[House Report 116-573]
[From the U.S. Government Publishing Office]


116th Congress }                                          { Report
                        HOUSE OF REPRESENTATIVES
  2d Session   }                                          { 116-573

======================================================================
 
 MAKING OBJECTIVE DRUG EVIDENCE REVISIONS FOR NEW LABELING ACT OF 2020

                                _______
                                

 November 16, 2020.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

 Mr. Pallone, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 5668]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 5668) to amend the Federal Food, Drug, and 
Cosmetic Act to modernize the labeling of certain generic 
drugs, and for other purposes, having considered the same, 
reports favorably thereon with an amendment and recommends that 
the bill as amended do pass.

                                CONTENTS

                                                                   Page
   I. Purpose and Summary.............................................4
  II. Background and Need for the Legislation.........................4
 III. Committee Hearings..............................................5
  IV. Committee Consideration.........................................6
   V. Committee Votes.................................................6
  VI. Oversight Findings..............................................6
 VII. New Budget Authority, Entitlement Authority, and Tax Expenditure6
VIII. Congressional Budget Office Estimate............................7
  IX. Federal Mandates Statement......................................8
   X. Statement of General Performance Goals and Objectives...........8
  XI. Duplication of Federal Programs.................................8
 XII. Committee Cost Estimate.........................................8
XIII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits.....8
 XIV. Advisory Committee Statement....................................8
  XV. Applicability to Legislative Branch.............................9
 XVI. Section-by-Section Analysis of the Legislation..................9
XVII. Changes in Existing Law Made by the Bill, as Reported..........11

    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Making Objective Drug Evidence 
Revisions for New Labeling Act of 2020'' or the ``MODERN Labeling Act 
of 2020''.

SEC. 2. MODERNIZING THE LABELING OF CERTAIN GENERIC DRUGS.

  Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 
et seq.) is amended by inserting after section 503C the following:

``SEC. 503D. PROCESS TO UPDATE LABELING FOR CERTAIN DRUGS.

  ``(a) Definitions.--For purposes of this section:
          ``(1) The term `covered drug' means a drug approved under 
        section 505(c)--
                  ``(A) for which there are no unexpired patents 
                included in the list under section 505(j)(7) and no 
                unexpired period of exclusivity;
                  ``(B) for which the approval of the application has 
                been withdrawn for reasons other than safety or 
                effectiveness; and
                  ``(C) for which--
                          ``(i)(I) there is new scientific evidence 
                        available pertaining to the existing conditions 
                        of use that is not reflected in the labeling;
                          ``(II) the approved labeling does not reflect 
                        current legal and regulatory requirements for 
                        content or format; or
                          ``(III) there is a relevant accepted use in 
                        clinical practice that is not reflected in the 
                        approved labeling; and
                          ``(ii) updating the labeling would benefit 
                        the public health.
          ``(2) The term `period of exclusivity', with respect to a 
        drug approved under section 505(c), means any period of 
        exclusivity under clause (ii), (iii), or (iv) of section 
        505(c)(3)(E), clause (ii), (iii), or (iv) of section 
        505(j)(5)(F), or section 505A, 505E, or 527.
          ``(3) The term `generic version' means a drug approved under 
        section 505(j) whose reference listed drug is a covered drug.
          ``(4) The term `relevant accepted use' means a use for a drug 
        in clinical practice that is supported by scientific evidence 
        that appears to the Secretary to meet the standards for 
        approval under section 505.
          ``(5) The term `selected drug' means a covered drug for which 
        the Secretary has determined through the process under 
        subsection (c) that the labeling should be changed.
  ``(b) Identification of Covered Drugs.--The Secretary may identify 
covered drugs for which labeling updates would provide a public health 
benefit. To assist in identifying covered drugs, the Secretary may do 
one or both of the following:
          ``(1) Enter into cooperative agreements or contracts with 
        public or private entities to review the available scientific 
        evidence concerning such drugs.
          ``(2) Seek public input concerning such drugs, including 
        input on whether there is a relevant accepted use in clinical 
        practice that is not reflected in the approved labeling of such 
        drugs or whether new scientific evidence is available regarding 
        the conditions of use for such drug, by--
                  ``(A) holding one or more public meetings;
                  ``(B) opening a public docket for the submission of 
                public comments; or
                  ``(C) other means, as the Secretary determines 
                appropriate.
  ``(c) Selection of Drugs for Updating.--If the Secretary determines, 
with respect to a covered drug, that the available scientific evidence 
meets the standards under section 505 for adding or modifying 
information to the labeling or providing supplemental information to 
the labeling regarding the use of the covered drug, the Secretary may 
initiate the process under subsection (d).
  ``(d) Initiation of the Process of Updating.--If the Secretary 
determines that labeling changes are appropriate for a selected drug 
pursuant to subsection (c), the Secretary shall provide notice to the 
holders of approved applications for a generic version of such drug 
that--
          ``(1) summarizes the findings supporting the determination of 
        the Secretary that the available scientific evidence meets the 
        standards under section 505 for adding or modifying information 
        or providing supplemental information to the labeling of the 
        covered drug pursuant to subsection (c);
          ``(2) provides a clear statement regarding the additional, 
        modified, or supplemental information for such labeling, 
        according to the determination by the Secretary (including, as 
        applicable, modifications to add the relevant accepted use to 
        the labeling of the drug as an additional indication for the 
        drug); and
          ``(3) states whether the statement under paragraph (2) 
        applies to the selected drug as a class of covered drugs or 
        only to a specific drug product.
  ``(e) Response to Notification.--Within 30 days of receipt of 
notification provided by the Secretary pursuant to subsection (d), the 
holder of an approved application for a generic version of the selected 
drug shall--
          ``(1) agree to change the approved labeling to reflect the 
        additional, modified, or supplemental information the Secretary 
        has determined to be appropriate; or
          ``(2) notify the Secretary that the holder of the approved 
        application does not believe that the requested labeling 
        changes are warranted and submit a statement detailing the 
        reasons why such changes are not warranted.
  ``(f) Review of Application Holder's Response.--
          ``(1) In general.--Upon receipt of the application holder's 
        response, the Secretary shall promptly review each statement 
        received under subsection (e)(2) and determine which labeling 
        changes pursuant to the Secretary's notice under subsection (d) 
        are appropriate, if any. If the Secretary disagrees with the 
        reasons why such labeling changes are not warranted, the 
        Secretary shall provide opportunity for discussions with the 
        application holders to reach agreement on whether the labeling 
        for the covered drug should be updated to reflect available 
        scientific evidence, and if so, the content of such labeling 
        changes.
          ``(2) Changes to labeling.--After considering all responses 
        from the holder of an approved application under paragraph (1) 
        or (2) of subsection (e), and any discussion under paragraph 
        (1), the Secretary may order such holder to make the labeling 
        changes the Secretary determines are appropriate. Such holder 
        of an approved application shall--
                  ``(A) update its paper labeling for the drug at the 
                next printing of that labeling;
                  ``(B) update any electronic labeling for the drug 
                within 30 days of such order; and
                  ``(C) submit the revised labeling through the form, 
                `Supplement--Changes Being Effected'.
  ``(g) Violation.--If the holder of an approved application for the 
generic version of the selected drug does not comply with the 
requirements of subsection (f)(2), such generic version of the selected 
drug shall be deemed to be misbranded under section 502.
  ``(h) Limitations; Generic Drugs.--
          ``(1) In general.--With respect to any labeling change 
        required under this section, the generic version shall be 
        deemed to have the same conditions of use and the same labeling 
        as its reference listed drug for purposes of clauses (i) and 
        (v) of section 505(j)(2)(A). Any labeling change so required 
        shall not have any legal effect for the applicant that is 
        different than the legal effect that would have resulted if a 
        supplemental application had been submitted and approved to 
        conform the labeling of the generic version to a change in the 
        labeling of the reference drug.
          ``(2) Supplemental applications.--Changes to labeling made in 
        accordance with this section shall not be eligible for an 
        exclusivity period under this Act.
          ``(3) Selection of drugs.--Nothing in this section shall be 
        construed to give the Secretary the authority to identify a 
        drug as a covered drug or select a drug label for updating 
        solely based on the availability of new safety information. 
        Upon identification of a drug as a covered drug, the Secretary 
        may then consider the availability of new, additional, or 
        different safety information in determining whether the drug is 
        a selected drug and in determining what labeling changes are 
        appropriate.
          ``(4) Maintenance of labeling.--Nothing in this section shall 
        be construed to affect the responsibility of the holder of an 
        approved application under section 505(j) to maintain its 
        labeling in accordance with existing requirements, including 
        subpart B of part 201 and sections 314.70 and 314.97 of title 
        21, Code of Federal Regulations (or any successor regulations).
  ``(i) Rules of Construction.--
          ``(1) Approval standards.--This section shall not be 
        construed as altering the applicability of the standards for 
        approval of an application under section 505. No order shall be 
        issued under this subsection unless the scientific evidence 
        supporting the changed labeling meets the standards for 
        approval applicable to any change to labeling under section 
        505.
          ``(2) Secretary authority.--Nothing in this section shall be 
        construed to limit the authority of the Secretary to require 
        labeling changes under section 505(o).
  ``(j) Reports.--Not later than 4 years after the date of the 
enactment of the Making Objective Drug Evidence Revisions for New 
Labeling Act of 2020, and every 4 years thereafter, the Secretary shall 
prepare and submit to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate, a report that--
          ``(1) describes the actions of the Secretary under this 
        section, including--
                  ``(A) the number of covered drugs and description of 
                the types of drugs the Secretary has selected for 
                labeling changes and the rationale for such recommended 
                changes; and
                  ``(B) the number of times the Secretary entered into 
                discussions concerning a disagreement with an 
                application holder or holders and a summary of the 
                decision regarding a labeling change, if any; and
          ``(2) includes any recommendations of the Secretary for 
        modifying the program under this section.''.

                         I. Purpose and Summary

    H.R. 5668, the ``Making Objective Drug Evidence Revisions 
for New Labeling Act of 2020'', or the ``MODERN Labeling Act of 
2020'', introduced by Reps. Doris O. Matsui (D-CA) and Brent 
Guthrie (R-KY), provides additional authority to the Food and 
Drug Administration (FDA) to require modifications of outdated 
labeling for certain generic drugs to ensure such labeling 
includes complete and accurate information. The bill would also 
require FDA to report to Congress any actions taken under this 
new authority to update labeling for such generic drugs, 
including the number of drugs, description of the changes and 
the rationale, as well as any FDA recommendation(s) to modify 
the program, among other things.

                II. Background and Need for Legislation

    Prescription drug product labeling contains information 
regarding the product based on an FDA analysis of the sponsor's 
new drug application or biologics license application. Labeling 
approved by FDA must contain all relevant information needed to 
support the safe and effective use of that drug product, such 
as conditions of use (including dosage and administration), 
warnings, contraindications, and any adverse reactions. Drug 
sponsors are required to update a marketed product's label as 
new information about the drug, such as new indications or 
safety-related information, becomes available. Generic drugs 
are generally required to have the same labeling as the brand 
drug they reference and generic drug manufacturers are not 
permitted to independently update labeling of their product to 
include new safety-related information if that information does 
not follow the approved labeling of the brand drug product.
    Labeling for brand drug products, however, does not always 
reflect new information about those products, such as new uses 
or safety information discovered after post-market use.\1\ This 
may be due to the lack of sufficient incentives for 
manufacturers to submit supplements to continually update their 
product labeling to include new scientific information, such as 
new uses, or because a brand drug has left the market and the 
brand drug manufacturer can no longer update the labeling when 
necessary.\2\ A recent study found that most oncology drug 
labels do not contain all appropriate uses, leaving providers 
and patients without labeling information reflecting all 
relevant efficacy information.\3\
---------------------------------------------------------------------------
    \1\Shea, M; Stewart, M; Van Dyke, H; Ostermann, L; Allen, J; Sigal, 
E. 2018. Outdated Prescription Drug Labeling: How FDA-Approved 
Prescribing Information Lags Behind Real-World Clinical Practice. 
Therapeutic Innovation and Regulatory Science. DIA. (doi.org/10.1177/
21684 79018759662).
    \2\Id.
    \3\Id.
---------------------------------------------------------------------------
    H.R. 5668 would help ensure that generic drug labels 
provide health care providers and patients with accurate and 
complete information about the use of the drug when the brand 
drug is no longer marketed. Specifically, this legislation 
would create a pathway to update labels in these circumstances 
and would provide FDA with the authority to require updated 
labeling to reflect current legal and regulatory requirements, 
such as the content and format requirements outlined in the 
2006 Physician Labeling Rule. According to the FDA, 
``Modernizing labeling to reflect the content and format 
requirements outlined in that rule could substantially increase 
the usefulness of the labeling as a communication tool to 
healthcare providers and other stakeholders.''\4\ Further, the 
agency has noted that the legislation would enable FDA to 
ensure generic labeling provides current information about 
existing and new conditions of use, in a modern format, ``all 
of which could help facilitate broader use of lower cost 
generic medicines.''\5\
---------------------------------------------------------------------------
    \4\FDA Technical Assistance on the ``Making Objective Drug Evidence 
Revisions for New Labeling Act of 2020,'' or the MODERN Labeling Act, 
prepared on February 27, 2020.
    \5\Id.
---------------------------------------------------------------------------

                        III. Committee Hearings

    For the purposes of section 103(i) of H. Res. 6 of the 
116th Congress, the following hearing was used to develop or 
consider H.R. 5668:
    The Subcommittee on Health held a legislative hearing on 
January 29, 2020, on H.R. 5668 and nine other bills. The 
hearing was entitled ``Improving Safety and Transparency in 
America's Food and Drugs.'' The Subcommittee received testimony 
from the following witnesses:

Panel I:

           Jeff Allen, Ph.D., President and CEO, 
        Friends of Cancer Research
           Richard Kaeser, Vice President, Global Brand 
        Protection, Johnson & Johnson
           Fernando Muzzio, Ph.D., Distinguished 
        Professor, Chemical and Biochemical Engineering, 
        Rutgers, the State University of New Jersey
           Kao-Ping Chua, M.D., Ph.D., Assistant 
        Professor, Department of Pediatrics, University of 
        Michigan Medical School

Panel II:

           Melanie Benesh, Legislative Attorney, 
        Environmental Working Group
           Tom Balmer, Executive Vice President, 
        National Milk Producers Federation
           J. David Carlin, Senior Vice President of 
        Legislative Affairs and Economic Policy, International 
        Dairy Foods Association
           Douglas Corey, D.V.M., Past President, 
        American Association of Equine Practitioners
           Talia Day, Patient Advocate
           Paul C. DeLeo, Ph.D., Principal, Integral 
        Consulting, Inc.
           Mardi Mountford, President, Infant Nutrition 
        Council of America
           Nancy Perry, Senior Vice President, 
        Government Relations, American Society for the 
        Prevention of Cruelty to Animals
           Sara Sorscher, Deputy Director of Regulatory 
        Affairs, Center for Science in the Public Interest

                      IV. Committee Consideration

    Reps. Matsui and Guthrie introduced H.R. 5668 on January 
24, 2020, and the bill was referred to the Committee on Energy 
and Commerce. H.R. 5668 was then referred to the Subcommittee 
on Health on January 25, 2020. A legislative hearing on the 
bill was held on January 29, 2020.
    The Subcommittee met in open markup session on March 11, 
2020, pursuant to notice, to consider H.R. 5668 and twelve 
other bills. During consideration of the bill, an amendment 
offered by Ms. Matsui was agreed to by a voice vote. Upon 
conclusion of consideration of the bill, the Subcommittee 
agreed to forward H.R. 5668 favorably to the full Committee, 
amended, by a voice vote, a quorum being present.
    On July 15, 2020, the full Committee met in virtual open 
markup session, pursuant to notice, to consider H.R. 5668 and 
twenty-nine other bills. During consideration of the bill, an 
amendment in the nature of a substitute offered by Ms. Matsui, 
on behalf of herself and Mr. Guthrie, was agreed to by a voice 
vote. Upon conclusion of consideration of the bill, the full 
Committee agreed to a motion of final passage offered by Mr. 
Pallone, Chairman of the committee, to order H.R. 5668 reported 
favorably to the House, amended, by a voice vote, a quorum 
being present.

                           V. Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list each record vote 
on the motion to report legislation and amendments thereto. The 
Committee advises that there were no record votes taken on H.R. 
5668, including the motion on final passage of the bill.

                         VI. Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1) 
of rule X of the Rules of the House of Representatives, the 
oversight findings and recommendations of the Committee are 
reflected in the descriptive portion of the report.

           VII. New Budget Authority, Entitlement Authority, 
                          and Tax Expenditures

    Pursuant to 3(c)(2) of rule XIII of the Rules of the House 
of Representatives, the Committee adopts as its own the 
estimate of new budget authority, entitlement authority, or tax 
expenditures or revenues contained in the cost estimate 
prepared by the Director of the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1974.

               VIII. Congressional Budget Office Estimate

                                     U.S. Congress,
                               Congressional Budget Office,
                                  Washington, DC, October 29, 2020.
Hon. Frank Pallone, Jr.,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 5668, the Making 
Objective Drug Evidence Revisions for New Labeling Act of 2020.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Ellen Werble.
            Sincerely,
                                         Phillip L. Swagel,
                                                          Director.
    Enclosure.

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    

    Under current law, labels on generic drugs must match those 
of their corresponding reference brand drug. H.R. 5668 would 
allow the Secretary of Health and Human Services to require 
label updates for certain generic drugs once the reference 
drug's patents and exclusivities expire, new information is 
available, and the Secretary determines that the public health 
would benefit from the updated label. The bill also would 
require the Secretary to report to the Congress every four 
years on the number and types of such determinations made and 
on the number of times manufacturers disagreed with those 
determinations.
    CBO expects that over the 2021-2025 period, implementing 
H.R. 5668 would require the work of less than one full-time 
staff member of the Food and Drug Administration. CBO estimates 
the cost would fall below $500,000 over the 2021-2025 period, 
although the amount could be higher if the Secretary determines 
that a significant number of labels require updates. Any 
spending would be subject to the availability of appropriated 
funds.
    H.R. 5668 would impose a private-sector mandate as defined 
in the Unfunded Mandates Reform Act (UMRA) by requiring 
manufacturers of certain drugs to update product labels. 
Because this requirement is not expected to apply to a large 
number of products in the first few years, CBO estimates that 
the aggregate cost would fall below the private-sector 
threshold established in UMRA ($168 million in 2020, adjusted 
annually for inflation).
    On July 16, 2019, CBO transmitted a cost estimate for S. 
1895, the Lower Health Care Costs Act, as ordered reported by 
the Senate Committee on Health, Education, Labor, and Pensions 
on June 26, 2019. Section 213 of S. 1895 is similar to H.R. 
5668, and CBO's estimates of their costs are the same.
    The CBO staff contacts for this estimate are Ellen Werble 
(for federal costs) and Andrew Laughlin (for mandates). The 
estimate was reviewed by Leo Lex, Deputy Director of Budget 
Analysis.

                     IX. Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

        X. Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to provide 
the FDA with new authorities to modernize labeling requirements 
for certain generic drug products to allow the agency to 
require changes to the labeling to reflect new information or 
scientific evidence about a generic drug when the brand drug 
product is no longer marketed.

                  XI. Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 5668 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111-139 or the 
most recent Catalog of Federal Domestic Assistance.

                      XII. Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, the Committee 
adopts as its own the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974.

           XIII. Earmarks, Limited Tax Benefits, and Limited 
                            Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 5668 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                   XIV. Advisory Committee Statement

    No advisory committee within the meaning of section 5(b) of 
the Federal Advisory Committee Act was created by this 
legislation.

                XV. Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

          XVI. Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 designates that the short title may be cited as 
the ``Making Objective Evidence Revisions for New Labeling Act 
of 2020'' or the ``MODERN Labeling Act of 2020''.

Sec. 2. Modernizing the labeling of certain generic drugs

    Section 2 amends the Federal Food, Drug, and Cosmetic Act 
(FFDCA) by inserting a new section that authorizes a process to 
update labeling for certain generic drugs, known as a ``covered 
drug''. The legislation defines the term ``covered drug'' as a 
drug approved under section 505(c) for which (1) there are no 
unexpired patents included in the list under section 505(j)(7) 
and no unexpired period of exclusivity, (2) the approval of the 
application has been withdrawn for reasons other than safety or 
effectiveness, and (3) there is new scientific evidence 
available pertaining to the existing conditions of use that is 
not reflected in the labeling, the approved labeling does not 
reflect current legal and regulatory requirements for content 
or format, or there is a relevant accepted use in clinical 
practice that is not reflected in the approved labeling, and 
updating the labeling would benefit public health. This section 
also defines ``generic version'' as a drug approved under 
section 505(j) whose reference listed drug is a covered drug; 
``relevant accepted use'' as a use for a drug in clinical 
practice that is supported by scientific evidence that appears 
to the Secretary of Health and Human Services (the Secretary) 
to meet the standards for approval under section 505; and 
``selected drug'' as a covered drug for which the Secretary has 
determined through the process under subsection (c) that the 
labeling should be changed.
    Subsection (b) states that the Secretary may identify 
covered drugs for which labeling updates would provide a public 
health benefit. To assist with this, the Secretary may do one 
or both of the following: enter into cooperative agreements or 
contracts with public or private entities to review available 
scientific evidence concerning such drugs, or seek public input 
on whether there is relevant accepted use in clinical practice 
that is not reflected in the approved labeling of such drugs or 
whether new scientific evidence is available regarding the 
conditions of use for such drug, by (1) holding one or more 
public meetings, (2) opening a public docket for the submission 
of public comments, or (3) other means as the Secretary deems 
appropriate.
    Subsection (c) states that if the Secretary determines, 
with respect to a covered drug, that the available scientific 
evidence meets the standards under section 505 of the FFDCA for 
adding or modifying information to the labeling or providing 
supplemental information to the labeling regarding the use of 
the covered drug, the Secretary may initiate this process under 
subsection (d).
    Subsection (d) states that if the Secretary determines that 
labeling changes are appropriate for a selected drug, the 
Secretary shall provide notice to the holders of the approved 
applications for a generic version of the drug that (1) 
summarizes the findings supporting the determination of the 
Secretary, (2) provides a clear statement regarding the 
additional, modified, or supplemental information for such 
labeling, according to the determination by the Secretary, and 
(3) states whether that statement applies to the selected drug 
as a class of covered drugs or only to a specific drug product.
    Subsection (e) states that within 30 days of receipt of the 
aforementioned notice provided by the Secretary, the holder of 
the approved application for a generic version of the selected 
drug shall (1) agree to change the approved labeling to reflect 
the additional, modified, or supplemental information the 
Secretary has determined to be appropriate, or (2) notify the 
Secretary that the holder of the approved application does not 
believe that the requested label changes are warranted and 
submit a statement detailing the reasons why such changes are 
not warranted.
    Subsection (f), upon receipt of the holder's response, 
requires the Secretary to promptly review each statement and 
determine which labeling changes pursuant to the Secretary's 
notice are appropriate, if any. If the Secretary disagrees with 
the reasons why such labeling changes are not warranted, the 
Secretary shall provide opportunity for discussions with the 
application holders to reach agreement on whether the labeling 
for the covered drug should be updated to reflect availability 
scientific evidence and if so, the content of such labeling 
changes. After considering all responses from the holder, and 
any further discussion, the Secretary may order such holder to 
make the labeling changes the Secretary determines are 
appropriate. Such holder of an approved application shall then 
(1) update its paper labeling for the drug at the next printing 
of that labeling, (2) update any electronic labeling for the 
drug within 30 days of such order, and (3) submit the revised 
labeling through the form ``Supplement--Changes Being 
Effected.''
    Subsection (g) states that if a holder of an approved 
application for the generic version of the selected drug does 
not comply with the requirements of the Secretary's order, such 
generic version of the selected drug shall be deemed to be 
misbranded under section 502 of the FFDCA.
    Subsection (h) states that the generic version shall be 
deemed to have the same conditions of use and the same labeling 
as its reference listed drug with respect to any labeling 
change required under this section. Any labeling change shall 
not have any legal effect for the applicant that is different 
than the legal effect that would have resulted from an approved 
supplemental application to conform the labeling of the generic 
version to the change in labeling for the reference listed 
drug. In addition, the subsection states that changes to 
labeling made in accordance with this section shall not be 
eligible for an exclusivity period under this Act. Further, the 
subsection clarifies that nothing in this section shall be 
construed to give the Secretary the authority to identify a 
drug as a covered drug or select a drug label for updating 
solely based on the availability of new safety information. 
Upon identification of a drug as a covered drug, the Secretary 
may then consider the availability of new, additional, or 
different safety information in determining what labeling 
changes are appropriate. Finally, the subsection makes clear 
that nothing in this section shall be construed to affect the 
responsibility of the holder of an approved application to 
maintain its labeling in accordance with existing regulatory 
requirements.
    Subsection (i) states that this section shall not be 
construed as altering the applicability of the standards for 
approval of an application under section 505 of FFDCA and that 
no order shall be issued under this subsection unless the 
scientific evidence supporting the changed labeling meets the 
standards for approval applicable to any change to labeling 
under section 505. Further, the subsection states that nothing 
in this section shall be construed to limit the authority of 
the Secretary to require changes under section 505(o) of the 
FFDCA.
    Subsection (j) states that not later than four years after 
the date of enactment of the ``MODERN Labeling Act of 2020'', 
and every four years thereafter, the Secretary shall prepare 
and submit to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate, a report that (1) describes 
the actions of the Secretary under this section, including the 
number of covered drugs and description of the types of drugs 
the Secretary has selected for labeling changes and the 
rationales for such recommended changes, and the number of 
times the Secretary entered into discussions concerning a 
disagreement with an application holder or holders and a 
summary of the decision regarding a labeling change, if any; 
and (2) includes any recommendations of the Secretary for 
modifying the program under this section.

      XVII. Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (new matter is 
printed in italics and existing law in which no change is 
proposed is shown in roman):

                  FEDERAL FOOD, DRUG, AND COSMETIC ACT




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                      CHAPTER V--DRUGS AND DEVICES


Subchapter A--Drugs and Devices

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SEC. 503D. PROCESS TO UPDATE LABELING FOR CERTAIN DRUGS.

  (a) Definitions.--For purposes of this section:
          (1) The term ``covered drug'' means a drug approved 
        under section 505(c)--
                  (A) for which there are no unexpired patents 
                included in the list under section 505(j)(7) 
                and no unexpired period of exclusivity;
                  (B) for which the approval of the application 
                has been withdrawn for reasons other than 
                safety or effectiveness; and
                  (C) for which--
                          (i)(I) there is new scientific 
                        evidence available pertaining to the 
                        existing conditions of use that is not 
                        reflected in the labeling;
                          (II) the approved labeling does not 
                        reflect current legal and regulatory 
                        requirements for content or format; or
                          (III) there is a relevant accepted 
                        use in clinical practice that is not 
                        reflected in the approved labeling; and
                          (ii) updating the labeling would 
                        benefit the public health.
          (2) The term ``period of exclusivity'', with respect 
        to a drug approved under section 505(c), means any 
        period of exclusivity under clause (ii), (iii), or (iv) 
        of section 505(c)(3)(E), clause (ii), (iii), or (iv) of 
        section 505(j)(5)(F), or section 505A, 505E, or 527.
          (3) The term ``generic version'' means a drug 
        approved under section 505(j) whose reference listed 
        drug is a covered drug.
          (4) The term ``relevant accepted use'' means a use 
        for a drug in clinical practice that is supported by 
        scientific evidence that appears to the Secretary to 
        meet the standards for approval under section 505.
          (5) The term ``selected drug'' means a covered drug 
        for which the Secretary has determined through the 
        process under subsection (c) that the labeling should 
        be changed.
  (b) Identification of Covered Drugs.--The Secretary may 
identify covered drugs for which labeling updates would provide 
a public health benefit. To assist in identifying covered 
drugs, the Secretary may do one or both of the following:
          (1) Enter into cooperative agreements or contracts 
        with public or private entities to review the available 
        scientific evidence concerning such drugs.
          (2) Seek public input concerning such drugs, 
        including input on whether there is a relevant accepted 
        use in clinical practice that is not reflected in the 
        approved labeling of such drugs or whether new 
        scientific evidence is available regarding the 
        conditions of use for such drug, by--
                  (A) holding one or more public meetings;
                  (B) opening a public docket for the 
                submission of public comments; or
                  (C) other means, as the Secretary determines 
                appropriate.
  (c) Selection of Drugs for Updating.--If the Secretary 
determines, with respect to a covered drug, that the available 
scientific evidence meets the standards under section 505 for 
adding or modifying information to the labeling or providing 
supplemental information to the labeling regarding the use of 
the covered drug, the Secretary may initiate the process under 
subsection (d).
  (d) Initiation of the Process of Updating.--If the Secretary 
determines that labeling changes are appropriate for a selected 
drug pursuant to subsection (c), the Secretary shall provide 
notice to the holders of approved applications for a generic 
version of such drug that--
          (1) summarizes the findings supporting the 
        determination of the Secretary that the available 
        scientific evidence meets the standards under section 
        505 for adding or modifying information or providing 
        supplemental information to the labeling of the covered 
        drug pursuant to subsection (c);
          (2) provides a clear statement regarding the 
        additional, modified, or supplemental information for 
        such labeling, according to the determination by the 
        Secretary (including, as applicable, modifications to 
        add the relevant accepted use to the labeling of the 
        drug as an additional indication for the drug); and
          (3) states whether the statement under paragraph (2) 
        applies to the selected drug as a class of covered 
        drugs or only to a specific drug product.
  (e) Response to Notification.--Within 30 days of receipt of 
notification provided by the Secretary pursuant to subsection 
(d), the holder of an approved application for a generic 
version of the selected drug shall--
          (1) agree to change the approved labeling to reflect 
        the additional, modified, or supplemental information 
        the Secretary has determined to be appropriate; or
          (2) notify the Secretary that the holder of the 
        approved application does not believe that the 
        requested labeling changes are warranted and submit a 
        statement detailing the reasons why such changes are 
        not warranted.
  (f) Review of Application Holder's Response.--
          (1) In general.--Upon receipt of the application 
        holder's response, the Secretary shall promptly review 
        each statement received under subsection (e)(2) and 
        determine which labeling changes pursuant to the 
        Secretary's notice under subsection (d) are 
        appropriate, if any. If the Secretary disagrees with 
        the reasons why such labeling changes are not 
        warranted, the Secretary shall provide opportunity for 
        discussions with the application holders to reach 
        agreement on whether the labeling for the covered drug 
        should be updated to reflect available scientific 
        evidence, and if so, the content of such labeling 
        changes.
          (2) Changes to labeling.--After considering all 
        responses from the holder of an approved application 
        under paragraph (1) or (2) of subsection (e), and any 
        discussion under paragraph (1), the Secretary may order 
        such holder to make the labeling changes the Secretary 
        determines are appropriate. Such holder of an approved 
        application shall--
                  (A) update its paper labeling for the drug at 
                the next printing of that labeling;
                  (B) update any electronic labeling for the 
                drug within 30 days of such order; and
                  (C) submit the revised labeling through the 
                form, ``Supplement--Changes Being Effected''.
  (g) Violation.--If the holder of an approved application for 
the generic version of the selected drug does not comply with 
the requirements of subsection (f)(2), such generic version of 
the selected drug shall be deemed to be misbranded under 
section 502.
  (h) Limitations; Generic Drugs.--
          (1) In general.--With respect to any labeling change 
        required under this section, the generic version shall 
        be deemed to have the same conditions of use and the 
        same labeling as its reference listed drug for purposes 
        of clauses (i) and (v) of section 505(j)(2)(A). Any 
        labeling change so required shall not have any legal 
        effect for the applicant that is different than the 
        legal effect that would have resulted if a supplemental 
        application had been submitted and approved to conform 
        the labeling of the generic version to a change in the 
        labeling of the reference drug.
          (2) Supplemental applications.--Changes to labeling 
        made in accordance with this section shall not be 
        eligible for an exclusivity period under this Act.
          (3) Selection of drugs.--Nothing in this section 
        shall be construed to give the Secretary the authority 
        to identify a drug as a covered drug or select a drug 
        label for updating solely based on the availability of 
        new safety information. Upon identification of a drug 
        as a covered drug, the Secretary may then consider the 
        availability of new, additional, or different safety 
        information in determining whether the drug is a 
        selected drug and in determining what labeling changes 
        are appropriate.
          (4) Maintenance of labeling.--Nothing in this section 
        shall be construed to affect the responsibility of the 
        holder of an approved application under section 505(j) 
        to maintain its labeling in accordance with existing 
        requirements, including subpart B of part 201 and 
        sections 314.70 and 314.97 of title 21, Code of Federal 
        Regulations (or any successor regulations).
  (i) Rules of Construction.--
          (1) Approval standards.--This section shall not be 
        construed as altering the applicability of the 
        standards for approval of an application under section 
        505. No order shall be issued under this subsection 
        unless the scientific evidence supporting the changed 
        labeling meets the standards for approval applicable to 
        any change to labeling under section 505.
          (2) Secretary authority.--Nothing in this section 
        shall be construed to limit the authority of the 
        Secretary to require labeling changes under section 
        505(o).
  (j) Reports.--Not later than 4 years after the date of the 
enactment of the Making Objective Drug Evidence Revisions for 
New Labeling Act of 2020, and every 4 years thereafter, the 
Secretary shall prepare and submit to the Committee on Energy 
and Commerce of the House of Representatives and the Committee 
on Health, Education, Labor, and Pensions of the Senate, a 
report that--
          (1) describes the actions of the Secretary under this 
        section, including--
                  (A) the number of covered drugs and 
                description of the types of drugs the Secretary 
                has selected for labeling changes and the 
                rationale for such recommended changes; and
                  (B) the number of times the Secretary entered 
                into discussions concerning a disagreement with 
                an application holder or holders and a summary 
                of the decision regarding a labeling change, if 
                any; and
          (2) includes any recommendations of the Secretary for 
        modifying the program under this section.

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