[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Draft Guidance for Industry on Fulfilling Regulatory Requirements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availability of a draft guidance for industry entitled ``Fulfilling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 This draft guidance responds to stakeholder requests for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 This draft guidance clarifies FDA's policies on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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 14, 2014.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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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]
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