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  • Capital Reporting CompanyHomeopathic Product Regulation 04-20-2015

    (866) 448 - DEPOwww.CapitalReportingCompany.com 2015

    1

    Homeopathic Product Regulation:

    Evaluating the Food And Drug Administration's

    Regulatory Framework After a Quarter-Century

    Part 15 Public Hearing

    Day 1

    Monday, April 20, 2015

    9:00 a.m.

    FDA White Oak Campus

    10903 New Hampshire Avenue

    Bldg 31, Room 1503(A)

    Silver Spring, Maryland 20993

    Reported by: Michael Farkas Capital Reporting Company

  • Capital Reporting CompanyHomeopathic Product Regulation 04-20-2015

    (866) 448 - DEPOwww.CapitalReportingCompany.com 2015

    2

    1 A P P E A R A N C E S

    2 JANET WOODCOCK

    3 JOHN WHYTE

    4 EDWARD P. KRENZELOK

    5 ADRIANE FUGH-BERMAN

    6 MICHAEL DEDORA

    7 WAYNE B. JONAS

    8 LISA AMERINE

    9 AMY ROTHENBERG

    10 BRUCE H. SHELTON

    11 JEANNINE RITCHOT

    12 MELANIE GRIMES

    13 MARCEL FRAIX

    14 M'LOU ARNETT

    15 ALISON TEITELBAUM

    16 JANINE JAGGER

    17 MARK LAND

    18 MARK PHILLIPS

    19 ERIC FOXMAN

    20 BARBARA A. KOCHANOWSKI

    21 PEGGY O'MARA

    22 LUANA COLLOCA

  • Capital Reporting CompanyHomeopathic Product Regulation 04-20-2015

    (866) 448 - DEPOwww.CapitalReportingCompany.com 2015

    3

    1 APPEARANCES CONTINUED:

    2ALYSSE WOSTREL

    3NANCY PEPLINSKY

    4TANYA KELL

    5ANTHONY VOZZOLO

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  • Capital Reporting CompanyHomeopathic Product Regulation 04-20-2015

    (866) 448 - DEPOwww.CapitalReportingCompany.com 2015

    4

    1 C O N T E N T S

    2 SPEAKER: PAGE NUMBER:

    3 John Whyte, Moderator 6

    4 Janet Woodcock, Director, CDER, FDA 6

    5 Edward Krenzelok, Rocky Mountain Poison and Drug Center 17

    6Adriane Fugh-Berman,

    7 Georgetown University Medical Center 35

    8 Michael DeDora, Center for Inquiry 50

    9 Wayne B. Jonas, Samueli Institute 62

    10 Lisa Amerine, Homeopathic Academy of Naturopathic Physicians 87

    11Dr. Bruce H. Shelton, Arizona Homeopathic

    12 and Integrative Medical Association 131

    13 Jeannine Ritchot, Health Canada 153

    14 Melanie Grimes 173

    15 Dr. Marcel Fraix, Western University of Health Sciences 179

    16M'Lou Arnett, Matrixx Initiatives, Inc. 191

    17Alison Teitelbaum,

    18 Natural Center for Homeopathy 203

    19 Janine Jagger, Familial Mediterranean Fever Found. 210

    20Dr. Mark Land, Mark Phillips, Eric Foxman 218

    21 American Assoc. of Homeopathic Pharmacists

    22 Barbara A. Kochanowski, Consumer Healthcare Products Assoc. 248

  • Capital Reporting CompanyHomeopathic Product Regulation 04-20-2015

    (866) 448 - DEPOwww.CapitalReportingCompany.com 2015

    5

    1Peggy O'Mara 259

    2Luana Colloca, Univ. of Maryland, Baltimore 269

    3Alyssa Wostrel,

    4 Integrative Health Policy Consortium 287

    5 Nancy Peplinsky, Holistic Moms Network 301

    6 Tanya Kell, North American Society of Homeopaths 311

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  • Capital Reporting CompanyHomeopathic Product Regulation 04-20-2015

    (866) 448 - DEPOwww.CapitalReportingCompany.com 2015

    6

    1 P R O C E E D I N G S

    2 DR. WHYTE: Well, good morning,

    3 everyone. I'm Dr. John Whyte. I'm the Director of

    4 Professional Affairs and Stakeholder Engagement

    5 Group here at the Food and Drug Administration at

    6 the Center for Drugs Evaluation and Research, and

    7 I'll be serving as the moderator for today's

    8 hearing.

    9 We're on a strict timeline today so I

    10 want to go ahead and get started, and I'm

    11 delighted to present to you Dr. Janet Woodcock,

    12 who is the Director of the Center for Drugs

    13 Evaluation and Research.

    14 DR. WOODCOCK: Thanks very much, John.

    15 Good morning, everyone. Thank you very much for

    16 coming to this. I'd like to welcome you to this

    17 two day hearing on FDA's regulation on drug

    18 products labeled as homeopathic.

    19 We recognize that this topic is of great

    20 importance and of interest to industry and other

    21 stakeholders based on the number of presenters

    22 scheduled to speak here today and tomorrow.

  • Capital Reporting CompanyHomeopathic Product Regulation 04-20-2015

    (866) 448 - DEPOwww.CapitalReportingCompany.com 2015

    7

    1 I want to thank you for all your

    2 interest in this topic and thank the people in the

    3 webcast, and hope that they are able to access

    4 this event.

    5 By providing specific feedback to our

    6 questions and our preliminary concepts, through

    7 your oral testimony and written comments to FDA's

    8 dockets, you will help us develop the appropriate

    9 path forward.

    10 The Federal Food, Drug, and Cosmetic

    11 Act, and I'll refer to it as the ACT, recognizes

    12 articles listed in the Homeopathic Pharmacopoeia

    13 of the United States as drugs. FDA has clear

    14 regulatory authority over drug products labeled as

    15 homeopathic, just as it does with all products

    16 that meet the definition of "drug" in the ACT.

    17 And I know there's been a great deal of confusion

    18 about this, but yes, FDA has authority over drugs

    19 that are labeled as homeopathic.

    20 However, under FDA's current enforcement

    21 policies that were issued in something we call a

    22 Compliance Policy Guide, in 1988 drug products

  • Capital Reporting CompanyHomeopathic Product Regulation 04-20-2015

    (866) 448 - DEPOwww.CapitalReportingCompany.com 2015

    8

    1 labeled as homeopathic are marketed without pre-

    2 market approval, provided those products are

    3 marketed in accordance with certain conditions,

    4 including ones related to labeling and

    5 manufacturing.

    6 So, it isn't that homeopathic drugs are

    7 not regulated by the FDA, they are regulated as

    8 drugs, it's simply they have a different structure

    9 right now under this compliance policy guide

    10 that's been in effect for a long time as far as

    11 how they are regulated.

    12 Today, prescription and non prescription

    13 drugs labeled as homeopathic are a multi-billion

    14 dollar industry in the United States.

    15 A majority of drug products that are

    16 labeled as homeopathic are marketed and sold

    17 direct consumer through magazines, the internet,

    18 and in both the big box retail establishments and

    19 traditional pharmacy retail outlets.

    20 Prescription drug products labeled

    21 homeopathic also exist and are available through

    22 both online pharmacies and through practitioners

  • Capital Reporting CompanyHomeopathic Product Regulation 04-20-2015

    (866) 448 - DEPOwww.CapitalReportingCompany.com 2015

    9

    1 licensed to dispense prescription drug products.

    2 So there are several outlets -- great over-the-

    3 counter use, direct to consumer, and also

    4 prescription use.

    5 Typically drug products are brought to

    6 the market through the new drug approval process,

    7 or via an over-the-counter monograph, and these

    8 are two regulatory structures that FDA has in

    9 place to allow new drugs or traditional drugs to

    10 be marketed.

    11 In contrast, both prescription and non

    12 prescription drug products that are labeled as

    13 homeopathic are manufactured and distributed

    14 without FDA approval, and without being subject to

    15 any FDA monograph under the Agency's enforcement

    16 policies that were set forth, as I mentioned, in

    17 this compliance policy guide. So, that is the

    18 regulatory -- currently regulatory regime for

    19 these homeopathic products.

    20 The public hearing, we hope, will allow

    21 FDA to obtain information about such products in

    22 an effort to better promote and protect the public

  • Capital Reporting CompanyHomeopathic Product Regulation 04-20-2015

    (866) 448 - DEPOwww.CapitalReportingCompany.com 2015

    10

    1 health, which is what we do, which is our mission.

    2 And we want to make sure that patients have the

    3 necessary information to make informed choices

    4 about products labeled as homeopathic, as well as,

    5 of course, make sure that all those products are

    6 appropriately safe for people to use.

    7 FDA is seeking input on several

    8 questions regarding products labeled as

    9 homeopathic, that include various topic areas;

    10 consumer and healthcare provider attitudes,

    11 potential data sources that could be used to

    12 assess the risks and benefits of the products, our

    13 enforcement policies, and the evalu