BIO Members Committed to Ensuring Public Access to Key Clinical Trial Results

Publicly Disclosed Clinical Trial Results Must Have Scientific Merit

Critical Research Must Not Be Stifled
WASHINGTON--(Business Wire)--
In testimony submitted to the National Institutes of Health (NIH) today, the
Biotechnology Industry Organization (BIO) stressed the commitment of its member
companies to help ensure that patients and health care providers have access to
key clinical trial results information from trials of unapproved products.

"BIO supports efforts to increase the availability of accurate, reliable,
scientific evidence to inform clinical decision-making," stated BIO President
and CEO Jim Greenwood. "We believe that individual patients, clinical
decision-makers and scientific researchers should be armed with the best
available information to help assess the relative clinical benefits and risks of
treatment options."

The Food and Drug Administration Amendments Act (FDAAA) directs NIH to address
whether or not results of clinical trials should be disseminated if the drugs
studied in the trial are unapproved. BIO's testimony today was part of a public
meeting required to be held to address this and other questions regarding public
disclosure of clinical trial results.

In testimony, BIO reiterated its support for FDAAA`s goal to, "provide more
complete results information and to enhance patient access to and understanding
of the results of clinical trials." BIO noted that disseminating certain
additional trial result information may reduce duplicative studies, which divert
industry resources that could be used to undertake innovative research, and
could also alleviate pressures on the Food and Drug Administration`s review
resources.

BIO urged the agency to ensure that data provided on ClinicalTrials.gov has
scientific merit and can enhance the treatment and safety of patients. BIO also
asked the NIH to consider carefully new requirements for the expansion of the
public database so such requirements are not overly burdensome, especially for
small, minimally-staffed biotechnology companies. The requirements should ensure
that the information released is useful, understandable, and will best serve the
public interest.

BIO`s testimony is available at
http://www.bio.org/healthcare/BIO_Comments_NIH_2009_0002.pdf.

About BIO

BIO represents more than 1,200 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. BIO also produces the BIO International Convention, the
world`s largest gathering of the biotechnology industry, along with
industry-leading investor and partnering meetings held around the world.

Upcoming BIO Events

BIO-LES Business Development Basics Course
May 15-17, 2009
Atlanta, GA

BIO-LES Advanced Business Development Course
May 15-17, 2009
Atlanta, GA

BIO Executive Presentation Workshop
May 17, 2009
Atlanta, GA

2009 BIO International Convention
May 18-21, 2009
Atlanta, GA

BioEquity Europe
June 9-10, 2009
Munich, Germany

World Congress on Industrial Biotechnology & Bioprocessing
July 19-22, 2009
Montreal, Quebec, Canada

BIO
Stephanie Fischer
202-312-9263
sfischer@bio.org
www.bio.org

Copyright Business Wire 2009