Public Policy

Biotech research holds a great deal of promise for future innovation in the treatment of previously untreatable diseases. But how long does it take for a biotech therapy to come to market?

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Citizen Petition with the Food and Drug Administration (FDA), requesting that the agency refrain from (1) publishing a draft guidance document setting forth standards for so-called follow-on or "generic" biotechnology-derived products, and (2) approving an application filed under section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 following expresses the agricultural values of the Biotechnology Industry Organization, and its more than 1,000 member companies located across the United States and in 33 countries.

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.

This report presents the estimates of the significant financial contributions of the biotechnology industry to the U.S. economy and to revenues collected by the federal, state and local governments.

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.

A new federal recommendation could hinder innovations from biotechnology R&D by limiting gene patents and licenses.

Disease resistant animals, environmentally friendly livestock, pharmaceuticals produced by goats - are these really possible?

At BIO’s recent Focus on Compliance workshop, participants learned about the responsible use of plant biotechnology during R&D.

In the biotech industry’s early days, the benchmark for success for any early-stage company was the nurturing of a biological discovery made in the lab through to market approval.

In 2010, a lessening of the regulatory burden on biotech startups looks promising.

Letters, Testimony & Comments

February 27 2013
    Dear Sir/Madam:    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration...
February 19 2013
    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
February 4 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide...
January 24 2013
Biologics are complex medicines manufactured from living organisms. Unlike traditional “small molecule” drugs, biologics are...
January 24 2013
The Biotechnology Industry Organization (BIO) is the world’s largest biotechnology trade association. BIO represents more than 1,...

Press Releases

October 9 2012
Any waiver of the RFS would have little to no effect on corn prices, but would certainly harm biofuel producers and...
September 25 2012
Washington, D.C. (September 25, 2012) – The Biotechnology Industry Organization (BIO) applauds Sens. Robert...
July 27 2012
Washington, D.C. (July 27, 2012) – Biotechnology Industry Organization (BIO) Vice President of Alliance ...
June 19 2012
Fifth biennial report by Battelle outlines 6.4% job growth in sector from 2001 to 2010,while overall economy recorded...
June 14 2012
WASHINGTON, DC (June 12, 2012) – The Biotechnology Industry Organization (BIO) announced today that New Jersey...