MODERN Labeling Act of 2020

IIB 116TH CONGRESS 2D SESSION H. R. 5668 IN THE SENATE OF THE UNITED STATES NOVEMBER 18, 2020 Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions 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 Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 18:19 Nov 19, 2020 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H5668.RFS H5668 pamtmann on DSKBC07HB2PROD with BILLS 2 HR 5668 RFS SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Making Objective Drug 2 Evidence Revisions for New Labeling Act of 2020’’ or the 3 ‘‘MODERN Labeling Act of 2020’’. 4 SEC. 2. MODERNIZING THE LABELING OF CERTAIN GE- 5 NERIC DRUGS. 6 Chapter V of the Federal Food, Drug, and Cosmetic 7 Act (21 U.S.C. 351 et seq.) is amended by inserting after 8 section 503C the following: 9 ‘‘SEC. 503D. PROCESS TO UPDATE LABELING FOR CERTAIN 10 DRUGS. 11 ‘‘(a) DEFINITIONS.—For purposes of this section: 12 ‘‘(1) The term ‘covered drug’ means a drug ap- 13 proved under section 505(c)— 14 ‘‘(A) for which there are no unexpired pat- 15 ents included in the list under section 505(j)(7) 16 and no unexpired period of exclusivity; 17 ‘‘(B) for which the approval of the applica- 18 tion has been withdrawn for reasons other than 19 safety or effectiveness; and 20 ‘‘(C) for which— 21 ‘‘(i)(I) there is new scientific evidence 22 available pertaining to the existing condi- 23 tions of use that is not reflected in the la- 24 beling; 25 VerDate Sep 11 2014 18:19 Nov 19, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5668.RFS H5668 pamtmann on DSKBC07HB2PROD with BILLS 3 HR 5668 RFS ‘‘(II) the approved labeling does not 1 reflect current legal and regulatory re- 2 quirements for content or format; or 3 ‘‘(III) there is a relevant accepted use 4 in clinical practice that is not reflected in 5 the approved labeling; and 6 ‘‘(ii) updating the labeling would ben- 7 efit the public health. 8 ‘‘(2) The term ‘period of exclusivity’, with re- 9 spect to a drug approved under section 505(c), 10 means any period of exclusivity under clause (ii), 11 (iii), or (iv) of section 505(c)(3)(E), clause (ii), (iii), 12 or (iv) of section 505(j)(5)(F), or section 505A, 13 505E, or 527. 14 ‘‘(3) The term ‘generic version’ means a drug 15 approved under section 505(j) whose reference listed 16 drug is a covered drug. 17 ‘‘(4) The term ‘relevant accepted use’ means a 18 use for a drug in clinical practice that is supported 19 by scientific evidence that appears to the Secretary 20 to meet the standards for approval under section 21 505. 22 ‘‘(5) The term ‘selected drug’ means a covered 23 drug for which the Secretary has determined 24 VerDate Sep 11 2014 18:19 Nov 19, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5668.RFS H5668 pamtmann on DSKBC07HB2PROD with BILLS 4 HR 5668 RFS through the process under subsection (c) that the la- 1 beling should be changed. 2 ‘‘(b) IDENTIFICATION OF COVERED DRUGS.—The 3 Secretary may identify covered drugs for which labeling 4 updates would provide a public health benefit. To assist 5 in identifying covered drugs, the Secretary may do one or 6 both of the following: 7 ‘‘(1) Enter into cooperative agreements or con- 8 tracts with public or private entities to review the 9 available scientific evidence concerning such drugs. 10 ‘‘(2) Seek public input concerning such drugs, 11 including input on whether there is a relevant ac- 12 cepted use in clinical practice that is not reflected in 13 the approved labeling of such drugs or whether new 14 scientific evidence is available regarding the condi- 15 tions of use for such drug, by— 16 ‘‘(A) holding one or more public meetings; 17 ‘‘(B) opening a public docket for the sub- 18 mission of public comments; or 19 ‘‘(C) other means, as the Secretary deter- 20 mines appropriate. 21 ‘‘(c) SELECTION OF DRUGS FOR UPDATING.—If the 22 Secretary determines, with respect to a covered drug, that 23 the available scientific evidence meets the standards under 24 section 505 for adding or modifying information to the 25 VerDate Sep 11 2014 18:19 Nov 19, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5668.RFS H5668 pamtmann on DSKBC07HB2PROD with BILLS 5 HR 5668 RFS labeling or providing supplemental information to the la- 1 beling regarding the use of the covered drug, the Secretary 2 may initiate the process under subsection (d). 3 ‘‘(d) INITIATION OF THE PROCESS OF UPDATING.— 4 If the Secretary determines that labeling changes are ap- 5 propriate for a selected drug pursuant to subsection (c), 6 the Secretary shall provide notice to the holders of ap- 7 proved applications for a generic version of such drug 8 that— 9 ‘‘(1) summarizes the findings supporting the 10 determination of the Secretary that the available sci- 11 entific evidence meets the standards under section 12 505 for adding or modifying information or pro- 13 viding supplemental information to the labeling of 14 the covered drug pursuant to subsection (c); 15 ‘‘(2) provides a clear statement regarding the 16 additional, modified, or supplemental information for 17 such labeling, according to the determination by the 18 Secretary (including, as applicable, modifications to 19 add the relevant accepted use to the labeling of the 20 drug as an additional indication for the drug); and 21 ‘‘(3) states whether the statement under para- 22 graph (2) applies to the selected drug as a class of 23 covered drugs or only to a specific drug product. 24 VerDate Sep 11 2014 18:19 Nov 19, 2020 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5668.RFS H5668 pamtmann on DSKBC07HB2PROD with BILLS 6 HR 5668 RFS ‘‘(e) RESPONSE TO NOTIFICATION.—Within 30 days 1 of receipt of notification provided by the Secretary pursu- 2 ant to subsection (d), the holder of an approved applica- 3 tion for a generic version of the selected drug shall— 4 ‘‘(1) agree to change the approved labeling to 5 reflect the additional, modified, or supplemental in- 6 formation the Secretary has determined to be appro- 7 priate; or 8 ‘‘(2) notify the Secretary that the holder of the 9 approved application does not believe that the re- 10 quested labeling changes are warranted and submit 11 a statement detailing the reasons why such changes 12 are not warranted. 13 ‘‘(f) REVIEW OF APPLICATION HOLDER’S RE- 14 SPONSE.— 15 ‘‘(1) IN GENERAL.—Upon receipt of the appli- 16 cation holder’s response, the Secretary shall prompt- 17 ly review each statement received under subsection 18 (e)(2) and determine which labeling changes pursu- 19 ant to the Secretary’s notice under subsection (d) 20 are appropriate, if any. If the Secretary disagrees 21 with the reasons why such labeling changes are not 22 warranted, the Secretary shall provide opportunity 23 for discussions with the application holders to reach 24 agreement on whether the labeling for the covered 25 VerDate Sep 11 2014 18:19 Nov 19, 2020 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5668.RFS H5668 pamtmann on DSKBC07HB2PROD with BILLS 7 HR 5668 RFS drug should be updated to reflect available scientific 1 evidence, and if so, the content of such labeling 2 changes. 3 ‘‘(2) CHANGES TO LABELING.—After consid- 4 ering all responses from the holder of an approved 5 application under paragraph (1) or (2) of subsection 6 (e), and any discussion under paragraph (1), the 7 Secretary may order such holder to make the label- 8 ing changes the Secretary determines are appro- 9 priate. Such holder of an approved application 10 shall— 11 ‘‘(A) update its paper labeling for the drug 12 at the next printing of that labeling; 13 ‘‘(B) update any electronic labeling for the 14 drug within 30 days of such order; and 15 ‘‘(C) submit the revised labeling through 16 the form, ‘Supplement—Changes Being Ef- 17 fected’. 18 ‘‘(g) VIOLATION.—If the holder of an approved appli- 19 cation for the generic version of the selected drug does 20 not comply with the requirements of subsection (f)(2), 21 such generic version of the selected drug shall be deemed 22 to be misbranded under section 502. 23 ‘‘(h) LIMITATIONS; GENERIC DRUGS.— 24 VerDate Sep 11 2014 18:19 Nov 19, 2020 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H5668.RFS H5668 pamtmann on DSKBC07HB2PROD with BILLS 8 HR 5668 RFS ‘‘(1) IN GENERAL.—With respect to any label- 1 ing change required under this section, the generic 2 version shall be deemed to have the same conditions 3 of use and the same labeling as its reference listed 4 drug for purposes of clauses (i) and (v) of section 5 505(j)(2)(A). Any labeling change so required shall 6 not have any legal effect for the applicant that is 7 different than the legal effect that would have re- 8 sulted if a supplemental application had been sub- 9 mitted and approved to conform the labeling of the 10 generic version to a change in the labeling of the ref- 11 erence drug. 12 ‘‘(2) SUPPLEMENTAL APPLICATIONS.—Changes 13 to labeling made in accordance with this section 14 shall not be eligible for an exclusivity period under 15 this Act. 16 ‘‘(3) SELECTION OF DRUGS.—Nothing in this 17 section shall be construed to give the Secretary the 18 authority to identify a drug as a covered drug or se- 19 lect a drug label for updating solely based on the 20 availability of new safety information. Upon identi- 21 fication of a drug as a covered drug, the Secretary 22 may then consider the availability of new, additional, 23 or different safety information in determining 24 VerDate Sep 11 2014 18:19 Nov 19, 2020 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H5668.RFS H5668 pamtmann on DSKBC07HB2PROD with BILLS 9 HR 5668 RFS whether the drug is a selected drug and in deter- 1 mining what labeling changes are appropriate. 2 ‘‘(4) MAINTENANCE OF LABELING.—Nothing in 3 this section shall be construed to affect the responsi- 4 bility of the holder of an approved application under 5 section 505(j) to maintain its labeling in accordance 6 with existing requirements, including subpart B of 7 part 201 and sections 314.70 and 314.97 of title 21, 8 Code of Federal Regulations (or any successor regu- 9 lations). 10 ‘‘(i) RULES OF CONSTRUCTION.— 11 ‘‘(1) APPROVAL STANDARDS.—This section 12 shall not be construed as altering the applicability of 13 the standards for approval of an application under 14 section 505. No order shall be issued under this sub- 15 section unless the scientific evidence supporting the 16 changed labeling meets the standards for approval 17 applicable to any change to labeling under section 18 505. 19 ‘‘(2) SECRETARY AUTHORITY.—Nothing in this 20 section shall be construed to limit the authority of 21 the Secretary to require labeling changes under sec- 22 tion 505(o). 23 ‘‘(j) REPORTS.—Not later than 4 years after the date 24 of the enactment of the Making Objective Drug Evidence 25 VerDate Sep 11 2014 18:19 Nov 19, 2020 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H5668.RFS H5668 pamtmann on DSKBC07HB2PROD with BILLS 10 HR 5668 RFS Revisions for New Labeling Act of 2020, and every 4 years 1 thereafter, the Secretary shall prepare and submit to the 2 Committee on Energy and Commerce of the House of 3 Representatives and the Committee on Health, Education, 4 Labor, and Pensions of the Senate, a report that— 5 ‘‘(1) describes the actions of the Secretary 6 under this section, including— 7 ‘‘(A) the number of covered drugs and de- 8 scription of the types of drugs the Secretary 9 has selected for labeling changes and the ra- 10 tionale for such recommended changes; and 11 ‘‘(B) the number of times the Secretary 12 entered into discussions concerning a disagree- 13 ment with an application holder or holders and 14 a summary of the decision regarding a labeling 15 change, if any; and 16 ‘‘(2) includes any recommendations of the Sec- 17 retary for modifying the program under this sec- 18 tion.’’. 19 Passed the House of Representatives November 17, 2020. Attest: CHERYL L. JOHNSON, Clerk. VerDate Sep 11 2014 18:19 Nov 19, 2020 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H5668.RFS H5668 pamtmann on DSKBC07HB2PROD with BILLS