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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5668 Engrossed in House (EH)]

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116th CONGRESS
  2d Session
                                H. R. 5668

_______________________________________________________________________

                                 AN ACT

 
  To amend the Federal Food, Drug, and Cosmetic Act to modernize the 
       labeling of certain generic drugs, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

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                been withdrawn for reasons other than safety or 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.''.

            Passed the House of Representatives November 17, 2020.

            Attest:

                                                                 Clerk.
116th CONGRESS

  2d Session

                               H. R. 5668

_______________________________________________________________________

                                 AN ACT

  To amend the Federal Food, Drug, and Cosmetic Act to modernize the 
       labeling of certain generic drugs, and for other purposes.
```