[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 3519 Introduced in Senate (IS)]

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115th CONGRESS
  2d Session
                                S. 3519

    To establish a process for the Food and Drug Administration to 
determine whether to modify the labeling of drugs whose labeling may be 
outdated, including drugs with accepted uses that are not reflected in 
                         the approved labeling.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 27, 2018

 Mr. Hatch (for himself and Mr. Bennet) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
    To establish a process for the Food and Drug Administration to 
determine whether to modify the labeling of drugs whose labeling may be 
outdated, including drugs with accepted uses that are not reflected in 
                         the approved labeling.

    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'' or the ``MODERN Labeling Act''.

SEC. 2. PROCESS TO UPDATE LABELING FOR DRUGS WITH OUTDATED LABELING.

    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 PROCESS TO UPDATE LABELING FOR DRUGS WITH OUTDATED 
              LABELING.

    ``(a) Definitions.--For purposes of this section:
            ``(1) The term `covered drug' means a drug approved under 
        section 505(c)--
                    ``(A) for which all patents and exclusivity periods 
                under this chapter have expired;
                    ``(B) for which the approval of the label has been 
                withdrawn; and
                    ``(C) whose labeling potentially should be modified 
                because--
                            ``(i) some aspects of the labeling of the 
                        drug may be outdated according to evidence 
                        that, since the date on which the drug was so 
                        approved, has become available regarding the 
                        conditions of use reflected in the approved 
                        labeling;
                            ``(ii) there is a relevant accepted use in 
                        clinical practice that is not reflected in the 
                        approved labeling; or
                            ``(iii) the labeling of such drug does not 
                        reflect current legal and regulatory 
                        requirements.
            ``(2) The term `exclusivity period', with respect to a drug 
        approved under section 505(c), means the period by which the 
        effective date of the approval of an application for a 
        different drug product could be delayed, or the different drug 
        product could otherwise be impacted, 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 drug is a covered drug.
            ``(4) The term `relevant accepted use' means a use for a 
        drug in clinical practice that is supported by evidence that 
        could 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 updated because 
        aspects of such labeling are outdated according to evidence 
        that has become available regarding the conditions of use 
        reflected in the approved labeling or to reflect one or more 
        relevant accepted uses.
    ``(b) Identification of Covered Drug Candidates for Revision.--The 
Secretary may consider requiring changes to the labeling of drugs where 
such updates would benefit the public health. To assist in deciding 
whether to require labeling changes for 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 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 aspects of the labeling of such drugs is 
        outdated according to evidence that has become available 
        regarding the conditions of use reflected in the approved 
        labeling by--
                    ``(A) holding 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 evidence 
is sufficient to meet the standards under section 505 for adding 
information to the labeling or modifying information in 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 evidence is sufficient to 
        meet the standards under section 505 for modifying the labeling 
        of the drug pursuant to subsection (c);
            ``(2) states the modifications to the labeling that should 
        be made in order to reflect such determination (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 drugs or only as 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 shall--
            ``(1) agree to change the approved labeling to reflect the 
        modifications the Secretary has determined are appropriate; or
            ``(2) notify the Secretary that the holder of the approved 
        application does not agree that the requested modifications are 
        warranted and submit a statement detailing the reasons why such 
        modifications are not warranted.
    ``(f) Review of Application Holder's Response.--
            ``(1) In general.--The Secretary shall promptly review each 
        statement received under subsection (e)(2) and determine which 
        modifications to the Secretary's notice under subsection (d) 
        are appropriate, if any.
            ``(2) Changes to labeling.--After considering a response 
        from a holder of an approved application under paragraph (1) or 
        (2) of subsection (e), 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; 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), 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 the modification of the 
        labeling sought through a supplemental application pursuant to 
        subsection (f)(2)(C) the manufacturer of any generic version 
        shall, by reason of the statement of the Secretary under 
        subsection (d)(2), be deemed to have the same conditions of use 
        and the same labeling as a reference drug for purposes of 
        clauses (i) and (v) of section 505(j)(2)(A). The approval of a 
        supplemental application shall not have any legal effects for 
        the applicant that are different than the legal effects that 
        would have resulted if the supplemental application had been 
        submitted 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 paragraph shall not be eligible for an 
        exclusivity period under this Act.
    ``(i) Drug Product Classes.--In the case of a selected drug for 
which the statement of the Secretary under subsection (d)(2) applies to 
the selected drug as a class of drugs, a supplemental application 
pursuant to subsection (f)(2)(C) may be submitted for each such drug 
product.
    ``(j) Rule of Construction.--This section shall not be construed as 
altering the applicability of any substantive approval standard under 
section 505.
    ``(k) Reports.--Not later than 4 years after the date of the 
enactment of the Making Objective Drug Evidence Revisions for New 
Labeling Act and every 4 years thereafter, the Secretary shall prepare 
and submit to the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Committee on Energy and Commerce of the House of 
Representatives, a report that describes the actions of the Secretary 
under this section and that provides any recommendations of the 
Secretary for modifying the program under this section, including any 
recommendations on whether the program should apply to a broader scope 
of drugs. Each report under this subsection shall be made publicly 
available on the Internet website of the Food and Drug 
Administration.''.
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