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FDA seeks to spur innovation in personalized medicine


By Jessica Zigmond
Posted: October 5, 2011 - 5:30 pm ET
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Establishing the infrastructure to support personalized medicine, creating a quick development pathway for therapies and improving the medical-device review process are among the major actions the Food and Drug Administration outlined in a new report released Wednesday designed to spur innovation.

“Today's medical product pipeline, despite a number of groundbreaking new drugs approved this year, does not have enough new products to sustain the health of the industry in the long-term or address many of the chronic diseases afflicting Americans every day,” the FDA noted in the report, Driving Biomedical Innovation: Initiatives for Improving Products for Patients.

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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.”


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