The 2010 GPMA would have authorized spending $150 million for expenses including education and training grants, contracts, or cooperative agreements; a Committee on Public Engagement consisting of private-sector personalized medicine professionals; and a new Office of Personalized Healthcare (OPH) within the Department of Health and Human Services’ (HHS) Office of the Secretary, charged with coordinating the activities of the OPH and other federal agencies with that of private and public entities outside of government.
Last year’s bill also proposed a committee to analyze laboratory review requirements under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, with an eye to eliminating red tape from FDA, the Centers for Medicare and Medicaid Services (CMS), and private laboratory-certifying entities. It also suggested setting up an advisory committee “to expand and accelerate knowledge related to the clinical validity and utility of genomics and personalized medicine.”
Miller said PMC envisions a single committee, a broader advisory panel of at least 21 people within HHS’ Office of the Secretary to support the advancement of personalized medicine within the department and the agencies it oversees, notably FDA and CMS. The Health and Human Services Personalized Medicine Advisory Committee would recommend policies, regulations, and programs to promote public and private funding.
“We don’t really need that many committees. We just need one really good one that works across HHS agencies,” Miller pointed out. As envisioned by PMC, the new bill would retain OPH but bring it within FDA.
OPH had more expansive duties when proposed last year, including developing a long-term strategic plan for personalized medicine, crafting recommendations to delineate the roles and responsibilities of the FDA and CMS, and resolving conflicts between the agencies.