Friends Newsletter
Dear Friends of the Pharmacopeia,
Since the last newsletter in September 2024, much has changed.
Legal update — The Center for Inquiry is a well-funded organization of skeptics that has targeted Homeopathy for extinction. In an ongoing suit against a manufacturer of homeopathic products, the HPCUS was subpoenaed for an extensive list of documents. After much legal wrangling (BETTER WORD?), the scope of the request was significantly reduced. Director Todd Hoover represented the Convention at a deposition in the second week of April. That ends the Convention’s involvement. Much time, energy, and money were expended in the process. As a Friend of the Pharmacopeia, your financial contribution helped to defray the expense.
White Paper Project update — The Convention’s Board of Directors approved the White Papers at its September 30th meeting. The 3rd Friends newsletter, published in October 2024, gives the background to understand what follows. You can find that and all other newsletters here.
Click the following link for a relatively non-technical introduction to the White Papers,
Here you will find summaries of each of the three White Papers.
We promptly sent the White Papers, accompanied by a meeting request, to the FDA Pharmaceutical Quality division. They promptly acknowledged receipt and noted that they had referred them for “internal review.” We didn’t expect acceptance of our request for a meeting to arrive for a couple of months.
On November 5th, a new President of the United States was elected. We expected that to create further delay. Since the inauguration, many top-level policy-level people at the FDA have either resigned or been placed on administrative leave — paid but forbidden to work. Cuts in administrative and support personnel and services have followed. The technical committee members we hope to meet remain at work. We expect a meeting to take place, but we don’t know when. Until a meeting is scheduled, the White Paper project is in limbo.
Other Activities in the Homeopathic Community
The National Homeopathic Products Certification Board, formerly known as the ‘Seal Project,’ is an independent non-profit sponsored by the American Institute of Homeopathy, has contracted with National Sanitation Foundation to begin the process of developing third-party independent Standards for homeopathic medicines. This is a long (usually 2 or more years), bureaucratically and administratively intense, and expensive process. For an example of such a process, click here. The initial step is for NSF to form a Joint Committee (chaired by a member of the Public Health Council. A 30-day notification went out through the American National Standards Institute a little more than 2 weeks ago. The Convention expects to be invited to join the Committee but has also conveyed our interest pre-emptively. We expect the FDA to also be invited.
There are many outstanding questions and concerns regarding this effort. I intend to report further developments in a future newsletter.
A look to the future — Given current high levels of political, regulatory, and economic uncertainty, the Convention is refining its Strategic Plan. I use the term “plan” with reservations. Uncertainty demands our best assessment of the current situation and setting a direction towards sustaining our efforts. Change is the only constant, and in this time of volatility and rapid change, we all need to be vigilant, nimble, and flexible.
Quality systems are required whether those medicines are made by individuals or at industrial scale. The HPCUS sets voluntary Standards for the starting material for each medicine listed in the HPUS. Those may come from plants, minerals, or the animal kingdom. We create and publish guidelines (Good Manufacturing Practices, or GMPs) for their quality assured production. We are the only group with the expertise needed for this ongoing task.
Access to safe, properly made medicines is vital to the future of Homeopathy as a healing art. Product quality and its regulatory oversight will be part of all imagined futures, and therefore the HPCUS’s continuance is critical.
Sustainability requires adequate financial resources and expertise in clinical homeopathy and scientific and technical areas. We are fortunate to have the support of some American and several European manufacturers for providing technical expertise. However, most American manufacturers find it difficult to do so.
We will soon begin recruiting homeopathic clinicians (with legal authority to practice) with an eye towards future leadership at the Convention. While developing and publishing the HPUS is largely a scientific and technical exercise, the core principles of homeopathy are embedded in the Pharmacopeia. Membership in the Convention requires a commitment to the Similia Principle. Understanding core principles is required at both committee and governance levels.
In the meantime, the Convention continues its normal operations. We continue to improve our quality controls, conduct extensive toxicological reviews, evaluate new sponsored monographs, and refining our operating procedures.
Director and Senior Scientist Eric Foxman and I are one session from completing a 12-session presentation on the HPUS for the Trinity Health Hub. Once the final session is recorded in June, we will provide free viewing links for Friends.
Growth in the Friends membership is slow, and much less than I’d hoped. I plan to renew outreach through licensed practitioners. We greatly appreciate your interest and continued participation.
As always, we welcome your comments, questions, and ideas. Please send them directly to me at [email protected]
William Shevin MD, DHt.
President, HPCUS