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Washington, D.C. (November 3, 2003) Gillian Woollett,
the Biotechnology Industry Organization's vice president for science
and regulatory affairs, issued the following statement in response
to the Food and Drug Administration's publication today of a draft
guidance on pharmacogenomics:
"This draft guidance proposes a mechanism for comfortably sharing
exploratory pharmacogenomic information with the FDA - without
stalling on-going drug development. Although we have not yet had
an opportunity to review the details, the biotechnology industry
supports the concept of such voluntary genomic data submissions.
This is an example of the FDA working with the industry to anticipate
regulations and understand what the appropriate regulations should
be.
"More importantly, for patients, this move is a significant step
toward the era of 'personalized medicine,' when genetic analysis
will help guide prescribing decisions and many drugs will be tailored
to treat genetically defined subsets of the population. The FDA
will need the information voluntarily submitted under this guidance
to prepare for evaluation of such products."
Details of the proposed guidance will be discussed in Washington
next week at a Drug Information Association conference called
Pharmacogenomics in Drug Development and Regulatory Decision-making:
The Genomic Data Submission (GDS) Proposal. The event, which BIO
is co-sponsoring, runs November 13-14. For details, visit www.diahome.org.
To be added to BIO's contact list for information on this subject,
e-mail Dr. Woollett at gwoollett@bio.org.
The Biotechnology Industry Organization (BIO) represents more
than 1,000 biotechnology companies, academic institutions, state
biotechnology centers and related organizations in all 50 U.S.
states and 33 other nations. BIO members are involved in the research
and development of health-care, agricultural, industrial and environmental
biotechnology products. For more information on BIO, visit our
website at www.bio.org
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