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Conference Presentation Notes:
Thank you for the invitation
to share my memories of family, homeopathy and its
regulation. These are all so tightly interwoven
that I use a time line to tease them apart. Let me tell
you of my homeopathic heroes, and then we will use a
calendar to keep track of events.
My personal heroes are
Constantine Hering, Royal Copeland, Harris Coulter,
Julian Winston, Wyrth Baker and Sandra Chase. Dr.
Hering, reflected accurately the teachings and
experiments of Hahnemann, codified, promoted and
defended the homeopathic medical method espoused by
Hahnemann, never straying from the proving and law of
similars as the theoretical basis for homeopathy.
The success of the homeopathic method of Cure in the US
can be attributed to Dr. Hering. Royal Copeland’s
courage and determination included the HPUS in the Food
Drug and Cosmetic Act (FDCA) of 1938. That action finds
its importance and relevance today in the recent
(Complementary and Alternative Medicine (CAM) activity.
Harris Coulter’s writings are a brilliant explanation
and defense of the homeopathic method of cure.
Wyrth’s understanding of political events, intuition,
foresight, courage and organizational skills are the
foundation of the Homoeopathic Pharmacopoeia Convention
of the United States (HPCUS). He reorganized a
homeopathic pharmacopoeia, which had languished as a
cookbook, with no major charges, for eight printings
(editions) and gave us a world renowned Homeopathic
Pharmacopoeia of the United States (HPUS) This HPUS is
useful to the homeopathic community, patients,
consumers, practitioners, industry and regulators.
Julian generously shared his keen observations and
analysis of the homeopathic universe. He helped put
things in focus for me. His report of his “trip” across
the country was a revelation. The Faces of Homeopathy is
a ready reference for all things homeopathic.
Sandra has been my conscience on the Board of Directors
with her “Now Jack”! Sandra serves on 8 homeopathic
boards (AIHF, AIH, ABHt, HPCUS, LMHI, HMSSP, SHMA, and
HAA) and I is among the executive officers of 6 of them
(AIHF, VP; ABHt, Pres; HPCUS, Sec; LMHI, Sec for PR;
HMSSP, Sec; and SHMA, Sec-Treas). Sandra is a Trustee on
the AIH Board and the ABHt Representative to the HAA
Board.
Hopefully, an understanding
of the homeopathic history and regulatory process will
help us understand the regulatory environment within
which homeopathy must exist in today. We are so
fortunate. This geographic area, beginning in Allentown
and later Philadelphia, is steeped in homeopathic lore
and flora.
THE HISTORY
1810 Constantine Hering
arrived in Philadelphia
1810 The Allentown Academy
opened the first Homeopathic College. Lectures and texts
were in German.
THE INDUSTRY
1841 Otis Clapp – began in
Boston
1852 Boericke & Tafel (B&T) began operations
1869 organized nine branches
1853 Luties (St Louis)
1857 Humphreys (NY) Later Manhattan and Caribbean, now
owned by American Distillers makers of Dickinson’s Witch
Hazel
1867 Hahnemann Medical College (HMC)
1870 B&T starts a branch in San Francisco
1880 Washington Homeopathic Pharmacy (WHP)
1905 Hylands (Standard Homeopathic Company)(SHC)
1910 Grandad, Dr. Borneman, and Urban Ehrhart leave
Boericke & Tafel (B&T) to start their own homeopathic
pharmacies.
1910 Dr. Borneman begins manufacturing and growing
botanicals in Norwood.
1911 Ehrhart & Karl (E&K) Chicago
Markets were regional and fiercely competitive. Industry
was in a state of decline. Physician dispensing habits
did not foster a viable industry capable of research and
dealing with adversaries and the FDA.
1910 Flexner Report by the Carnegie Fdn. had a
devastating effect on Homeopathic hospitals, colleges
and the growth of homeopathy.
Promised funding from Carnegie/Rockefeller was not
forthcoming.
1915 Dr. Borneman’s sales office 615 N 15th St. was a
meeting place for students, across from nurse’s
residence
1915 Dr. Borneman appointed chief pharmacist at
Hahnemann Hospital.
1918 Dr. Borneman teaches medical Botany, pharmacognosy
and prescription writing at HMC
1924 A H.M.C catalog lists as graduates our best
customers who practiced 26 years before I joined the
business.
1929 Homeopathic courses cease at HMC
1938 Royal Copeland FDCA
1940 Homeopathy at HMC becomes elective.
HMSPA meetings at Skytop, Galen Hall, Pocono Manor, Mt
Pocono, Hershey, Bellveue Stratford
1951 Durham Humphrey Act established Rx/OTC Categories
OTC business begins.
1950 Industry was B&T, Borneman, Otis Clapp, E&K, B&R,
SHC, WHP, Humphreys and Luyties.
1950 Grandad ceases teaching at Hahnemann
1950 Bornemans survived by preparing combinations
remedies, parenterals and physician
supplies.
1952 I graduate PCP&S and formally join the business
1955 Homeopathy is no longer an elective course at
Hahnemann.
REGULATORY CHALLENGES
1951 Durham Humphrey
1962 Kefauver/Kennedy amendments “Drug Amendments Act
1962
1962 FDA assumes all homeopathics are RX and no new
remedies (failed)
1974 Dr. Baker publishes Compendium of Homeotherapeutics.
Roger Ehrhart, Forest Murphy, Alan Neiswander, Gus Tafel,
Henry Williams, Bill Young.
1978 Science of Homeopathy Vithoulkas published
1979 Proposal to change HPUS regulatory status (failed)
TURBULENT TIMES 1980s
The native industry
languished and was suffering from the effects of Flexner
Report, closing of hospitals and colleges. Hahnemann
graduates were in an advanced age. Lacking energy and
resources we had to deal with adversaries and the FDA.
1980 Influx of homeopathic Drug Products (HDPs) from
Europe: Electro-acupuncture Voll (EAV) nosode &
parenteral remedies causes FDA alarm.
FDA questions homeopathic status of Anthroposophic,
Phytopharmaceuticals, and Nosodes and tries the big net
approach.
1980 Dr Baker reincorporates the HPCUS that had eight
Editions (printings) and was no longer relevant.
HPCUS Begins 20 year review of all remedies in HPUS,
Compendium, anthroposophic and sponsored remedies. (Oscillo)
1982-88 FDA meetings lay ground for Compliance Policy
Guide (CPG). Sandra Chase, Bill Sheven, Wyrth Baker,
Will Eldredge (Humphreys) and myself.
HPUS included in FDA act 1938, homeopathic drug products
were generally unregulated until May 1988 with
publication of the Compliance Policy Guide (CPG)
1732.15. (See web FDA CPG 400.400)
1982 Boiron Borneman Merge
1988 C.P.G. Established invest able environment too late
to save the native industry.
1988 Decline of US firms and beginnings of Boiron,
Dolisos, Heel, DHU (Schwabe),
1988 FDA upset by Influx of ”new” homeopathics”, Bach,
Parenterals Nosodes, Sarcodes, Organotherapy, and
gemmotherapy, phytopharmaceuticals, anthroposophy and
Electro-acupuncture Voll
1988 B&T joins DHU, VSM, Schwabe, and Natures’s Way
1988 HPUS begins transition from a cookbook to a world
acclaimed regulatory document
1994 HPCUS begins a massive, expensive project to
develop standards and control data for homeopathic
remedies.
Native industry takes advantage of the new regulatory
environment and resurges.
Hahnemann Laboratories, Joe Lillard Washington
Homeopathic Products (WHP), Natural Health Products
begin operations. Similisan, Coldeze, Zicam begin
operations.
2004 I am appointed chief
pharmacist at TXOptions Pharmacy and Homeopathic
Laboratories, PA in King of Prussia, a division of SHC.
Visit
www.TxOptions.com
2005 HPUS-RS On-line
provides reasonable accessibility to everyone from
single one-day users
weekly, yearly and to the international homeopathic
industry.
CURRENT EVENTS
2005 Standards and controls
(assay data) continues for all remedies
2005 P.T.W. G. reviews twenty remedies/year@ $8000.00
2006 FDA expresses a renewed interest in “safety” of
homeopathics (Mad Cow)
2007 APhA Will approach Congress to hold Homeopathic
Drug Products (HDP)s to allopathic standards. This will
be echoed by BBB, and their National Advertising
Division (NAD)
Report of the 2002 APhA
House of Delegates
Actions of the official legislative body of the American
Pharmaceutical Association.
Adopted Policies
The following policies were adopted by the 2002 APhA
House of Delegates and are now official
Association policy:
S60 supplement to the Journal of the American
Pharmaceutical Association
Homeopathy
1. APhA supports the demonstration of safety and
efficacy of homeopathic products from adequate,
well-designed scientific studies before pharmacists
advocate or sell homeopathic products.
2. APhA recognizes patient autonomy regarding the use of
homeopathic products. Pharmacists should educate
patients who choose to use homeopathic products.
3. APhA shall work with Congress to modify the Food,
Drug and Cosmetic Act or enact other legislation to
require that homeopathic manufacturers provide evidence
of efficacy and safety for all products, including
products currently in the marketplace.
2007 Complementary and
Alternative Medicine (CAM) issued Dec 07, distributed
March 07. 2007 Demand for “clinical studies” for
Similisan, Heads Up by BBB, NAD, Consumer reports and
soon FTC.
2007 FDA CAM report
Separates us from all other complementary and
alternative medical methods and reinforces our core
reliance on Provings and Principles.
The US Dept of Health and
Human Services FDA, Center for Biologics Revaluation and
Research, Center for Drug Evaluation and Research,
Center for Devices and Radiological Health and Center
published this paper December 2006 for Food Safety and
Applied Nutrition.
In the review of
biologically based practices, energy medicine, mind body
medicines and whole medical systems, homeopathy was
examined, but not changed. I believe our regulatory
environment is benefiting from the drug status of
Homeopathic Drug Products, particularly the mention of
HPCUS within the meaning of “drug” in the FDCA as
mentioned in the FDA guidance on CAM products.
Important Considerations
FUNCTION OF PHARMACOPOEIA:
The HPUS is the envy of every other country. It is the
only non-governmental homeopathic pharmacopeia in the
world and is the standard used by many foreign
countries. Acceptance of a remedy by the HPCUS is
equivalent to an NDA. This is a fragile arrangement we
have with FDA and is dependent upon the HPCUS’s ability
to demonstrate proper oversight esp. in regard to
safety.
HPCUS is a standard-setting
organization that focuses on the regulatory approval of
official homeopathic drug products and the development
and publication of general pharmacy practices and
standards. Currently the HPCUS tasks are:
Publish and disseminate the
Homoeopathic Pharmacopoeia of the United States (HPUS).
Discover and monograph homeopathic medicines, (sponsored
& Homeopathic Community)
Establish standards for manufacture and testing,
Establish standardized procedures and processes for
manufacturing Homeopathic Drug products (HDPs).
In addition, the FDA
anticipates that the HPCUS will exercise proper
oversight for identification, preparation and safety of
homeopathic remedies and establish appropriate (safe)
dosage levels for those remedies, due to increased
availability of new dosage forms.
Homeopathic remedies are
DRUGS.
Articles recognized in the USP, HPUS or NF
Articles intended for use in diagnosis, cure,
mitigation, treatment, or prevention of disease
Articles (other than food) intended to effect the
structure or function of the body
At his time here are only
two classes of drugs: Rx and Non-Rx OTC DRUG
No Statutory Definition
Drug for which adequate directions for use by layman can
be written
(Rx drugs are exempt from this requirement)
A drug for self-limiting conditions which a consumer can
diagnose and treat by himself/herself
Some Homeopathic Drug
Remedies are Rx Because:
They are not labeled for self-limiting conditions
(Hypertension, Diabetes,)
The condition requires diagnosis & monitoring (Crataegus,
Cactus)
It may be in a toxic dosage form. (Digitalis MT,
Belladonna MT, Arnica MT)
It may not be official because it cannot be accurately
described (Carcinosinum)
It may be unofficial for other reasons.
Never submitted for monographing because no sponsor or
lack of interest or lacking qualifications.
There are 1400 official
homeopathic remedies
450 are restricted is some potencies. E.g. Belladonna
Tr. is Rx 3X is non Rx
A few are restricted in all potencies. E.g. Crataegus,
Only use is cardiotonic.
NEW DRUG
Any drug, which is not generally recognized as safe and
effective by qualified experts for it’s labeled uses.
Any drug, which is so recognized, but which has not been
used to a material time or to a material extent.
September/October 2002 Vol.
42, No. 5, Suppl. 1 Vol 42,
In Addition from Compliance Policy Guide (CPG)\
Homeopathic Drug. The CPG defines a homeopathic drug as
any drug labeled as being "homeopathic" which in listed
in the HPUS, or an addendum or supplement to it.
Although this definition would appear to exclude all
other substances, the CPG does recognize that some
homeopathic remedies are not listed in the HPUS, or an
addendum or supplement. In the CPG section dealing with
declaration of ingredients, FDA states "Documentation
must be provided to support that those products or
ingredients which are not recognized officially in the
HPUS, an addendum to it, or its supplements are
generally recognized as homeopathic products or
ingredients.” The need to demonstrate that a product or
ingredient not recognized by the HPUS or an addendum or
supplement to it is indeed homeopathic could arise
either in an enforcement proceeding or in connection
with an attempt to bring the product through U.S.
Customs. For such products, it in clear that the burden
of demonstrating its homeopathic status in on the person
offering it for sale or importation. Finally, the CPG
notes that a product containing a combination of
homeopathic and non-homeopathic active ingredients is
not considered to be a homeopathic drug product.
In addition from CPG
Prescription/OTC Status.
Homeopathic drugs are subject to the same criteria as
non-homeopathic drugs in determining whether they may be
marketed as over-the-counter ("OTC") products.
Specifically, a drug within the scope of the following
statutory criteria must be dispensed only pursuant to a
prescription:
1.a drug that is habit-forming;
2 a drug that in not safe-for use except under the
supervision of a licensed medical practitioner because
of its toxicity, method of use, or necessary collateral
measures; or
3. drug that is explicitly approved in a new drug
application only for dispensing pursuant to a
prescription.
21 U.S.C. § 353(b)(1);
section 503(b)(1) of the FD&C Act. FDA interprets this
provision to mean that only homeopathic products
intended for self-limiting disease conditions amenable
to self-treatment may be marketed as OTC products. All
other products must be marketed as prescription
products.
In any case in which the HPUS specifies more stringent
criteria for OTC use than do FDA regulations, the former
will apply.
Health Fraud
Agency personnel will consider whether a homeopathic
drug is being promoted significantly beyond recognized
or customary practice of homeopathy in assessing the
possibility of health fraud.
IN CONCLUSION
If homeopathy is to survive and serve the homeopathic
community, we must support the HPCUS. The HPCUS is
vigilant and, when it becomes opportune, we will support
a third class of drugs for qualified homeopathic
practitioners.
I cannot close without
sharing my recollection of the turbulent days of the
pharmacopoeia convention when Dr. Wyrth Post Baker was
still with us. I will always be grateful for the
dedication of Drs. Chase and Shevin, when we visited
with the FDA and explained to the FDA “Who We Are”. We
achieved credibility during those meetings. It is the
reason we are treated differently and fairly.
In addition, we should all
be grateful for the financial assistance of Boiron and
Standard are supporting the Potency Table Working Group
(PTWG) efforts, which are costing $8,000 per year.
Acceleration of the effort, through other contributions,
would be beneficial.
And a special thank you to
Drs. Chase and Wember for their successful efforts to
achieve a annual renewable grant from the The Woodward
Foundation.
Excellent references
The Life of Hering - Calvin Brobst Knerr
Faces of Homeopathy Winston
The Social Transformation of American Medicine -
Pulitzer Prize, Paul Starr
http://www.homeowatch.org/reg/meeting.html a pivotal
meeting with FDA
Google: Research Report National Center for
Complementary and Alternative Medicine
Its from NIH and it’s an Eye Opener. |
Homeopathic
Medical Society of the 
