March XX, 2018
Scott Gottlieb, M.D.
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-002
Dear Dr. Gottlieb:
We write in regard to the draft guidance on homeopathic drug products that the Food and Drug Administration (FDA) released on December 18, 2017, “Drug Products Labeled as Homeopathic.”
We applaud FDA for a risk-based approach in deciding whether to bring enforcement action against homeopathic drug products, as outlined in the draft guidance. This is a common-sense strategy that allows FDA to wisely use its limited resources to properly focus its enforcement on the areas where attention is most needed for the protection of public health.
While we support the approach of the draft guidance, in general, we are concerned with the document’s silence on a few key regulatory issues which are currently addressed in Compliance Policy Guide (CPG), 400.400, “Conditions Under Which Homeopathic Drugs May Be Marketed.” We believe that the Agency’s intention to revoke CPG 400.400 in its entirety without dealing with these issues in a new guidance will create confusion and uncertainty to the detriment of both the agency and the regulated community. This in turn could negatively impact both consumer access to these products and consumer health.
Specifically, we are referring to the guidelines laid out in CPG 400.400 for supporting homeopathic claims, how homeopathic products should be labeled, as well as defining what is and what is not a homeopathic drug. These topics are critical to address in the new homeopathic guidance as they provide the regulated industry and the public clear direction on the appropriate manufacturing and marketing of these products. By taking a risk-based enforcement approach but eliminating the current standards, the agency may encourage a rash of new and inappropriate products, which may not be authentically homeopathic, to enter the market. Such an outcome would not be in the public interest.
We believe that both the millions of U.S. consumers of homeopathic products and the FDA stand to benefit by having the key elements of CPG 400.400, which have established coherent and measurable regulatory parameters, incorporated into a risk-based enforcement posture. While we are not opposed to reasonable modifications or updates surrounding the important regulatory issues associated with CPG 400.400, we are concerned that completely ignoring those areas in the Agency’s new guidance could have undesirable ramifications for all homeopathic drug product stakeholders.
We appreciate your commitment to ensuring quality and safe drug products and U.S. consumers and trust that you will address the regulatory gaps in the agency’s draft guidance before it is finalized.
ORRIN G. HATCH