Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Guidance for Industry; Availability, 27605-27609 [2018-12632]
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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
Type of information
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total
hours
Recommended information to be included when firms
choose to disseminate communications that are consistent 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
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. Electronic Access
AGENCY:
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/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.
ACTION:
[FR Doc. 2018–12631 Filed 6–12–18; 8:45 am]
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[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
Food and Drug Administration,
HHS.
Dated: June 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
VerDate Sep<11>2014
Food and Drug Administration
Jkt 244001
Notice of availability.
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
SUMMARY:
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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
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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
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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/201523389.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,
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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.
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
1 The term ‘‘medical product’’ refers to both drugs
and devices.
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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
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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
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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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.
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 ThirdParty 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
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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 FDAapproved 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:
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Type of information
Recommended information to be included when firms
choose to disseminate HCEI materials to payors about
approved prescription drugs.
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Number of
responses per
respondent
440
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Total annual
responses
10
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4,400
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Average
burden per
response
(hours)
20 ...................
Total hours
88,000
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27609
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Type of information
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(hours)
Total hours
Recommended information to be included when firms
choose to disseminate HCEI materials to payors about
approved or cleared medical devices.
Recommended information to be included when firms
choose to disseminate information about unapproved
products or unapproved uses of approved or cleared
products.
Followup information to payors regarding previously communicated about unapproved products or unapproved
uses of approved or cleared products.
236
10
2,360
20 ...................
47,200
717
2
1,434
.5 (30 minutes)
717
359
2
718
2 .....................
1,436
Total ..............................................................................
........................
........................
........................
........................
137,353
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/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/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]
amozie on DSK3GDR082PROD with NOTICES1
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:01 Jun 12, 2018
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
service acceptance receipt is on or
before that date.
Food and Drug Administration
Electronic Submissions
[Docket No. FDA–2018–N–2065]
Alternative or Streamlined
Mechanisms for Complying With the
Current Good Manufacturing Practice
Requirements for Combination
Products; Proposed List Under the
21st Century Cures Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
As required by the 21st
Century Cures Act (Cures Act), the Food
and Drug Administration (FDA or
Agency) is proposing a list of alternative
or streamlined mechanisms for
complying with the current good
manufacturing practice (CGMP)
requirements for combination products.
Combination products are products
composed of two or more different types
of medical products (drug, device, and/
or biological product).
DATES: Submit either electronic or
written comments on this notice by
September 11, 2018 to ensure that the
Agency considers your comment on this
proposed list before it begins work on
the final list.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before September 11,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of September 11, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
SUMMARY:
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
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
E:\FR\FM\13JNN1.SGM
13JNN1
]]>Agencies
[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Pages 27605-27609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12632]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 [email protected]. 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.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; 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,
[email protected].
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.
---------------------------------------------------------------------------
\1\ The term ``medical product'' refers to both drugs and
devices.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
-----------------------------------------------------------------------------------
Total................... .............. .............. .............. .................. 137,353
----------------------------------------------------------------------------------------------------------------
\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
