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President Urges breaking down .pdf



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Related Articles: 4
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President Urges Breaking Down Of
Drug, Device Distinctions, Regulatory
Barriers
By Ferdous Al-Faruque / Email the Author
Regulatory & Policy News / Word Count: 1154 / Article # 01160229017 /
Posted: February 25 2016 5:50 PM

FDA Funding Proposal Includes
Cross-Cutting Oncology Focus,
Disappoints Budget Advocates
“The Gray Sheet” Feb. 10, 2016
A Sharing Tool For Next-Gen
Sequencing: FDA Launches
precisionFDA
“The Gray Sheet” Dec. 17, 2015
FDA Reorganization Advocates
Seek Senate Boost For DiseaseOriented Structure
“The Gray Sheet” Nov. 30, 2015
Precision Medicine Plan 'Golden
Opportunity' For Device,
Diagnostic Firms
“The Gray Sheet” Sep. 18, 2015

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includes taking down outdated regulations while still protecting patients.

Topics Covered in
this Article
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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

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regulatory circles – the need to break
down silos between drug and device
regulatory reviews and requirements.

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"FDA traditionally has
thought about protecting the
public health in terms of,
these are medical devices
and these are drugs, and
there are certain categories,
and there are certain
protocols that we go
through," President Obama
says. "Sometimes we’re
fitting square pegs into
round holes."

"The FDA traditionally has thought about
protecting the public health in terms of,
these are medical devices and these are
drugs, and there are certain categories,
and there are certain protocols that we go
through," the president said. "When it
comes to gathering data, disseminating
data, making sure it’s accurate and valid,
figuring out how it’s communicated to the
patient or the individual who’s interested
in it – sometimes we’re fitting square
pegs into round holes, and we may have
to re-conceptualize how we think about this to open up this space."

The sentiment is consistent with a provision in the administration's latest budget
request to create an Oncology Center of Excellence that would cross-cut the
traditional product centers and emphasize the development of combination
therapies for cancer. (See "FDA Funding Proposal Includes Cross-Cutting Oncology
Focus, Disappoints Budget Advocates" — "The Gray Sheet," Feb. 10, 2016.) This
follows a growing effort by prominent public health advocates to get FDA to rethink
is product-center-oriented structure. (See "FDA Reorganization Advocates Seek
Senate Boost For Disease-Oriented Structure" — "The Gray Sheet," Nov. 30,
2015.)
"One of the charges I've given to all of the federal agencies working together on this
is looking at the regulatory framework we have that was designed for another era of
medicine and making sure we update it," Obama said. "And that's where I think the
work that we do with Congress can be very important here and there's good
bipartisan support for how we think about this."
Even while pushing to "break down regulations," the president also emphasized that
"there are a whole range of areas where we may need new safeguards, for example
in terms of privacy and security of the data that's being disseminated."
Further, he urged renewed efforts by medical companies to take advantage of new
opportunities.
"This won't work unless we have the private sector coming up with innovation, and
that includes drug companies and that includes manufacturers," he added, pointing
at his Fitbit. "You know, ultimately, something that's just tracking your heart-rate
may be able to track a whole bunch of other stuff that is giving you a constant flow
of information on a daily basis that is keeping you healthier. We want to encourage
that kind of innovation and we want that kind of innovation, and we don't want
bureaucracy standing in the way of that."

FDA Issues New Challenge To Develop DNA Tests
During the summit, multiple new specific projects and funding efforts were
announced. For FDA, the White House also announced that the agency had
launched its first challenge as part of its precisionFDA project. The precisionFDA

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Consistency Challenge
is intended to prompt the research community to employ
the new precisionFDA
electronic portal to develop DNA quality standards and
test results to advance personalized medicine.
The precisionFDA portal was launched at the end of last year to give researchers
access to information to personalize treatments to patient needs and help regulate
next-generation sequencing tests. Stakeholders in the diagnostics space are
especially interested in how the platform can be used to aggregate genomic data to
support development of new next-generation sequencing tests. (See "A Sharing
Tool For Next-Gen Sequencing: FDA Launches precisionFDA" — "The Gray
Sheet," Dec. 17, 2015.)
The White House summit was also the first public appearance of Robert Califf as
the agency's new commissioner. While he did not make a public speech during the
meeting, several speakers including National Institutes of Health Director Francis
Collins and President Obama congratulated him on his confirmation and noted
FDA's key role in moving the Precision Medicine Initiative forward.
Collins noted FDA is developing a regulatory framework for reviewing genomic
technologies that will take advantage of existing and evolving standards and is
using researcher crowdsourcing such as the precisionFDA project to identify the
most accurate genetic testing tools.
"We will work to the highest standards of data quality, working with our colleagues
at the FDA," Collins said. "I am also thrilled that the commissioner is here with us
this morning because he's been such a leader in thinking through the ways we can
be sure … the information people receive about themselves is meaningful and
clinically valid."

NIH Seeks A Million Volunteers
Collins also announced several additional new initiatives for NIH. In particular, the
agency is supporting a pilot program that will be launched by Vanderbilt University
in Nashville, Tenn., in conjunction with the Google health-focused spinoff Verily to
start enrolling volunteers for "the first phase of the Precision Medicine Initiative
Cohort" as a first step to collecting genomic and other data from a million
Americans.
NIH also says it will collaborate with the Health Resources and Services
Administration to work with community health centers to help enroll underserved
and underrepresented volunteers into the cohort.
NIH will also work with the Office of the National Coordinator for Health IT on a
project called "Sync for Science" to develop open standards with multiple electronic
health records companies.
Collins also announced that the NIH has established a central institutional review
board to oversee how the Precision Medicine Initiative is conducted and to protect
the rights of its participants.
The NIH director said this is the fastest he has seen any such project progress in
his more than 20 years in government. By the summer, the remaining parts of the
Precision Medicine Initiative will go into effect, Collins said, including establishing a
coordinating center, developing a network of health care providers to engage and

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enroll patients, establishing a biobank to store genetic material, and the creation of
a participant technology center to monitor and harness mobile health data.
This copy is for your personal, non-commercial use. For high-quality copies or
electronic reprints for distribution to colleagues or customers, click here or call
+1 (908) 547-2200 .
Printed by Mr. Norm Rabin, Maetrics LLC

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