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President Urges breaking down.pdf

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President Urges Breaking Down Of
Drug, Device Distinctions, Regulatory
By Ferdous Al-Faruque / Email the Author
Regulatory & Policy News / Word Count: 1154 / Article # 01160229017 /
Posted: February 25 2016 5:50 PM

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Executive Summary
The White House held a summit on its Precision Medicine Initiative where
President Obama emphasized the need to break down outmoded regulations,
and suggested that the barriers between drug and device oversight need to
be loosened. Also at the meeting: FDA and NIH announced new competitions
and projects, including the launch of an effort to gather data from a million
Americans over the next few years.

President Barack Obama emphasized the need to break down regulatory barriers,
including regulatory distinctions between drugs and devices, to advance more
coordinated, personalized medicine during a Feb. 25 White House summit.
The gathering was held to discuss the next steps of the Precision Medicine Initiative
, which the president launched more than a year ago to bring different
stakeholders together to advance genomics-based treatments and other
technologies. (See "Precision Medicine Plan 'Golden Opportunity' For Device,
Diagnostic Firms" — "The Gray Sheet," Sep. 18, 2015.)
During the summit, the president emphasized that the goal of the initiative is to
figure out how to break down some of the structural and institutional barriers that
are preventing patients from getting treatment on a personalized level, and that
includes taking down outdated regulations while still protecting patients.

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He alluded to one particular issue that
appears to be gaining some traction in

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/9/president-urges-break... 2/26/2016