By Mark Land, M.S., RAC, AAHP President
AAHP held its first complimentary and open-to-industry town hall on June 27, 2023 with two goals. First, we wanted to take the pulse of the industry to learn the most important issues for manufacturers and marketers of homeopathic drug products. Second, we wanted to provide helpful insight to our members and the industry at large.
To maximize our time during the town hall itself, AAHP had its management firm The Markens Group survey attendees in advance (to assure anonymity). More than 100 responses were received to five questions, which allowed speakers to develop introductory responses before moving into open Q&A. This article will review the top industry concerns expressed through those five questions and AAHP’s preliminary answers.
Survey Question #1: What are your primary concerns as a manufacturer, marketer, labeler, etc. within the retail environment? Response was provided by Mary Borneman, AAHP Treasurer and Hyland’s Naturals Legal and Communications.
Issue: What is AAHP doing to maintain confidence in homeopathic medicines among retailers?
AAHP Response: AAHP is building bridges with retailers through its annual Integrative Medicine Retailer Award, now it its fifth year. The program creates an opportunity to further inform the “retailer of the year” about homeopathy.
Most importantly, AAHP has spent at least the last decade developing its leadership and partnering with regulatory agencies and the community so it can be an effective resource for your retailers to ask questions and get informed answers. AAHP is well suited to assist its member companies with information about FDA announcements and subsequent media headlines.
Survey Question #2: As a manufacturer, what matters most when it comes to product quality? Responses were provided by Eric L. Foxman, AAHP Secretary and industry consultant.
Issue: The survey yielded a variety of responses related to current Good Manufacturing Practices (cGMP), and specifically sourcing of materials.
AAHP Response: Homeopathic products are drugs and must comply with cGMPs. The Homeopathic Pharmacopoeia Convention of the United States (HPCUS) is working to address gaps in cGMPs that impact homeopathic drug products. To ensure high quality of incoming components, you must audit suppliers. This is a basic cGMP requirement and makes sense: if one doesn't know the ability of a vendor to supply required quality, how can one depend on them as a supplier of materials? There is a cost to ensure appropriate quality and compliance with cGMPs; however, in the long run, non-compliance is even more expensive.
Issue: What insights do you have regarding FDA Warning Letters?
AAHP Response: Microbial contamination has been cited in numerous warning letters. It is preventable. To quote Ben Franklin, “An ounce of prevention is worth a pound of cure.” Water systems are the most frequent contributor to microbial contamination problems. A first step might be hiring the services of a water systems expert on a regular basis. The former director of FDA CDER’s Division of Microbiology Assessment will discuss microbial contamination in non-sterile drug products at the AAHP GMP Seminar on Oct. 18.
Responses to Survey Question #3: When it comes to manufacturing, what are the key issues that affect your operation? Responses were provided by Mark Land, AAHP President.
Issue: What can you say about process validation in the homeopathic environment?
AAHP Response: Homeopathic medicines are drugs and therefore manufacturers must be able to demonstrate that their manufacturing process is reliable and results in final products that meet specifications. To ensure the reliability of homeopathic dilutions being used in the production of homeopathic drug products, manufacturers must conduct tests to demonstrate the reliability of their dilution process. This means conducting dilution steps as you have designed them and then measuring the resultant deconcentration of a marker compound. The results must be in a narrow range of acceptance criteria and should be carried out until the marker is no longer detectable. These results should be analyzed statistically to ensure that the process supports extrapolation to higher dilutions. The HPCUS is working to establish process validation guidance specifically for the preparation of Hahnemannian dilutions.
Issue: What about identifying and quantifying the active ingredient in final products?
AAHP Response: Finished product testing including identification and quantification of all active ingredients in the final drug product is required by cGMP regulations. For diluted homeopathic active ingredients this may not be possible with current analytical methods. FDA originally proposed exempting homeopathic drugs from this requirement but changed its mind more than 20 years later, saying that there may be instances in which finished product testing is required.
In general, if you can technically test for an active ingredient you should test for it. If testing is beyond what can be reasonably accomplished, then the documentation of the process coupled with all other reasonable quality parameters must be completed such as identification of diluents, preservatives, physical tests like viscosity, tablet hardness, etc. HPCUS is working on standards in this area.
Responses to Survey Question #4: As a manufacturer, labeler, marketer, etc., what are your top concerns regarding regulatory matters? Response was provided by Al Lorman, AAHP Counsel.
Issue: Several participants expressed concern about the new FDA guidance and the ambiguity some see in it. For example, will FDA continue to use a risk-based enforcement approach? Will they stop imports of homeopathic drug products based solely on "unapproved new drug" status?
AAHP Response: A risk-based approach is the best way to protect public health at this time. Manufacturers and marketers of homeopathic medicines have a great deal of influence over the future of the risk-based regulatory enforcement. Compliance with regulations and guidance is the best way to maintain the regulatory environment in favor of risk-based enforcement. This holds true for imports as well.
Responses to Survey Question #5: Your input is essential in shaping AAHP's focus and priorities. What specific areas would you like us to concentrate on? Responses were provided by Alissa Gould, AAHP Chair of Communications Committee, and Boiron USA Director of Corporate Communications and Public Affairs.
Issue: Several comments asked for more information on cGMPs and updates on regulations.
AAHP Response: These are core subjects of AAHP’s webinars and news articles. If you haven’t already signed up for AAHP’s monthly newsletter, breaking news e-blasts, and webinar announcements, you can do so on the homepage of www.TheAAHP.org.
Issue: How is AAHP maintaining awareness of homeopathy and our issues among legislators? What are future plans in this area?
AAHP Response: AAHP launched a federal relations program in 2010. We have a Washington D.C.-based lobbyist who identifies which Members of Congress have the greatest impact for our products. We continually educate staff in those offices due to high turnover.
Issue: Are there any ways that AAHP can support research activities? How can we stimulate clinical research?
AAHP Response: Companies need to play their role in conducting research to support their product. We understand most homeopathic companies are small, so AAHP recommends manufacturers financial donate to the Homeopathic Research Institute. It’s a London-based non-profit that is making great progress and coordinating global efforts. Its chief executive will host an AAHP webinar on research on Sept. 20. Beyond this, perhaps a fundraising campaign can be started to support research if that’s what the membership wants.
Thank you to everyone who attended the Town Hall and responded to the survey questions and AAHP thanks our host Emily Leonczyk at The Markens Group and our panelists. We plan to host more town halls in the future. Watch your email for information on these and other AAHP events.