Document ID: FDA-2021-N-0387-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of 
Management and Budget Review; Comment Request; Recommended 
Content of Medical Product Communications That Are Consistent 
With the Food and Drug Administration-Required Labeling and 
Recommendations for Drug and Device Manufacturer Communications 
With Payors, Formulary Committees, and Similar Entities
Posted Date: 2021-07-23T04:00Z

[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39035-39038]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15653]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0387]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Recommended Content 
of Medical Product Communications That Are Consistent With the Food and 
Drug Administration-Required Labeling and Recommendations for Drug and 
Device Manufacturer Communications With Payors, Formulary Committees, 
and Similar Entities

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is 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: Submit written comments (including recommendations) on the 
collection of information by August 23, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control numbers for 
the collections of information are 0910-0856 and 0910-0857. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St. North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

I. Medical Product Communications That Are Consistent With the FDA-
Required Labeling--Questions and Answers

OMB Control Number 0910-0856--Extension

    This information collection supports the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) and FDA's implementing regulations that govern 
drug and device labeling and prescription drug and restricted device 
advertising. Section 502(a) of the FD&C Act (21 U.S.C. 352(a)) 
specifies that a drug or device shall be deemed to be misbranded if its 
labeling is false or

[[Page 39036]]

misleading in any particular, and that labeling may be considered 
misleading if it fails to reveal material facts about the product being 
promoted, including facts that are material in light of the 
representations made in a promotional piece (section 201(n) of the FD&C 
Act (21 U.S.C. 321(n))). Similarly, under sections 201(n) and 502(n) of 
the FD&C Act and FDA's implementing regulations (21 CFR 202.1(e)(5)(i) 
and (iii)), an advertisement for a prescription drug must not be false 
or misleading with respect to side effects, contraindications, or 
effectiveness, or fail to reveal material facts about the product being 
advertised, including facts that are material in light of the 
representations made in a promotional piece. The FD&C Act also 
specifies that restricted device advertisements must not be false or 
misleading (section 502(q)(1)) and must reveal facts that are material 
about the product being advertised (section 201(n)).
    To assist respondents with drug and device labeling requirements 
and prescription drug and restricted device advertising, we developed 
the guidance for industry entitled ``Medical Product Communications 
That Are Consistent With the FDA-Required Labeling--Questions and 
Answers'' (June 2018) (medical product communications guidance), 
available at https://www.fda.gov/media/133619/download. This medical 
product communications guidance includes recommendations that firms 
consider when developing ``consistent with the FDA-required labeling 
(CFL)'' presentations in their labeling and advertising materials to 
help ensure the presentations are not false or misleading in violation 
of the FD&C Act and FDA's implementing regulations. The guidance also 
describes FDA's thinking when examining the consistency of a firm's 
product communications with that product's own FDA-required labeling.
    As explained in the guidance, if a firm communicates information 
that is not contained in its product's FDA-required labeling but that 
is determined to be consistent with the FDA-required labeling, FDA does 
not intend to rely on that communication to establish a new intended 
use that is different from the use or uses for which the product is 
legally marketed. Establishing a product's intended uses is an element 
in establishing certain violations under the FD&C Act and Public Health 
Service Act. Firms' communications about their products that are 
consistent with the products' FDA-required labeling but that are false 
or misleading may subject a firm to enforcement action under the FD&C 
Act. Thus, the guidance not only describes FDA's thinking on 
communications that are consistent with the FDA-required labeling, but 
also provides general recommendations intended to help firms comply 
with requirements in the FD&C Act and FDA's implementing regulations 
for conveying information that is consistent with the FDA-required 
labeling in a truthful and non-misleading way. The medical product 
communications guidance recommends that firms accurately represent in 
the communications any study results or other data and information that 
are relied upon to support a firm's CFL promotional communication. 
Other recommendations include the clear and prominent disclosure of 
aspects of study design and methodology that are material for audiences 
to accurately interpret the information being presented (e.g., type of 
study, study objectives, product dosage and use regimens, control or 
controls used, patient population studied), as well as material 
limitations related to the study design, methodology, and results. 
Also, the guidance recommends that firms accurately characterize and 
contextualize the relevant information about the product, including by 
disclosing unfavorable or inconsistent findings. In addition, the 
guidance recommends that firms disclose material contextual information 
from the FDA-required labeling in these communications, such as data 
and information from studies in the FDA-required labeling that are 
relevant to the data or information presented in the CFL promotional 
communication.
    The recommendations will help ensure that health care professional 
and consumer audiences receive truthful information about the benefits 
and risks of drugs and devices in firms' CFL promotional communications 
and that material contextual information is included in these 
communications so that audiences are not misled. Accurate information 
helps these audiences know whether drugs or devices may be appropriate 
for them or their patients and know what they can expect to experience 
when prescribing or using these products.
    In the Federal Register of May 10, 2021 (86 FR 24868), we published 
a 60-day notice requesting public comment on the proposed collection of 
information. Two comments were received; one appearing to question the 
effectiveness of the information collection and the other offering its 
support. Neither comment suggested FDA revise its estimate of the 
attendant information collection.
    We estimate the burden of this collection of information as 
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                  Information collection activity                       Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommended information to be included when firms choose to                     324               30            9,720                4           38,880
 disseminate communications that are consistent with the FDA-
 required labeling.................................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Since our last request for OMB approval, we have made no 
adjustments to the currently approved burden estimate.

II. Recommendations for Drug and Device Manufacturer Communications 
With Payors, Formulary Committees, and Similar Entities

OMB Control Number 0910-0857--Extension

    This information collection also supports implementation of section 
502(a) of the FD&C Act and applicable Agency regulations. Section 
502(a)(1) of the FD&C Act provides that a drug or device is deemed to 
be misbranded ``[i]f its labeling is false or misleading in any 
particular.'' Under longstanding FDA practice and FDA's statute and 
regulations, and under case law,

[[Page 39037]]

labeling encompasses more than merely the label of the drug, but 
extends to other written, printed, or graphic matter ``accompanying 
such article'' (section 201(m) of the FD&C Act; see also 21 CFR 
1.3(a)). Section 502(a) of the FD&C Act also includes a provision about 
communication of health care economic information (HCEI) to payors 
through labeling or advertising. To assist respondents in this regard, 
we developed the guidance for industry and review staff entitled ``Drug 
and Device Manufacturer Communications With Payors, Formulary 
Committees, and Similar Entities--Questions and Answers'' (June 2018) 
(drug and device communications guidance), available at https://www.fda.gov/media/133620/download.
    This drug and device communications guidance includes 
recommendations regarding information 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, if a manufacturer communicates HCEI for approved 
prescription drugs (including biological products that also meet the 
definition of drug under the FD&C Act and approved or cleared medical 
devices (collectively referred to as medical products)) to payors, FDA 
recommends that firms include in HCEI materials disseminated to payors 
information about: (1) Various aspects of study design and methodology 
of an economic analysis (i.e., type of analysis, modeling technique, 
patient population, perspective or viewpoint, treatment comparator, 
time horizon, outcome measures, cost estimates, and assumptions); (2) 
factors that limit generalizability of an economic analysis; 
limitations to an economic analysis; and (3) sensitivity analyses, if 
applicable, to allow for informed decision making by payors.
    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, HCEI materials 
must disclose any additional risk information related to assumptions 
that vary from the approved labeling. In addition, HCEI materials 
should disclose potential financial or affiliation biases to the extent 
reasonably known by firms at the time of dissemination.
    The drug and device communications 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 or cleared products, FDA 
recommends that firms include a clear statement with their 
communications that the product or use is not approved or cleared and 
that the safety or effectiveness of the product or use has not been 
established.
    In the Federal Register of May 10, 2021, we published a 60-day 
notice requesting public comment on the proposed collection of 
information. Two comments were received; one appearing to question the 
effectiveness of the information collection and the other offering its 
support. Neither comment suggested FDA revise its estimate of the 
attendant information collection.
    We estimate the burden of this collection of information as 
follows:

                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
       Information collection activity            Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommended information to be included when               430          10.465           4,500  20.......................................          90,000
 firms choose to disseminate HCEI materials
 to payors about approved prescription drugs.
Recommended information to be included when               236              10           2,360  20.......................................          47,200
 firms choose to disseminate HCEI materials
 to payors about approved or cleared devices.
Recommended information to be included when               717               2           1,434  0.5 (30 minutes).........................             717
 firms choose to disseminate information
 about unapproved products or unapproved uses
 of approved or cleared products.
Followup information to payors regarding                  359               2             718  2........................................           1,436
 previously communicated information about
 unapproved products or unapproved uses of
 approved or cleared products.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............           9,012  .........................................         139,353
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 39038]]

    We have adjusted the estimate of burden we associate with the 
information collection recommendations in the guidance to reflect an 
increase of 2,000 hours and 100 responses annually.

    Dated: July 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-15653 Filed 7-22-21; 8:45 am]
BILLING CODE 4161-01-P