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Science Board Makes
Recommendations To CFSAN
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FDA's advisory Science Board, tasked with
reviewing the intramural research program at each
agency center, first undertook a review of the Center
for Food Safety and Applied Nutrition's research
activities, support programs and alignment with
regulatory responsibilities ("The
Tan Sheet" Aug. 24,
2009, In Brief). At
the Aug. 16 Science Board meeting in Bethesda, Md.,
Rhona Applebaum, chair of the board's CFSAN Research
Review Subcommittee and chief scientific &
regulatory officer at Coca-Cola, summarized
a reportwith
observations of and recommendations for the food
center. Excerpts of her presentation
follow.
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"The key to
doing what is absolutely essential is to get more
collaboration and more networking. ... What we
look at in the industry when we're looking at science
and regulatory affairs, which is basically the
component within business to focus in on regulatory
science, we focus in on five competencies: science,
policy, networking, communications and governance. So
it shouldn't be any different than when you're dealing
with similar bodies within an organization like CFSAN.
That's why networking is so key - not only for
intelligence gathering, but also to broaden your
capabilities and your expertise."
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"One of the
opportunities that we identified is the current
economic challenges have resulted in the availability
of highly qualified scientists. And CFSAN has
some really good scientists that have come from the
food industry and from academic institutions. So yes,
there's an opportunity to grow from within, but there's
also an opportunity to borrow from
outside."
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"You have a wealth
of [consumer research] data. Share it! And again, if
there's an issue related to proprietary information,
then we have to have a better understanding of that.
But your information is golden, it needs to be
shared with the public at large."
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"Further
develop CFSAN's external research program.
That's how you're going to be able to leverage your
skills and your capabilities. ... That's where your
legacy is going to be coming from when you do that
extramural research, where they see the opportunities
within CFSAN, especially from the food science
departments and others."
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"Stop being the
best-kept secret [at FDA]. Work hand-in-hand with
your public affairs and your communications
people, because we're not trained to pat
ourselves on the back. In today's world you have to,
because you do a great job."
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"[Dedicate]
resources for both a reactive focus to mitigate current
problems in a more timely fashion and a proactive focus
to anticipate and act on future problems. Why?
Because we expect CFSAN to solve today's problems
but also anticipate, identify and resolve tomorrow's
problems."
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"You continue to be
reviewed. And if I use an analogy that we have in the
food industry, it's kind of like having the FDA
inspectors there every day, 24/7, and it impacts your
ability to get work done. So our plea from a
subcommittee perspective is, you have a number of
reviews that have been done, whether it's GAO, whether
it's OMB, whether it's this one. ... Let [CFSAN
leaders] assess what the recommendations are.
Have them compare it and align it with their
strategic plan, and then perhaps implement first those
recommendations that are similar. Because those
are going to drive the strategic plan."
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"Establish a
formalized process for identifying emerging
issues. This can't happen if your scientists
are on the bench - and I'm not being facetious - either
cleaning the test tubes or ordering supplies. They
can't go up to 30,000 feet to identify where the smoke
is before the fire erupts. So that is absolutely
essential in order for you to identify where those
emerging issues are. Because by the time you read it on
the Internet, if you think you're going to be able to
find it in a blog - oh, please. You're going to find it
when you're at a professional meeting and somebody's
whispering it in your ear."
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