The Bush administration's Council of Advisors on Science and Technology said in November that the FDA needs to implement a more transparent, systematic and iterative approach to regulating genomics-based molecular diagnostics. The recommendation was part of a council report on “Priorities for Personalized Medicine.”
The report defines personalized medicine as the tailoring of medical treatment to the individual characteristics of each patient. It says the current high level of interest from a policy perspective is attributable not only to the promise of improved patient care and disease prevention, but also to the potential for personalized medicine to have a positive impact on two other important trends—the increasing cost of healthcare and the decreasing rate of new medical product development.
The council says that while the FDA has made progress in defining its approach to regulating genomics-based molecular diagnostics, its guidance remains ambiguous or incomplete in several areas. It expresses dismay at the slow progress to date on the FDA's Critical Path Initiative that was intended to stimulate and facilitate modernization of the development path for drugs and devices. The report calls for adequate funding of the Critical Path Initiative and for industry to adopt a proactive and constructive role as FDA seeks to identify and fulfill its regulatory responsibilities.