[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Notices]
[Pages 6568-6571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01011]


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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; 
Draft Guidance for Industry and Review Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry and review staff 
entitled ``Drug and Device Manufacturer Communications With Payors, 
Formulary Committees, and Similar Entities--Questions and Answers.'' 
This draft guidance provides answers to common questions regarding the 
communication of health care economic information (HCEI) about approved 
prescription drugs 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 This draft guidance also provides answers to common questions 
about firms' communications regarding investigational drugs and devices 
(investigational products) to payors before FDA approval or clearance 
of such products. The Agency is issuing this draft guidance to explain 
FDA's current thinking on frequently asked questions regarding such 
communications in order to provide clarity for firms and payors.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 19, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-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 https://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this 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; the 
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; the 
Office of the Center Director, Guidance and Policy Development, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg.66, Rm. 5431, 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 this draft guidance document.

FOR FURTHER INFORMATION CONTACT: Elaine Hu Cunningham, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3203, Silver Spring, MD 20993-0002, 301-

[[Page 6569]]

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; Paul Gadiock, Center 
for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5448, Silver Spring, MD 20993-0002, 301-796-5736; or Kristin 
Davis, Office of the Commissioner, 10903 New Hampshire Ave., Bldg. 32, 
Rm. 4252, Silver Spring, MD 20993-0002, 301-796-0418.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and review staff entitled ``Drug and Device Manufacturer Communications 
With Payors, Formulary Committees, and Similar Entities--Questions and 
Answers.'' This draft guidance provides answers to common questions 
regarding firms' communications of HCEI about their approved 
prescription drugs to payors. This draft guidance also addresses common 
questions relating to firms' dissemination of information about 
investigational products to payors before FDA approval or clearance of 
such products. For purposes of this draft 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 drug selection, 
formulary management, and/or coverage and reimbursement decisions on a 
population basis regarding drugs and/or devices for 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 drugs, 
including information from firms, to help support their drug 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 drug approval 
decisions. Because coverage and reimbursement decisions by payors 
impact a large number of patients, FDA believes it is essential that 
HCEI provided by firms to payors about their approved drugs be truthful 
and non-misleading.
    With respect to HCEI regarding approved drugs, section 502(a) of 
the Federal Food, Drug, and Cosmetic 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) 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 draft guidance provides FDA's current thinking on key concepts 
in section 502(a) 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 draft guidance, when finalized, 
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 draft guidance, when finalized, as 
providing 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 (referred to in this draft guidance as investigational products). 
Section III.B discusses FDA's thinking with respect to communication by 
firms to payors of information about investigational products. As with 
HCEI about approved prescription drugs, it is essential that 
information provided by firms about their investigational products be 
truthful and non-misleading. Therefore, section III.B also lays out a 
series of recommendations to help achieve these goals.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the availability of a draft guidance for industry entitled ``Medical 
Product Communications That Are Consistent With the Food and Drug 
Administration-Required Labeling--Questions and Answers.'' The guidance 
provides information for medical product firms about how FDA evaluates 
their medical product communications, including their promotional 
materials, that present information that is not contained in the FDA-
required labeling for the product but that may be consistent with the 
FDA-required labeling for the product.
    In addition, FDA is announcing in this issue of the Federal 
Register that it is reopening the comment period for the notice of 
public hearing that appeared in the Federal Register of September 1, 
2016, concerning manufacturer communications regarding unapproved uses 
of approved or cleared medical products. The comment period will be 
reopened for 90 days, until January 19, 2017. As announced in the 
notice of public hearing, FDA is engaged in a comprehensive review of 
its regulations and policies governing communications by firms about 
unapproved uses of approved or cleared medical products, and the 
comments it receives will inform FDA's policy development in this area.
    FDA will consider the feedback it receives in all three of these 
dockets as the Agency continues to review its policies on firm 
communications about medical products, and interested persons may wish 
to review the documents FDA has issued in all three dockets before 
submitting comments to any of the relevant dockets.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This draft guidance, 
when finalized, will represent the current thinking of FDA on certain 
commonly asked questions regarding firms' communications with payors. 
It does not establish any rights for any person and is not binding on 
FDA or the public. You can use an alternative approach if it satisfies 
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests

[[Page 6570]]

or requirements that members of the public submit reports, keep 
records, or provide information to a third party. Section 3506(c)(2)(A) 
of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to 
provide a 60-day notice in the Federal Register concerning each 
proposed collection of information before submitting the collection to 
OMB for approval. To comply with this requirement, FDA is publishing 
notice of the proposed collection of information set forth in this 
document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Drug Manufacturer Communications of Health Care Economic 
Information to Payors Under FD&C Act Section 502(a); Drug and Device 
Manufacturer Communications With Payors Regarding Investigational 
Products.
    Description of Respondents: For information that should be included 
when HCEI is disseminated to payors, respondents to this collection of 
information are firms that manufacture prescription human drug 
products, including biological products; for information that should be 
included with communications with payors about investigational 
products, respondents to this collection of information are firms that 
manufacture prescription human drug products, including biological 
products, and medical devices.
    Burden Estimate: This draft guidance includes 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). 
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 
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 and to help ensure that 
the HCEI is not false or misleading.
    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), 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 such selective inclusion 
of 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), 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.
    If firms choose to make communications to payors about 
investigational products, FDA recommends that firms include a clear 
statement with their communications that the product is under 
investigation and that the safety or effectiveness of the product has 
not been established. In addition, FDA recommends providing information 
related to the stage of product development (e.g., the phase of 
clinical trial in which a product is being studied and how it relates 
to the overall product development plan). Moreover, FDA recommends that 
firms provide followup information to payors if previously communicated 
information becomes outdated as a result of significant changes or as a 
result of new information regarding the product or its review status.
    Based on the post-marketing submissions of promotional materials 
using Form FDA 2253 received in calendar year (CY) 2015 for 
prescription drugs, FDA estimates that approximately 400 firms will 
disseminate 4,000 distinct HCEI materials annually. FDA estimates that 
it will take firms approximately 20 hours to compile and draft the 
information that this draft guidance recommends should be included if 
they choose to disseminate HCEI materials to payors.
    Based on the number of prescription drugs and devices approved/
cleared in CY 2015, FDA estimates that approximately 520 firms will 
prepare 1,040 distinct communications of information to payors about 
their investigational products annually. FDA estimates that it will 
take firms approximately 0.5 hours to compile and draft the information 
that this draft guidance recommends should be provided with 
communications to payors about investigational products. In addition, 
FDA estimates that approximately half of the firms will spend 
approximately 2 hours to compile and provide 520 distinct 
communications of followup information regarding previously 
communicated information to payors about their investigational products 
annually.
    FDA estimates the burden of this collection of information as 
follows:

                                                      Table 1--Estimated Annual Reporting Burden 1
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                                                                    Number of
               Type of information                  Number of     responses per   Total annual          Average burden per response          Total hours
                                                   respondents     respondent       responses
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Recommended information to be included when                400                10         4,000  20........................................        80,000
 firms choose to disseminate HCEI materials to
 payors about prescription drugs under section
 502(a).
Recommended information to be included when                520                 2         1,040  0.5 (30 minutes)..........................           520
 firms choose to disseminate pre-approval
 communications about investigational drugs or
 devices to payors.

[[Page 6571]]

 
Follow up information to payors regarding                  260                 2           520  2.........................................         1,040
 previously communicated information about
 investigational drugs and devices.
                                                 -------------------------------------------------------------------------------------------------------
    Total.......................................  ............  ................  ............  ..........................................        81,560
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    This draft 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.

III. Other Issues for Consideration

    Although section 502(a) is specific to approved drugs and section 
III.A of this draft guidance addresses firms' communications of HCEI to 
payors only about approved drugs, FDA is interested in whether similar 
principles to those outlined in that section should apply to firms' 
communications of HCEI to payors about approved/cleared devices or 
whether different principles should be considered. FDA is specifically 
interested in identifying principles that, if applied to communications 
of HCEI about approved/cleared devices, could help ensure that such 
information is truthful and non-misleading and aids payors in making 
informed selection and/or coverage and reimbursement decisions about 
these products. FDA is interested in comments from interested parties 
on any of the topics addressed in this draft guidance and specifically 
requests comments from interested parties on the extent to which the 
principles provided in section III.A could be applicable to 
communications of HCEI about approved/cleared devices. 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.
    FDA is also seeking comments from interested parties regarding 
communications of HCEI about animal drugs. Although FDA recognizes that 
the audience for HCEI about animal drugs may be different from that 
identified in section III.A as a result of differences in how payment 
decisions are made for animal drugs, FDA is interested in learning the 
extent to which the principles provided in section III.A could be 
applicable to communications of HCEI about animal drugs with 
appropriate audiences for such information. To the extent that 
commenters believe that different considerations should apply to animal 
drugs or that guidance is needed on additional issues with respect to 
animal drug firms' communications of HCEI about approved new animal 
drugs to appropriate audiences, FDA is interested in input on those 
topics as well.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or https://www.regulations.gov.

    Dated: January 6, 2017.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-01011 Filed 1-18-17; 8:45 am]
 BILLING CODE 4164-01-P