[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Pages 27602-27605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12631]


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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; 
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 guidance for industry entitled ``Medical Product 
Communications That Are Consistent With the FDA-Required Labeling--
Questions and Answers.'' This 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 that present information that is 
not contained in the FDA-required labeling for the product but that may 
be

[[Page 27603]]

consistent with the FDA-required labeling for the product. The Agency 
is issuing this guidance to explain FDA's current thinking on commonly 
asked questions regarding such communications to provide clarity for 
firms. FDA is also announcing that a proposed collection of information 
has been submitted to the Office of Management and Budget (OMB) for 
review and clearance under the Paperwork Reduction Act of 1995.

DATES: The announcement of the guidance is published in the Federal 
Register on June 13, 2018. Submit written comments on the collection of 
information by July 13, 2018.

ADDRESSES: To ensure comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910--NEW and 
title ``Recommended Content of Medical Product Communications That Are 
Consistent With the FDA-Required Labeling--Questions and Answers; 
Guidance for Industry.'' Also include the FDA docket number found in 
brackets in the heading of this document.
    You may submit either electronic or written comments on Agency 
guidances at any time 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 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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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; 
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 Dockets Management Staff 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 Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this 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 Policy and Regulations Staff (HFV-6), Center for Veterinary 
Medicine, Food and Drug Administration, 7500 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 guidance document.

FOR FURTHER INFORMATION CONTACT: 
    Regarding the guidance: 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 Elizabeth Pepinsky, Center for 
Drug Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3248, 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 Ana Loloei 
Marsal, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5452, Silver 
Spring, MD 20993-0002, 301-796-8774; or Thomas Moskal, Center for 
Veterinary Medicine, Food and Drug Administration, 7519

[[Page 27604]]

Standish Pl. (HFV-216), Rockville, MD 20855, 240-402-6251.
    Regarding the information collection: Domini Bean, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
11601 Landsdown St., 10A-12M, North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Medical Product Communications That Are Consistent With the 
FDA-Required Labeling--Questions and Answers.'' This guidance provides 
information for firms about how FDA evaluates their medical product 
communications (that fall within the scope of FDA's regulatory 
authority) 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 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 (510(k)) requirements or exempt from premarket review, 
the term FDA-required labeling includes the labeling that provides 
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 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, clears, or licenses 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 told FDA that they are interested in 
communicating, including in their promotional materials, data and 
information about the approved/cleared/licensed uses of their products 
that are not contained in their products' FDA-required labeling. We are 
aware that firms have questions about how FDA determines whether such 
communications are consistent with the FDA-required labeling.
    The guidance describes FDA's thinking when examining the 
consistency of a firm's product communications with that product's own 
FDA-required labeling. As explained in the guidance, if a firm 
communicates information that is not contained in its product's FDA-
required labeling but that is determined to be consistent with the FDA-
required labeling, FDA does not intend to rely on that communication to 
establish a new intended use, different from the use(s) for which the 
product is legally marketed. Establishing a product's intended uses is 
an element in establishing certain violations under the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) and Public Health Service Act. 
However, firms' communications about their products that are consistent 
with the products' FDA-required labeling but that are false or 
misleading may subject a firm to enforcement action under the FD&C Act. 
Thus, the guidance not only describes FDA's thinking on communications 
that are consistent with the FDA-required labeling, but also provides 
general recommendations intended to aid firms in complying with 
requirements in the FD&C Act and FDA's implementing regulations for 
conveying information that is consistent with the FDA-required labeling 
in a truthful and non-misleading way. The general recommendations 
provided in the guidance for conveying information in a truthful and 
non-misleading way are applicable only to drug and device labeling and 
prescription drug and restricted device advertising 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.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on 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. This guidance 
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    In compliance with 44 U.S.C. 3507, FDA has submitted the following 
proposed collection for OMB review and clearance.
    Title: Recommended Content of Medical Product Communications That 
Are Consistent With the FDA-Required Labeling; OMB Control No. 0910--
NEW.
    The 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 guidance) if they choose to publicly disseminate 
such materials. The guidance 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. Additionally, the guidance recommends that firms 
accurately characterize and contextualize the relevant information 
about the product, including by disclosing unfavorable or inconsistent 
findings. Finally, the guidance 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 observed in clinical 
trials to provide context).
    In the Federal Register of January 19, 2017 (82 FR 6575), we 
published a notice announcing the availability of the draft guidance 
document and included an analysis under the PRA of the information 
collection burden associated with our recommendations. No comments were 
received in response to the four information collection topics 
solicited in the notice.
    According to FDA data, approximately 162,000 FDA-regulated

[[Page 27605]]

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 
described in the guidance, submitted by approximately 64 percent (or 
324) of the firms. Anticipating that 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 the FDA-required labeling, as described in the 
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 guidance, if 
they choose to disseminate this information.
    We therefore estimate the burden of the information collection 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.

    FDA is issuing this final guidance subject to OMB approval of the 
collection of information. Before implementing the information 
collection provisions of the guidance, FDA will publish a notice in the 
Federal Register announcing OMB's decision to approve, modify, or 
disapprove the collection of information, including OMB control 
number(s) for newly approved collections.

III. Electronic Access

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

    Dated: June 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12631 Filed 6-12-18; 8:45 am]
 BILLING CODE 4164-01-P