Specialty Update
Physicians’ advocacy efforts
It is a pleasure to write this
specialty article for the Dallas
Medical Journal, and update
my physician colleagues in
the Dallas County House of
Medicine on what’s happening
in the specialty of Dermatology. I
wanted to present varied topics
of interest to readers, however,
discussing what we as a specialty are
doing in advocacy for Dermatology fits
best with these rapidly changing times
in health care.
We are fortunate in Dermatology
to have so many active organizations
supporting dermatologists, notably,
the American Academy of Dermatology
Association, the American Society for
Dermatologic Surgery Association, the
American College of Mohs Surgery, the
American Society for Mohs Surgery,
the Skin of Color Society, and the
Society of Pediatric Dermatologists.
This article will focus on our AADA
efforts in the rapidly evolving area of
compounding, as well as what we as
a specialty are doing at the American
Medical Association to support
physicians of all specialties. I have
the privilege of having been elected
to the AAD board of directors and
representing the voices of more than
cross specialties Seemal R. Desai, MD, FAAD
18,000 dermatologists and members
worldwide. In addition, I serve on
the US Food & Drug Administration,
Pharmacy Compounding Advisory
Committee, along with numerous
other leadership roles. It is through
this work that I have seen firsthand
the vital importance of physicians to
be involved in advocacy.
WORKING WITH FDA
ON COMPOUNDED MEDICATIONS
The AADA and other organizations
continue to engage with the FDA
and United States Pharmacopeia
on policies affecting access to
compounded medications in
dermatology. In its first draft guidance
on Insanitary Conditions, FDA
proposed including physician offices
in its definition of “compounding
facilities” subject to federal
government oversight. As a result of
advocacy by AADA leadership and
relationship building with FDA, FDA
stated in its 2018 Compounding
Policy Priorities that it will revise this
guidance to “address concerns raised
by some providers who compound
small quantities of drugs in their
offices for patient use, and as part of
6 Dallas Medical Journal November 2018
their routine clinical practice. This
came up in the setting of certain
dermatological procedures, for
example.” On September 25, FDA
published its revised draft guidance
for comment, removing physician
offices from the types of settings that
it considered to be compounding
facilities. It also stated that the agency
generally does not intend to take
action against physicians who are
compounding or repackaging a drug
product, or who are mixing, diluting
or repackaging a biological product,
provided that such activities occur in a
physician’s office where the products
are administered or dispensed to the
physician’s own patients.
The FDA proposed policy would
leave oversight of physician in-office
preparations to the states. USP is
an independent, standard-setting
organization that sets standards
for both sterile and nonsterile
compounding. AADA has been
engaged with USP regarding its
second set of proposed revisions to
Chapter 797 involving compounded
sterile preparations, such as buffered
lidocaine and triamcinolone acetonide.
In the proposed revisions, USP
proposes a one-hour exemption from