According to the FDA, the release of the study launches a new FDA-wide Innovation Initiative that aims to redouble the agency's efforts to encourage innovations that will promote public health and strengthen the nation's economy.
Other action items include rebuilding the FDA's small-business outreach services; streamlining and reforming FDA regulations; training the next generation of innovators; and applying the potential of data-mining and information-sharing while protecting patient privacy.
The report was released on the same day the journal Health Affairs and the Center for the Study of the Presidency and Congress sponsored a briefing on Capitol Hill about personalized medicine, which tailors medical treatment to the individual characteristics of each patient. While the first panel of experts focused on scientific and clinical progress, the second panel centered on policy issues related to the topic. Dr. Jeffrey Roche, medical officer for the Coverage and Analysis Group at the CMS, expressed the agency's primary concern, which is whether the evidence is adequate to show that personalized medicine leads to improved clinical outcomes.
“I didn't come here to criticize what I think is a noble effort for us to try and understand ourselves better,” Roche told a crowded audience. “But I hope that people realize that whole genome sequencing itself is probably something CMS would never cover.”