[Federal Register Volume 74, Number 181 (Monday, September 21, 2009)]
[Notices]
[Pages 48083-48088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22618]


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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.

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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: <a href="/cdn-cgi/l/email-protection#ffb6918b9a8d919a8baf8a9d93969cb29a9a8b969198bf999b9ed197978cd1989089"><span class="__cf_email__" data-cfemail="6b22051f0e19050e1f3b1e09070208260e0e1f02050c2b0d0f0a45030318450c041d">[email protected]</span></a>.

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 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\
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    \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.
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    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.).
    <bullet> 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:
    <bullet> 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?
    <bullet> 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?
    <bullet> How should companies disclose their involvement or 
influence over discussions or material, particularly discussions or 
material on third-party sites?
    <bullet> 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?
    <bullet> 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)).
    <bullet> 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?
    <bullet> Are there data to support conclusions about whether 
different types or formats of presentations have a positive or negative 
impact on the public health?
    <bullet> 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?
    <bullet> 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.
    <bullet> The agency is interested in any data or research on how 
companies have approached these issues.
    <bullet> 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?
    <bullet> 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.
    <bullet> 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.
    <bullet> Should parameters be established for links to and from Web 
sites?
    <bullet> 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:
    <bullet> 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]]

    <bullet> How is adverse event information from these sources being 
received, reviewed, and processed?
    <bullet> What challenges are presented in handling adverse event 
information from these sources?
    <bullet> 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


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