Location: Online www.jahc.info
Recorded on September 16th 2020 – A Comparison Nux Vomica Sulfur and Lachesis – Dr. Cyrus Thomas
Dr. Cyrus Thomas discusses the similarities and differences that help with the use of Sulfur, Nux and Lanches. During the discussion, Dr. Thomas will answer brought up during the webinar.
Dr. Cyrus D.C., DNBHE, MDH has studied with many of the great American homeopaths over the years, and has a medical degree for homeopathy from India. He practices under his California doctor of Chiropractic licensure utilizing adjustments, nutrition, blood testing and classical homeopathy as modalities.
For 42 years he has been listening to people to arrive at the core essence of what motivates us to live and love.
Interview of Dr. Robert Melo, President, OHM pharma By Paola Brown, President, Americans for Homeopathy Choice
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 the 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.
—Beginning of interview—
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:
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/sucussion 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 the interview—
I found my interview with Dr. Melo very interesting. It is incumbent upon consumers to support manufacturers who are investing so heavily on 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.
Co-Author: Paola Brown, President of Americans for Homeopathy Choice
Paola Brown is president and founder of Americans for Homeopathy Choice, the voice of a growing number of mothers and other homeopathy users who want to protect their right to choose homeopathy. Paola is a wife and mother of three who has previously taught many introductory homeopathy classes. She received a B.A. in English education and an M.A. in curriculum and instruction from Arizona State University graduating summa cum laude both times. She taught college English for 13 years and high school English before that. Fluent in Portuguese and Spanish, Paola was also a health instructor with Care for Life, a nonprofit organization working to develop sustainable communities in Mozambique.
Co-Author: Robert Melo, MD and President of OHM pharma
Dr. Robert Melo is a medical doctor trained at The Royal London Homeopathic Hospital, where he got involved in research programs led by Dr. Peter Fisher and Professor Flavio Dantas. At the present time, he is president of OHM pharma inc. He currently serves as an appointed member of the HPCUS (Homeopathic Pharmacopoeia Convention of the United States), the organization that maintains the policies and procedures of the official compendium (HPUS) of homeopathy manufacturing in the US. Dr. Melo is also a member of the American Association of Homeopathic Pharmacists, American Institute of Homeopathy, Liga Medicorum Homoeopathica Internationalis, Council of Homeopathic Certification, North American Society of Homeopaths, and National Center for Homeopathy. He is passionate about unifying the homeopathy community and elevating the scientific/qualitative standards for manufacturing, research, education, certification, and practice of homeopathy.
NCH is extremely saddened to have to report the death of Peter Fisher. Our deepest sympathies go out to his family, the UK Faculty of Homeopathy and all of those he has touched in the homeopathic community. Truly sad news: https://www.standard.co.uk/news/london/doctor-to-the-queen-peter-fisher-killed-after-being-hit-by-lorry-while-cycling-in-holborn-a3912801.html
Wegmans Receives AAHP Integrative Medicine Award MILWAUKIE, Ore., July 11, 2019 —The American Association of Homeopathic Pharmacists (AAHP) has awarded Wegmans Food Markets with the Integrative Medicine Award. This honor recognizes a retailer that promotes and sells products that encompass a broad range of therapeutic approaches to achieve optimal health and wellness for consumers seeking to participate actively in their healthcare. The award was presented during the opening reception of AAHP’s Summit on Challenges and Solutions in Quality & Safety of Homeopathic Drug Products, June…
MILWAUKIE, Ore., July 13, 2018 — The American Association of Homeopathic Pharmacists (AAHP) mourns the loss of an industry legend. John A. (Jack) Borneman, III, grandson of one of the founding members of AAHP, passed away on July 9, 2018. Among the many industry leadership positions he held, Borneman was an integral member of AAHP for 66 years. During his 87 years, and as part of a multigenerational family passionate about providing homeopathic medicines, Borneman contributed to monumental changes in the development of homeopathic drugs and their regulation. Always a champion of medical ethics, he represented and defended homeopathy against uninformed regulation and vanity medical products masquerading as homeopathic.
As part of his legacy, Borneman was a founding director of HPCUS in 1980, serving as its President until 2008. At HPCUS, Borneman was responsible for the creation of the regulatory structure used to govern homeopathic drug products in the United States, a structure still used today.
In recognition of his many contributions to the field of homeopathy, Borneman was awarded an honorary doctorate from the Philadelphia College of Pharmacy in 2009. Through the course of his career, he counseled thousands of patients and was the formulator of many of the homeopathic drugs sold in pharmacies and retail stores today.
Born in 1931, Borneman was the eldest of nine children to John A. Borneman, Jr. and Madeleine C. Borneman (nee Henhoeffer) in Norwood, Pennsylvania. A graduate of LaSalle College High School, Borneman was the third of four generations of his family to attend the Philadelphia College of Pharmacy and Science, graduating with a Bachelor’s Degree in Pharmacy in 1952.
He entered his family business, John A. Borneman and Sons, Homeopathic Pharmacists, and practiced homeopathic pharmacy there until the business was sold to Boiron Laboratories in 1983. Borneman retired from his career at Arrowroot Pharmacy and Standard Homeopathic Company last December at 86, marking a 66-year career as a homeopathic pharmacist.
Borneman married his beloved Nancy Conway in 1952 and raised three children: Maureen (John Devlin), John P. (Anne Marie) and James (Dawn Laurie). He was blessed with five grandchildren who loved him as “Grandad Jack” and four great-grandchildren. After his wife Nancy passed away in 2013, he moved to Shannondell in Audubon, Pennsylvania and met his companion, Gillian Sharp.
He wished his work at HPCUS be carried on. Donations in his honor can be made at www.hpus.com or mailed to HPCUS, Box 87, Bryn Mawr, PA. 19010.
June 13, 2018
May 18, 2018
To: Dr. Gottlieb, Dockets Management Staff, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and other pertinent FDA Staff, Re: FDA-2017-D-6580, Docket No. 6580-27157 Draft Guidance “Drug Products Labeled as Homeopathic” The National Center for Homeopathy, the largest homeopathy consumer organization in the US, thanks the Food and Drug Administration for the opportunity to comment on the recently released Draft Guidance “Drug Products Labeled as Homeopathic.” On behalf of our over 2600 consumer members, we want to share our serious concerns about this proposal and urge the FDA to reconsider some proposed actions. Our primary concern is that the Draft Guidance proposes removing the existing Compliance Policy Guide 400.400 that has provided guidance and safety for decades and suggests, instead, substituting a less effective, less comprehensive Risk Assessment criteria: • Risk Assessment is designed for and essential to the oversight of chemically-based medicines, but not for low-risk, highly-diluted homeopathy medicines. • Homeopathic medicines are unique and are not the equivalent of chemically-based conventional drugs. They are prepared and manufactured differently and are used based upon a distinct set of principles. They should not be shoehorned into a category intended to increase the safety of chemically-based medicines, but completely unsuited for homeopathic medicines. • The proposed Risk Assessment categories overlook the characteristic preparation and dilution of homeopathy medicines, which are in the nanoscale range and remove the potential for toxicity from the sourced substances. • The CPG 400.400, created by the FDA and used by manufacturers for 30 years, has ensured the manufacturing of homeopathy medicines to high standards and has resulted in an exemplary safety record for homeopathic medicines. • Removal of the CPG 400.400, which specifically identifies homeopathy medicines within the HPUS protocols, opens the door for hybrid products to be sold improperly as homeopathic medicines. • Removal of the CPG 400.400 takes away the standardized production of homeopathy medicines, which may jeopardize safety. • The CPG 400.400 has guided the manufacturers and protected the consumers of homeopathy for 30 years. It is a comprehensive document and contains all the needed solutions to the challenges raised by the FDA in the Draft Guidance. We understand that the main goal of the FDA is to protect consumers from unsafe products. However, we believe that many of the proposed actions in the FDA Draft Guidance will instead limit consumers’ choice and access to homeopathy products, while potentially opening up other areas of risk. In our experience, consumers of homeopathy are intelligent and well-prepared to assess and make their own health care choices, especially with inherently safe homeopathy products. The increasingly positive experience of consumers with homeopathy and their confidence in the medicines are due in large part to the influence of the CPG 400.400, providing guidance and standardization of homeopathy medicines. It is of equal concern to us that in creating the proposed Draft Guidance, the FDA officials seem to have overlooked the two days of presentations to the FDA panel in 2015 and thousands of individual comments posted to the FDA comment page. Among the presentations and subsequent comments were significant documentation of the long and admirable safety record of homeopathy medicine and a survey by the National Center for Homeopathy showing consumer use and satisfaction. In this age of dramatic advances in health care, new medicines require novel approaches of study and regulation. Homeopathy is a 200-year-old medicine that foretold the modern use of nanotechnology. It is not appropriate to regulate it with criteria developed for chemically-based conventional medicines. Consumers like homeopathy; they use homeopathy; they understand homeopathy. We encourage the FDA to engage the consumers and others in the homeopathy community, the manufacturers and practitioners, to successfully support this health promoting, holistic medicine. We urge the FDA to continue the CPG 400.400 that has protected consumers for decades and safeguard our consumers’ choice of and access to all homeopathy medicines. Sincerely, The National Center for Homeopathy (Representing over 2600 satisfied consumers of homeopathy) Deborah Dupnik, Executive Director Abby Beale, Board President Tina Quirk, President-Elect; Public Policy and Advocacy Committee Glenna Tinney, Treasurer; Public Policy and Advocacy Committee
March 27, 2018
Integrative Health & Wellness Caucus Focuses on Putting HealthBack in Healthcare
Bipartisan Effort Cites Prevention and Integrative Health Solutions to Combat Opioid Crisis
WASHINGTON, D.C., March 21, 2018 – Reps. Mike Coffman, R-CO and Jared Polis, D-CO, welcomed members of Congress, their staff and healthcare stakeholders to an inaugural meeting of the new Integrative Health and Wellness Caucus to a standing room only crowd on March 15, 2018. The collective efforts of the bipartisan team of Coffman and Polis, supported by the Integrative Healthcare Policy Consortium (IHPC), attracted a wide array of staff members representing the House of Representatives and Senate elected officials from states of Alaska, Colorado, Georgia, Maryland, Michigan, Pennsylvania, South Dakota, Texas and Utah. “I think it’s important for patients to have all the facts and latest research when it comes to therapies and treatments available to them when making medical decisions,” Coffman said. “This is why it was my honor to welcome the Integrative Health and Wellness Caucus members to Capitol Hill last week.”
Rep. Polis addressed that, “Through this Caucus we are having conversations about how Congress can solve the major healthcare issues of this country and better meet the healthcare needs of everybody, including integrative health and wellness options.” He emphasized the importance of the timing of this Caucus to bring attention to successful non-pharmacological and other whole-person care options to the nation’s pain management crisis and opioid epidemic – which the Council on Foreign Relations cites as beyond the risks it poses to public health, it is becoming a drag on the economy and a threat to national security.
Other caucus attendees included representatives from the US Department of Defense, the US Department of Veterans Affairs and the US Air Force Medical Service. Registrants were also representatives from as many as thirty medical groups, insurers, hospitals, service providers, learning institutions, health care lobbying firms and patient groups that support integrative healthcare. “This caucus is the start of an important conversation to shift our healthcare paradigm from a reactive model to whole-person preventive outcomes,” said Len Wisneski, M.D., Chair Integrative Health Policy Consortium. “American’s have spent billions of dollars out-of-pocket on complementary and integrative care. It is time that Congress and healthcare payers and systems respond by including all credentialed and licensed providers and evidence-based care approaches into the choices available to all Americans.”
The educational forum included an impressive panel of experts, including Margaret Chesney, PhD, Past Chair, Academic Consortium for Integrative Medicine and Health and Former Deputy Director of NCCIH; Eric Schoomaker, M.D., PhD, LTG U.S. Army (RET), former U.S. Army Surgeon General and Commanding General of the U.S. Army Medical Command; and Benjamin Kligler, M.D., National Director of the Integrative Health Coordinating Center Office of Patient-Centered Care & Cultural Transformation at the Veterans Health Administration (VA). Speakers discussed effective solutions and innovative protocols in public health and among military personnel and veterans for addiction and pain management that emphasize nonpharmacological approaches.
“I was excited to be part of the inaugural congressional caucus proceedings,” said Peter F. Demitry, M.D., MPH, Executive Director, National Foundation for Integrative Medicine (NFIM) and former Assistant Air Force Surgeon General for Modernization. “The various organizations and stakeholders that attended and presented to Congress were very well informed with articulate, rational arguments that were well received by the United States legislators. I think there was clear consensus that the time to fix US health care policy is now and NFIM is happy to be both meeting and joining these various dedicated stakeholders.”
This kick-off to the newly formed Integrative Health and Wellness Caucus is the start of informing and educating Congress, policy-makers and agencies about the improved outcomes and cost-saving possible when healthcare is oriented to prevention, wellness and well-being.
Rep. Jared Polis, D-Colo., and Rep. Mike Coffman, R-Colo., launched the Integrative Health and Wellness Congressional Caucus in the House of Representatives Oct. 25, 2017. The Caucus serves as a non-partisan educational forum for legislators to receive up-to-date information from experts related to best practices and new research, and to discuss legislative and administrative opportunities for integrative health. Media requests for Rep. Polis, contact firstname.lastname@example.org; for Rep. Coffman, contact Daniel.Bucheli@mail.house.gov.
The Integrative Health Policy Consortium is the national policy and advocacy voice of integrative health and wellness healthcare professional organizations, representing the voice of more than 600,000 healthcare providers. IHPC functions as a critical watchdog and monitor of federal agencies charged with overseeing America’s health and health research needs, working towards eliminating barriers to health. IHPC Chair Dr. Len Wisneski is a Clinical Professor of Medicine at George Washington University Medical Center, Adjunct Faculty at Georgetown University, and is on faculty at The University of Colorado. He has published over 30 scientific articles and a landmark textbook, “The Scientific Basis of Integrative Health.” Website: http://www.ihpc.org.
March 22, 2018
FDA COMMENT PERIOD EXTENDED! CONTACT YOUR LEGISLATORS NOW!!
If you haven’t yet contacted your legislators to comment on the FDA Draft Guidance, you have more time! The FDA has extended the comment period for 60 days. It is very important to write your legislators and ask them to co-sign either Senator Orin Hatch’s letter or Representative Ryan Costello’s letter. (SEE BELOW) These letters to the FDA are asking to merge the existing CPG 400.400 (Compliance Policy Guide) for manufacturing homeopathy medicines that has been in place for over 30 years with the new Draft Guidance.
These contacts to your own legislators are the most important thing you can do for homeopathy in this issue. The FDA has ignored consumer comments but it is expected that they will take Congressional opinions more seriously, especially those coming from the committees that oversee the FDA.
Senator Hatch is a ranking member of the Senate’s Committee on Health, Education, Labor and Pensions that oversees the FDA. https://www.help.senate.gov/ranking/newsroom
Representative Costello is a member of the Committee on Energy and Commerce subcommittee on Oversight and Investigations that oversees the FDA from the House. https://energycommerce.house.gov/subcommittees/oversight-and-investigations-116th-congress
If your legislator is a member of either of these committees, be sure to contact them! All legislators are welcome!
Of course, you are free to post a personal comment on the FDA comment page if you choose, but please make your comments respectful, professional and on message. https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2017-D-6580
The extension is for an additional 60 days. We expect the FDA will be updating their site to accept public comments in the next few days.
NCH, along with other homeopathy organizations, will be posting a letter on the FDA comment page.
HOW TO CONTACT YOUR LEGISLATORS (from the AAHP)
Below are the VoterVoice links that we are asking each of you to use. We are asking EVERY state senator and representative to sign on to the respective letters that Hatch and Costello (respectively) have agreed to send to the FDA.
Healthcare Professionals Link
(These states (CO, NM, TN, PA, UT, and WA) will not be able to submit through these links. Please contact legislators directly.)
Since the 2015 public hearing, the American Association of Homeopathic Pharmacists (AAHP) has been suggesting several ways to improve the CPG so that it addresses both industry’s and the agency’s concerns. AAHP’s view is that FDA has a responsibility to the American consumer to provide more clarity than the initial draft guidance provides. Specifically, AAHP will submit comments to FDA asking the agency to incorporate key aspects of CPG 400.400 into the new draft guidance, a solution that provides uniformity in enforcement and clarity in regulation. AAHP believes this will significantly help ensure Americans have the safest and highest quality products for the personal health care choice that they want and deserve.
NCH and indeed all of the homeopathy organizations are working together to present our concerns and opinions with a coordinated harmonious message and powerful voice and we need your help!