounts for about 15 percent of the state’s total economic output.

Letters, Testimony & Comments

March 1 2013
  BIO’s comments on the Centers for Medicare and Medicaid Services’ (CMS) draft 2014 Call Letter, submitted Friday,...
March 1 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
February 27 2013
    Dear Sir/Madam:    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration...
February 21 2013
Ms. Marilyn Tavenner, B.S.N., M.H.A. Acting Administrator Centers for Medicare & Medicaid Services Room 445–G, Hubert H....
February 19 2013
    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...

Press Releases

February 28 2013
WASHINGTON, DC – February 28, 2013 –The Biotechnology Industry Organization (BIO) lauds the Senate for...
January 25 2013
The Biotechnology Industry Organization lauds the House of Representatives for passing H.R. 307, the Pandemic and All...
October 1 2012
Washington, D.C. (October 1, 2012) — Pharmaceutical Research and Manufacturers of America (PhRMA) President and...
July 23 2012
Groups Issue Booklet to Help Biotechnology and Pharmaceutical Companies Identify Pipeline Medicines with Doping...
June 28 2012
  Pleased to move forward on biosimilars pathway Washington, D.C. (June 28, 2012) –Biotechnology...