Originally Published IVD Technology May 2005
INDUSTRY NEWS
FDA releases pharmacogenomics guidance
Richard Park
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In an effort to facilitate the development of new medical products through pharmacogenomics, FDA issued a final guidance titled “Pharmacogenomic Data Submissions.” This guidance clarifies how the agency will evaluate pharmacogenomic data. It also describes what data will be needed during the marketing application review process, the format for submissions, and the data that will be used during regulatory decision making.
“It is important for FDA to have a role in the evaluation of pharmacogenomic tests, both to ensure that evolving FDA policies are based on the best science and to provide public confidence in the field,” the agency stated in the final guidance. “FDA developed this guidance to facilitate the use of pharmacogenomic tests during drug development and encourage open and public sharing of data and information on pharmacogenomic test results.”
Developing a guidance on the submission of information on pharmacogenomic tests has been an ongoing effort at FDA. During the past few years, the agency has undertaken a process for obtaining input from the scientific community and the public. This process has included holding workshops and presentations, publishing a draft guidance and soliciting public comment on that draft, and developing internal policies related to pharmacogenomics and voluntary submissions. Industry analysts believe that this final guidance is a move in the right direction.
“This document has been eagerly anticipated by the molecular diagnostics industry as an important step on the road to making personalized medicine a reality,” says Richard S. Schifreen, PhD, director of technology and market development at Promega Corp. (Madison, WI). “In some cases, delays result in a stale product. However, in this case, FDA has delivered a thoughtful proposal that should accelerate the development of this field.”
The final guidance also explains a new mechanism for the IVD industry to submit research data voluntarily in order to further the scientific exchange of information as efforts are made to move into more-advanced areas of pharmacogenomic research. The voluntary data, which will be reviewed by an internal, agencywide group and will not be used for regulatory decision making, will help FDA and the industry gain valuable experience as this new field continues to evolve.
“An exciting element of the guidance is its approach to encouraging voluntary participation to build the knowledge base required to support adoption of personalized medicine,” says Schifreen. “It is an innovative way to accelerate sharing of data that should benefit all of us: companies, scientists, FDA, and patients.”
In conjunction with the final guidance, FDA launched a new pharmacogenomics Web page, “Genomics at FDA,” that is available at
www.fda.gov/cder/genomics/default.htm. The Web site contains detailed information on submitting genomic data, including a decision tree to simplify data submissions, relevant regulatory information, and FDA contact information.
Other industry analysts believe that the fundamental impact of the final guidance on the IVD industry will be positive since it will encourage greater cooperation between pharmaceutical companies and IVD manufacturers. This cooperation has historically been limited because pharmaceutical companies wanted to control their own destiny and be able to market their drugs as widely as possible. However, if more pharmacogenomic data are used and submitted, their quality will be scrutinized by FDA. Such a development will likely lead to and require increased partnerships between pharmaceutical and IVD companies.
Industry analysts added that through such partnerships, a wide range of revenue-sharing strategies can be envisioned. For example, by coupling some of the pharmaceutical industry’s revenues to IVD tests, the balance of revenues between pharmaceutical and IVD companies may shift.
For more information about the final guidance on pharmacogenomic data submissions, visit the FDA Web site at www.fda.gov.
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