[Federal Register Volume 79, Number 117 (Wednesday, June 18, 2014)]
[Notices]
[Pages 34760-34763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-14221]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0447]


Draft Guidance for Industry on Internet/Social Media Platforms: 
Correcting Independent Third-Party Misinformation About Prescription 
Drugs and Medical Devices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Internet/
Social Media Platforms: Correcting Independent Third-Party 
Misinformation About Prescription Drugs and Medical Devices.'' This 
draft guidance responds to (among other things) stakeholder requests 
for specific guidance and describes FDA's current thinking on how 
manufacturers, packers, and distributors (firms) of prescription human 
and animal drugs (drugs) and medical devices for human use (devices), 
including biological products, should respond, if they choose to 
respond, to misinformation related to a firm's own FDA-approved or 
cleared products when that information is created or disseminated by 
independent third parties. This draft guidance updates and clarifies 
FDA's policies on the correction of misinformation created or 
disseminated by independent third parties on the Internet or through 
social media platforms, regardless of whether that misinformation 
appears on a firm's own forum or an independent third-party forum or 
Web site. The draft guidance represents FDA's current thinking on 
specific aspects of FDA's evolving consideration of social media 
platforms and other Internet-related matters. FDA continues actively to 
review, analyze, and develop approaches to a variety of topics related 
to the labeling and advertising of medical products, including the 
development of this and other guidance addressing the use of social 
media platforms and the Internet.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 16, 2014. Submit written comments on the proposed 
collection of information by August 18, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; to 
the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; 
to the Communications Staff (HFV-12), Center for Veterinary Medicine, 
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855; 
or to the Office of the Center Director, Guidance and Policy 
Development, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section

[[Page 34761]]

for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: 
    Regarding human prescription drugs: Julie Chronis, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Silver Spring, MD 20993-0002, 301-796-1200.
    Regarding human prescription biological products: Stephen Ripley, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993-0002, 240-402-7911.
    Regarding animal prescription drugs: Thomas Moskal, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9300.
    Regarding medical devices for human use: Deborah Wolf, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 3414, Silver Spring, MD 20993-0002, 
301-796-5732.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Internet/Social Media Platforms: Correcting Independent 
Third-Party Misinformation About Prescription Drugs and Medical 
Devices.'' On November 12-13, 2009, FDA held a public hearing entitled 
``Promotion of Food and Drug Administration-Regulated Medical Products 
Using the Internet and Social Media Tools'' to provide an opportunity 
for broad public participation and comment on the following questions 
that relate specifically to promotional issues:
    1. For what online communications are manufacturers, packers, or 
distributors accountable?
    2. How can manufacturers, packers, or distributors fulfill 
regulatory requirements (e.g., fair balance, disclosure of indication 
and risk information, and 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 and mobile technology)?
    3. What parameters should apply to the posting of corrective 
information on Web sites controlled by third parties?
    4. When is the use of links appropriate?

Subsequent to the live testimony heard at the public hearing, FDA 
received 72 comments to the docket.
    This draft guidance provides FDA's recommendations regarding how 
manufacturers, packers, and distributors of prescription human and 
animal drugs and medical devices for human use, including biological 
products, should respond, if they choose to respond, to misinformation 
created or disseminated by independent third parties related to a 
firm's own FDA-approved or cleared products on the Internet or through 
social media platforms.
    This draft guidance provides FDA's recommendations to firms that 
voluntarily choose to correct misinformation that appears on the 
Internet or through social media platforms. This draft guidance 
discusses the type of information that is considered misinformation, 
recommends parameters for corrective information, and recommends 
approaches to correcting misinformation. It refers only to 
misinformation that is created or disseminated by an independent third 
party and that is not produced by, or on behalf of, or prompted by the 
firm in any particular. When a firm chooses to correct misinformation 
in a truthful and non-misleading manner and according to the 
recommendations in this draft guidance, FDA does not intend to object 
if the corrective information voluntarily provided by the firm does not 
satisfy otherwise applicable regulatory requirements regarding labeling 
or advertising, if any. If a firm chooses to respond to misinformation 
about its products using non-truthful or misleading information or in a 
manner other than that recommended in this draft guidance, however, FDA 
may object if the information provided by the firm does not comply with 
applicable regulatory requirements related to labeling or advertising, 
if any.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on correcting 
misinformation created or disseminated by independent third parties. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

II. The Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information collected; and (4) ways to 
minimize the burden of information collected on the respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Internet/Social Media Platforms: Correcting Independent 
Third-Party Misinformation About Prescription Drugs and Medical 
Devices.
    Description of Respondents: Respondents to this collection of 
information are manufacturers, packers, and distributors (firms) of 
prescription human and animal drugs and medical devices for human use, 
including biological products.
    Burden Estimate: The draft guidance pertains to the correction of 
misinformation created or disseminated by independent third parties 
related to a firm's own FDA-approved or -cleared products on the 
Internet or through social media platforms.
    The draft guidance explains FDA's current policy position that a 
firm may voluntarily correct misinformation about its own FDA-approved 
or -cleared products that is created or disseminated by independent 
third parties who are not under the firm's control or

[[Page 34762]]

influence. If a firm does so in a truthful and non-misleading manner 
and in accordance with the recommendations in the draft guidance, FDA 
does not intend to object if the corrective information voluntarily 
provided by the firm does not satisfy otherwise applicable regulatory 
requirements related to labeling and advertising, if any.
    Because the draft guidance recommends that a firm disclose certain 
information to others when correcting misinformation created or 
disseminated by independent third parties, this ``third-party 
disclosure'' constitutes a ``collection of information'' under the PRA. 
In addition, the PRA is triggered because the draft guidance also 
recommends that a firm maintain certain records related to this 
disclosure--the content of the misinformation, where the misinformation 
appeared, the date the misinformation appeared or was located, the 
corrective information that was provided, and the date the corrective 
information was provided.
    Specifically, the draft guidance recommends that firms provide 
appropriate truthful and non-misleading corrective information, or 
alternatively, it may provide a reputable source from which to obtain 
the correct information. For the purposes of the draft guidance, to be 
considered ``appropriate corrective information,'' a firm's 
communication should:
     Be relevant and responsive to the misinformation;
     Be limited and tailored to the misinformation;
     Be non-promotional in nature, tone, and presentation;
     Be accurate;
     Be consistent with the FDA-required labeling for the 
product;
     Be supported by sufficient evidence, including substantial 
evidence, when appropriate, for prescription drugs;
     Either be posted in conjunction with the misinformation in 
the same area or forum (if posted directly to the forum by the firm), 
or should reference the misinformation and be intended to be posted in 
conjunction with the misinformation (if provided to the forum operator 
or author); and
     Disclose that the person providing the corrective 
information is affiliated with the firm that manufactures, packs, or 
distributes the product.
    The FDA-required labeling should be included or provided in a 
readily accessible format. (As two examples, a firm may provide a link 
that goes directly to the FDA-required labeling or may provide a link 
that opens a new window to a portable document format (PDF) file.)
    The draft guidance also recommends that a firm correct all the 
misinformation in one clearly defined portion of a forum, but it is not 
expected to correct each occurrence of independent third-party 
misinformation throughout an entire forum. When a firm decides to 
correct all the misinformation in one clearly defined portion of a 
forum, the firm should clearly identify the misinformation it is 
correcting, define the portion of the forum it is correcting, describe 
the location or the nature of the misinformation that was corrected, 
and provide a date the correction is made.
    A firm may provide the correct information to the independent 
author for the author to incorporate or request the author remove the 
misinformation or allow comments to be posted. The firm may request 
that the site administrator remove the misinformation or allow comments 
to be posted.
    FDA estimates that approximately 400 firms annually undertake 
correcting 50 pieces of misinformation created or disseminated by 
independent third parties on the Internet or through social media. FDA 
estimates that it will take firms approximately 3 hours to correct 
misinformation as recommended in the draft guidance.
    FDA also estimates that approximately 20,000 records will be 
maintained by firms that have chosen to correct misinformation created 
or disseminated by independent third parties on the Internet or through 
social media and that each record will take approximately 30 minutes to 
prepare and maintain.

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                  Number of
  Draft guidance on correcting independent       Number of       records per      Total annual              Hours per record               Total hours
         third-party misinformation            recordkeepers     recordkeeper       records
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Records related to the correction of                     400               50           20,000   0.5 (30 minutes)......................          10,000
 independent third-party misinformation.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                         Number of
       Draft guidance on correcting independent  third-party            Number of       disclosures      Total annual      Hours per       Total hours
                           misinformation                              respondents    per  respondent    disclosures       disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Corrections of independent third-party misinformation..............             400               50           20,000                3           60,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Comments

    In addition to general comments, FDA specifically requests comments 
on the following issue: The draft guidance recommends that a firm 
should identify the misinformation or define the portion of the forum 
it is correcting and should correct all the misinformation that appears 
in that clearly defined portion. Is this an appropriate and effective 
way for firms to correct misinformation without correcting all 
misinformation that might appear in a forum? When or under what 
conditions should a sponsor choose a specific portion of a forum to 
correct? What factors, such as the platform(s) or technology(ies) that 
can be used to view the forum, the relative location of pieces of 
misinformation the firm chooses to correct, the nature of the forum, 
the quantity of information, and the length of time the forum 
encompasses, should be taken into account in choosing the portion of a 
forum to correct?
    Interested persons may submit either electronic comments regarding 
this

[[Page 34763]]

document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or http://www.regulations.gov.

    Dated: June 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14221 Filed 6-17-14; 8:45 am]
BILLING CODE 4160-01-P