83 FR 27605 - Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 114 (June 13, 2018)

Page Range		27605-27609
FR Document		2018-12632

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers.'' This guidance provides answers to common questions regarding the communication of health care economic information (d) about approved prescription drugs and approved or cleared medical devices by medical product manufacturers, packers, distributers, and their representatives (firms) to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis (collectively referred to as payors). This guidance also provides answers to common questions about both firms' dissemination of information to payors about medical products that are not yet approved or cleared for any use and firms' dissemination of information to payors about unapproved uses of approved or cleared medical products. The Agency is issuing this guidance to explain FDA's current thinking on frequently asked questions regarding these topics in order to provide clarity for firms and payors. 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.

Federal Register, Volume 83 Issue 114 (Wednesday, June 13, 2018)

[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Pages 27605-27609]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-12632]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1307]

Drug and Device Manufacturer Communications With Payors,
Formulary Committees, and Similar Entities--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 ``Drug and Device
Manufacturer Communications With Payors, Formulary Committees, and
Similar Entities--Questions and Answers.'' This guidance provides
answers to common questions regarding the communication of health care
economic information (d) about approved prescription drugs and approved
or cleared medical devices by medical product manufacturers, packers,
distributers, and their representatives (firms) to payors, formulary
committees, or other similar entities with knowledge and expertise in
the area of health care economic analysis (collectively referred to as
payors). This guidance also provides answers to common questions about
both firms' dissemination of information to payors about medical
products that are not yet approved or cleared for any use and firms'
dissemination of information to payors about unapproved uses of
approved or cleared medical products. The Agency is issuing this
guidance to explain FDA's current thinking on frequently asked
questions regarding these topics in order to provide clarity for firms
and payors. 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 ``Recommendations for Drug and Device Manufacturer Communications
With Payors, Formulary Committees, and Similar Entities.'' 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

[[Page 27606]]

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-1307 for ``Drug and Device Manufacturer Communications With
Payors, Formulary Committees, and Similar Entities--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.thefederalregister.org/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; or to
the Office of Communication, Education and Radiation Programs, Division
of Small Manufacturers, International and Consumer Assistance, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 4613, 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 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; Sheila Ryan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3320, Silver Spring, MD 20993-0002, 301-
796-1200; 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.
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 and
review staff entitled ``Drug and Device Manufacturer Communications
With Payors, Formulary Committees, and Similar Entities--Questions and
Answers.'' This guidance provides answers to common questions regarding
firms' communications of HCEI about their approved prescription drugs
to payors. The guidance also provides answers to common questions
regarding firms' communications of HCEI about their approved or cleared
medical devices to payors. In addition, the guidance addresses common
questions relating to firms' dissemination to payors of information
about medical products \1\ that are not yet approved or cleared for any
use and about unapproved uses of approved/cleared medical products. For
purposes of this guidance, the term ``payors'' collectively refers to
payors, formulary committees, or other similar entities with knowledge
and expertise in the area of health care economic analysis that are
responsible for making product selection or acquisition, formulary
management, and/or coverage and reimbursement decisions on a population
basis regarding drugs and/or devices on behalf of health care
organizations, which may include entities such as integrated health
care delivery networks, hospitals, and hospital systems.
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\1\ The term ``medical product'' refers to both drugs and
devices.
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FDA is aware that payors seek a range of information on
effectiveness, safety, and cost-effectiveness of approved/cleared
medical products, including information from firms, to help support
their medical product selection, formulary management, and/or coverage
and reimbursement decisions on a

[[Page 27607]]

population basis. This information may differ from and may be in
addition to the information FDA reviews in order to make drug and
device approval or clearance decisions. Because coverage and
reimbursement decisions by payors impact many patients, FDA believes it
is critical that HCEI provided by firms to payors about their approved
drugs and approved/cleared devices be truthful and non-misleading.
With respect to HCEI regarding approved drugs, section 502(a) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352(a)),
as amended by section 114 of the Food and Drug Administration
Modernization Act of 1997 (Pub. L. 105-115) and section 3037 of the
21st Century Cures Act (Pub. L. 114-255), includes a provision
regarding communication of HCEI about such drugs to payors. Section
502(a) of the FD&C Act indicates that HCEI provided to payors carrying
out their responsibilities for the selection of drugs for coverage or
reimbursement shall not be considered to be false or misleading if the
HCEI relates to an FDA-approved indication for the drug, is based on
competent and reliable scientific evidence, and includes, where
applicable, a conspicuous and prominent statement describing any
material differences between the health care economic information and
the FDA-approved labeling for the drug. Section III.A of this guidance
provides FDA's current thinking on key concepts in section 502(a) of
the FD&C Act and recommendations for how firms can communicate HCEI
about approved drugs to payors in accordance with this section to help
ensure that payors have information needed to make informed drug
selection, formulary management, and/or coverage and reimbursement
decisions and to help ensure that the information is not false or
misleading. Section III.A also discusses how FDA's requirements for
submission of promotional materials apply to HCEI about approved drugs
disseminated by firms to payors. If a firm disseminates HCEI about an
approved drug in accordance with this guidance, FDA does not intend to
consider such information false or misleading. In addition, FDA does
not intend to use HCEI about approved drugs disseminated consistent
with this guidance as evidence of a new intended use.
When FDA published a notice announcing the availability of the
draft guidance document in the Federal Register of January 19, 2017 (82
FR 6568), the Agency specifically requested comments from interested
parties on the extent to which the principles provided in section III.A
of the draft guidance could be applicable to communications of HCEI
about approved/cleared devices (82 FR 6568 at 6571). We also stated
that, to the extent that interested parties believe that different
considerations should apply to medical devices or that guidance is
needed on additional issues with respect to medical device firms'
communications of HCEI about approved/cleared medical devices to
payors, FDA is interested in input on those topics as well (Id.). FDA
received 23 comments on the draft guidance; 3 comments expressed
support for applying the recommendations in section III.A of the
guidance to medical devices and no comments opposed applying these
recommendations to medical devices. In response to this feedback,
section III.B of the guidance provides FDA's recommendations for how
firms can communicate HCEI about approved or cleared devices to payors
to help ensure that device firms' communication of HCEI to payors is
not false or misleading. These recommendations generally follow the
recommendations in section III.A of the guidance. If a device firm
disseminates HCEI about an approved or cleared device in accordance
with this guidance, FDA does not intend to consider such information
false or misleading. In addition, FDA does not intend to use HCEI about
approved or cleared devices disseminated consistent with this guidance
as evidence of a new intended use.
FDA also recognizes that due in part to their need, in some
situations, to plan for and make coverage and reimbursement decisions
far in advance of the effective date of such decisions, payors are also
interested in receiving information from drug and device firms about
medical products that are not yet approved or cleared by FDA for any
use, and about unapproved uses of approved/cleared medical products.
Section III.C of the guidance discusses FDA's thinking with respect to
communication by firms to payors of information about unapproved
products \2\ and about unapproved uses of approved/cleared medical
products. The draft guidance provided similar recommendations, but the
relevant section only addressed communications related to unapproved
products. As noted above, FDA received 23 comments on the draft
guidance; 17 of these comments requested that the Agency also provide
recommendations for firms' communications to payors of information
about unapproved uses of approved/cleared medical products. No comments
opposed providing recommendations on this topic. In response to these
comments, section III.C of this guidance provides FDA's recommendations
on firms' dissemination to payors of information about both unapproved
products and about unapproved uses of approved/cleared medical
products. As with firms' communications to payors of HCEI about
approved prescription drugs and approved or cleared devices, it is
essential that information provided by firms about their unapproved
products and about unapproved uses of their approved/cleared medical
products be truthful and non-misleading. Therefore, section III.C also
lays out a series of recommendations to help achieve these goals.
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\2\ As used in this guidance, the term ``unapproved products''
refers to drugs and devices that are not yet approved/cleared by FDA
for any use (but which must be approved/cleared to be legally
marketed), including products for which firms have submitted or plan
to submit a new drug application, a biologics license application
(including an application submitted under the 351(k) pathway), an
abbreviated new drug application, a premarket approval application,
a 510(k) submission, a De Novo submission under section 513(f)(2) of
the FD&C Act (21 U.S.C. 360c(f)(2)), or a Humanitarian Device
Exemption application.
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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 drug and device manufacturer communications
with payors, formulary committees, and similar entities. 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: Recommendations for Drug and Device Manufacturer
Communications With Payors, Formulary Committees, and Similar Entities;
OMB Control No. 0910--NEW.
The information collection supports Agency guidance and includes
Third-Party Disclosure recommendations regarding information that firms
should include in HCEI for prescription drugs if they choose to
disseminate such materials (``HCEI materials'') to payors, in
accordance with section 502(a) of the FD&C Act. Specifically, FDA
recommends that various aspects of study design and methodology of an
economic analysis (i.e., type of analysis, modeling technique, patient
population, perspective/viewpoint, treatment

[[Page 27608]]

comparator, time horizon, outcome measures, cost estimates, and
assumptions); factors that limit generalizability of an economic
analysis; limitations to an economic analysis; and sensitivity
analyses, if applicable, be included in HCEI materials disseminated to
payors to allow for informed decision-making.
Furthermore, FDA recommends that firms include other information
when disseminating HCEI materials, as applicable, to provide a balanced
and complete presentation. Such information includes a statement of the
FDA-approved indication of the drug and a copy of the most current FDA-
approved labeling. Under section 502(a) of the FD&C Act, firms must
also include a conspicuous and prominent statement to describe any
material differences between the HCEI and the FDA-approved labeling.
HCEI materials should also disclose whether certain studies or data
sources were omitted from an economic analysis and how the omission of
those studies or data sources may alter the conclusions presented in
the analysis. Moreover, FDA recommends that HCEI materials disclose
important risk information associated with the approved use of the
drug, and pursuant to section 502(a) of the FD&C Act, must disclose any
additional risk information related to assumptions that vary from the
approved labeling. Finally, HCEI materials should disclose potential
financial or affiliation biases to the extent reasonably known by firms
at the time of dissemination.
The guidance provides similar recommendations for HCEI materials
disseminated to payors about approved or cleared devices.
If firms choose to make communications to payors about unapproved
products or unapproved uses of approved/cleared products, FDA
recommends that firms include a clear statement with their
communications that the product or use is not approved/cleared and that
the safety or effectiveness of the product or use has not been
established. In addition, FDA recommends providing information related
to the stage of product development (e.g., the status of any study(ies)
in which a product/new use is being investigated and how it relates to
the overall product development plan; whether a marketing application
for the product or new use has been submitted to FDA or when such a
submission is planned). FDA also recommends that communications that
include factual presentations of results from studies also describe
material aspects of study design and methodology and disclose material
limitations related to the study design, methodology, and results.
Moreover, FDA recommends that firms provide followup information to
payors if previously communicated information becomes materially
outdated as a result of significant changes or as a result of new
information regarding the product or its review status.
Description of Respondents: For information that should be included
when HCEI about approved prescription drugs is disseminated to payors,
respondents to this collection of information are firms that
manufacture prescription human drugs products, including biological
products; for information that should be included when HCEI about
approved or cleared medical devices is disseminated to payors,
respondents to this collection of information are firms that
manufacture medical devices; for information that should be included in
communications with payors about unapproved products and about
unapproved uses of approved/cleared products, respondents to this
collection of information are firms that manufacture prescription human
drug products, including biological products, and medical devices.
As noted, in the Federal Register of January 19, 2017, 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 recommendations found in the draft guidance. Although
no comments were received in response to the four information
collection topics solicited in the notice, we revised the guidance as
discussed above. These revisions resulted in a significant increase to
the number of respondents to the information collection and also
recommended new data elements. However, because our estimate reflects
the average burden of the information collection distributed among all
respondents, we believe any increase resulting from revisions to the
guidance would be nominal.
Based on the post-marketing submissions of promotional materials
using Form FDA 2253 received in calendar year 2016 for approved human
prescription drugs, including prescription biological products, FDA
estimates that approximately 440 manufacturers will disseminate 4,400
distinct HCEI materials for approved human prescription drugs annually.
FDA estimates that approximately 236 manufacturers will disseminate
2,360 distinct HCEI materials for approved/cleared devices annually.
FDA estimates it will take firms approximately 20 hours to compile and
draft the information that this final guidance recommends should be
included when disseminating HCEI materials for approved human
prescription drugs and approved/cleared devices. Based on the number of
human prescription drugs and devices approved/cleared and the number of
efficacy supplements approved/cleared (i.e., approving/clearing a new
use for an approved/cleared product) in a calendar year, FDA estimates
that approximately 717 manufacturers will prepare 1,434 distinct
communications of information to payors about their unapproved products
or unapproved uses of approved/cleared products annually. FDA estimates
it will take firms approximately 0.5 hour to compile and draft the
information that this final guidance recommends should be provided with
communications to payors about unapproved products or unapproved uses
of approved/cleared products. Additionally, FDA estimates that 50
percent of the firms will spend approximately 2 hours to compile and
provide 718 distinct communications of followup information regarding
previously communicated information to payors about their unapproved
products or unapproved uses of approved/cleared products annually. We
therefore estimate the burden of the information collection as follows:

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of information Number of responses per Total annual per response Total hours
respondents respondent responses (hours)
----------------------------------------------------------------------------------------------------------------
Recommended information to 440 10 4,400 20................ 88,000
be included when firms
choose to disseminate HCEI
materials to payors about
approved prescription drugs.

[[Page 27609]]

Recommended information to 236 10 2,360 20................ 47,200
be included when firms
choose to disseminate HCEI
materials to payors about
approved or cleared medical
devices.
Recommended information to 717 2 1,434 .5 (30 minutes)... 717
be included when firms
choose to disseminate
information about
unapproved products or
unapproved uses of approved
or cleared products.
Followup information to 359 2 718 2................. 1,436
payors regarding previously
communicated about
unapproved products or
unapproved uses of approved
or cleared products.
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Total................... .............. .............. .............. .................. 137,353
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

This guidance also refers to previously approved collections of
information found in FDA regulations. The collections of information in
21 CFR 314.81(b)(3)(i) (Form FDA 2253) have been approved under OMB
control number 0910-0001.
FDA is issuing this final guidance subject to OMB approval of the
collections 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 collections 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
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, or https://www.regulations.gov.

Dated: June 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12632 Filed 6-12-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 27605

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

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual Total
Type of information burden per
respondents per disclosures hours
disclosure
respondent

Recommended information to be included when firms
choose to disseminate communications that are con-
sistent with the FDA-required labeling ............................. 324 30 9,720 4 38,880
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA is issuing this final guidance DEPARTMENT OF HEALTH AND thinking on frequently asked questions
subject to OMB approval of the HUMAN SERVICES regarding these topics in order to
collection of information. Before provide clarity for firms and payors.
implementing the information Food and Drug Administration FDA is also announcing that a proposed
collection provisions of the guidance, [Docket No. FDA–2016–D–1307] collection of information has been
FDA will publish a notice in the Federal submitted to the Office of Management
Register announcing OMB’s decision to Drug and Device Manufacturer and Budget (OMB) for review and
approve, modify, or disapprove the Communications With Payors, clearance under the Paperwork
collection of information, including Formulary Committees, and Similar Reduction Act of 1995.
OMB control number(s) for newly Entities—Questions and Answers; DATES: The announcement of the
approved collections. Guidance for Industry; Availability guidance is published in the Federal
AGENCY: Food and Drug Administration, Register on June 13, 2018. Submit
III. Electronic Access written comments on the collection of
HHS.
information by July 13, 2018.
Persons with access to the internet ACTION: Notice of availability.
may obtain the guidance at either ADDRESSES: To ensure comments on the
https://www.fda.gov/Drugs/Guidance SUMMARY: The Food and Drug information collection are received,
Administration (FDA or Agency) is OMB recommends that written
ComplianceRegulatoryInformation/
announcing the availability of a comments be faxed to the Office of
Guidances/default.htm, https://
guidance for industry entitled ‘‘Drug Information and Regulatory Affairs,
www.fda.gov/BiologicsBloodVaccines/
and Device Manufacturer OMB, Attn: FDA Desk Officer, Fax: 202–
GuidanceComplianceRegulatory Communications With Payors, 395–7285, or emailed to oira_
Information/Guidances/default.htm, Formulary Committees, and Similar submission@omb.eop.gov. All
https://www.fda.gov/MedicalDevices/ Entities—Questions and Answers.’’ This comments should be identified with the
DeviceRegulationandGuidance/ guidance provides answers to common OMB control number 0910-New and
GuidanceDocuments/default.htm, questions regarding the communication title ‘‘Recommendations for Drug and
https://www.fda.gov/AnimalVeterinary/ of health care economic information (d) Device Manufacturer Communications
GuidanceComplianceEnforcement/ about approved prescription drugs and With Payors, Formulary Committees,
GuidanceforIndustry/default.htm, or approved or cleared medical devices by and Similar Entities.’’ Also include the
https://www.regulations.gov. medical product manufacturers, FDA docket number found in brackets
Dated: June 7, 2018. packers, distributers, and their in the heading of this document.
representatives (firms) to payors, You may submit either electronic or
Leslie Kux,
formulary committees, or other similar written comments on Agency guidances
Associate Commissioner for Policy. entities with knowledge and expertise at any time as follows:
[FR Doc. 2018–12631 Filed 6–12–18; 8:45 am] in the area of health care economic
BILLING CODE 4164–01–P analysis (collectively referred to as Electronic Submissions
payors). This guidance also provides Submit electronic comments in the
answers to common questions about following way:
both firms’ dissemination of information • Federal eRulemaking Portal:
amozie on DSK3GDR082PROD with NOTICES1

to payors about medical products that https://www.regulations.gov. Follow the
are not yet approved or cleared for any instructions for submitting comments.
use and firms’ dissemination of Comments submitted electronically,
information to payors about unapproved including attachments, to https://
uses of approved or cleared medical www.regulations.gov will be posted to
products. The Agency is issuing this the docket unchanged. Because your
guidance to explain FDA’s current comment will be made public, you are

VerDate Sep<11>2014 18:01 Jun 12, 2018 Jkt 244001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\13JNN1.SGM 13JNN1

Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 27607

population basis. This information may in section III.A of the draft guidance recommendations, but the relevant
differ from and may be in addition to could be applicable to communications section only addressed communications
the information FDA reviews in order to of HCEI about approved/cleared devices related to unapproved products. As
make drug and device approval or (82 FR 6568 at 6571). We also stated noted above, FDA received 23
clearance decisions. Because coverage that, to the extent that interested parties comments on the draft guidance; 17 of
and reimbursement decisions by payors believe that different considerations these comments requested that the
impact many patients, FDA believes it is should apply to medical devices or that Agency also provide recommendations
critical that HCEI provided by firms to guidance is needed on additional issues for firms’ communications to payors of
payors about their approved drugs and with respect to medical device firms’ information about unapproved uses of
approved/cleared devices be truthful communications of HCEI about approved/cleared medical products. No
and non-misleading. approved/cleared medical devices to comments opposed providing
With respect to HCEI regarding payors, FDA is interested in input on recommendations on this topic. In
approved drugs, section 502(a) of the those topics as well (Id.). FDA received response to these comments, section
Federal Food, Drug, and Cosmetic Act 23 comments on the draft guidance; 3 III.C of this guidance provides FDA’s
(FD&C Act) (21 U.S.C. 352(a)), as comments expressed support for recommendations on firms’
amended by section 114 of the Food and applying the recommendations in dissemination to payors of information
Drug Administration Modernization Act section III.A of the guidance to medical about both unapproved products and
of 1997 (Pub. L. 105–115) and section devices and no comments opposed about unapproved uses of approved/
3037 of the 21st Century Cures Act applying these recommendations to cleared medical products. As with
(Pub. L. 114–255), includes a provision medical devices. In response to this firms’ communications to payors of
regarding communication of HCEI about feedback, section III.B of the guidance HCEI about approved prescription drugs
such drugs to payors. Section 502(a) of provides FDA’s recommendations for and approved or cleared devices, it is
the FD&C Act indicates that HCEI how firms can communicate HCEI about essential that information provided by
provided to payors carrying out their approved or cleared devices to payors to firms about their unapproved products
responsibilities for the selection of help ensure that device firms’ and about unapproved uses of their
drugs for coverage or reimbursement communication of HCEI to payors is not approved/cleared medical products be
shall not be considered to be false or false or misleading. These truthful and non-misleading. Therefore,
misleading if the HCEI relates to an recommendations generally follow the section III.C also lays out a series of
FDA-approved indication for the drug, recommendations in section III.A of the recommendations to help achieve these
is based on competent and reliable guidance. If a device firm disseminates goals.
scientific evidence, and includes, where HCEI about an approved or cleared This guidance is being issued
applicable, a conspicuous and device in accordance with this consistent with FDA’s good guidance
prominent statement describing any guidance, FDA does not intend to practices regulation (21 CFR 10.115).
material differences between the health consider such information false or The guidance represents the current
care economic information and the misleading. In addition, FDA does not thinking of FDA on drug and device
FDA-approved labeling for the drug. intend to use HCEI about approved or manufacturer communications with
Section III.A of this guidance provides cleared devices disseminated consistent payors, formulary committees, and
FDA’s current thinking on key concepts with this guidance as evidence of a new similar entities. It does not establish any
in section 502(a) of the FD&C Act and intended use. rights for any person and is not binding
recommendations for how firms can FDA also recognizes that due in part on FDA or the public. You can use an
communicate HCEI about approved to their need, in some situations, to plan alternative approach if it satisfies the
drugs to payors in accordance with this for and make coverage and requirements of the applicable statutes
section to help ensure that payors have reimbursement decisions far in advance and regulations. This guidance is not
information needed to make informed of the effective date of such decisions, subject to Executive Order 12866.
drug selection, formulary management, payors are also interested in receiving
and/or coverage and reimbursement II. Paperwork Reduction Act of 1995
information from drug and device firms
decisions and to help ensure that the about medical products that are not yet In compliance with 44 U.S.C. 3507,
information is not false or misleading. approved or cleared by FDA for any use, FDA has submitted the following
Section III.A also discusses how FDA’s and about unapproved uses of proposed collection for OMB review
requirements for submission of approved/cleared medical products. and clearance:
promotional materials apply to HCEI Section III.C of the guidance discusses Title: Recommendations for Drug and
about approved drugs disseminated by FDA’s thinking with respect to Device Manufacturer Communications
firms to payors. If a firm disseminates communication by firms to payors of With Payors, Formulary Committees,
HCEI about an approved drug in information about unapproved and Similar Entities; OMB Control No.
accordance with this guidance, FDA products 2 and about unapproved uses 0910—NEW.
does not intend to consider such The information collection supports
of approved/cleared medical products.
information false or misleading. In Agency guidance and includes Third-
The draft guidance provided similar
addition, FDA does not intend to use Party Disclosure recommendations
HCEI about approved drugs 2 As used in this guidance, the term ‘‘unapproved regarding information that firms should
disseminated consistent with this products’’ refers to drugs and devices that are not include in HCEI for prescription drugs
guidance as evidence of a new intended yet approved/cleared by FDA for any use (but if they choose to disseminate such
use. which must be approved/cleared to be legally materials (‘‘HCEI materials’’) to payors,
amozie on DSK3GDR082PROD with NOTICES1

marketed), including products for which firms have
When FDA published a notice submitted or plan to submit a new drug application,
in accordance with section 502(a) of the
announcing the availability of the draft a biologics license application (including an FD&C Act. Specifically, FDA
guidance document in the Federal application submitted under the 351(k) pathway), recommends that various aspects of
Register of January 19, 2017 (82 FR an abbreviated new drug application, a premarket study design and methodology of an
approval application, a 510(k) submission, a De
6568), the Agency specifically requested Novo submission under section 513(f)(2) of the
economic analysis (i.e., type of analysis,
comments from interested parties on the FD&C Act (21 U.S.C. 360c(f)(2)), or a Humanitarian modeling technique, patient population,
extent to which the principles provided Device Exemption application. perspective/viewpoint, treatment

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Document Created: 2018-06-12 23:59:20
Document Modified: 2018-06-12 23:59:20

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
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.
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; Sheila Ryan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3320, Silver Spring, MD 20993-0002, 301- 796-1200; 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.
FR Citation		83 FR 27605

83 FR 27605 - Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 114 (June 13, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration