The Federal Register
http://www.homeowatch.org/reg/fda_hearing_2015/announcement.pdf[*QUOTE*]
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Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Proposed Rules
16327
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 15
[Docket No. FDA–2015–N–0540]
Homeopathic Product Regulation:
Evaluating the Food and Drug
Administration’s Regulatory
Framework After a Quarter-Century;
Public Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice public hearing; request
of for comments.
SUMMARY:
The Food and Drug
Administration (FDA) is announcing a
public hearing to obtain information
and comments from stakeholders about
the current use of human drug and
biological products labeled as
homeopathic, as well as the Agency’s
regulatory framework for such products.
These products include prescription
drugs and biological products labeled as
homeopathic and over-the-counter
(OTC) drugs labeled as homeopathic.
FDA is seeking participants for the
public hearing and written comments
from all interested parties, including,
but not limited to, consumers, patients,
caregivers, health care professionals,
patient groups, and industry. FDA is
seeking input on a number of specific
questions, but is interested in any other
pertinent information participants
would like to share.
DATES: The public hearing will be held
on April 20 and 21, 2015, from 9 a.m.
to 4 p.m. The meeting may be extended
or may end early depending on the level
of public participation. Register to
attend or provide oral testimony at the
hearing by April 13, 2015. See
Registration and Request to Provide Oral
Testimony for information on how to
register or make an oral presentation at
the hearing. Written or electronic
comments will be accepted until June
22, 2015.
ADDRESSES: public hearing will be
Theheld at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
rm. 1503A, Silver Spring, MD, 20993–
0002. Participants must enter through
Building 1 and undergo security
screening. For parking and security
information, please refer to
http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm FOR FURTHER INFORMATION CONTACT:
Lesley DeRenzo, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20903–0002, 240–402–4612, FAX: 301–
847–8747, Lesley.derenzo@fda.hhs.gov;
or Cynthia Ng, Center for Drug
Evaluation and Research, 10903 New
Hampshire Ave., Silver Spring, MD
20903–0002, 301–796–7512, FAX: 301–
847–8747, cynthia.ng.@fda.hhs.gov.
Registration and Request to Provide
Oral Testimony: The public hearing is
free and seating will be on a first-come,
first-served basis. If you wish to attend
or make an oral presentation, see section
III (Attendance and/or Participation in
the Public Hearing) for information on
how to register and the deadline for
registration. If you cannot attend in
person, information about how you can
access a live Webcast will be located at
https://collaboration.fda.gov/hprapril2015/ Comments and Transcripts: You may
submit either electronic comments
regarding this document to
http://www.regulations.gov or written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. You should
annotate and organize your comments to
identify the specific questions or topic
to which they refer. It is only necessary
to send one set of comments. Please
identify your comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at
http://www.regulations.gov Transcripts of the hearing will be
available for review at the Division of
Dockets Management and at
http://www.regulations.gov approximately 45
days after the hearing. You may submit
a request to obtain a hard copy or CD–
ROM transcript. Send your request to
the Division of Freedom of Information
(ELEM–1029), Office of Management
Programs, Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg., Rockville, MD 20857.
SUPPLEMENTARY INFORMATION:
FDA is
evaluating its current enforcement
policies for drug products labeled as
homeopathic from scientific, risk, and
process perspectives. The Agency is
now soliciting opinions about whether
and how to adjust the current
enforcement policies to reflect changes
in the homeopathic product
marketplace over the last approximately
25 years.
P1.SGM
27MRP1
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Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Proposed Rules
I. Background
A. Homeopathic Products and the
Federal Food, Drug, and Cosmetic Act
The definition of a ‘‘drug’’ under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) includes: (1) Articles
recognized in the official United States
Pharmacopoeia (USP), official
Homoeopathic Pharmacopoeia of the
United States (HPUS); (2) articles
intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of
disease in man or other animals; and (3)
articles (other than food) intended to
affect the structure or any function of
the body of man or other animals. See
section 201(g)(1)(A) to (C) of the FD&C
Act (21 U.S.C. 321(g)(1)(A) to(C)).
Accordingly, an article that meets this
definition of a ‘‘drug’’ is subject to
regulation under the FD&C Act,
regardless of whether it is labeled as
homeopathic. An article that also meets
the definition of a ‘‘biological product’’
(as defined in section 351(i) of the
Public Health Service Act (PHS Act) (42
U.S.C 262(i))) is subject to regulation
under both the FD&C Act and the PHS
Act.
The FD&C Act recognizes the HPUS,
along with the USP, as an official
compendium. See section 201(j) of the
FD&C Act. The HPUS is produced by a
non-governmental organization known
as the Homeopathic Pharmacop*ia
Convention of the United States
(HPCUS) and has been in continuous
publication since 1897 (Ref. 1). The
HPCUS determines which ingredients,
including permissible potency levels,
are officially monographed homeopathic
ingredients. To date, there are over 1200
officially monographed ingredients in
the HPUS. Since 2004, the HPCUS has
added over 500 new ingredient
monographs. The standards set forth in
the HPUS and the USP affect the
naming, quality, and labeling of drug
products. See e.g., sections 501(b) and
502(g) of the FD&C Act (21 U.S.C. 351(b)
and 352(g)).
Nothing in the FD&C Act exempts
drugs labeled as homeopathic from any
of the requirements related to approval,
adulteration, and misbranding,
including labeling requirements. If a
drug labeled as homeopathic is a new
drug under the FD&C Act, it is subject
to the same premarket approval
requirements and the same standards for
safety and efficacy as all new drugs. A
new drug is defined, in part, as any drug
that is not generally recognized, among
experts qualified by scientific training
and experience to evaluate the safety
and effectiveness of drugs, as safe and
effective for use under the condition
prescribed, recommended, or suggested
in the labeling thereof. See section
201(p) of the FD&C Act).
B. Homeopathic Drugs and the OTC
Drug Review
In 1972, FDA initiated rulemaking
procedures (the OTC Drug Review) to
determine which OTC drugs are
generally recognized among qualified
experts as safe and effective and not
misbranded under prescribed,
recommended, or suggested conditions
of use. See ‘‘Procedures for
Classification of Over-the-Counter
Drugs’’ (37 FR 9464, May 11, 1972).
FDA deferred review of drugs labeled as
homeopathic due to the uniqueness of
homeopathic medicine and stated that
FDA would review them as a separate
category at a later time (37 FR 9464 at
9466). To date, FDA has not reviewed
this class of products for safety and
efficacy. Accordingly, there are
currently no FDA monographs for drug
products labeled as homeopathic.
C. FDA’s Compliance Policy Guide
Since 1988, prescription and
nonprescription drug products labeled
as homeopathic have been
manufactured and distributed without
FDA approval under the enforcement
policies set forth in FDA’s Compliance
Policy Guide (CPG) 400.400 entitled
‘‘Conditions Under Which Homeopathic
Drugs May be Marketed’’ (see 53 FR
21728, June 9, 1988). The CPG defines
a homeopathic drug as any drug labeled
as being homeopathic which is listed in
the HPUS, an addendum to it, or its
supplements. The CPG includes
conditions specific to ingredients,
labeling, prescription status, and current
good manufacturing practice. The CPG
can be found at
http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074360.htm D. Growth in the Sale of Drugs Labeled
as ‘‘Homeopathic’’
The homeopathic drug industry has
continued on an upward growth
trajectory since FDA issued its CPG in
1988, especially with respect to OTC
drug products labeled as homeopathic.
The CPG noted that, at the time of
original publication in 1988, the
homeopathic drug market was a
multimillion dollar industry in the
United States. In 2007, the National
Health Interview Survey, conducted by
the Centers for Disease Control and
Prevention’s National Center for Health
Statistics, estimated that adults spent
about $2.9 billion on the purchase of
homeopathic medicine (Ref. 2). Many
drugs labeled as homeopathic are sold
OTC in major retail stores and are often
marketed as natural, safe, and effective
alternatives to other prescription and
nonprescription products.
E. Safety of Drug Products Labeled as
Homeopathic
Drugs products labeled as
homeopathic can contain a wide range
of substances, including ingredients
derived from plants, healthy or diseased
animal or human sources, minerals, and
chemicals (either as active or inactive
ingredients). As with ingredients in
other drug and biological products,
homeopathic ingredients, even if highly
diluted, can cause side effects, drug
interactions, and allergic or other
adverse reactions. Negative health
effects from drug products labeled as
homeopathic have been reported
through the FDA’s Adverse Event
Reporting System and the National
Poison Data System (NPDS), which is
maintained by the American
Association of Poison Control Centers
and tracks human poison exposure
cases. Data in the NPDS pertaining to
homeopathic drug products is tracked
under the category ‘‘Homeopathic
Agents.’’ The 2012 American
Association of Poison Control Center
Annual Report indicated that there were
10,311 reported poison exposure cases
related to ‘‘Homeopathic Agents,’’ with
8,788 of those reported cases attributed
to children 5 years of age and younger
(Ref. 3). Of the 10,311 reported cases,
697 required treatment in a health care
facility (Id.).
II. Scope of the Public Hearing
FDA is seeking broad public input on
the current enforcement policies related
to drug products labeled as
homeopathic in an effort to better
promote and protect the public health.
FDA has developed a list of questions to
facilitate a more productive discussion
at the public hearing. This list is not
intended to be exclusive, and FDA
encourages comments on other matters
related to the development and
regulation of drug and biological
products labeled as homeopathic. Issues
that are of specific interest to the
Agency include the following:
• What are consumer and health care
provider attitudes towards human drug
and biological products labeled as
homeopathic?
• What data sources can be identified
or shared with FDA so that the Agency
can better assess the risks and benefits
of drug and biological products labeled
as homeopathic?
• Are the current enforcement
policies under the CPG appropriate to
protect and promote public health in
light of the tremendous growth in the
Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Proposed Rules
16329
homeopathic drug market? Are there
alternatives to the current enforcement
policies of the CPG that would inform
FDA’s regulatory oversight of drugs
labeled as homeopathic? If so, please
explain.
• Are there areas of the current CPG
that could benefit from additional
clarity? If so, please explain.
• Is there information regarding the
regulation of homeopathic products in
other countries that could inform FDA’s
thinking in this area?
• A large majority of human drug
products labeled as homeopathic are
marketed as OTC drugs. These products
are available for a wide variety of
indications, and many of these
indications have never been considered
for OTC use under a formal regulatory
process. What would be an appropriate
regulatory process for evaluating such
indications for OTC use?
• Given the wide range of indications
on drug products labeled as
homeopathic and available OTC, what
processes do companies currently use to
evaluate whether such products,
including their indications for use, are
appropriate for marketing as an OTC
drug?
• Do consumers and health care
providers have adequate information to
make informed decisions about drug
products labeled as homeopathic? If not,
what information, including, for
example, information in labeling, would
allow consumers and health care
providers to be better informed about
products labeled as homeopathic?
III. Attendance and/or Participation in
the Public Hearing
The public hearing is free and seating
will be on a first-come, first-served
basis. If you wish to make an oral
presentation during the hearing, you
must register by submitting either an
electronic or a written request by 5 p.m.
on April 13, 2015, to Lesley DeRenzo or
Cynthia Ng (see FOR FURTHER
INFORMATION CONTACT). Submit
electronic requests to
CDERHOMEOPATHICPRODUCT@
fda.hhs.gov. You must provide your
name, title, business affiliation (if
applicable), address, telephone and fax
numbers, email address, and type of
organization you represent (e.g.,
industry, consumer organization, etc.).
You also should submit a brief summary
of the presentation, including the
discussion topic(s) that will be
addressed and the approximate time
requested for your presentation. FDA
encourages individuals and
organizations with common interests to
coordinate and give a joint, consolidated
presentation. Registrants will receive
confirmation once they have been
accepted to attend the meeting. FDA
may limit both the number of
participants from individual
organizations and the total number of
attendees based on space limitations.
Registered presenters should check in
before the hearing.
Participants should submit a copy of
each presentation to Lesley DeRenzo or
Cynthia Ng (see FOR FURTHER
INFORMATION CONTACT) no later than 5
p.m. on April 13, 2015. We will file the
hearing schedule, indicating the order
and time allotted for each presenter,
with the Division of Dockets
Management (see COMMENTS AND
TRANSCRIPTS). FDA will post an
agenda of the public hearing and other
background material at least 3 days
before the public hearing, along with
additional information, at:
http://www.fda.gov/Drugs/NewsEvents/ucm132703.htm(select this hearing
from the events list).
We will mail, email, or telephone the
schedule to each participant before the
hearing. In anticipation of the hearing
presentations moving ahead of
schedule, participants are encouraged to
arrive early to ensure their designated
order of presentation. Participants who
are not present when called risk
forfeiting their scheduled time.
If you need special accommodations
due to a disability, contact Lesley
DeRenzo or Cynthia Ng (see FOR
FURTHER INFORMATION CONTACT) at least 7
days in advance of the hearing.
IV. Notice of Hearing Under 21 CFR
Part 15
The Commissioner of Food and Drugs
is announcing that the public hearing
will be held in accordance with part 15
(21 CFR part 15). A presiding officer,
who will be accompanied by FDA
senior management from the Office of
the Commissioner and the relevant
centers, will conduct the hearing.
Under § 15.30(f), the hearing is
informal and the rules of evidence do
not apply. Only the presiding officer
and panel members may question any
person during or at the conclusion of
each presentation (§ 15.30(e)). Public
hearings under part 15 are subject to
FDA’s policy and procedures for
electronic coverage of FDA’s
media public administrative proceedings (21
CFR part 10, subpart C) (§ 10.203(a)).
Under § 10.205, representatives of the
electronic media may be permitted,
subject to certain limitations, to
videotape, film, or otherwise record
FDA’s public administrative
proceedings, including presentations by
participants. The hearing will be
transcribed as stipulated in § 15.30(b).
To the extent that the conditions for the
hearing as described in this document
conflict with any provisions set out in
part 15, this notice acts as a waiver of
those provisions as specified in
§ 15.30(h).
V. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at
http://www.regulations.gov(FDA has verified
all the Web site addresses in this
reference section, but we are not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. The Homeopathic Pharmacopoeia of the
United States (HPUS), ‘‘What is the
HPUS?’’, available at
http://www.hpus.com/what-is-the-hpus.php (last visited Dec. 23, 2014).
2. Nahin, R. L., P. M. Barnes, B. J. Stussman,
and B. Bloom, ‘‘Costs of Complementary
and Alternative Medicine (CAM) and
Frequency of Visits to CAM
Practitioners: United States, 2007.’’
National Health Statistics Reports; no
18. Hyattsville, MD: National Center for
Health Statistics, 2009.
3. James B. Mowry, et al., ‘‘2012 Annual
Report of the American Association of
Poison Control Centers’ National Poison
Data System (NPDS): 30th Annual
Report,’’ 51 Clinical Toxicology, 949,
1188 (2013).
Dated: March 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–07018 Filed 3–26–15; 8:45 am]
BILLING CODE 4164–01–P
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