SAN FRANCISCO (GenomeWeb News) – A US Department of Health and Human Services committee next month will issue its final report with suggestions for the Food and Drug Administration’s role in overseeing pharmacogenomic tests, a high-ranking FDA official said today.
Speaking today at the Molecular Medicine Tri-Conference here, Steve Gutman, director of the FDA's Office of In Vitro Diagnostic Device Evaluation and Safety, said that the HHS Secretary’s Advisory Committee on Genetics, Health, and Society would issue a report containing more than 200 pages of recommendations. He said the guidelines, which are being published ahead of schedule, “will be challenging for HHS to address.”
Guttman added that it is too early to say how much more of a role FDA will play than it currently does in the regulatory process for genetic tests.
Last year, the SACGHS issued a draft report in which it said that there is not enough data regarding how pharmacogenomic tools can inform clinical decisions, such as dose adjustments, and the FDA needs help defining these gaps in knowledge.
The draft report recommended the FDA work with professional medical organizations to develop dosing guidelines, encourage clinical trials exploring the relationships between diagnostics and drug response, and seek input from stakeholders in industry and academia to translate the findings from prospective studies into treatment guidelines.