or proceeding based on the
company’s existing information.
Be mindful that once you ask
the question, an individual FDA
employee’s answer will be difficult
to ignore even if it may not align
to the consensus FDA point-of-view.
APPROACH: If you determine
FDA input is necessary, approach
the agency in the right way. Start
with an exploratory contact to
assess the agency’s true views on
a given matter. For example, a
coalition might probe the FDA
by saying “we think the agency’s
position is X.” It is not unusual to
then find that the coalition did not
understand the agency’s position
at all. Even an industry’s collective
wisdom can be wrong.
DON’T BE VAGUE: Avoid
overly abstract discussions. Put a
fact pattern in front of the FDA
to get a concrete answer. You’d be
surprised how often the answer is
one you didn’t expect.
ADVOCATE: Once you have
figured out the agency’s true,
current position, you can proceed
or advocate for change if you
disagree, but that is a topic for
Bottom line, there is a systematic
way to debunk a myth. Sometimes
it’s easy. Sometimes it’s hard and
takes time. But if you have a digital
health strategy worth pursuing,
and the only thing holding you
back is an FDA uncertainty, it
often makes sense to challenge
historical understanding of regulatory policy. Patients’ lives are
counting on digital health innovation, and you may just be
surprised how passionately FDA
agrees with that. •
Associate Director, Digital Health, The
Boston Consulting Group
Chris directs digital health initiatives across
large payer, provider, med tech and bio/
pharma companies. He leverages the best of
BCG Consulting, BCG Digital Ventures, BCG
Gamma Data-Science, and B.Capital to help clients formulate a
strategy, build a solution, and jointly invest in greenfield ventures
or new business units.
The Boston Consulting Group (BCG) partners with clients in
solving the hardest problems challenging their businesses, and the
world, by channeling the diversity of its people and their thinking, as well as a shared commitment to uncovering the truth.
The solutions they develop in partnership with clients transform
not just companies but also entire industries and even segments
of society. BCG has more than 90 offices in 50 countries, more
than 14,000 employees, more than 900 partners, and more than
Bradley Merrill Thompson
Member, Epstein Becker & Green, P.C.
Bradley counsels medical device, drug, and
combination product companies on a wide
range of FDA regulatory issues. He serves as
Chairman of the Board of EBG Advisors, Inc.,
a Washington, D.C., based consultancy that
takes a multidisciplinary approach to helping
health care and life sciences companies navigate the many ob-
stacles that they face. EBG Advisors is a network of international
attorneys, regulatory affairs professionals, reimbursement experts,
engineers, clinicians, quality systems advisors, and other profes-
sionals who specialize in providing coordinated guidance and solu-
tions across various segments of the health care industry.
Epstein Becker & Green, P.C., is a national law firm with a primary focus on health care and life sciences; employment, labor,
and workforce management; and litigation and business disputes.
Founded in 1973 as an industry-focused firm, Epstein Becker
Green has decades of experience serving clients in health care,
financial services, retail, hospitality, and technology, among other
industries, representing entities from startups to Fortune 100
companies. Operating in offices throughout the U.S. and supporting clients in the U.S. and abroad, the firm’s attorneys are committed to uncompromising client service and legal excellence.