Notice2026-11060
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability
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Published
June 3, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry titled "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers." This revised draft guidance, when finalized, will provide answers to common questions regarding the communication of health care economic information (HCEI) about approved prescription drugs and approved/ cleared (as defined in the guidance) medical devices (collectively referred to in the guidance as approved/cleared medical products) by medical product manufacturers, packers, distributors, and their representatives (collectively referred to as firms) to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis, carrying out their responsibilities for the selection of medical products for coverage or reimbursement (collectively referred to as payors). This revised draft guidance also provides answers to common questions about firms' dissemination of information to payors about medical products that are not yet approved/cleared for any use (collectively referred to as unapproved medical products) and firms' dissemination of information to payors about unapproved uses of approved/cleared medical products.
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<title>Federal Register, Volume 91 Issue 106 (Wednesday, June 3, 2026)</title>
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[Federal Register Volume 91, Number 106 (Wednesday, June 3, 2026)]
[Notices]
[Pages 33181-33184]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11060]
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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;
Revised Draft Guidance for Industry; Availability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 revised draft guidance for industry titled ``Drug
and Device Manufacturer Communications With Payors, Formulary
Committees, and Similar Entities--Questions and Answers.'' This revised
draft guidance, when finalized, will provide answers to common
questions regarding the communication of health care economic
information (HCEI) about approved prescription drugs and approved/
cleared (as defined in the guidance) medical devices (collectively
referred to in the guidance as approved/cleared medical products) by
medical product manufacturers, packers, distributors, and their
representatives (collectively referred to as firms) to payors,
formulary committees, or other similar entities with knowledge and
expertise in the area of health care economic analysis, carrying out
their responsibilities for the selection of medical products for
coverage or reimbursement (collectively referred to as payors). This
revised draft guidance also provides answers to common questions about
firms' dissemination of information to payors about medical products
that are not yet approved/cleared for any use (collectively referred to
as unapproved medical products) and firms' dissemination of information
to payors about unapproved uses of approved/cleared medical products.
DATES: Submit either electronic or written comments on the draft
guidance by August 3, 2026 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9
[[Page 33182]]
a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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. 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:
With regard to the guidance: Twyla Mosey, 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; Phillip Kurs, Center for Biologics Evaluation and Research,
Food and Drug Administration, 240-402-7911; or Stephanie Philbin,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5513, Silver
Spring, MD 20993-0002, 301-837-7151.
With regard to the proposed collection of information: Anne Taylor,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-402-
5683, <a href="/cdn-cgi/l/email-protection#7c2c2e3d2f081d1a1a3c1a181d5214140f521b130a"><span class="__cf_email__" data-cfemail="a7f7f5e6f4d3c6c1c1e7c1c3c689cfcfd489c0c8d1">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft guidance for
industry titled ``Drug and Device Manufacturer Communications With
Payors, Formulary Committees, and Similar Entities--Questions and
Answers.'' This revised draft guidance incorporates updates to the
Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by section
3630 of the Consolidated Appropriations Act, 2023 and, when final, will
replace the final guidance of the same title issued in June 2018. This
revised draft guidance provides answers to common questions regarding
firms' communications of HCEI about their approved/cleared medical
products to payors. In addition, the guidance addresses common
questions relating to firms' dissemination to payors of information
about unapproved medical products and about unapproved uses of
approved/cleared medical products. In 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 medical product
selection or acquisition, formulary management, and/or coverage and
reimbursement decisions on a population basis regarding medical
products on behalf of health care organizations, which may include
entities such as integrated health care delivery networks, hospitals,
and hospital systems.
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 population basis. This information may
differ from and may be in addition to the information FDA reviews in
order to make medical product approval or clearance decisions. HCEI and
product information provided by firms to payors about their medical
products must be truthful and not misleading (see section 502(a) and
502(gg) of the FD&C Act (21 U.S.C. 352(a) and 352(gg))).
With respect to HCEI regarding approved/cleared medical products,
section 502(a) of the FD&C Act, as amended by section 114 of the Food
and Drug Administration Modernization Act of 1997 (Pub. L. 105-115),
section 3037 of the 21st Century Cures Act (Pub. L. 114-255), and
section 3630 of the Consolidated Appropriations Act, 2023 (Pub. L. 117-
328), includes a provision regarding communication of HCEI about such
medical products to payors. Section 502(a) of the FD&C Act indicates
that HCEI provided to payors carrying out their responsibilities for
the selection of medical products for coverage or reimbursement shall
not be considered to be false or misleading if the HCEI (1) relates to
an FDA-approved indication for the medical product (in this guidance,
approved is defined to include cleared, among other things), (2) is
based on competent and reliable scientific evidence, and (3) 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 medical product (in this guidance,
the term FDA-approved labeling includes FDA-required labeling). 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/cleared medical products to payors in
accordance with section 502(a). This information is intended to help
ensure that payors have information needed to make informed medical
product 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. Section 502(a) of
the FD&C Act provides that HCEI disseminated in accordance with its
terms is not false or misleading. If a firm disseminates to an
appropriate audience HCEI that is of the type of information described
in section 502(a) of the FD& C Act, i.e., HCEI that relates to an
approved indication and is based on
[[Page 33183]]
competent and reliable scientific evidence (CARSE), as each of these
elements is described in the guidance, FDA does not intend to consider
such information false or misleading. In addition, FDA does not intend
to use HCEI about approved/cleared medical products disseminated
consistent with this guidance, standing alone, as evidence of a new
intended use.
FDA also recognizes that due in part to payors' 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 medical product firms about
unapproved medical products and about unapproved uses of approved/
cleared medical products. Section III.B of this guidance discusses
FDA's thinking with respect to communication by firms to payors
regarding unapproved medical products and unapproved uses of approved/
cleared medical products. As with firms' communications to payors of
HCEI about approved/cleared medical products, it is essential that
information provided by firms about their unapproved medical products
and about unapproved uses of their approved/cleared medical products be
truthful and non-misleading. Section 502(gg) of the FD&C Act provides
that medical products shall not be deemed to be misbranded under
section 502(f)(1) through a communication by a firm to a payor about
investigational medical products or investigational uses of approved/
cleared medical products if such communication is (1) the type of
product information as defined in section 502(gg)(2); (2) truthful and
not misleading; (3) presented with the information set forth in section
502(gg)(1)(A); and (4) not presented with the information set forth in
section 502(gg)(1)(B). While section 502(gg) of the FD&C Act addresses
investigational medical products or investigational uses of medical
products, FDA does not intend to object under section 502(f)(1) on the
basis of a firm's communication of product information to payors about
unapproved medical products or unapproved uses of medical products,
even where such unapproved medical products or uses may not be
considered investigational, if the communication of product information
is consistent with section 502(gg).
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 ``Drug and
Device Manufacturer Communications With Payors, Formulary Committees,
and Similar Entities--Questions and Answers.'' 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.
As we develop any final guidance on this topic, FDA will consider
comments on costs or cost savings the guidance may generate, relevant
for Executive Order 14192.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), 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.
Drug and Device Manufacturer Communications With Payors, Formulary
Committees, and Similar Entities--Questions and Answers
OMB Control Number 0910-0686--Revision
As noted, the revised draft guidance document ``Drug and Device
Manufacturer Communications With Payors, Formulary Committees, and
Similar Entities--Questions and Answers'' provides answers to common
questions regarding firms' communications of HCEI about their approved/
cleared medical products to payors. In addition, the guidance addresses
common questions relating to firms' dissemination to payors of
information about unapproved medical products and about unapproved uses
of approved/cleared medical products.
The revised draft guidance incorporates recent updates to the FD&C
Act. Section 3630 of the Consolidated Appropriations Act, 2023,
``Facilitating Exchange of Product Information Prior To Approval,''
amended section 502(a) of the FD&C Act to make the provisions regarding
communication of HCEI to payors under section 502(a) applicable to
devices. In addition, a new subsection (gg) was added to section 502 of
the FD&C Act that addresses firms' provision of information to payors
regarding investigational medical products and investigational uses of
approved/cleared medical products. This revised draft guidance includes
updates to reflect the revised statutory text, including updates to
align the guidance recommendations with the new section 502(gg) of the
FD&C Act, which provides ``no drug or device shall be deemed to be
misbranded'' under section 502(f)(1) (21 U.S.C. 352(f)(1)) because of
certain truthful and not misleading information provided to payors.
While section 502(gg) of the FD&C Act applies to information about
investigational medical products and investigational uses of medical
products that are approved/cleared, section III.B of the revised draft
guidance applies to information about all unapproved medical products
and unapproved uses of medical products. We request OMB approval of
these changes to our statutory authority for this collection of
information.
Although section 3630 of the Consolidated Appropriations Act, 2023
amended section 502(a) of the FD&C Act to make the provisions regarding
communication of HCEI to payors under section 502(a) applicable to
devices, we previously had included recommendations to communicate HCEI
about devices in the final guidance of the same title issued in June
2018. Thus, in our burden estimate for that guidance, we included
burden hours for both drugs and devices (83 FR 27605). We also included
burden hours for both drugs and devices when we sought reauthorization
of OMB approval in 2021 (86 FR 39035). For efficiency reasons, OMB
control number 0910-0857 was consolidated into 0910-0686. As a result,
the information collection
[[Page 33184]]
burden estimates currently approved under 0910-0686 incorporate the
burden of communicating HCEI about both drugs and devices.
As stated above, the analysis of the collection of information and
its related burden on respondents for this guidance included the burden
related to HCEI about both drugs and devices; thus, for this revised
guidance there is no additional estimated burden beyond the burden
hours that were included in the PRA analysis of the final guidance
issued in June 2018, as reauthorized in 2021. We are, however, revising
the information collection currently approved under OMB control number
0910-0686 to reflect the changes to our statutory authority for this
collection of 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
Information collection activity Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures
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Recommended information to be included when 600 13 7,800 20........................................ 156,000
firms choose to disseminate HCEI materials to
payors about approved prescription drugs.
Recommended information to be included when 260 10 2,600 20........................................ 52,000
firms choose to disseminate HCEI materials to
payors about approved or cleared devices.
Recommended information to be included when 853 2 1,706 0.5 (30 minutes).......................... 853
firms choose to disseminate information about
unapproved medical products or unapproved uses
of approved or cleared medical products.
Follow-up information to payors regarding 427 2 854 2......................................... 1,708
previously communicated information about
unapproved medical products or unapproved uses
of approved or cleared medical products.
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Total....................................... ............ ................ 12,960 .......................................... 210,561
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the postmarketing submissions of promotional materials
using Form FDA 2253 (<a href="https://www.fda.gov/media/73013/download">https://www.fda.gov/media/73013/download</a>) received
in calendar year (CY) 2023 for approved human prescription drugs
(including prescription biological products) and approved or cleared
medical devices, FDA estimates that approximately 600 manufacturers
will disseminate 7,800 distinct HCEI materials for approved human
prescription drugs annually. FDA estimates that approximately 260
manufacturers will disseminate 2,600 distinct HCEI materials for
approved or cleared devices annually. FDA further estimates that firms
will expend approximately 20 hours to compile and draft the information
that the guidance recommends should be included when disseminating HCEI
materials for approved human prescription drugs and approved or cleared
devices.
Based on the number of human prescription medical products approved
or cleared and number of efficacy supplements approved or cleared in a
CY (i.e., approving or clearing a new use for an approved medical
product), FDA estimates that approximately 853 manufacturers will
prepare 11,706 distinct communications of information to payors about
their unapproved medical products or unapproved uses of approved or
cleared medical products annually. FDA estimates firms will expend
approximately 0.5 hours to compile and draft the information that the
guidance recommends should be provided with communications to payors
about unapproved medical products or unapproved uses of approved or
cleared medical products. Additionally, FDA estimates that 50 percent
of the firms will expend approximately 2 hours annually to compile and
provide 854 distinct communications of follow-up information regarding
previously communicated information to payors about their unapproved
medical products or unapproved uses of approved or cleared medical
products.
Our estimated burden for the information collection reflects an
overall increase of 7,883 hours and a corresponding increase of 472
disclosures. We attribute this adjustment to an increase in the number
of HCEI materials disseminated over the last few years.
This revised draft guidance also refers to previously approved FDA
collections of information. The collections of information in 21 CFR
part 314 relating to submission of investigational new drug
applications and Form FDA 2253 (Transmittal of Advertisements and
Promotional Labeling for Drugs and Biologics for Human Use) have been
approved under OMB control number 0910-0001. The collections of
information in 21 CFR part 601 relating to submission of labeling in a
biologics license application have been approved under OMB control
number 0910-0338. The collections of information in 21 CFR parts 801
and 809 relating to Medical Device Labeling have been approved under
OMB control number 0910-0485.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-11060 Filed 6-2-26; 8:45 am]
BILLING CODE 4164-01-P
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