Title: A bill to establish a process for updating the labeling of certain drugs with outdated labeling.
Policy area: Health

Summary:
This bill authorizes the Food and Drug Administration (FDA) to require updates to outdated labels for certain generic drugs if the updates will provide a public health benefit. Generally, the FDA may use this authority to update the label of a generic version of a brand-name drug that has been withdrawn from the market for reasons other than safety or effectiveness.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 1897 Introduced in Senate (IS)]

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116th CONGRESS
  1st Session
                                S. 1897

To establish a process for updating the labeling of certain drugs with 
                           outdated labeling.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 19, 2019

 Mr. Bennet (for himself and Mr. Enzi) 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 updating the labeling of certain drugs with 
                           outdated labeling.

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

SECTION 1. PROCESS TO UPDATE LABELING FOR DRUGS WITH OUTDATED LABELING.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 PROCESS TO UPDATE LABELING FOR DRUGS WITH OUTDATED 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 there are no unexpired patents 
                included in the list under section 505(j)(7) and no 
                unexpired period of market exclusivity;
                    ``(B) for which the approval of the application has 
                been withdrawn for reasons other than safety or 
                effectiveness; and
                    ``(C) for which, with respect to the labeling--
                            ``(i) new scientific evidence is available 
                        regarding the conditions of use of the drug;
                            ``(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 `period of market exclusivity', with respect 
        to a drug approved under section 505(c), means any period of 
        market 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 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 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 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 current 
        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; 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 a reference 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 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 labeling changes ordered by the Secretary under subsection 
(d)(2) are required for a class of covered drugs, such labeling changes 
shall be made for generic versions of such drug in that class.
    ``(j) 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 evidence supporting the 
        changed labeling meets the standards for approval applicable to 
        any change to labeling under section 505.
            ``(2) Removal of information.--Nothing in this section 
        shall be construed to give the Secretary additional authority 
        to remove approved indications for drugs, other than the 
        authority to remove certain indications from the labels of 
        certain covered drugs, as described in this section.
    ``(k) Reports.--Not later than 4 years after the date of the 
enactment of this section 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--
            ``(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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