Healthy Skepticism Library item: 16532

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Government Document

FDA: Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools; Notice of Public Hearing
PharmaLive 2009 Sep 2174:(181):
http://pharmalive.com/news/index.cfm?articleID=653925

Full text:

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: http://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 http://www.regulations.gov. Transcripts of the hearing will be available for review at the
Division of Dockets Management and on the Internet at http://
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® 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 http://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 http://newmedia.hhs.gov/socialmedia101.html
Social Media 101 Overview: The WHAT and the WHY. Accessed on August
14, 2009. \2\ Adapted from http://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® 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 http://
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
http://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?
[[Page 48088]] 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 http://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