II 115th CONGRESS 2d Session S. 3519 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process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling.

1. Short title This Act may be cited as the Making Objective Drug Evidence Revisions for New Labeling Act or the MODERN Labeling Act . 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 Process to update labeling for drugs with outdated labeling Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq.)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: 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 Process to update labeling for drugs with outdated labeling (a) Definitions For purposes of this section: (1) The term covered drug means a drug approved under section 505(c)— (A) for which all patents and exclusivity periods under this chapter have expired; (B) for which the approval of the label has been withdrawn; and (C) whose labeling potentially should be modified because— (i) some aspects of the labeling of the drug may be outdated according to evidence that, since the date on which the drug was so approved, has become available regarding the conditions of use reflected in the approved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. .