Pharmacogenomics Draft Guidance A Significant Step Toward Personalized Medicine

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affairs, issued the following statement in response to the Food and Drug Administration's publication today of a draft guidance on pharmacogenomics:

"This draft guidance proposes a mechanism for comfortably sharing exploratory pharmacogenomic information with the FDA—without stalling on-going drug development.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

To be added to BIO's contact list for information on this subject, e-mail Dr. Woollett at

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