ACMA Comments on TM Regulatory Model




To: Traditional Medicines Congress
From: American Chinese Medicine Association (ACMA)
http://www.AmericanChineseMedicineAssociation.org
Re: Comments on A Proposed Regulatory Model for Traditional Medicines
Date: June 1, 2006

Dear Traditional Medicines Congress:

The American Chinese Medicine Association (ACMA) has received and reviewed your November 2005 A Proposed Regulatory Model for Traditional Medicines (it will be called “Model” below).

Following please find the ACMA comments on the “Model”.


I. Similarities

In 2002, ACMA had initiated and submitted a “Letter to the Congress” [1]. After reading the “Model”, we found that many ideas mentioned in the “Model” are very similar to the proposals in the ACMA 2002 “Letter to the Congress”. Followings are several examples.

(1) The “Model” mentions that a new category for traditional medicine should be established.

Currently in the FDA classifications, there are only two categories of healthcare products: food dietary supplement and drug.

The 2002 “Letter to the Congress” had elucidated in details that the “herbal medicine” is a special category neither belonging to the food dietary supplement category nor to the drug category. Based on this reason, the 2002 “Letter to the Congress” proposed that a new category -- “herbal medicine” category – should be established in order to differentiate the “herbal medicine” from the drug and food dietary supplements categories.

The “Model” is very similar to the 2002 “Letter to the Congress” on this issue. The only difference is that the “Model” uses “traditional medicine” while the 2002 “Letter to the Congress” used “herbal medicine” in nominating the new category.

Therefore, the “Model” is similar to ACMA 2002 “Letter to the Congress” on this issue.

(2) The “Model” mentions that the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Dietary Supplement Health and Education Act (DSHEA) are inappropriate for traditional medicines.

The ACMA 2002 “Letter to the Congress” and its follow up letter “Letter to Congress Follow-up (1)” had explained in details that both FFDCA and DSHEA are inappropriate and should be amended in order to establish the new category -- herbal medicine category. Some amendment proposals were proposed in the 2002 “Letter to the Congress” and its follow-up letter. For more details on these issues, please see [1, 2].

Therefore, the “Model” is similar to ACMA 2002 “Letter to the Congress” and its follow-up letter on these issues.

(3) The “Model” proposes to establish a “Traditional Medicine Advisory Board”.

The ACMA 2002 “Letter to the Congress” had proposed to establish a new “FDA Division of Herbal Medicine” within the FDA in order to supervise the new category -- “herbal medicine” category in the United States.

The “Model” proposes to establish a “Traditional Medicine Advisory Board” outside the FDA. The function and role of such agency is similar to the “FDA Division of Herbal Medicine” proposed in the 2002 “Letter to the Congress”. The only difference between the “Model” and the 2002 “Letter to the Congress” is whether this agency should be established within or outside the FDA.

Therefore, the “Model” is similar to ACMA 2002 “Letter to the Congress” on this issue.

Above are similarities between the “Model” and the ACMA 2002 “Letter to the Congress”. ACMA believes that resolutions of above issues will be to the best interests of the American patients and the public.


II. Questions

Despite the similarities between the Model and the ACMA 2002 “Letter to the Congress”, ACMA reserves some questions on the “Model”.

(1) Traditional Medicine (TM)

Literally speaking, the term “traditional medicine” is similar to the term “complementary and alternative medicine (CAM)”. It is a group term, which includes many different medicines. As a descriptive term, TM has some positive meanings to distinguish the group of medicines from other medicines (e.g. Western Medicine).

However, the definition of “traditional medicine” is unclear because it has not resolved the following questions:
(a) What is the extension of “traditional medicine”?
(b) What is the connotation of “traditional medicine”?
(c) What are the established, comprehensive, independent, consistent, and complete principles and theories of TM that are of significant differences from other professional medicines?
(d) In appearance, the term TM should include not only herbal medicine, but also acupuncture, moxibustion, taiji, qi gong, tui na, an mo, gua sha, cupping, etc. all branches of Chinese Medicine.
(e) However, in reality, the term “Traditional Medicine” used in the “Model” actually refers to “herbal medicine” mainly. Therefore, there is a mismatch and inconsistency of the term “Traditional Medicine” in its intended use (referring to herbal medicine in the “Model”) and its literally meaning (covering everything in traditional medicine).

Medicine, as a profession relating to life and death, is a rigorous scientific field. Vague terms, such as CAM and TM, can be used for description purpose only. However, they should not be used for definitions, regulations, and administrations of rigorous professional medicines. Otherwise, medical incidents might follow in the future due to the vagueness. Therefore, the term “Traditional Medicine” may be inappropriate in the “Model”.

In sum, the intended meaning of “Traditional Medicine” in the “Model” is restricted to “herbal medicine” only. It does not include acupuncture, moxibustion, taiji, qi gong, tui na, an mo, gua sha, cupping, etc. However, the literal meaning of “Traditional Medicine” will include those non-herbal medicine areas. The term “Traditional Medicine” is unclear and inconsistent here. It will mislead readers and cause confusion.

Therefore, for accuracy purpose, ACMA deems that the term “herbal medicine” is more appropriate than the term “Traditional Medicine”, as described in the 2002 “Letter to the Congress”.

(2) “FDA Division of Herbal Medicine” vs. “Traditional Medicine Advisory Board”

There is a difference between the 2002 “Letter to the Congress” and the “Model” on whether to establish a new “FDA Division of Herbal Medicine” within the FDA, or to establish a “Traditional Medicine Advisory Board” outside the FDA.

ACMA deems that the branch of “herbal medicine” together with the branch of food and the branch of drug form a complete product system for healthcare. All three branches (food, herbal medicine, and drug) should be coordinated together because they are closely related and are integral parts of the entire healthcare system. Therefore, the “Division of Herbal Medicine” should be incorporated into the current FDA system rather than separated and established outside of the FDA.

As explained in the 2002 “Letter to the Congress”, current FDA does not have a division on herbal medicine. Therefore, current FDA is incomplete. It will help coordinate all three branches of the healthcare product system by establishing a new “FDA Division of Herbal Medicine” within the FDA. Accordingly, the current FDA should be renamed as FDHA (Food, Drug, and Herb Administration) [1].

(3) Chinese Medicine References

In the “Model”, “Key Components”, Section I, b, i, only the Pharmacopoeia of the People’s Republic of China is listed.

The Pharmacopoeia of the People’s Republic of China is a very important government reference in China. However, because Chinese Medicine has a very long history, any government references on Chinese Medicine only represent a part of Chinese Medicine in that era. So far, there is no government reference that could cover the entire Chinese Medicine. Therefore, use this reference as the sole source for Chinese Medicine is incomplete and inappropriate. It will significantly limit and restrict the scope and completeness of Chinese Medicine, and will severely obstruct the growth and development of Chinese Medicine in the United States of America. Therefore, many other authoritative comprehensive references on Chinese Medicine should be included in addition to the Pharmacopoeia of the People’s Republic of China.

Due to this reason, ACMA deems that with respect to the references in China, the sentences should be revised as follows:

“All editions of the Pharmacopoeia of the People’s Republic of China, as well as
any classic and contemporary authoritative sources and references on Chinese Medicine recognized by the profession of Chinese Medicine.”

(4) Intellectual Property Right Protection of Chinese Medicine

The intellectual property right protection is a very important issue to the healthy growth and development of Chinese Medicine. This issue is of long-term significance to patients as well as the profession of Chinese Medicine. However, the “Model” has not addressed this issue.

ACMA deems that the issue of Chinese Medicine intellectual property right protection should be included, addressed, and resolved.

Above are the comments on the “Model” from ACMA. You are welcome to direct your feedbacks on the comments to info@americanchinesemedicineassociation.org.

Thank you.

Sincerely,

American Chinese Medicine Association (ACMA)
http://www.AmericanChineseMedicineAssociation.org



References:

1. Xu, B. Letter to the Congress. ACMA Publication Issue Aug 2002. http://www.americanchinesemedicineassociation.org

2. American Chinese Medicine Association (ACMA). Letter to the Congress – Follow-up (1). ACMA Publication Issue Feb 16, 2004. http://www.americanchinesemedicineassociation.org


ACMA Home | ACMA Publications | About ACMA | About Us | Archives | Special Links | Contact Us
ACMA Patient Association | ACMA Patient Group
ACMA Cancer Center: Cancer Breakthrough | To Cancer Patients | ACMA Prostate Cancer Treatment |
ACMA Leukemia Treatment
ACMA Treatment Center: | Frequently Asked Questions | Letters from Patients | ACMA Cancer Center | Fees
Lupus Program | Kidney Failure Program | Asthma Program | Leukemia Program | AIDS/HIV Program | Heart Diseases Program