Draft Guidance for Industry on Internet/Social Media Platforms With Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices; Availability, 34759-34760 [2014-14220]

Download as PDF Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Notices Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002 PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: On April 22, 2014, the Agency submitted a proposed collection of information entitled ‘‘Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun))’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0471. The approval expires on May 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. Dated: June 12, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–14252 Filed 6–17–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–0397] Draft Guidance for Industry on Internet/Social Media Platforms With Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Internet/ Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and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 This draft guidance responds to, among other things, stakeholder requests for specific guidance and describes FDA’s current thinking on how manufacturers, packers, and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, that choose to present benefit emcdonald on DSK67QTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:35 Jun 17, 2014 Jkt 232001 information should present both benefit and risk information within advertising and promotional labeling of their FDAregulated medical products on electronic/digital platforms that are associated with character space limitations, specifically on the Internet and through social media or other technological venues (Internet/social media). 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. 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; or 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; 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 for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// 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: Jean-Ah Kang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD 20993, 301–796–1200. PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 34759 Regarding prescription human 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: Dorothy McAdams, 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, Silver Spring, MD 20993, 301–796–5732. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.’’ On November 12 and 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. Specifically, this draft guidance presents considerations to illustrate FDA’s thinking on factors that are relevant to the communication of benefit and risk information on Internet/ social media platforms with character space limitations. Examples of Internet/ E:\FR\FM\18JNN1.SGM 18JNN1 34760 Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Notices emcdonald on DSK67QTVN1PROD with NOTICES social media platforms with character space limitations include online microblog messaging (e.g., messages on Twitter or ‘‘tweets,’’ which are currently limited to 140 character spaces per tweet) and online paid search (e.g., sponsored links on search engines such as Google and Yahoo, which have limited character spaces as well as other platform-imposed considerations). Please note that this draft guidance does not address promotion via product Web sites, Web pages on social media networking platforms (e.g., individual product pages on Web sites such as Facebook, Twitter, YouTube), and online Web banners as the Agency believes that these specific types of Internet/social media platforms do not impose the same character space constraints as online microblog messaging and online paid search. This draft guidance also does not address responsive Web design or other technology-specific layout features that may result in product promotion presentations that differ depending on the technology used to view them (e.g., desktop computer monitors, mobile devices, tablets). 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 presenting risk and benefit information for prescription drugs and medical devices on Internet/social media platforms with character space limitations. 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 This draft guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520). The collections of information in 21 CFR 202.1 and 21 CFR parts 801 and 809 have been approved under OMB control numbers 0910–0686 and 0910–0485, respectively. In accordance with the PRA, prior to publication of any final guidance document, FDA intends to solicit public comment and obtain OMB approval for any information collections recommended in this guidance that are new or that would represent material modifications to previously approved collections of information found in FDA regulations or guidances. VerDate Mar<15>2010 16:35 Jun 17, 2014 Jkt 232001 III. Comments Interested persons may submit either electronic comments regarding this document to https://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 https:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm, https:// www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm, https://www.fda.gov/MedicalDevices/ deviceregulationandguidance/ guidancedocuments/default.htm, or https://www.regulations.gov. 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES 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. Food and Drug Administration ADDRESSES: Dated: June 13, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–14220 Filed 6–17–14; 8:45 am] BILLING CODE 4160–01–P [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. 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, SUMMARY: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 DATES: 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 selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section E:\FR\FM\18JNN1.SGM 18JNN1

Agencies

[Federal Register Volume 79, Number 117 (Wednesday, June 18, 2014)]
[Notices]
[Pages 34759-34760]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14220]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0397]

Draft Guidance for Industry on Internet/Social Media Platforms
With Character Space Limitations: Presenting Risk and Benefit
Information for Prescription Drugs and Medical Devices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Internet/
Social Media Platforms with Character Space Limitations: Presenting
Risk and Benefit Information for 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, that choose to
present benefit information should present both benefit and risk
information within advertising and promotional labeling of their FDA-
regulated medical products on electronic/digital platforms that are
associated with character space limitations, specifically on the
Internet and through social media or other technological venues
(Internet/social media). 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.

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; or 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;
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 for electronic access to the draft guidance
document.
Submit electronic comments on the draft guidance to https://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: Jean-Ah Kang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Silver Spring, MD 20993, 301-796-1200.
Regarding prescription human 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: Dorothy McAdams, 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, Silver Spring, MD 20993, 301-796-5732.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``Internet/Social Media Platforms with Character Space
Limitations: Presenting Risk and Benefit Information for Prescription
Drugs and Medical Devices.''
On November 12 and 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.
Specifically, this draft guidance presents considerations to
illustrate FDA's thinking on factors that are relevant to the
communication of benefit and risk information on Internet/social media
platforms with character space limitations. Examples of Internet/

[[Page 34760]]

social media platforms with character space limitations include online
microblog messaging (e.g., messages on Twitter or ``tweets,'' which are
currently limited to 140 character spaces per tweet) and online paid
search (e.g., sponsored links on search engines such as Google and
Yahoo, which have limited character spaces as well as other platform-
imposed considerations).
Please note that this draft guidance does not address promotion via
product Web sites, Web pages on social media networking platforms
(e.g., individual product pages on Web sites such as Facebook, Twitter,
YouTube), and online Web banners as the Agency believes that these
specific types of Internet/social media platforms do not impose the
same character space constraints as online microblog messaging and
online paid search. This draft guidance also does not address
responsive Web design or other technology-specific layout features that
may result in product promotion presentations that differ depending on
the technology used to view them (e.g., desktop computer monitors,
mobile devices, tablets).
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 presenting
risk and benefit information for prescription drugs and medical devices
on Internet/social media platforms with character space limitations. 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

This draft guidance contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520).
The collections of information in 21 CFR 202.1 and 21 CFR parts 801 and
809 have been approved under OMB control numbers 0910-0686 and 0910-
0485, respectively. In accordance with the PRA, prior to publication of
any final guidance document, FDA intends to solicit public comment and
obtain OMB approval for any information collections recommended in this
guidance that are new or that would represent material modifications to
previously approved collections of information found in FDA regulations
or guidances.

III. Comments

Interested persons may submit either electronic comments regarding
this document to https://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 https://www.regulations.gov.

IV. Electronic Access

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

Dated: June 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14220 Filed 6-17-14; 8:45 am]
BILLING CODE 4160-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.