WASHINGTON, Sept. 22 /PRNewswire/ -- Jim Greenwood, President and CEO
of the Biotechnology Industry Organization (BIO), today issued the
following statement in initial response to release of "The Future of Drug
Safety: Promoting and Protecting the Health of the Public," a report
written by the Institute of Medicine Committee on the Assessment of the
U.S. Drug Safety System:
"The U.S. drug safety system continues to be the 'gold standard' for
the world. Even so, we support consideration of efforts to further
strengthen the system through increased Congressional funding and the
development of new tools to improve drug safety. We are committed to
working with other stakeholders to assist FDA in enhancing its capacity to
ensure the safety and effectiveness of marketed biopharmaceuticals and
therapies."
BIO members are leaders in developing breakthrough tools for evaluating
product safety and reducing the potential for adverse events. For example,
pharmacogenomics research may help identify early in development which
potential products will present safety issues. Better animal models,
improved computer-based models, and new clinical evaluation techniques also
are evolving.
The FDA's Critical Path Initiative holds great promise for ensuring
these tools are applied in product development and regulatory processes.
Through the Critical Path Initiative, the FDA is also advancing the
development of Personalized Medicine, which allows therapy to be tailored
to the individual patient. For example, Critical Path projects will further
the development of biomarkers that help scientists and physicians monitor
the progress of disease and evaluate which product will work best for a
particular patient. That is why BIO has supported fully funding the
Critical Path Initiative.
"Modernization of the medical product development sciences through the
Critical Path Initiative will employ new fields of science such as
genomics, proteomics and related disciplines, to improve scientific
understanding and prevention of safety problems, and will create new
opportunities to improve product safety by strengthening post-market
surveillance of adverse events." Greenwood said.
Greenwood added that BIO also supports FDA's establishment of the Drug
Safety Oversight Board (DSB). The DSB provides oversight and advice to
leadership of the Center for Drug Evaluation and Research on managing drug
safety issues and the flow of emerging safety information to healthcare
professionals and patients. "Over the past two years, the Drug Safety
Oversight Board has conducted timely and comprehensive evaluations of drug
safety concerns and assisted the FDA in ensuring that safe and effective
drugs are available for patients," he said.
"BIO values patient safety above all other priorities. When considering
enhancements to the U.S. system, we must be cognizant that implementing
undue hurdles in the drug review process will harm patients by delaying
access to life-enhancing and life-saving products," Greenwood said.
BIO represents more than 1,100 biotechnology companies, academic
institutions, state biotechnology centers and related organizations across
the United States and 31 other nations. BIO members are involved in the
research and development of healthcare, agricultural, industrial and
environmental biotechnology products.
SOURCE Biotechnology Industry Organization
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Related links:
http://www.bio.org/
CONTACT:
Kim Coghill, +1-202-962-9232, or Jeff Joseph,
+1-202-962-9230, both of BIO
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