[Federal Register Volume 79, Number 9 (Tuesday, January 14, 2014)]
[Notices]
[Pages 2449-2450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00519]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1430]


Draft Guidance for Industry on Fulfilling Regulatory Requirements 
for Postmarketing Submissions of Interactive Promotional Media for 
Prescription Human and Animal Drugs and Biologics; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Fulfilling 
Regulatory Requirements for Postmarketing Submissions of Interactive 
Promotional Media for Prescription Human and Animal Drugs and 
Biologics.'' This draft guidance responds to stakeholder requests for 
specific guidance on FDA's current views on how manufacturers, packers, 
and distributors (firms), that may either be the applicant or acting on 
behalf of the applicant, of prescription human and animal drug and 
biological products (drugs) can fulfill regulatory requirements for 
postmarketing submissions of interactive promotional media for their 
FDA-approved products. This draft guidance clarifies FDA's policies on 
what the Agency considers to be interactive promotional media.

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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 14, 2014. General comments on Agency guidance 
documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 (HFM-40), Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448; or to the 
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and 
Drug Administration, 7519 Standish Pl., Rockville, MD 20855. 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 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: Barbara Chong, 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 (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

[[Page 2450]]

    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.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Fulfilling Regulatory Requirements for Postmarketing 
Submissions of Interactive Promotional Media for Prescription Human and 
Animal Drugs and Biologics.''
    On November 12-13, 2009, FDA held a 21 CFR part 15 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 part 15 public hearing, 
FDA received 72 comments to the docket.
    This draft guidance provides FDA's recommendations to drug firms on 
fulfilling the regulatory requirements under 21 CFR 314.81(b)(3)(i), 21 
CFR 601.12(f)(4), and 21 CFR 514.80(b)(5)(ii) for postmarketing 
submissions of interactive promotional media for their FDA-approved 
products. For the purposes of this draft guidance, the phrase 
``interactive promotional media'' includes tools and technologies that 
often allow for real-time communications and interactions (e.g., blogs, 
microblogs, social networking sites, online communities, live podcasts, 
etc.), which firms use to promote their drugs. FDA's regulation of 
prescription drug product promotion extends both to promotional 
activities that are carried out by the firm itself, and to promotion 
conducted on the firm's behalf. In determining whether the firm is 
accountable for a communication about its product(s), the Agency 
considers whether the firm, or anyone acting on its behalf, is 
influencing or controlling the product promotional activity or 
communication in whole or part.
    Firms may have a variety of options for how much control they exert 
over activities that utilize interactive promotional media, regardless 
of whether the promotional activity occurs on firm sponsored venues or 
on third-party venues. For example, a firm may promote its products 
through product Web sites, discussion boards, chat rooms, or other 
public electronic forums that it maintains and over which it has full 
control. In addition, third-party sites (i.e., Web sites and other 
venues that are either entirely independent of a firm's control and 
influence or not fully controlled by a firm) also may promote a firm's 
products. This draft guidance outlines considerations FDA takes into 
account in determining when product communications using interactive 
technologies are subject to substantive influence by firms that market 
the product, therefore triggering postmarketing submission 
requirements.
    In addition, this draft guidance provides FDA's recommendations for 
how firms can fulfill the regulatory requirement to submit 
postmarketing promotional materials to FDA in a practical manner to 
address the potential volume of real-time information that is 
continuously posted and shared through various interactive promotional 
media platforms.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). When finalized, it will 
represent the Agency's current thinking on fulfilling the regulatory 
requirements for postmarketing submissions of interactive promotional 
media for drugs. 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 guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collection of information in 21 CFR 314.81(b)(3)(i), 21 CFR 
601.12(f)(4), and 21 CFR 514.80(b)(5)(ii) including Forms FDA 2253 and 
FDA 2301, have been approved under OMB control numbers 0910-0001, 0910-
0338, and 0910-0284.

III. Comments

    Interested persons may submit either electronic comments regarding 
this 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, or http://www.regulations.gov.

    Dated: January 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00519 Filed 1-13-14; 8:45 am]
BILLING CODE 4160-01-P