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President Urges breaking down.pdf


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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

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