Reprinted from the NCH website courtesy Dr. Robert Melo
Introduction by Paola Brown
Nobel Memorial Prize recipient and American economist, Milton Friedman, has said that “The most important single central fact about a free market is that no exchange takes place unless both parties benefit.” In the case of pharmaceutical drugs, no other system of medicine has more fully achieved this precept better than homeopathic medicine. Homeopathic manufacturers have been able to make a living by producing homeopathics with the added satisfaction that consumers have access to effective and inherently safe medicine—one that is backed by thousands of research papers, studies, and clinical trials.
In a 2020 survey created by the American Association of Homeopathic Pharmacists (AAHP), the AAHP reported that consumers are 95% satisfied with homeopathic medicine (26.7% are satisfied, 31.9% are extremely satisfied, and a whopping 36.1% are very satisfied).
Despite the overwhelming support and demand for homeopathy, homeopathy in the United States (US) has been under pressure for a long time, especially in recent years. But one aspect that continues to rise from the struggle is the consumer voice.
We have witnessed the consumer voice create powerful shifts in various facets of our country—from shifts in our medical care, business, education, and more. But what is unique about the homeopathy consumer at large is that they are an informed group who has a degree of understanding about homeopathic medicine. To keep this group of consumers empowered, we need to continue educating them on various aspects of homeopathy, and one area in particular that consumers are learning more about is the challenges homeopathic manufacturers are facing. These pressures risk consumer access to homeopathic medicine and the viability of homeopathy in the US at large.
In this article, I interviewed Dr. Robert Melo, owner of OHM pharma, a Food and Drug Administration (FDA) registered and inspected facility, and manufacturer of homeopathic medicines for students of homeopathy, practitioners, and their patient/clients. His candid responses about the challenges faced by homeopathic manufacturers are critical so that consumers can find ways of supporting our homeopathy manufacturers.
Dr. Robert Melo Paola Brown
What is your greatest challenge when it comes to homeopathy manufacturing?
Dr. Melo: This is an easy question to answer. Aside from the normal challenges that come from running a company, homeopathy manufacturers have the added pressure of complying with drug manufacturing regulations even though their profit margins are a fraction of what conventional drug manufacturers make.
Let me explain what I mean: Homeopathic remedies have been classified as “drugs” since their inclusion in the Federal Food, Drug, and Cosmetic Act in 1938 by the bill’s primary author, Senator Royal Copeland, MD, of New York. Senator Copeland had studied homeopathy at Michigan and was later dean at the New York Homeopathic Medical College and Health Commissioner for the City of New York.
Because homeopathic remedies are not dietary supplements, they must comply with strict drug regulations that are designed for standard allopathic pharmaceuticals. These compliance measures are extremely expensive, and even conventional drug manufacturers have difficulties with compliance; just look at the warning letters FDA regularly gives to conventional pharmaceutical manufacturers.
You may find it interesting that homeopathic drugs—like conventional drugs—are legal drugs under the law. The challenge for a small homeopathy manufacturer is bigger because the price of a homeopathic remedy averages $8-10 dollars and additionally, our batch sizes per remedy are small.
Conventional pharmaceutical manufacturers are used to producing much bigger batches (millions of units per batch) and have much higher profits which allows them to pay for regulatory compliance, and even then, they still have issues.
So conventional pharmaceutical companies still have issues with compliance. Why?
Dr. Melo: Because compliance is not easy and is expensive. To give you an example, simple testing equipment will cost you a minimum of $50,000, but the documentation, IQ/OQ/PQ (installation qualification, operation qualification and performance qualification) calibration, and validation will cost you another $30,000, for a total of at a minimum $80,000.
Of course, if you go into more complex testing, then the price increases accordingly. This is not a big expense for conventional pharmaceutical manufacturers, but it is substantial for homeopathy manufacturers. Additionally, you need highly trained professionals to operate such equipment and perform the required tests.
What can you say to help consumers better understand the types of manufacturing and regulatory compliance challenges you face as a homeopathy manufacturer?
Dr. Melo: We need to comply with the same standards used to manufacture conventional pharmaceuticals. This means that we are following the Code of Federal Regulations, CFR Title 21 part 210 & 211 from the FDA, The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the standards for homeopathy manufacturing stated in the Homeopathic Pharmacopoeia of the United States (HPUS).
You can learn a bit more about these requirements in the links below. Even if you don’t read each link, you will see that we have an incredible amount of compliance requirements:
FDA Guidelines
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=210
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211
ICH Guidelines
https://www.ich.org/page/quality-guidelines
https://database.ich.org/sites/default/files/Q7%20Guideline.pdf
Homeopathic Pharmacopoeia of the United States Guidelines
You mentioned the fact that homeopathy manufacturers produce smaller batches of medicines. Can you tell me a little bit more about that?
Dr. Melo: FDA’s standards force a manufacturer to produce very large batches in order to be able to afford regulatory compliance. Compliance is difficult and costly, and it needs to be applied systematically to every single manufactured batch. So the larger your batch, the more profitable the production of that one drug.
In other words, the system is designed to manufacture one pharmaceutical product that is intended to be used or prescribed to millions of people. The key factor is quantity. For this system to work, it must assume that all humans are basically the same and not take into consideration the individuality factor.
The conventional system works for manufacturing a drug when a company can manufacture millions of units per year (additionally, it is preferable for the drug to be patented, so no one else can manufacture it). To those very large batches, all the fixed costs must be applied, which include all testing and required compliance.
Once you divide the high fixed costs of a single batch into the number of units manufactured, then the regulatory cost impact is reduced. Therefore, the only way to minimize the impact of regulatory compliance is to manufacture high quantity batches.
I can already see how this is a problem in homeopathy manufacturing, but go ahead and explain it to us:
Dr. Melo: You’re right. For us who work with homeopathy, each person is different, and we prescribe to the person not to the disease. Based on a person’s individuality, our system uses many different remedies and different potencies.
The result is that in homeopathy we manufacture many different products (there are 1,300 remedies listed in the HPUS) in many different potencies, and we make small batches of each one. Our fixed cost per batch is very high, and since we manufacture and sell small batches, it is very difficult to balance the equation. Additionally, we do not have patented drugs; most of our drugs have been manufactured for more than 200 years.
On the other hand, for regulators, a batch is a batch, so all the regulatory requirements and testing is applied to a batch independent of the size. This puts a huge costly burden on homeopathy manufacturers which makes it a big challenge to overcome.
What is an FDA inspection like?
Dr. Melo: FDA comes to the manufacturing facility unannounced to start an onsite inspection. Our last inspection lasted almost four weeks.
The inspection covers six systems:
- Quality System
- Facility and Equipment System
- Materials System
- Production System
- Packaging and Labeling System
- Laboratory Control System
The most important points the FDA inspector will emphasize are: quality unit, comprehensive robust quality system, standard operation procedures, water system validation, equipment IQ/OQ/PQ, equipment validation, quality control testing for raw materials (including identification), intermediate and finished products, calibration of all testing equipment, compliance with CFR part 11 (electronic signatures, electronic documentation and computer data control), six-system inspection model, cleaning validations, manufacturing process validations, validation of the dilution/succussion process, blend uniformity, content uniformity, stability studies, finished product testing, personnel training records, annual product reviews, change controls, out of specifications, deviations, pharmacovigilance, corrective actions preventive actions, internal audits, and promoting improvement, etc. Whew!
According to FDA, anything that is testable needs to be tested; this applies to raw materials and lower dilutions. For higher dilutions where there is no technology to test the finished product, FDA requires that the process in which we dilute and succuss the medicines is validated. This validated process assures that the finished product is what it says it is. We must demonstrate that all our processes are standardized, reproducible, and under control.
These types of operations can only be run by competent, qualified, trained professionals who also operate the required high-tech analytical instruments and testing equipment.
Additionally, the amount of documentation is staggering. As per FDA, “if it isn’t documented, it didn’t happen,” so imagine the amount of Standard Operation Procedures (SOPs), work instructions, records, etc. that we need to fill and store.
Additionally, most operations have to be witnessed and verified/signed by a second qualified person. The acronym GMP officially stands for “Good Manufacturing Practices” but for us it also means “Get More People” and “Get More Paper.” It’s not an easy job.
Why is it important to support US manufacturers of homeopathic medicine?
Dr. Melo: Homeopathy originated in Europe more than 200 years ago, and it has expanded to most of the world. Europe has a longer history with homeopathy, and they have different regulations for manufacturing homeopathic remedies.
The US has only one regulation to manufacture drugs, and since homeopathic remedies are considered drugs, then that’s the regulation we must comply with. FDA not only inspects US manufacturers but also foreign manufacturers that sell their products in the US, and if they do not comply with FDA standards, they easily place an import ban on such manufacturers which automatically stops them from exporting their products into the US.
Some respected longstanding manufacturers in Europe do not want to deal with FDA and its regulations and prefer not to ship to the US. Some other manufacturers in Europe are still shipping remedies into the US, but it’s only because the FDA has never inspected their facilities.
Once FDA inspects them, the situation will change. Once FDA enforces regulatory compliance, they will probably have to cease shipping into the US because compliance is difficult, expensive, and requires additional qualified personnel and testing equipment. Most manufacturers will not think it is worth the investment and will just stop shipping into the US as others have already done.
For example, the company Heel, a highly recognized German homeopathy manufacturer and one of the largest manufacturers in Europe, decided to voluntarily exit the US market a few years ago.
The French company, Boiron, the biggest manufacturer of homeopathic remedies in the world, has been inspected by FDA and had to increase their manufacturing standards to satisfy the FDA. Boiron manufactures in France and sells in over 50 countries, has annual sales of hundreds of millions, manufactures big batches, and is able to follow the regulatory requirements from FDA.
We are grateful Boiron has been FDA inspected and allowed to import medicines into the US; at the same time, it’s important to support our manufacturers who are on US soil as well. If one particular company is targeted or they decide to exit the US market, then what will happen with homeopathy in the US? We can’t put the availability of homeopathy in this country in the hands of an FDA customs officer.
This ordeal started in 2015 with the Hyland’s teething tablets issue and the FDA hearings; now we are 5 years into this and things are definitively getting worse, particularly in the last 2 years; one can easily see this in the many warning letters homeopathy manufacturers have received from the FDA.
This is why it’s so important to support Americans for Homeopathy Choice in their advocacy work. But either way, manufacturers like us and others must continue the efforts for compliance; there is no other way.
Another point to support the compliance effort here in the US is because if we fail, many other countries will follow this lead. If homeopathy falls in the US, it will fall in many other countries because they will use the US as an example. Remember what happened with the Australian National Health and Medical Research Council (NHMRC), mostly known as the Australian Report and the devastating consequences it had for homeopathy worldwide.
Why is it important for homeopathy to have official, legally compliant remedies?
Dr. Melo: Remedies are the base of homeopathy. Without remedies there is no homeopathy. We have done research in homeopathy, but we all know more is needed. To validate any research done with homeopathy, including observational, clinical trials, case reports, provings, data collection, experimental, etc., all those remedies need to be manufactured according to current GMP, following FDA and HPUS guidelines.
If we do not have legal, reproducible, in compliance remedies, all the research will not be valid. In addition, there is the topic of liability; using noncompliant remedies opens the door to liability issues in a practice, but this is a whole different topic.
If we want homeopathy to achieve its rightful place in the healthcare system, the first step is to have official, legally compliant remedies. If we want homeopathy to be fully accepted by the scientific community as a viable useful therapeutic system, we must speak the same language as the scientific community, and the first step in this communication are the remedies, which must be manufactured according to current regulations.
This is the only way homeopathy can further develop in the 21st century and show the many benefits it has to offer to the many in need. We have a responsibility to transfer homeopathy to the next generations. This can only be achieved if we as a community unite and work together; we must focus on what brings us together and not what sets us apart.
In these difficult times, the consumer voice is the strongest voice, so we must all bond together and push in the same direction. Homeopathy is at stake and what we decide to do will impact future generations.
I want to support the manufacturers that have been FDA compliant. How do I know if I’m supporting the right ones?
Dr. Melo: Look on the label of any homeopathy bottle. If it has an NDC number (National Drug Code) or an FEI number (FDA Establishment Identification Number), then you know that this manufacturer is working hard to remain FDA compliant. You can also search if the facility is registered with FDA here: https://www.accessdata.fda.gov/scripts/cder/drls/default.cfm
Purchasing brands that have the NDC or FEI number is supporting manufacturers who are making the effort to maintain our access to legally compliant homeopathic medicines.
Purchasing from unregistered, unlicensed, facilities not inspected by the FDA, using dubious unidentified starting materials and fast questionable magnetic manufacturing methods is not worth the savings of $3 or $5. It’s just not worth the health risk or risking the demise of high-quality homeopathics that we know work as Hahnemann intended.
On the positive side, if we as manufacturers follow FDA and HPUS regulations, then rest assured that the remedy that you are taking is a very high quality remedy and what is printed on the label is exactly what is in the bottle. This is a win-win situation for the compliant manufacturer and the consumer. The consumer deserves high quality legally compliant homeopathic remedies.
End of Interview…
I found my interview with Dr. Melo very interesting. It is incumbent upon consumers to support manufacturers who are investing so heavily in proper compliance—indeed they are investing heavily on my health and yours, because they want us to have access to this blessed, amazing and inherently safe medicine.
If you’d like to watch a live interview I conducted with Dr. Melo, visit the Facebook page of Americans for Homeopathy Choice. Be sure to like and follow our page so that you can get regular updates on what we are doing to protect your access to homeopathic medicine in the US.
