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The FDA’s
Proposed Draft Guidance for Drug
Products Labeled as Homeopathic:
A Statement by the Washington
State Homeopathy Association
written by William Rogers II
The
Washington State Homeopathy
Association (WaHA) endorses the
FDA’s vital role in ensuring the
safety and efficacy of all
medications that are marketed to
the public. The well established
tradition of collaboration
between the FDA and the
homeopathic community of
practitioners, pharmacists, and
consumers has enhanced the
health of the American public
through ready access to
authentic homeopathic
medications in
non--‐prescription formulations.
By enforcing the proper
preparation and labeling of
these medications, the FDA’ past
efforts have expanded and
improved the options for
self--‐care that are available
to lay consumers.
Clear
policies and equitable
enforcement guidelines have
prevailed for 30 years under the
provisions of Compliance Policy
Guide (CPG) 400.400. As the FDA
looks to the future, we hope
that the letter and the spirit
of this long established and
constructive regulatory approach
will continue.
The
publication by the FDA of
recently issued Draft Guidelines*
raises concerns that warrant
further discussion:
-
How valid are claims that
homeopathic remedies pose a
unique challenge to public
safety, especially since
those claims may not have
been reliably substantiated?
-
**Indeed,
the preponderance of risk to
consumers from
self--‐prescribing is hardly
confined to homeopathic
medications, especially in
vulnerable populations.***
Do the proposed draft
guidelines thus represent
equitable enforcement of the
FDA’s regulatory oversight?
-
Will
the proposed draft
guidelines effectively
protect the public from the
marketing of products that
are inaccurately described
as ‘homeopathic’ as well as
products in which
homeopathic and
non--‐homeopathic components
have been improperly
combined?
It is
WaHA’s position that the FDA’s
Draft Guidelines, as published
in December 2017, do not
sufficiently address these
issues.
As we move
forward, homeopathic
practitioners, pharmacists, and
consumers will be seeking
assurances from the FDA that it
will fulfill its mandated
responsibilities equitably. It
is our expectation that this
will be demonstrated through
specific and detailed regulatory
enactments as well as
consistent, transparent, and
clear articulations of FDA
policy vis--‐a--‐vis
homeopathic pharmacy practice.
Issues that will be important to
the homeopathic community in
assessing the FDA’ policies and
enforcement priorities include:
(1) Are
labeling and enforcement
guidelines sufficiently
stringent to prevent
non--‐homeopathic medications
from being marketed and sold as
non--‐prescription, homeopathic
medications?
(2) Are
labeling and enforcement
guidelines sufficiently
stringent to prevent combination
products with non--‐homeopathic
components from being marketed
and sold as non--‐prescription
homeopathic medications?
(3) Are
the standards for safety and
efficacy applied equitably to
homeopathic and
non--‐homeopathic medications?
(4) Are
enforcement measures pursued
with equal and unbiased
vigilance for homeopathic and
non--‐homeopathic medications?
We join
our colleagues in the
homeopathic pharmacy industry as
well as our patients in
encouraging further discussion
of these issues with the goal of
preserving the atmosphere of
constructive engagement that has
legitimately enhanced the
practice standards of homeopathy
and the health of the public.
*Center
for Drug Evaluation and Research
and Center for Biologics
Evaluation and Research, Food
and Drug Administration, U.S.
Department of Health and Human
Services, “Drug Products Labeled
as Homeopathic: Guidance for FDA
Staff and Industry,” December
2017. Marked “Draft – Not for
Implementation.”
**Lennihan
B. “Food and Drug Administration
action against homeopathic
teething tablets lacked evidence
base.” Published by Mary Ann
Liebert, Inc., Publishers. Open
access PDF version available on
the World Wide Web at:
https://www.liebertpub.com/doi/pdf/10.1089/act.2017.29148.ble
***Rimza
ME, Newberry S. Unexpected
infant deaths associated with
the use of cough and cold
mediations. Pediatrics.
2008 Aug;122(2):e318--‐22. doi:
10.1542/peds.2007--‐3813.
Abstract
available through the NCBI on
the World Wide Web at:
https://www.ncbi.nlm.nih.gov/pubmed/18676517
Click
HERE
to send a letter to your
senators and representatives to
help protect access to
homeopathic remedies.
Click
HERE
to learn about the issues
regarding the FDA Challenge to
Homeopathy. |
