Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools; Notice of Public Hearing, 48083-48088 [E9-22618]
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events within the protections of the
Patient Safety Act and Patient Safety
Rule. As a result, healthcare providers,
and those committed to improving the
safety and quality of patient care, have
a strong interest in the integrity of PSOs
and their ability to carry out this
statutory mission.
AHRQ administers the provisions of
the Patient Safety Rule relating to listing
and operation of PSOs, which are the
focus of this guide. The HHS Office for
Civil Rights is responsible for enforcing
the confidentiality protections of the
Patient Safety Act and Patient Safety
Rule.
For an entity to be listed, and remain
listed, as a PSO, the Patient Safety Rule
relies primarily upon a system of
attestations. An entity seeking listing for
a three-year period as a PSO must
submit to AHRQ a form, Certification for
Initial Listing, to attest that it meets the
Patient Safety Rule’s eligibility and
listing requirements at the time the
entity submits its certifications. During
its period of listing, a PSO must submit
a form, Two Bona Fide Contract
Requirement, every two years attesting
that it has at least two contracts with
different providers. If the PSO has other
relationships, specified in section
3.102(d)(2), with any contracting
provider, it must also submit the form,
PSO Disclosure Statement, regarding its
relationships with the provider and
attest to the completeness and accuracy
of its disclosures. Finally, a PSO must
submit the form, Certification for
Continued Listing, to seek continued
listing for an additional three-year
period and attest that it meets the
requirements for continued listing. This
process places the burden for
understanding and complying with the
Patient Safety Rule on the PSO.
The Patient Safety Rule also
authorizes AHRQ to assess or verify
PSO compliance with the rule’s
requirements at any time through
requests for information or by
conducting announced or unannounced
reviews of, or site visits to, PSOs
(section 3.110). In addition to routine
compliance reviews, AHRQ may also
conduct site visits or request additional
information if, for example, AHRQ
becomes aware that a PSO is not in
compliance with the requirements of the
statute or the Patient Safety Rule.
The Patient Safety Rule provides
PSOs latitude in complying with its
requirements. In part, this reflects a
recognition that PSOs will vary in terms
of size, complexity, and sophistication
and, over time, PSOs will vary
significantly in the breadth and scope of
their activities. For example, PSOs can
be local, regional, or national in
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orientation; they can focus narrowly or
broadly in terms of the clinical or
analytic services they offer providers;
they can target their services toward one
type of healthcare facility or multiple
healthcare settings; and, they are likely
to vary in the sophistication and
complexity of information technology
employed.
Each PSO will need to develop its
approach to compliance by taking into
account the specific mission it has
chosen for itself, the specific activities
and expertise it offers to healthcare
providers, and its size and mode of
operation. As a consequence, AHRQ
developed this self-assessment guide
recognizing that individual PSOs are
likely to approach compliance from
different perspectives. Thus, the guide
does not propose a uniform approach to
compliance, Instead, the guide presents
sample questions—some of which may
not be applicable or appropriate to a
specific PSO—to encourage each PSO to
take a comprehensive and systematic
approach to compliance that best meets
its circumstances.
The questions in the guide do not
establish new standards or
requirements; they are only presented
for an illustrative purpose. If there is
any inadvertent discrepancy between
the text of the guide and the Patient
Safety Rule, PSOs should consider the
text of the rule as authoritative.
More information on the ‘‘Patient
Safety Organizations: A Compliance Self
Assessment Guide’’ and PSOs can be
obtained through AHRQ’s PSO Web site:
https://www.pso.ahrq.qov/.
Dated: September 11, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9–22594 Filed 9–18–09; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0441]
Promotion of Food and Drug
Administration-Regulated Medical
Products Using the Internet and Social
Media Tools; Notice of Public Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Notice of public hearing;
request for comments.
SUMMARY: The Food and Drug
Administration’s (FDA’s) Center for
Drug Evaluation and Research (CDER),
in collaboration with FDA’s Center for
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Biologics Evaluation and Research
(CBER), Center for Veterinary Medicine
(CVM), and Center for Devices and
Radiological Health (CDRH), is
announcing a public hearing to discuss
issues related to the promotion of FDAregulated medical products (including
prescription drugs for humans and
animals, prescription biologics, and
medical devices) using the Internet and
social media tools. FDA is seeking
participation in the public hearing and
written comments from all interested
parties, including, but not limited to,
consumers, patients, caregivers, health
care professionals, patient groups,
Internet vendors, advertising agencies,
and the regulated industry. This
meeting and the written comments are
intended to help guide FDA in making
policy decisions on the promotion of
human and animal prescription drugs
and biologics and medical devices using
the Internet and social media tools. FDA
is seeking input on a number of specific
questions but is interested in any other
pertinent information participants in the
hearing would like to share.
Dates and Times: The public hearing
will be held on November 12 and 13,
2009, from 8 a.m. to 5 p.m. each day.
Submit written or electronic registration
by close of business on October 9, 2009.
Written and electronic comments will
be accepted until February 28, 2010.
Location: The public hearing will be
held at the National Transportation
Safety Board Conference Center, 429
L’Enfant Plaza, SW., Washington, DC
20594, 202–314–6305; Metro: L’Enfant
Plaza station on the yellow, green,
orange, and blue lines; see: https://
ntsb.gov/events/newlocation.htm. (FDA
has verified the Web site address, but
FDA is not responsible for any changes
to the Web site after this document
publishes in the Federal Register.)
ADDRESSES: Submit written registration
and written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic registration and
electronic comments, identified with
the docket number found in brackets in
the heading of this document, to https://
www.regulations.gov.
Transcripts of the hearing will be
available for review at the Division of
Dockets Management and on the
Internet at https://www.regulations.gov
approximately 30 days after the hearing
(see section VI of this document).
Registration to Attend and/or to
Participate in the Meeting: Seating at the
hearing is limited. People interested in
attending should submit written or
electronic registration as specified above
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(see ADDRESSES) by close of business on
October 9, 2009. Registration is free and
will be accepted on a first-come, firstserved basis. Written or electronic
comments will be accepted until
February 28, 2010.
The procedures governing the hearing
are found in 21 CFR part 15 (see section
IV of this document). If you wish to
make an oral presentation at the
hearing, you must state your intention
on your registration submission (see
ADDRESSES). To speak, submit your
name, title, business affiliation,
addresses, telephone and fax numbers,
and e-mail address. FDA has included
questions for comment in section III of
this document. You should also identify
by number each question you wish to
address in your presentation and the
approximate time requested. FDA will
do its best to accommodate requests to
speak. Individuals and organizations
with common interests should
consolidate or coordinate their
presentations and request time for a
joint presentation. FDA will determine
the amount of time allotted to each
presenter and the approximate time that
each oral presentation is scheduled to
begin. Once FDA notifies registered
participants of their scheduled times,
presenters should submit to FDA two
copies of each presentation to be given
(see FOR FURTHER INFORMATION CONTACT).
If you need special accommodations
because of a disability, please inform
Jean-Ah Kang (see FOR FURTHER
INFORMATION CONTACT) at the time of
registration.
FOR FURTHER INFORMATION CONTACT:
Jean-Ah Kang, Division of Drug
Marketing, Advertising, and
Communications, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 3270,
Silver Spring, MD, 20993–0002, 301–
796–4269, FAX: 301–796–8444, e-mail:
InternetPublicMeeting@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Internet has become a widely
used medium for companies, including
manufacturers, packers, or distributors
of medical products regulated by FDA,
to disseminate information about their
products. The Internet’s ability to
facilitate communication, information
sharing, information exchange between
systems, user-centered design, and
collaboration has also evolved as a
result of the second generation of Web
development and Web design, or ‘‘Web
2.0.’’ Web 2.0 has led to the emergence
of a variety of social media tools (i.e.,
Web properties whose online content is
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primarily created and published by
users rather than the property owners).
The continually evolving nature of the
Internet, including Web 2.0 and social
media tools, as well as their expansion
to applications such as mobile
technology, have raised questions and
concerns over how to apply existing
regulations to promotion in these newer
media. FDA is evaluating how the
statutory provisions, regulations, and
policies concerning advertising and
promotional labeling should be applied
to product-related information on the
Internet and newer technologies.
Although the agency believes that many
issues can be addressed through existing
FDA regulations, special characteristics
of Web 2.0 and other emerging
technologies may require the agency to
provide additional guidance to the
industry on how the regulations should
be applied.
A. Regulation of Advertising and
Labeling
Under the Federal Food, Drug, and
Cosmetic Act (the act), FDA has
responsibility for regulating the labeling
of prescription drugs and medical
devices and the advertising of
prescription drugs and restricted
medical devices. If an activity or
material is considered to be either
advertising or labeling, it must meet
certain requirements.
Under section 201(m) of the act (21
U.S.C. 321(m)), labeling is defined as
‘‘all labels and other written, printed, or
graphic’’ materials ‘‘upon’’ or
‘‘accompanying’’ an article. The term
‘‘accompanying’’ has been broadly
defined by the Supreme Court (Kordel v.
United States, 335 U.S. 345, 349–350
(1948)). FDA’s regulations give
examples of labeling materials,
including brochures, mailing pieces,
detailing pieces, calendars, price lists,
letters, motion picture films, and sound
recordings (§ 202.1(l)(2) (21 CFR
202.1(l)(2))).
FDA regulates the labeling of all drugs
and devices under its jurisdiction.
Labeling must be truthful and
nonmisleading (section 502(a) of the act
(21 U.S.C. 352(a))).
FDA also regulates the advertising for
prescription drugs and biologics.
Although the act does not define what
constitutes an ‘‘advertisement,’’ FDA
generally interprets the term to include
information (other than labeling) that is
issued by, or on behalf of, a
manufacturer, packer, or distributor and
is intended to promote a product. This
includes, for example, ‘‘advertisements
in published journals, magazines, other
periodicals, and newspapers, and
advertisements broadcast through media
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such as radio, television, and telephone
communication systems’’ (§ 202.1(l)(1)).
According to the act (section 502(n)), a
prescription drug is misbranded if its
advertising does not include, in
addition to the product’s established
name and quantitative composition, a
‘‘true statement’’ of information in brief
summary ‘‘relating to side effects,
contraindications and effectiveness’’ of
the advertised product. For prescription
drug advertisements, FDA’s
implementing regulations (21 CFR part
202) specify that, among other things,
the statutory requirement of a ‘‘true
statement’’ is not satisfied if an
advertisement is false or misleading
with respect to side effects,
contraindications or effectiveness or if it
fails to reveal material facts about
‘‘consequences that may result from the
use of the drug as recommended or
suggested in the advertisement’’
(§ 202.1(e)(5)). The prescription drug
regulations also specify that
advertisements must ‘‘present a fair
balance between information relating to
side effects and contraindications and
information relating to effectiveness of
the drug,’’ which is achieved when ‘‘the
presentation of true information relating
to side effects and contraindications is
comparable in depth and detail with the
claims for effectiveness or safety’’
(§ 202.1(e)(5)(ii)).
FDA similarly regulates advertising
for restricted devices. A ‘‘restricted
device’’ is a device that may be
restricted to sale, distribution, or use
only with the written or oral
authorization of a licensed practitioner,
or in accordance with other conditions
if FDA determines that there cannot
otherwise be reasonable assurance of its
safety and effectiveness (21 U.S.C.
360j(e)). FDA also restricts devices
through the approval orders granted to
many class III devices (21 U.S.C.
360e(d)(1)(B)(ii)). According to the act, a
restricted device is misbranded if its
advertising is false or misleading in any
particular (section 502(q) of the act), or
if its advertising does not contain a brief
statement of the intended uses of the
device and relevant warnings,
precautions, side effects, and
contraindications (section 502(r) of the
act). There are currently no regulations
establishing specific requirements for
the content and format of
advertisements for restricted devices.
Although FDA has not
comprehensively addressed when
Internet promotion of prescription drugs
and medical devices is labeling versus
advertising, the agency has jurisdiction
over all prescription drug and biologic
product promotion as well as all
restricted device advertising and all
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device promotional labeling when
conducted by or on behalf of a
manufacturer, packer, or distributor.
There are no regulations that
specifically address Internet promotion
separately from the other types of
promotion discussed above, nor are
there any regulations that prohibit the
use of certain types of media to promote
drugs and medical devices. Although no
rule has specifically addressed Internet
promotion, it is fairly clear that some
promotional efforts are substantially
similar in presentation and content to
promotional materials in other media or
publications. At the same time, FDA
recognizes that the Internet possesses
certain unique technological features
and that some online tools that may be
used for promotion offer novel
presentation and content features.
Another emerging issue involves the
reporting of adverse event data because
such information may initially be
revealed using social media platforms in
the context of Internet promotion for
FDA-regulated medical products.
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B. 1996 Meeting on Promotion of FDARegulated Products on the Internet
On October 16 and 17, 1996, FDA
held a public meeting to discuss issues
related to the promotion of FDAregulated medical products on the
Internet (see 61 FR 48707, September
16, 1996). The agency’s objective was to
receive broad public input and to hear
various points of view and opinions on
Internet issues from a discussion among
interested persons. A discussion group
format was used and covered the
following topics: Investigational product
information, chatrooms and
newsgroups, and Web site links. A
transcript of the meeting is available at
https://www.fda.gov/AboutFDA/
CentersOffices/CDER/ucm175775.htm.)
C. New Internet Tools and Technology
Since the 1996 public meeting, there
has been a massive expansion of new
tools and technologies, such as blogs,
microblogs, podcasts, social network
sites (‘‘social networks’’) and online
communities, video sharing, widgets,
and wikis, which are defined as
follows:1,2
• Blogs (e.g., Blogger, WordPress,
TypePad): Blogs are Web sites with
regular updates (in reverse
chronological order—newest update at
the top) that typically combine text,
1 Adapted from https://newmedia.hhs.gov/
socialmedia101.html Social Media 101 Overview:
The WHAT and the WHY. Accessed on August 14,
2009.
2 Adapted from https://www.usa.gov/webcontent/
technology/other_tech.shtml Social Media and Web
2.0 in Government. Accessed on August 14, 2009.
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images (graphics or video), and links to
other Web pages. Blogs are usually
informal and take on the tone of a diary
or journal entry. Some blogs are very
personal, while others provide
mainstream news updates. Most blogs
encourage dialogue by allowing their
readers to leave comments.
• Microblogs (e.g., Twitter):
Microblogs are comprised of extremely
short written blog posts, similar to text
messages, and provide real-time
updates. Twitter is an example of a
popular microblog service that lets users
broadcast short messages up to 140
characters long (‘‘tweets’’) using
computers or mobile phones.
• Podcasts (e.g., audio sharing):
Podcasts (a blend of the terms ‘‘iPod’’
and ‘‘broadcast’’) are audio or video files
that users can listen to or watch on
computers or on a variety of portable
media devices (like an iPod, Zune, and
certain cell phones). Podcasts are
usually short and often free, and users
can arrange via subscription to receive
new podcasts automatically via their
computers or other media devices.
• Social networks and online
communities (e.g., Facebook, MySpace,
LinkedIn, Friendster, Sermo): Social
networks and online communities give
users opportunities to connect with or
provide resources to clients, colleagues,
family, and friends who share common
interests. In many social networks, users
create profiles and then invite people to
join as ‘‘friends.’’ There are many
different types of social networks and
online communities, many of which are
free, and they range from general to
those tailored for a specific
demographic or interest area.
• Video sharing (e.g., YouTube,
Blip.tv, Vimeo): Also called a ‘‘video
hosting service,’’ video sharing allows
individuals to upload video clips to an
Internet Web site. The video host will
then store the video on its server and
show the individual different types of
code to allow others to view or
comment on the video.
• Widgets: Supposedly short for
‘‘window gadget,’’ a widget is a graphic
control on a Web page that allows the
user to interact with it in some way.
Widgets can also be easily posted on
multiple Web sites, have the added
benefit of hosting ‘‘live’’ content, and
often take the form of on-screen tools
(clocks, event countdowns, auctiontickers, stock market tickers, flight
arrival information, daily weather, etc.).
• Wikis (e.g., Wikipedia, Medpedia):
The term ‘‘wiki’’ comes from the
Hawaiian word for ‘‘fast.’’ Wiki
technology creates a Web page that
anyone with access can modify—
quickly and easily. A wiki can be either
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open or closed, depending on the
preferences of the community using it.
An open wiki allows anybody to make
changes and view content. A closed
wiki allows only community members
to make changes and view its content.
Some wikis allow anyone to view
content but only members to edit the
content.
As the use of social media tools on the
Internet has proliferated, the agency has
engaged in a fact-finding process by
communicating with companies, thirdparty providers, trade associations, and
other groups to gain a better
understanding of the nature of, and the
technical aspects to, promotion of FDAregulated medical products using these
tools. FDA appreciates the time and
effort that these individuals, companies,
and associations have invested in
assisting the agency in understanding
the challenges and issues involved with
Internet promotion using these newer
Web 2.0 technologies.
II. Purpose and Scope of the Hearing
This hearing is intended to provide an
opportunity for broad public
participation and comment concerning
Internet promotion of FDA-regulated
medical products, including human and
animal prescription drugs and biologics
and medical devices. Please note that
this hearing does not address
nonprescription drug promotion. FDA is
particularly interested in hearing views
from the public as to how expanding
Web 2.0 technologies may be used to
promote medical products to both
health care professionals and consumers
in a truthful, nonmisleading, and
balanced manner. In addition, FDA is
seeking public comment on Internet
adverse event reporting.
III. Issues for Discussion
Questions have arisen regarding the
application of the prescription drug and
device advertising and labeling
provisions, regulations, and policies of
promotion on the Internet, especially
with regard to the use of emerging
technologies such as blogs, microblogs,
podcasts, social networks and online
communities, video sharing, widgets,
and wikis. This section briefly discusses
the issues the agency has identified as
most frequently raised by regulated
companies and other interested parties.
It should be noted that although a
question may raise a particular issue,
that does not necessarily mean that the
agency will issue guidance or a
regulation on that issue.
The agency invites comment at the
public hearing on the general concept of
Internet promotion, positive or negative;
on any aspect of Internet promotion that
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is of interest to the presenter; and on the
topics outlined in the following
paragraphs. We are specifically
interested in data and research on the
use of social media tools in promotion,
including data from companies on their
own experiences, the extent to which
health care professionals and consumers
are using and are influenced by various
social media tools, and the impact of
Internet and social media promotion on
the public health.
1. For what online communications are
manufacturers, packers, or distributors
accountable?
FDA regulates promotion of medical
products that is conducted by or on
behalf of a manufacturer, packer, or
distributor. In determining whether a
manufacturer, packer, or distributor is
accountable for a communication about
its product(s), the agency considers
whether the manufacturer, packer, or
distributor or anyone acting on behalf of
the manufacturer, packer, or distributor,
such as an ad agency, created the
promotional communication. In
addition, the agency considers whether
the manufacturer, packer, or distributor
or anyone acting on behalf of the
manufacturer, packer, or distributor is
influencing or controlling the
promotional activity or communication
in whole or in part.
Manufacturers, packers, and
distributors may have a variety of
options for how much control they exert
over activities on the Internet, regardless
of whether the promotional activity
occurs on company-sponsored venues
or on third-party venues. For example,
in setting up a program about its
product(s) through a chatroom, a
manufacturer, packer, or distributor may
allow comments to be posted in real
time with no editing or review by the
manufacturer, packer, or distributor;
alternatively, the manufacturer, packer,
or distributor may have the option of
reviewing and editing comments before
they are posted. Furthermore, the
manufacturer, packer, or distributor may
have control over the length of time
comments are visible. As a result,
information may be available to a much
broader audience than originally
engaged in the communication or
program if the comments/entries are
posted for an indefinite period of time
(‘‘archived materials’’). Similarly, a
manufacturer, packer, or distributor
posting a video on a video-sharing site
such as YouTube may choose whether
or not to allow viewers to post
comments.
In addition, various Web sites and
tools can allow manufacturers, packers,
or distributors to prompt others to
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communicate about their products. For
example, a manufacturer, packer, or
distributor may ask or otherwise
encourage users to post their own
videos about its product(s) on sites such
as YouTube. A manufacturer, packer, or
distributor may also send out packets of
information to prominent bloggers with
the aim of prompting the blogger to
write about its product(s). Alternatively,
a manufacturer, packer, or distributor
may create an online community for
patients or health care professionals to
discuss disease states, which may
prompt discussion about the
manufacturer’s, distributor’s, or packer’s
product(s). The agency is interested in
hearing the views of the public on the
following topics:
• What parameters or criteria should
be applied to determine when thirdparty communications occurring on the
Internet and through social media
technologies are subject to substantive
influence by companies that market
products related to the communication
or discussion?
• In particular, when should thirdparty discussions be treated as being
performed by, or on behalf of, the
companies that market the product, as
opposed to being performed
independent of the influence of the
companies marketing the products?
• How should companies disclose
their involvement or influence over
discussions or material, particularly
discussions or material on third-party
sites?
• Are there different considerations
that should be weighed depending on
the specific social media platform that
is used or based on the intended
audience? If so, what are these
considerations?
• With regard to the potential for
company communications to be altered
by third parties, what is the experience
to date with respect to the unauthorized
dissemination of modified product
information (originally created by a
company) by noncompany users of the
Internet?
2. How can manufacturers, packers, or
distributors fulfill regulatory
requirements (e.g., fair balance,
disclosure of indication and risk
information, postmarketing submission
requirements) in their Internet and
social media promotion, particularly
when using tools that are associated
with space limitations and tools that
allow for real-time communications
(e.g., microblogs, mobile technology)?
FDA’s regulations require that any
promotional communications that make
claims about a company’s product
include certain required disclosures,
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such as the indicated use of the product
and the risks associated with the use of
the product (note that ‘‘reminder’’
promotion, which calls attention to the
name of a product but does not make
any representations or suggestions about
the product, is exempt from these
disclosure requirements (see 21 CFR
200.200, 201.100(f), 201.105(d)(2),
202.1(e)(2)(i), 801.109(d)). The
prescription drug regulations also
require that drug advertisements present
a fair balance between information
relating to risk and information relating
to benefit (§ 202.1(e)(5)(ii)). They also
specify that risk information must be
presented with a prominence and
readability reasonably comparable to
claims about drug benefits
(§ 202.1(e)(7)(viii)). Furthermore, for
advertisements to be truthful and
nonmisleading, they must contain risk
information in each part as necessary to
qualify any representations and/or
suggestions made in that part about the
drug (§ 202.1(e)(3)(i)). Similarly, section
502(r) of the act requires a ‘‘brief
statement’’ of intended use and relevant
risk information for restricted device
advertising. In addition, section 201(n)
of the act provides that a determination
of whether product advertising or
labeling is misleading relies in part on
the extent to which labeling or
advertising reveals facts material with
respect to possible consequences of the
use of the products as represented in the
labeling or advertising material. Except
for medical device applicants,
applicants are also responsible for
submitting copies of promotional
materials to FDA (see, e.g.,
§§ 314.81(b)(3)(i), 314.550, 314.640,
514.80(b)(5)(ii), 601.12(f)(4), 601.45, and
601.94 (21 CFR 314.81(b)(3)(i), 314.550,
314.640, 514.80(b)(5)(ii), 601.12(f)(4),
601.45, and 601.94)).
• How should product information be
presented using various social media
tools to ensure that the user has access
to a balanced presentation of both risks
and benefits of medical products?
• Are there data to support
conclusions about whether different
types or formats of presentations have a
positive or negative impact on the
public health?
• Are there proposed solutions that
may help address regulatory concerns
when using social media tools
associated with space limitations or
tools that allow for real-time
communications to present product
information?
• How should companies address the
potential volume of information shared
on various social media sites with
regard to real-time information that is
continuously posted and regulatory
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requirements to submit promotional
materials to FDA as applicable (see, e.g.,
§§ 314.81(b)(3)(i), 314.550, 314.640,
514.80(b)(5)(ii), 601.12(f)(4), 601.45, and
601.94)?
mstockstill on DSKH9S0YB1PROD with NOTICES
3. What parameters should apply to the
posting of corrective information on
Web sites controlled by third parties?
Some manufacturers, packers, or
distributors have expressed a desire to
correct what are, in their belief,
misconceptions or misinformation about
their products, including unapproved
uses of their products that are being
conveyed on a Web site outside their
control, such as on a blog, social
networking site, or a wiki Web site (i.e.,
Wikipedia). Other companies have
stated that they have not corrected what
they believe is misinformation in the
belief that they could be viewed by such
an action as being responsible for all the
information on the target Web site rather
than just the information that they post
or submit.
• The agency is interested in any data
or research on how companies have
approached these issues.
• Are there any parameters or criteria
that could be used to determine the
appropriateness of correcting
misinformation and/or scope of
information a company can provide
when trying to correct misinformation
on a Web site outside a company’s
control?
• Should the parameters differentiate
with regard to the prominence of the
third-party site (i.e., readership), its
intended audience (e.g., general public,
health care professionals, patients), its
intended purpose (e.g., personal diary,
encyclopedia-type reference), and/or the
author of the information on the site?
4. When is the use of links appropriate?
The Internet allows users to move
easily between Web sites or sources that
provide information on many related
topics. Under the act, companies are
prohibited from promoting approved
human and animal drugs, biologics, and
medical devices for unapproved uses.
However, sponsors sometimes provide
links from their branded (e.g., mentions
a product) Web sites to other
informational sources about diseases,
such as support groups, some of which
may contain information about
unapproved disease conditions or
unapproved uses of approved products.
Furthermore, some companies are using
unbranded (e.g., does not mention a
product) uniform resource locators
(URLs) that, when clicked on, take users
directly to branded information.
• The agency is interested in any
comments about the appropriateness of
VerDate Nov<24>2008
17:24 Sep 18, 2009
Jkt 217001
various techniques regarding the use of
links (including between various social
media tools) and data or research about
whether or not users find these
approaches to be misleading.
• Should parameters be established
for links to and from Web sites?
• In addition, the agency is interested
in any data or research concerning the
frequency with which users actually
click on different categories of links
(e.g., banner ads, links within Web sites,
sponsored links, organic search result
links) to get additional information
about products.
5. Questions specific to Internet adverse
event reporting
FDA regulations require the
submission of postmarketing adverse
event reports.
For drugs, adverse event reporting
obligations are described for approved
new drug applications (NDAs),
abbreviated new drug applications
(ANDAs), and prescription drugs
marketed without an approved
application under §§ 310.305, 314.80,
and 314.98 (21 CFR 310.305, 314.80,
and 314.98, respectively. For new
animal drugs, adverse event reporting
obligations are described for approved
new animal drug applications (NADAs)
and abbreviated new animal drug
applications (ANADAs) under § 514.80.
Licensed manufacturers that hold
biological license applications (BLAs)
are also subject to adverse event
reporting requirements under § 600.80
(21 CFR 600.80). These regulations
cover requirements for submission of
individual case safety reports on either
an expedited basis (i.e., 15-day ‘‘Alert
reports’’) or on a less frequent (periodic)
basis, as specified in the regulations.
Nonprescription (over-the-counter or
OTC) drugs marketed without an
approved application also have
reporting obligations under the Dietary
Supplement and Nonprescription Drug
Consumer Protection Act (Public Law
109–462). Under this act, reports of
serious adverse events associated with
OTC products must be submitted to
FDA within 15 days.
FDA’s Medical Device Reporting
(MDR) regulation, 21 CFR part 803,
requires medical device manufacturers
to identify and monitor significant
adverse events involving their medical
devices. The regulation requires
manufacturers of medical devices to
report device-related deaths, serious
injuries, and malfunctions to FDA
whenever they become aware of
information that reasonably suggests
that a reportable event occurred (i.e.,
one of their devices has or may have
caused or contributed to the event).
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Fmt 4703
Sfmt 4703
48087
The expectation is that entities
responsible for reporting will promptly
review all adverse event information
received or otherwise obtained, which
potentially includes information from
the Internet and social media tools.
According to FDA’s March 2001 draft
guidance for industry entitled
‘‘Postmarketing Safety Reporting for
Human Drug and Biological Products
Including Vaccines’’ (available at https://
www.fda.gov/downloads/Biologics
BloodVaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
Vaccines/ucm092257.pdf), adverse
experience information that is
submitted via the Internet to an entity
with postmarketing reporting
obligations under §§ 310.305, 314.80,
and 600.80 should be reported to FDA
if there is knowledge of the four basic
elements for submission of an
individual case safety report (see section
IV.B in the draft guidance). The draft
guidance also states that those entities
should review any Internet sites
sponsored by them for adverse
experience information, but are not
responsible for reviewing any Internet
sites that they do not sponsor; however,
if they become aware of an adverse
experience on an Internet site that they
do not sponsor, they should review the
adverse experience and determine if it
should be reported to FDA. For OTC
products, the July 2009 guidance for
industry entitled ‘‘Postmarketing
Adverse Event Reporting for
Nonprescription Human Drug Products
Marketed Without an Approved
Application’’ (available at https://
www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/ucm171672.pdf)
lists the Internet as an example of a
means for a reporter to convey adverse
event information associated with an
OTC product to the responsible person
(i.e., ‘‘manufacturer, packer, or
distributor whose name * * * appears
on the label of an OTC drug marketed
in the United States without an
approved application’’).
With the increasing use of Web-based
technology by manufacturers of FDAregulated medical products, health care
systems, and patients, and the continual
emergence of different types of Webbased media, FDA is interested in
hearing the views of the public on the
following topics related to Web-based
media:
• How are entities with
postmarketing reporting responsibilities
and other stakeholders using the
Internet and social media tools with
regard to monitoring adverse event
information about their products?
E:\FR\FM\21SEN1.SGM
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Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices
• How is adverse event information
from these sources being received,
reviewed, and processed?
• What challenges are presented in
handling adverse event information
from these sources?
• What uncertainties are there
regarding what should be reported from
these sources to meet FDA adverse
event reporting obligations?
mstockstill on DSKH9S0YB1PROD with NOTICES
IV. Notice of Hearing Under 21 CFR
Part 15
The Commissioner is announcing that
the public hearing will be held in
accordance with part 15 (21 CFR part
15). The hearing will be conducted by
a presiding officer, accompanied by
FDA senior management from the Office
of the Commissioner and the Center for
Drug Evaluation and Research.
Under § 15.30, the hearing is informal,
and the rules of evidence do not apply.
No participant may interrupt the
presentation of another participant.
Only the presiding officer and panel
members may question any person
during or at the conclusion of each
presentation. Public hearings under part
15 are subject to FDA’s policy and
procedures for electronic media
coverage of FDA’s public administrative
proceedings (part 10 (21 CFR part 10),
subpart C). 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
document acts as a waiver of those
provisions as specified in § 15.30(h).
V. Comments
Regardless of attendance at the public
hearing, interested persons may submit
written or electronic comments to the
Division of Dockets Management (see
ADDRESSES). Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments should be identified
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.
VI. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://
VerDate Nov<24>2008
17:24 Sep 18, 2009
Jkt 217001
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see ADDRESSES). A transcript will also
be available in either hardcopy or on
CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (HFI–35), Office
of Management Programs, Food and
Drug Administration, 5600 Fishers
Lane, rm. 6–30, Rockville, MD 20857.
Dated: September 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–22618 Filed 9–18–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Request for Information Regarding
Development and Operation of a
Transplantation Sentinel Network
AGENCY: Office of Blood, Organ and
Other Tissue Safety, Division of
Healthcare Quality Promotion, Center
for Preparedness, Detection, and Control
of Infectious Diseases, Centers for
Disease Control and Prevention,
Department of Health and Human
Services.
ACTION: Request for information notice.
SUMMARY: The Centers for Disease
Control and Prevention (CDC) is seeking
information on development and
operation of a national transplantation
sentinel network (TSN) for the United
States, including resources needed for
management of such a system. The
purpose of the network is to detect and
prevent disease transmission from organ
and tissue allografts recovered for
transplantation.
In June 2005, the CDC announced a
Request for Application (RFA) through
a cooperative agreement for
development of a TSN for organizations
that recover, process, distribute, and
implant organs and tissues. The overall
goal of the system was to improve
patient safety for organ and tissue
recipients. The RFA objectives were to:
(1) Identify and track organs and tissues
to facilitate intervention following
recognition of infections among
recipients or donors; (2) improve
communication among those in the
transplant community, healthcare
facilities and public health agencies
concerning potential risks for
transmission of infections; and (3)
improve pathologic and microbiologic
capabilities on cadaveric donor
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
specimen samples through shared
resources. Development and field
testing of the prototype was completed
in 2008.
For this RFI, respondents are asked to
describe experiences, plans or opinions
regarding aspects of completing and
operating a TSN system; system
governance, security, and marketing;
user training; and operational and
infrastructure management. Responses
need not address every aspect of this
RFI; responses may be limited to
address specific components or portions
of a section. The specific sections
requested for comments are: (1)
Transition of Transplantation
Transmission Sentinel Network (TTSN)
Prototype to Full Production; (2)
Standardization and Compatibility
Issues; (3) Reporting Criteria; (4)
Interoperability and Interfacing with
Existing Data Sources; (5) System
Operation and Infrastructure
Management; (6) Analysis Plan
including Feedback to Users; (7) Patient
Health Information Privacy and
Security; and (8) System Governance.
DATES: Comments must be submitted on
or before December 11, 2009.
ADDRESSES: The entire TSN RFI can be
accessed at https://wwwdev.cdc.gov/
ncidod/dhqp/pdf/ttsn/RFI_TSN_
FedRegDoc_9909.pdf. Electronic
responses are preferred and should be
sent to TransplantRFI@cdc.gov.
Responses sent in hard copy format
must be securely bound and sent to
Debbie Seem, Office of Blood, Organ
and other Tissue Safety, Division of
Healthcare Quality Promotion, Centers
for Disease Control and Prevention,
Building 16, MS–A07, 1600 Clifton
Road, NE., Atlanta, GA, 30329–4018,
Telephone number: 404–639–3234, Email Address: gqi4@cdc.gov.
SUPPLEMENTARY INFORMATION: Each year
in the United States, more than 28,000
solid organs and 2 million tissues are
transplanted, including heart, lung,
liver, kidneys, pancreas, intestine, bone,
skin, heart valves, tendons, fascia and
corneas. Donor-derived infections have
been identified as a source of morbidity
and mortality among both solid organ
and tissue transplant recipients.
Infectious transmission identified in
the past few years among solid organs
have reflected a broad array of viruses,
bacteria, and parasites, resulting in a
high proportion of mortality amongst
infected recipients; examples include
HIV, hepatitis C virus (HCV),
lymphocytic choriomeningitis virus,
Mycobacterium tuberculosis,
Pseudomonas aeruginosa, Strongyloides
spp, and Trypanosoma cruzi, the
etiologic agent of Chagas Disease.
E:\FR\FM\21SEN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 181 (Monday, September 21, 2009)]
[Notices]
[Pages 48083-48088]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22618]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0441]
Promotion of Food and Drug Administration-Regulated Medical
Products Using the Internet and Social Media Tools; Notice of Public
Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public hearing; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA's) Center for Drug
Evaluation and Research (CDER), in collaboration with FDA's Center for
Biologics Evaluation and Research (CBER), Center for Veterinary
Medicine (CVM), and Center for Devices and Radiological Health (CDRH),
is announcing a public hearing to discuss issues related to the
promotion of FDA-regulated medical products (including prescription
drugs for humans and animals, prescription biologics, and medical
devices) using the Internet and social media tools. FDA is seeking
participation in the public hearing and written comments from all
interested parties, including, but not limited to, consumers, patients,
caregivers, health care professionals, patient groups, Internet
vendors, advertising agencies, and the regulated industry. This meeting
and the written comments are intended to help guide FDA in making
policy decisions on the promotion of human and animal prescription
drugs and biologics and medical devices using the Internet and social
media tools. FDA is seeking input on a number of specific questions but
is interested in any other pertinent information participants in the
hearing would like to share.
Dates and Times: The public hearing will be held on November 12 and
13, 2009, from 8 a.m. to 5 p.m. each day. Submit written or electronic
registration by close of business on October 9, 2009. Written and
electronic comments will be accepted until February 28, 2010.
Location: The public hearing will be held at the National
Transportation Safety Board Conference Center, 429 L'Enfant Plaza, SW.,
Washington, DC 20594, 202-314-6305; Metro: L'Enfant Plaza station on
the yellow, green, orange, and blue lines; see: https://ntsb.gov/events/newlocation.htm. (FDA has verified the Web site address, but FDA is not
responsible for any changes to the Web site after this document
publishes in the Federal Register.)
ADDRESSES: Submit written registration and written comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic registration and electronic comments, identified
with the docket number found in brackets in the heading of this
document, to https://www.regulations.gov.
Transcripts of the hearing will be available for review at the
Division of Dockets Management and on the Internet at https://www.regulations.gov approximately 30 days after the hearing (see
section VI of this document).
Registration to Attend and/or to Participate in the Meeting:
Seating at the hearing is limited. People interested in attending
should submit written or electronic registration as specified above
[[Page 48084]]
(see ADDRESSES) by close of business on October 9, 2009. Registration
is free and will be accepted on a first-come, first-served basis.
Written or electronic comments will be accepted until February 28,
2010.
The procedures governing the hearing are found in 21 CFR part 15
(see section IV of this document). If you wish to make an oral
presentation at the hearing, you must state your intention on your
registration submission (see ADDRESSES). To speak, submit your name,
title, business affiliation, addresses, telephone and fax numbers, and
e-mail address. FDA has included questions for comment in section III
of this document. You should also identify by number each question you
wish to address in your presentation and the approximate time
requested. FDA will do its best to accommodate requests to speak.
Individuals and organizations with common interests should consolidate
or coordinate their presentations and request time for a joint
presentation. FDA will determine the amount of time allotted to each
presenter and the approximate time that each oral presentation is
scheduled to begin. Once FDA notifies registered participants of their
scheduled times, presenters should submit to FDA two copies of each
presentation to be given (see FOR FURTHER INFORMATION CONTACT).
If you need special accommodations because of a disability, please
inform Jean-Ah Kang (see FOR FURTHER INFORMATION CONTACT) at the time
of registration.
FOR FURTHER INFORMATION CONTACT: Jean-Ah Kang, Division of Drug
Marketing, Advertising, and Communications, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, rm. 3270, Silver Spring, MD, 20993-0002, 301-796-4269, FAX:
301-796-8444, e-mail: InternetPublicMeeting@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Internet has become a widely used medium for companies,
including manufacturers, packers, or distributors of medical products
regulated by FDA, to disseminate information about their products. The
Internet's ability to facilitate communication, information sharing,
information exchange between systems, user-centered design, and
collaboration has also evolved as a result of the second generation of
Web development and Web design, or ``Web 2.0.'' Web 2.0 has led to the
emergence of a variety of social media tools (i.e., Web properties
whose online content is primarily created and published by users rather
than the property owners).
The continually evolving nature of the Internet, including Web 2.0
and social media tools, as well as their expansion to applications such
as mobile technology, have raised questions and concerns over how to
apply existing regulations to promotion in these newer media. FDA is
evaluating how the statutory provisions, regulations, and policies
concerning advertising and promotional labeling should be applied to
product-related information on the Internet and newer technologies.
Although the agency believes that many issues can be addressed through
existing FDA regulations, special characteristics of Web 2.0 and other
emerging technologies may require the agency to provide additional
guidance to the industry on how the regulations should be applied.
A. Regulation of Advertising and Labeling
Under the Federal Food, Drug, and Cosmetic Act (the act), FDA has
responsibility for regulating the labeling of prescription drugs and
medical devices and the advertising of prescription drugs and
restricted medical devices. If an activity or material is considered to
be either advertising or labeling, it must meet certain requirements.
Under section 201(m) of the act (21 U.S.C. 321(m)), labeling is
defined as ``all labels and other written, printed, or graphic''
materials ``upon'' or ``accompanying'' an article. The term
``accompanying'' has been broadly defined by the Supreme Court (Kordel
v. United States, 335 U.S. 345, 349-350 (1948)). FDA's regulations give
examples of labeling materials, including brochures, mailing pieces,
detailing pieces, calendars, price lists, letters, motion picture
films, and sound recordings (Sec. 202.1(l)(2) (21 CFR 202.1(l)(2))).
FDA regulates the labeling of all drugs and devices under its
jurisdiction. Labeling must be truthful and nonmisleading (section
502(a) of the act (21 U.S.C. 352(a))).
FDA also regulates the advertising for prescription drugs and
biologics. Although the act does not define what constitutes an
``advertisement,'' FDA generally interprets the term to include
information (other than labeling) that is issued by, or on behalf of, a
manufacturer, packer, or distributor and is intended to promote a
product. This includes, for example, ``advertisements in published
journals, magazines, other periodicals, and newspapers, and
advertisements broadcast through media such as radio, television, and
telephone communication systems'' (Sec. 202.1(l)(1)). According to the
act (section 502(n)), a prescription drug is misbranded if its
advertising does not include, in addition to the product's established
name and quantitative composition, a ``true statement'' of information
in brief summary ``relating to side effects, contraindications and
effectiveness'' of the advertised product. For prescription drug
advertisements, FDA's implementing regulations (21 CFR part 202)
specify that, among other things, the statutory requirement of a ``true
statement'' is not satisfied if an advertisement is false or misleading
with respect to side effects, contraindications or effectiveness or if
it fails to reveal material facts about ``consequences that may result
from the use of the drug as recommended or suggested in the
advertisement'' (Sec. 202.1(e)(5)). The prescription drug regulations
also specify that advertisements must ``present a fair balance between
information relating to side effects and contraindications and
information relating to effectiveness of the drug,'' which is achieved
when ``the presentation of true information relating to side effects
and contraindications is comparable in depth and detail with the claims
for effectiveness or safety'' (Sec. 202.1(e)(5)(ii)).
FDA similarly regulates advertising for restricted devices. A
``restricted device'' is a device that may be restricted to sale,
distribution, or use only with the written or oral authorization of a
licensed practitioner, or in accordance with other conditions if FDA
determines that there cannot otherwise be reasonable assurance of its
safety and effectiveness (21 U.S.C. 360j(e)). FDA also restricts
devices through the approval orders granted to many class III devices
(21 U.S.C. 360e(d)(1)(B)(ii)). According to the act, a restricted
device is misbranded if its advertising is false or misleading in any
particular (section 502(q) of the act), or if its advertising does not
contain a brief statement of the intended uses of the device and
relevant warnings, precautions, side effects, and contraindications
(section 502(r) of the act). There are currently no regulations
establishing specific requirements for the content and format of
advertisements for restricted devices.
Although FDA has not comprehensively addressed when Internet
promotion of prescription drugs and medical devices is labeling versus
advertising, the agency has jurisdiction over all prescription drug and
biologic product promotion as well as all restricted device advertising
and all
[[Page 48085]]
device promotional labeling when conducted by or on behalf of a
manufacturer, packer, or distributor. There are no regulations that
specifically address Internet promotion separately from the other types
of promotion discussed above, nor are there any regulations that
prohibit the use of certain types of media to promote drugs and medical
devices. Although no rule has specifically addressed Internet
promotion, it is fairly clear that some promotional efforts are
substantially similar in presentation and content to promotional
materials in other media or publications. At the same time, FDA
recognizes that the Internet possesses certain unique technological
features and that some online tools that may be used for promotion
offer novel presentation and content features. Another emerging issue
involves the reporting of adverse event data because such information
may initially be revealed using social media platforms in the context
of Internet promotion for FDA-regulated medical products.
B. 1996 Meeting on Promotion of FDA-Regulated Products on the Internet
On October 16 and 17, 1996, FDA held a public meeting to discuss
issues related to the promotion of FDA-regulated medical products on
the Internet (see 61 FR 48707, September 16, 1996). The agency's
objective was to receive broad public input and to hear various points
of view and opinions on Internet issues from a discussion among
interested persons. A discussion group format was used and covered the
following topics: Investigational product information, chatrooms and
newsgroups, and Web site links. A transcript of the meeting is
available at https://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm175775.htm.)
C. New Internet Tools and Technology
Since the 1996 public meeting, there has been a massive expansion
of new tools and technologies, such as blogs, microblogs, podcasts,
social network sites (``social networks'') and online communities,
video sharing, widgets, and wikis, which are defined as follows:\1,2\
---------------------------------------------------------------------------
\1\ Adapted from https://newmedia.hhs.gov/socialmedia101.html
Social Media 101 Overview: The WHAT and the WHY. Accessed on August
14, 2009.
\2\ Adapted from https://www.usa.gov/webcontent/technology/other_tech.shtml Social Media and Web 2.0 in Government. Accessed
on August 14, 2009.
---------------------------------------------------------------------------
Blogs (e.g., Blogger, WordPress, TypePad): Blogs are Web
sites with regular updates (in reverse chronological order--newest
update at the top) that typically combine text, images (graphics or
video), and links to other Web pages. Blogs are usually informal and
take on the tone of a diary or journal entry. Some blogs are very
personal, while others provide mainstream news updates. Most blogs
encourage dialogue by allowing their readers to leave comments.
Microblogs (e.g., Twitter): Microblogs are comprised of
extremely short written blog posts, similar to text messages, and
provide real-time updates. Twitter is an example of a popular microblog
service that lets users broadcast short messages up to 140 characters
long (``tweets'') using computers or mobile phones.
Podcasts (e.g., audio sharing): Podcasts (a blend of the
terms ``iPod'' and ``broadcast'') are audio or video files that users
can listen to or watch on computers or on a variety of portable media
devices (like an iPod, Zune, and certain cell phones). Podcasts are
usually short and often free, and users can arrange via subscription to
receive new podcasts automatically via their computers or other media
devices.
Social networks and online communities (e.g., Facebook,
MySpace, LinkedIn, Friendster, Sermo): Social networks and online
communities give users opportunities to connect with or provide
resources to clients, colleagues, family, and friends who share common
interests. In many social networks, users create profiles and then
invite people to join as ``friends.'' There are many different types of
social networks and online communities, many of which are free, and
they range from general to those tailored for a specific demographic or
interest area.
Video sharing (e.g., YouTube, Blip.tv, Vimeo): Also called
a ``video hosting service,'' video sharing allows individuals to upload
video clips to an Internet Web site. The video host will then store the
video on its server and show the individual different types of code to
allow others to view or comment on the video.
Widgets: Supposedly short for ``window gadget,'' a widget
is a graphic control on a Web page that allows the user to interact
with it in some way. Widgets can also be easily posted on multiple Web
sites, have the added benefit of hosting ``live'' content, and often
take the form of on-screen tools (clocks, event countdowns, auction-
tickers, stock market tickers, flight arrival information, daily
weather, etc.).
Wikis (e.g., Wikipedia, Medpedia): The term ``wiki'' comes
from the Hawaiian word for ``fast.'' Wiki technology creates a Web page
that anyone with access can modify--quickly and easily. A wiki can be
either open or closed, depending on the preferences of the community
using it. An open wiki allows anybody to make changes and view content.
A closed wiki allows only community members to make changes and view
its content. Some wikis allow anyone to view content but only members
to edit the content.
As the use of social media tools on the Internet has proliferated,
the agency has engaged in a fact-finding process by communicating with
companies, third-party providers, trade associations, and other groups
to gain a better understanding of the nature of, and the technical
aspects to, promotion of FDA-regulated medical products using these
tools. FDA appreciates the time and effort that these individuals,
companies, and associations have invested in assisting the agency in
understanding the challenges and issues involved with Internet
promotion using these newer Web 2.0 technologies.
II. Purpose and Scope of the Hearing
This hearing is intended to provide an opportunity for broad public
participation and comment concerning Internet promotion of FDA-
regulated medical products, including human and animal prescription
drugs and biologics and medical devices. Please note that this hearing
does not address nonprescription drug promotion. FDA is particularly
interested in hearing views from the public as to how expanding Web 2.0
technologies may be used to promote medical products to both health
care professionals and consumers in a truthful, nonmisleading, and
balanced manner. In addition, FDA is seeking public comment on Internet
adverse event reporting.
III. Issues for Discussion
Questions have arisen regarding the application of the prescription
drug and device advertising and labeling provisions, regulations, and
policies of promotion on the Internet, especially with regard to the
use of emerging technologies such as blogs, microblogs, podcasts,
social networks and online communities, video sharing, widgets, and
wikis. This section briefly discusses the issues the agency has
identified as most frequently raised by regulated companies and other
interested parties. It should be noted that although a question may
raise a particular issue, that does not necessarily mean that the
agency will issue guidance or a regulation on that issue.
The agency invites comment at the public hearing on the general
concept of Internet promotion, positive or negative; on any aspect of
Internet promotion that
[[Page 48086]]
is of interest to the presenter; and on the topics outlined in the
following paragraphs. We are specifically interested in data and
research on the use of social media tools in promotion, including data
from companies on their own experiences, the extent to which health
care professionals and consumers are using and are influenced by
various social media tools, and the impact of Internet and social media
promotion on the public health.
1. For what online communications are manufacturers, packers, or
distributors accountable?
FDA regulates promotion of medical products that is conducted by or
on behalf of a manufacturer, packer, or distributor. In determining
whether a manufacturer, packer, or distributor is accountable for a
communication about its product(s), the agency considers whether the
manufacturer, packer, or distributor or anyone acting on behalf of the
manufacturer, packer, or distributor, such as an ad agency, created the
promotional communication. In addition, the agency considers whether
the manufacturer, packer, or distributor or anyone acting on behalf of
the manufacturer, packer, or distributor is influencing or controlling
the promotional activity or communication in whole or in part.
Manufacturers, packers, and distributors may have a variety of
options for how much control they exert over activities on the
Internet, regardless of whether the promotional activity occurs on
company-sponsored venues or on third-party venues. For example, in
setting up a program about its product(s) through a chatroom, a
manufacturer, packer, or distributor may allow comments to be posted in
real time with no editing or review by the manufacturer, packer, or
distributor; alternatively, the manufacturer, packer, or distributor
may have the option of reviewing and editing comments before they are
posted. Furthermore, the manufacturer, packer, or distributor may have
control over the length of time comments are visible. As a result,
information may be available to a much broader audience than originally
engaged in the communication or program if the comments/entries are
posted for an indefinite period of time (``archived materials'').
Similarly, a manufacturer, packer, or distributor posting a video on a
video-sharing site such as YouTube may choose whether or not to allow
viewers to post comments.
In addition, various Web sites and tools can allow manufacturers,
packers, or distributors to prompt others to communicate about their
products. For example, a manufacturer, packer, or distributor may ask
or otherwise encourage users to post their own videos about its
product(s) on sites such as YouTube. A manufacturer, packer, or
distributor may also send out packets of information to prominent
bloggers with the aim of prompting the blogger to write about its
product(s). Alternatively, a manufacturer, packer, or distributor may
create an online community for patients or health care professionals to
discuss disease states, which may prompt discussion about the
manufacturer's, distributor's, or packer's product(s). The agency is
interested in hearing the views of the public on the following topics:
What parameters or criteria should be applied to determine
when third-party communications occurring on the Internet and through
social media technologies are subject to substantive influence by
companies that market products related to the communication or
discussion?
In particular, when should third-party discussions be
treated as being performed by, or on behalf of, the companies that
market the product, as opposed to being performed independent of the
influence of the companies marketing the products?
How should companies disclose their involvement or
influence over discussions or material, particularly discussions or
material on third-party sites?
Are there different considerations that should be weighed
depending on the specific social media platform that is used or based
on the intended audience? If so, what are these considerations?
With regard to the potential for company communications to
be altered by third parties, what is the experience to date with
respect to the unauthorized dissemination of modified product
information (originally created by a company) by noncompany users of
the Internet?
2. How can manufacturers, packers, or distributors fulfill regulatory
requirements (e.g., fair balance, disclosure of indication and risk
information, postmarketing submission requirements) in their Internet
and social media promotion, particularly when using tools that are
associated with space limitations and tools that allow for real-time
communications (e.g., microblogs, mobile technology)?
FDA's regulations require that any promotional communications that
make claims about a company's product include certain required
disclosures, such as the indicated use of the product and the risks
associated with the use of the product (note that ``reminder''
promotion, which calls attention to the name of a product but does not
make any representations or suggestions about the product, is exempt
from these disclosure requirements (see 21 CFR 200.200, 201.100(f),
201.105(d)(2), 202.1(e)(2)(i), 801.109(d)). The prescription drug
regulations also require that drug advertisements present a fair
balance between information relating to risk and information relating
to benefit (Sec. 202.1(e)(5)(ii)). They also specify that risk
information must be presented with a prominence and readability
reasonably comparable to claims about drug benefits (Sec.
202.1(e)(7)(viii)). Furthermore, for advertisements to be truthful and
nonmisleading, they must contain risk information in each part as
necessary to qualify any representations and/or suggestions made in
that part about the drug (Sec. 202.1(e)(3)(i)). Similarly, section
502(r) of the act requires a ``brief statement'' of intended use and
relevant risk information for restricted device advertising. In
addition, section 201(n) of the act provides that a determination of
whether product advertising or labeling is misleading relies in part on
the extent to which labeling or advertising reveals facts material with
respect to possible consequences of the use of the products as
represented in the labeling or advertising material. Except for medical
device applicants, applicants are also responsible for submitting
copies of promotional materials to FDA (see, e.g., Sec. Sec.
314.81(b)(3)(i), 314.550, 314.640, 514.80(b)(5)(ii), 601.12(f)(4),
601.45, and 601.94 (21 CFR 314.81(b)(3)(i), 314.550, 314.640,
514.80(b)(5)(ii), 601.12(f)(4), 601.45, and 601.94)).
How should product information be presented using various
social media tools to ensure that the user has access to a balanced
presentation of both risks and benefits of medical products?
Are there data to support conclusions about whether
different types or formats of presentations have a positive or negative
impact on the public health?
Are there proposed solutions that may help address
regulatory concerns when using social media tools associated with space
limitations or tools that allow for real-time communications to present
product information?
How should companies address the potential volume of
information shared on various social media sites with regard to real-
time information that is continuously posted and regulatory
[[Page 48087]]
requirements to submit promotional materials to FDA as applicable (see,
e.g., Sec. Sec. 314.81(b)(3)(i), 314.550, 314.640, 514.80(b)(5)(ii),
601.12(f)(4), 601.45, and 601.94)?
3. What parameters should apply to the posting of corrective
information on Web sites controlled by third parties?
Some manufacturers, packers, or distributors have expressed a
desire to correct what are, in their belief, misconceptions or
misinformation about their products, including unapproved uses of their
products that are being conveyed on a Web site outside their control,
such as on a blog, social networking site, or a wiki Web site (i.e.,
Wikipedia). Other companies have stated that they have not corrected
what they believe is misinformation in the belief that they could be
viewed by such an action as being responsible for all the information
on the target Web site rather than just the information that they post
or submit.
The agency is interested in any data or research on how
companies have approached these issues.
Are there any parameters or criteria that could be used to
determine the appropriateness of correcting misinformation and/or scope
of information a company can provide when trying to correct
misinformation on a Web site outside a company's control?
Should the parameters differentiate with regard to the
prominence of the third-party site (i.e., readership), its intended
audience (e.g., general public, health care professionals, patients),
its intended purpose (e.g., personal diary, encyclopedia-type
reference), and/or the author of the information on the site?
4. When is the use of links appropriate?
The Internet allows users to move easily between Web sites or
sources that provide information on many related topics. Under the act,
companies are prohibited from promoting approved human and animal
drugs, biologics, and medical devices for unapproved uses. However,
sponsors sometimes provide links from their branded (e.g., mentions a
product) Web sites to other informational sources about diseases, such
as support groups, some of which may contain information about
unapproved disease conditions or unapproved uses of approved products.
Furthermore, some companies are using unbranded (e.g., does not mention
a product) uniform resource locators (URLs) that, when clicked on, take
users directly to branded information.
The agency is interested in any comments about the
appropriateness of various techniques regarding the use of links
(including between various social media tools) and data or research
about whether or not users find these approaches to be misleading.
Should parameters be established for links to and from Web
sites?
In addition, the agency is interested in any data or
research concerning the frequency with which users actually click on
different categories of links (e.g., banner ads, links within Web
sites, sponsored links, organic search result links) to get additional
information about products.
5. Questions specific to Internet adverse event reporting
FDA regulations require the submission of postmarketing adverse
event reports.
For drugs, adverse event reporting obligations are described for
approved new drug applications (NDAs), abbreviated new drug
applications (ANDAs), and prescription drugs marketed without an
approved application under Sec. Sec. 310.305, 314.80, and 314.98 (21
CFR 310.305, 314.80, and 314.98, respectively. For new animal drugs,
adverse event reporting obligations are described for approved new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) under Sec. 514.80. Licensed manufacturers that
hold biological license applications (BLAs) are also subject to adverse
event reporting requirements under Sec. 600.80 (21 CFR 600.80). These
regulations cover requirements for submission of individual case safety
reports on either an expedited basis (i.e., 15-day ``Alert reports'')
or on a less frequent (periodic) basis, as specified in the
regulations.
Nonprescription (over-the-counter or OTC) drugs marketed without an
approved application also have reporting obligations under the Dietary
Supplement and Nonprescription Drug Consumer Protection Act (Public Law
109-462). Under this act, reports of serious adverse events associated
with OTC products must be submitted to FDA within 15 days.
FDA's Medical Device Reporting (MDR) regulation, 21 CFR part 803,
requires medical device manufacturers to identify and monitor
significant adverse events involving their medical devices. The
regulation requires manufacturers of medical devices to report device-
related deaths, serious injuries, and malfunctions to FDA whenever they
become aware of information that reasonably suggests that a reportable
event occurred (i.e., one of their devices has or may have caused or
contributed to the event).
The expectation is that entities responsible for reporting will
promptly review all adverse event information received or otherwise
obtained, which potentially includes information from the Internet and
social media tools. According to FDA's March 2001 draft guidance for
industry entitled ``Postmarketing Safety Reporting for Human Drug and
Biological Products Including Vaccines'' (available at https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm092257.pdf), adverse experience information that is submitted via
the Internet to an entity with postmarketing reporting obligations
under Sec. Sec. 310.305, 314.80, and 600.80 should be reported to FDA
if there is knowledge of the four basic elements for submission of an
individual case safety report (see section IV.B in the draft guidance).
The draft guidance also states that those entities should review any
Internet sites sponsored by them for adverse experience information,
but are not responsible for reviewing any Internet sites that they do
not sponsor; however, if they become aware of an adverse experience on
an Internet site that they do not sponsor, they should review the
adverse experience and determine if it should be reported to FDA. For
OTC products, the July 2009 guidance for industry entitled
``Postmarketing Adverse Event Reporting for Nonprescription Human Drug
Products Marketed Without an Approved Application'' (available at
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm171672.pdf) lists
the Internet as an example of a means for a reporter to convey adverse
event information associated with an OTC product to the responsible
person (i.e., ``manufacturer, packer, or distributor whose name * * *
appears on the label of an OTC drug marketed in the United States
without an approved application'').
With the increasing use of Web-based technology by manufacturers of
FDA-regulated medical products, health care systems, and patients, and
the continual emergence of different types of Web-based media, FDA is
interested in hearing the views of the public on the following topics
related to Web-based media:
How are entities with postmarketing reporting
responsibilities and other stakeholders using the Internet and social
media tools with regard to monitoring adverse event information about
their products?
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How is adverse event information from these sources being
received, reviewed, and processed?
What challenges are presented in handling adverse event
information from these sources?
What uncertainties are there regarding what should be
reported from these sources to meet FDA adverse event reporting
obligations?
IV. Notice of Hearing Under 21 CFR Part 15
The Commissioner is announcing that the public hearing will be held
in accordance with part 15 (21 CFR part 15). The hearing will be
conducted by a presiding officer, accompanied by FDA senior management
from the Office of the Commissioner and the Center for Drug Evaluation
and Research.
Under Sec. 15.30, the hearing is informal, and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (part 10 (21 CFR part 10), subpart C). Under Sec. 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 Sec.
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 document acts as a waiver of those provisions as
specified in Sec. 15.30(h).
V. Comments
Regardless of attendance at the public hearing, interested persons
may submit written or electronic comments to the Division of Dockets
Management (see ADDRESSES). Submit a single copy of electronic comments
or two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments should be identified 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.
VI. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at https://www.regulations.gov. It may be viewed at
the Division of Dockets Management (see ADDRESSES). A transcript will
also be available in either hardcopy or on CD-ROM, after submission of
a Freedom of Information request. Written requests are to be sent to
Division of Freedom of Information (HFI-35), Office of Management
Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30,
Rockville, MD 20857.
Dated: September 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-22618 Filed 9-18-09; 8:45 am]
BILLING CODE 4160-01-S
