23 May 2008
The US Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) released a draft report on pharmacogenomics for public comment in March 2007 (see previous news). Following a review of the comments by the Task Force in August/September 2007, SACGHS finalized the recommendations in November 2007 and a final report has been published this month. The report: Realizing the Potential of Pharmacogenomics: Opportunities and Challenges, outlines a number of recommendations and considerations in relation to the pharmacogenomics research and development and its integration into clinical practice and public health.
The final report clarifies and expands on some of the recommendations put forward in the draft report by identifying points of action and organisations to carry them out. Additional recommendations have been made in relation to clinical research and mechanisms to facilitate the evidence base needed in order for translation into clinical practice to occur. This includes calling upon the United States Department of Health and Human Services (HHS) to require grantees and contractors participate in the FDA’s Voluntary Genomic Data Submission Programme, fund clinical trials to provide evidence for clinical utility and form guidelines and standards on how studies investigating biomarkers associated with drug response are carried out. In addition, SACGHS recommends that the HHS should facilitate the development of evidence based clinical practice guidelines by supporting consensus-building efforts among developers of guidelines.
Recommendations have also been made in relation to coverage and reimbursement for pharmacogenomic products; SACGHS calls on the Centers for Medicare & Medicaid Services (CMS) to develop a guidance document on current health insurance programmes coverage and reimbursement of pharmacogenomics products and conduct surveys in order to inform its future decisions. Finally the report recommends that the HHS secretary should take all the necessary steps to review and prioritise the recommendations, assess how to implement them, monitor HHS progress and report back to SACGHS.