[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Notices]
[Pages 6575-6578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01012]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2285]


Medical Product Communications That Are Consistent With the Food 
and Drug Administration-Required Labeling--Questions and Answers; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Medical 
Product Communications That Are Consistent With the FDA-Required 
Labeling--Questions and Answers.'' This draft guidance provides 
information for manufacturers, packers, and distributors and their 
representatives (collectively ``firms'') of drugs and medical devices 
for humans, including those that are licensed as biological products, 
and animal drugs (collectively ``medical products''), about how FDA 
evaluates their medical product communications, including their 
promotional materials, that present information that is not contained 
in the FDA-required labeling for the product but that may be consistent 
with the FDA-required labeling for the product. The Agency is issuing 
this draft guidance to explain FDA's current thinking on commonly asked 
questions regarding such communications in order to provide clarity for 
firms.

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 comment 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 19, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a

[[Page 6576]]

third party may not wish to be posted, such as medical information, 
your or anyone else's Social Security number, or confidential business 
information, such as a manufacturing process. Please note that if you 
include your name, contact information, or other information that 
identifies you in the body of your comments, that information will be 
posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-2285 for ``Medical Product Communications That Are 
Consistent With the FDA-Required Labeling--Questions and Answers; Draft 
Guidance for Industry; Availability.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; 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; 
Division of Small Manufacturers, International and Consumer Assistance, 
Office of Communication, Education and Radiation Programs, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002; 
or to 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.

FOR FURTHER INFORMATION CONTACT: Kristin Davis, Office of Policy, 
Office of the Commissioner, 10903 New Hampshire Ave., Bldg. 32, Rm. 
4252, Silver Spring, MD 20993-0002, 301-796-0418; or Catherine Gray, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 51, Rm. 3203, Silver Spring, MD 20993-
0002, 301-796-1200; or 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; or 
Angela Krueger, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1666, 
Silver Spring, MD 20993-0002, 301-796-6380; or Thomas Moskal, Center 
for Veterinary Medicine, Food and Drug Administration, 7519 Standish 
Pl. (HFV-1), Rockville, MD 20855, 240-402-6251.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Medical Product Communications That Are Consistent With the 
FDA-Required Labeling--Questions and Answers.'' This draft guidance 
provides information for firms about how FDA evaluates their medical 
product communications, including their promotional materials, that 
present information that is not contained in the FDA-required labeling 
\1\ for the product but that may be consistent with the FDA-required 
labeling for the product.
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    \1\ As used in the draft guidance, the term FDA-required 
labeling includes the labeling reviewed and approved by FDA as part 
of the medical product marketing application review process. For 
products not subject to premarket approval, but instead subject to 
premarket notification requirements or exempt from premarket review, 
the term also includes the labeling relied on to provide adequate 
directions for use and other information required to appear on the 
label or in labeling.
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    FDA determines whether a medical product is safe and effective for 
use under the conditions prescribed, recommended, or suggested in the 
proposed labeling submitted to FDA with the product's marketing 
application or submission (and for devices, also during the 
classification process). In making this determination, FDA evaluates 
whether the conditions of use in the proposed labeling are supported by 
the required levels and types of evidence of safety and effectiveness 
and whether the benefits of using the product under those specific 
conditions of use outweigh the risks of the product. After FDA approves 
or clears a medical product, the FDA-required labeling sets forth the 
conditions of use under which the product has been shown to meet the 
relevant standard for marketing, and it provides directions and 
information on how to use the product safely and effectively under 
those conditions.
    Medical product firms have expressed interest in communicating, 
including in promotional materials, data and

[[Page 6577]]

information that are not contained in their products' FDA-required 
labeling but concern the approved/cleared uses of the products. We are 
aware that firms have questions about how FDA determines when such 
communications are consistent with the FDA-required labeling, and how 
they are viewed by FDA.
    The draft guidance describes FDA's thinking on these topics. As 
explained in the draft guidance, a firm's communication of information 
that is not contained in the product's FDA-required labeling, but that 
is determined to be consistent with the FDA-required labeling, is not 
alone considered evidence of a new intended use. However, even if a 
communication is consistent with the FDA-required labeling, the 
representations or suggestions made about the product would misbrand 
the product and could subject firms to enforcement action if the 
representations or suggestions are false or misleading. Accordingly, 
the draft guidance both describes FDA's thinking on the types of 
information that are consistent with the FDA-required labeling and 
provides general recommendations for how this information can be 
conveyed in a truthful and non-misleading way. The draft guidance also 
provides some examples to illustrate these concepts. The 
recommendations provided in the draft guidance to help ensure that 
communications are not false or misleading are specific to 
communications that are consistent with the FDA-required labeling; 
communication of information that is not consistent with the FDA-
required labeling is outside the scope of these recommendations.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the availability of a draft guidance for industry entitled ``Drug and 
Device Manufacturer Communications With Payors, Formulary Committees, 
and Similar Entities--Questions and Answers.'' This draft guidance 
provides answers to common questions regarding firms' communications of 
health care economic information about their approved prescription 
drugs to payers and similar entities. This draft guidance also 
addresses common questions relating to firms' dissemination of 
information about investigational products to payers before FDA 
approval or clearance of such products.
    In addition, FDA is announcing in this issue of the Federal 
Register that it is reopening the comment period for the notice of 
public hearing that appeared in the Federal Register of September 1, 
2016, concerning manufacturer communications regarding unapproved uses 
of approved or cleared medical products. The comment period will be 
reopened for 90 days, until April 19, 2017. As announced in the notice 
of public hearing, FDA is engaged in a comprehensive review of its 
regulations and policies governing communications by firms about 
unapproved uses of approved or cleared medical products, and the 
comments it receives will inform FDA's policy development in this area.
    FDA will consider the feedback it receives in all three of these 
dockets as the Agency continues to review its policies on firm 
communications about medical products, and interested persons may wish 
to review the documents FDA has issued in all three dockets before 
submitting comments to any of the relevant dockets.
    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 current thinking of FDA on certain 
commonly asked questions regarding firms' communications for their 
medical products that may be consistent with the FDA-required labeling. 
It does not establish any rights for any person and is not binding on 
FDA or the public. You can use an alternative approach if it satisfies 
the requirements of the applicable statutes and regulations.

II. 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 to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Recommended Content of Medical Product Communications That 
Are Consistent With the FDA-Required Labeling.
    Description of Respondents: Respondents to the proposed collection 
of information are manufacturers, packers, and distributors and their 
representatives (firms) of human drugs and devices, including those 
licensed as biological products, and animal drugs.
    Burden Estimate: The draft guidance includes Third-Party Disclosure 
recommendations regarding information that firms should include in 
communications that contain information not found in the FDA-required 
labeling for their medical products but that are consistent with the 
FDA-required labeling (as explained in the draft guidance) if they 
choose to publically disseminate such materials.
    Specifically, FDA recommends that various aspects of study design 
and methodology for studies relied on in such communications be 
disclosed to provide material contextual information (e.g., type of 
study, study objectives, product dosage/use regimens, control(s) used, 
patient population studied), and that material limitations related to 
the study design, methodology, and results also be disclosed in a clear 
and prominent manner to help ensure that the communications are not 
false or misleading.
    Furthermore, FDA recommends that firms accurately characterize and 
contextualize the relevant information about the product, including by 
disclosing unfavorable or inconsistent findings. FDA also recommends 
that firms disclose material contextual information from the FDA-
required labeling in these communications, such as data and information 
from studies in the FDA-required labeling that are relevant to the data 
or information presented in the communication (e.g., if a communication 
provides post-market information about the types and rates of 
occurrence of adverse events that have been observed in practice, the 
communication should also include information from the FDA-required 
labeling about the types and rates of occurrence of adverse reactions

[[Page 6578]]

observed in clinical trials to provide context).
    According to FDA data, approximately 162,000 FDA-regulated 
promotional materials are prepared by approximately 500 firms annually. 
Of these materials, we estimate approximately 5 percent contain unique 
presentations of information consistent with FDA-required labeling, as 
that term is described in the draft guidance, submitted by 
approximately 64 percent (or 324) of the firms. Anticipating the number 
of these FDA-regulated promotional materials will soon increase to 6 
percent, we estimate the 324 firms will prepare and disseminate 
annually 9,720 FDA-regulated promotional materials that contain unique 
presentations of information that is consistent with FDA-required 
labeling, as that term is described in the draft guidance, and that 
therefore are recommended to include the proposed third party 
disclosures. Based on our experience reviewing FDA-regulated 
promotional materials for medical products, we estimate it will take 
respondents approximately 4 hours per unique presentation to prepare 
and incorporate the disclosures recommended in the draft guidance, if 
they choose to disseminate this information.
    We estimate the burden of this collection of information as 
follows:

                                                Table 1--Estimated Annual Third-Party Disclosure Burden 1
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                                                                                          Number of
                        Type of information                             Number of      disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent       disclosures     per disclosure
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Recommended information to be included when firms choose to                     324                30            9,720                4          38,880
 disseminate communications that are consistent with the FDA-
 required labeling.................................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm,
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm,
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or
https://www.regulations.gov.

    Dated: January 6, 2017.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-01012 Filed 1-18-17; 8:45 am]
 BILLING CODE 4164-01-P