AAHP 2019: Reawakening the Regulatory and Retail Dialog

By Mark Land, AAHP President

This year marks the fifth year in a cycle of regulatory review of homeopathic drug product labeling, safety, and quality. AAHP has been there for the industry as an advocate and representative over the entire duration. In 2019 AAHP provided direction and regulatory thought-leadership within the homeopathic community, met with FDA’s Office of Compliance, and hosted a highly successful Quality and Regulatory Summit preceded by our inaugural reception with retailers. This work challenged us but it significantly contributed to opening a dialog with FDA and strengthened our position as an expert resource to retailers.

Just one of our most insightful interactions with FDA this year was with Donald Ashley and Brad Pace of the agency’s Office of Compliance in March. During that meeting Al Lorman and I discussed AAHP’s concerns with FDA’s draft homeopathic guidance and with rogue products entering the market. We gained a great deal of insight into the Office of Compliance enforcement approach and we invited Mr. Ashley to speak at the AAHP Summit.

Community outreach and thought-leadership included liaisons with multiple allied associations including NCH, AIH and Americans for Homeopathy Choice. Our work with these groups included routine communications on regulatory issues, collaboration on legislative initiatives, and financial support of the Annual Joint American Homeopathic Conference. AAHP tripled its reach by substantially expanding its mailing list.

Member engagement was also considerably improved—both in operational efficiency and participation numbers. First, AAHP conducted its first ever Executive Conference in March of this year in conjunction with CHPA’s Annual Executive Conference. AAHP organized a breakfast briefing for senior level executives in homeopathic companies, knowing many of them would attend the CHPA event. Our goal was to reach decision makers in member firms that don’t normally attend our annual meeting in Anaheim. Second, we pioneered a virtual semi-annual membership meeting in November, resulting in double the participation compared to the traditional in-person format for this meeting.

The Quality and Safety Summit in June was a success on many levels. There were 104 participants from the U.S. and five other countries—which far exceeded our expectations for this first-time effort! We presented scientific concepts and research results covering nine subjects in three topics (quality, safety, and regulatory). Among the participants were three representatives from FDA’s Office of Compliance. Francis Godwin, Director of Office of Manufacturing Quality and our keynote speaker, advised AAHP to present its list of seven subject areas requiring publication of more in-depth guidance to FDA’s Office of Compendial Affairs. I am pleased to say HPCUS discussed and gained alignment on the priority of these subjects with this branch of FDA in early October. I can’t overstate how important the Summit has been to reawaken the compliance dialog with FDA.

AAHP hosted our inaugural Retail Reception in June. The reception was a two-hour evening of presentations on the state of the homeopathic industry from a retail and regulatory standpoint. The AAHP Board was joined by representatives from Consumer Healthcare Products Association, National Association of Chain Drug Stores, Chain Drug Review magazine, The Emerson Group, The Wegman Company, Whole Foods Market, the Board of the National Center for Homeopathy, and 80 industry guests. The reception marked the beginning of building the AAHP brand as the leading source of information on the homeopathic industry for the retail community.

The resiliency we created in 2019, the dedication of all AAHP volunteers, and the support of our members enabled AAHP to achieve these accomplishments. Thank you everyone.