Transcript Introduction to Intellectual Property

U.S. Regulation and Legislation of
Traditional Chinese Medicine
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Ryan Abbott, M.D., J.D., M.T.O.M.
Professor of Law and Health Sciences
• University of Surrey, School of Law
• Adjunct Assistant Professor of Medicine
University of California Los Angeles (UCLA), David Geffen
School of Medicine, Center for East-West Medicine
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[email protected]
UCLA CCIM Webpage:
www.ccim.med.ucla.edu
ExploreIM Web Portal:
http://exploreim.ucla.edu/
Center for East-West Medicine
Ka-Kit Hui, MD, FACP
(Chair)
Center for Excellence in Pancreatic
Diseases
Vay Liang W. (Bill) Go, MD
Center for Human Nutrition
David Heber, MD, PhD
Center for Neurobiology of Stress
Emeran Mayer, MD
Bruce D. Naliboff, PhD
Cousins Center for
Psychoneuroimmunology
Michael Irwin, MD
e-CAM
Edwin L. Cooper, PhD, ScD
Doctoring Program, UCLA School
of Medicine
Margaret L. Stuber, MD
Mindful Awareness Research Center
(MARC)
Susan Smalley, MD
Pediatric Pain Program
Lonnie K. Zeltzer, MD
School of Public Health
Michael Goldstein, PhD
RAND/Samueli Institute
Ian Coulter, PhD
Simms/Mann Center for Integrative
Oncology
Anne Coscarelli, PhD
Mary Hardy, MD
Stiles Program in Integrative
Oncology
Richard Pietras, MD, PhD
UCLArts and Healing
Ping Ho, MA, MPH
TCM in the U.S.
• National Health Interview Surveys (NHIS)
• 2007
• About 40% of adults use some form of Complementary and
Alternative Medicine (CAM)
• 2012
• $30.2 billion spent out-of-pocket on CAM products and
services
• $14.7 billon visits to CAM practitioners
• In 2015, $36.7 billion on dietary supplements (NBJ)
• National Center for Complementary and Integrative
Health (NCCIH)—$132 million budget
Licensed CAM Practitioners
Profession
Number
Licensed
Accredited
Schools
States
Regulated
(Licensed)
Accrediting
Agency
U.S. Dept of
Education
Recognition
Standard
National
Exam
Acupuncture
28,000
61
44
1982
1990
1985
Chiropractic
72,000
15
50
1971
1974
1963
Massage
280,000
88
44
1982
2002
1994
Direct-entry
Midwife
2,000
10
26
1991
2001
1994
Naturopathic
5,500
7
18
1978
1987
1986
2,800 MD/DOs certified by ABIHM; 1,100 MD/DOs completed UoA Fellowship in IM;
1,349 nurses certified by AHNCC (894,000 total MD/DOs and 3.3 million nurses)
Source: Academic Consortium for Complementary and Alternative Health Care (2013)
Dietary Supplement Health and
Education Act of 1994 (DSHEA)
• Focused on ensuring widespread consumer
access
• Creates a new category of food for dietary
supplements distinct from conventional foods
and drugs; excludes dietary supplements from
regulation as food additives
• Under DSHEA, it is the FDA’s responsibility to prove a
dietary supplement is unsafe before it can be removed from
the market. To withdraw a product, the FDA must prove
that the product places consumers at “significant or
unreasonable risk”
Product Liability
Botanical Drugs
• In October, 2006, the FDA approved the first
botanical pharmaceutical drug, Veregen, a purified
green tea extract for the topical treatment of human
papilloma virus
• Fulyzaq (crofelemer), the first anti-diarrheal drug for
HIV/AIDS patients, is the second FDA approved
botanical drug. Made from the sap of the Croton
lechleri plant, which is used in traditional medicine to
treat diarrhea.
CONTACT:
[email protected]
Me with Bruce Lee