A bill to establish a process for updating the labeling of certain drugs with outdated labeling.

II 116TH CONGRESS 1ST SESSION S. 1897 To establish a process for updating the labeling of certain drugs with outdated labeling.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on Health, Education, Labor, and Pensions A BILL To establish a process for updating the labeling of certain drugs with outdated labeling.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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. PROCESS TO UPDATE LABELING FOR DRUGS 3 WITH OUTDATED LABELING. 4 Chapter V of the Federal Food, Drug, and Cosmetic 5 Act (21 U.S.C. 351 et seq.) is amended by inserting after 6 section 503C the following: 7 ‘‘SEC. 503D. PROCESS TO UPDATE LABELING FOR DRUGS 8 WITH OUTDATED LABELING. 9 ‘‘(a) DEFINITIONS.—For purposes of this section: 10 VerDate Sep 11 2014 02:02 Jun 21, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1897.IS S1897 pamtmann on DSKBFK8HB2PROD with BILLS 2 •S 1897 IS ‘‘(1) The term ‘covered drug’ means a drug ap- 1 proved under section 505(c)— 2 ‘‘(A) for which there are no unexpired pat- 3 ents included in the list under section 505(j)(7) 4 and no unexpired period of market exclusivity; 5 ‘‘(B) for which the approval of the applica- 6 tion has been withdrawn for reasons other than 7 safety or effectiveness; and 8 ‘‘(C) for which, with respect to the label- 9 ing— 10 ‘‘(i) new scientific evidence is available 11 regarding the conditions of use of the 12 drug; 13 ‘‘(ii) there is a relevant accepted use 14 in clinical practice that is not reflected in 15 the approved labeling; or 16 ‘‘(iii) the labeling of such drug does 17 not reflect current legal and regulatory re- 18 quirements. 19 ‘‘(2) The term ‘period of market exclusivity’, 20 with respect to a drug approved under section 21 505(c), means any period of market exclusivity 22 under clause (ii), (iii), or (iv) of section 23 505(c)(3)(E), clause (ii), (iii), or (iv) of section 24 505(j)(5)(F), or section 505A, 505E, or 527. 25 VerDate Sep 11 2014 02:02 Jun 21, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1897.IS S1897 pamtmann on DSKBFK8HB2PROD with BILLS 3 •S 1897 IS ‘‘(3) The term ‘generic version’ means a drug 1 approved under section 505(j) whose reference drug 2 is a covered drug. 3 ‘‘(4) The term ‘relevant accepted use’ means a 4 use for a drug in clinical practice that is supported 5 by scientific evidence that appears to the Secretary 6 to meet the standards for approval under section 7 505. 8 ‘‘(5) The term ‘selected drug’ means a covered 9 drug for which the Secretary has determined 10 through the process under subsection (c) that the la- 11 beling should be changed. 12 ‘‘(b) IDENTIFICATION OF COVERED DRUGS.—The 13 Secretary may identify covered drugs for which labeling 14 updates would provide a public health benefit. To assist 15 in identifying covered drugs, the Secretary may do one or 16 both of the following: 17 ‘‘(1) Enter into cooperative agreements or con- 18 tracts with public or private entities to review the 19 available scientific evidence concerning such drugs. 20 ‘‘(2) Seek public input concerning such drugs, 21 including input on whether there is a relevant ac- 22 cepted use in clinical practice that is not reflected in 23 the approved labeling of such drugs or whether new 24 VerDate Sep 11 2014 02:02 Jun 21, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1897.IS S1897 pamtmann on DSKBFK8HB2PROD with BILLS 4 •S 1897 IS scientific evidence is available regarding the condi- 1 tions of use for such drug, by— 2 ‘‘(A) holding one or more public meetings; 3 ‘‘(B) opening a public docket for the sub- 4 mission of public comments; or 5 ‘‘(C) other means, as the Secretary deter- 6 mines appropriate. 7 ‘‘(c) SELECTION OF DRUGS FOR UPDATING.—If the 8 Secretary determines, with respect to a covered drug, that 9 the available scientific evidence meets the standards under 10 section 505 for adding or modifying information to the 11 labeling or providing supplemental information to the la- 12 beling regarding the use of the covered drug, the Secretary 13 may initiate the process under subsection (d). 14 ‘‘(d) INITIATION OF THE PROCESS OF UPDATING.— 15 If the Secretary determines that labeling changes are ap- 16 propriate for a selected drug pursuant to subsection (c), 17 the Secretary shall provide notice to the holders of ap- 18 proved applications for a generic version of such drug 19 that— 20 ‘‘(1) summarizes the findings supporting the 21 determination of the Secretary that the available sci- 22 entific evidence meets the standards under section 23 505 for adding or modifying information or pro- 24 VerDate Sep 11 2014 02:02 Jun 21, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1897.IS S1897 pamtmann on DSKBFK8HB2PROD with BILLS 5 •S 1897 IS viding supplemental information to the labeling of 1 the covered drug pursuant to subsection (c); 2 ‘‘(2) provides a clear statement regarding the 3 additional, modified, or supplemental information for 4 such labeling, according to the determination by the 5 Secretary (including, as applicable, modifications to 6 add the relevant accepted use to the labeling of the 7 drug as an additional indication for the drug); and 8 ‘‘(3) states whether the statement under para- 9 graph (2) applies to the selected drug as a class of 10 covered drugs or only as to a specific drug product. 11 ‘‘(e) RESPONSE TO NOTIFICATION.—Within 30 days 12 of receipt of notification provided by the Secretary pursu- 13 ant to subsection (d), the holder of an approved applica- 14 tion for a generic version of the selected drug shall— 15 ‘‘(1) agree to change the approved labeling to 16 reflect the additional, modified, or supplemental in- 17 formation the Secretary has determined to be appro- 18 priate; or 19 ‘‘(2) notify the Secretary that the holder of the 20 approved application does not believe that the re- 21 quested labeling changes are warranted and submit 22 a statement detailing the reasons why such changes 23 are not warranted. 24 VerDate Sep 11 2014 02:02 Jun 21, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1897.IS S1897 pamtmann on DSKBFK8HB2PROD with BILLS 6 •S 1897 IS ‘‘(f) REVIEW OF APPLICATION HOLDER’S RE- 1 SPONSE.— 2 ‘‘(1) IN GENERAL.—Upon receipt of the appli- 3 cation holder’s response, the Secretary shall prompt- 4 ly review each statement received under subsection 5 (e)(2) and determine which labeling changes pursu- 6 ant to the Secretary’s notice under subsection (d) 7 are appropriate, if any. If the Secretary disagrees 8 with the reasons why such labeling changes are not 9 warranted, the Secretary shall provide opportunity 10 for discussions with the application holders to reach 11 agreement on whether the labeling for the covered 12 drug should be updated to reflect current scientific 13 evidence, and if so, the content of such labeling 14 changes. 15 ‘‘(2) CHANGES TO LABELING.—After consid- 16 ering all responses from the holder of an approved 17 application under paragraph (1) or (2) of subsection 18 (e), and any discussion under paragraph (1), the 19 Secretary may order such holder to make the label- 20 ing changes the Secretary determines are appro- 21 priate. Such holder of an approved application 22 shall— 23 ‘‘(A) update its paper labeling for the drug 24 at the next printing of that labeling; 25 VerDate Sep 11 2014 02:02 Jun 21, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1897.IS S1897 pamtmann on DSKBFK8HB2PROD with BILLS 7 •S 1897 IS ‘‘(B) update any electronic labeling for the 1 drug within 30 days; and 2 ‘‘(C) submit the revised labeling through 3 the form, ‘Supplement—Changes Being Ef- 4 fected’. 5 ‘‘(g) VIOLATION.—If the holder of an approved appli- 6 cation for the generic version of the selected drug does 7 not comply with the requirements of subsection (f)(2), 8 such generic version of the selected drug shall be deemed 9 to be misbranded under section 502. 10 ‘‘(h) LIMITATIONS; GENERIC DRUGS.— 11 ‘‘(1) IN GENERAL.—With respect to any label- 12 ing change required under this section, the generic 13 version shall be deemed to have the same conditions 14 of use and the same labeling as a reference drug for 15 purposes of clauses (i) and (v) of section 16 505(j)(2)(A). Any labeling change so required shall 17 not have any legal effect for the applicant that is 18 different than the legal effect that would have re- 19 sulted if a supplemental application had been sub- 20 mitted and approved to conform the labeling of the 21 generic version to a change in the labeling of the ref- 22 erence drug. 23 ‘‘(2) SUPPLEMENTAL APPLICATIONS.—Changes 24 to labeling made in accordance with this paragraph 25 VerDate Sep 11 2014 02:02 Jun 21, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1897.IS S1897 pamtmann on DSKBFK8HB2PROD with BILLS 8 •S 1897 IS shall not be eligible for an exclusivity period under 1 this Act. 2 ‘‘(i) DRUG PRODUCT CLASSES.—In the case of a se- 3 lected drug for which the labeling changes ordered by the 4 Secretary under subsection (d)(2) are required for a class 5 of covered drugs, such labeling changes shall be made for 6 generic versions of such drug in that class. 7 ‘‘(j) RULES OF CONSTRUCTION.— 8 ‘‘(1) APPROVAL STANDARDS.—This section 9 shall not be construed as altering the applicability of 10 the standards for approval of an application under 11 section 505. No order shall be issued under this sub- 12 section unless the evidence supporting the changed 13 labeling meets the standards for approval applicable 14 to any change to labeling under section 505. 15 ‘‘(2) REMOVAL OF INFORMATION.—Nothing in 16 this section shall be construed to give the Secretary 17 additional authority to remove approved indications 18 for drugs, other than the authority to remove certain 19 indications from the labels of certain covered drugs, 20 as described in this section. 21 ‘‘(k) REPORTS.—Not later than 4 years after the 22 date of the enactment of this section and every 4 years 23 thereafter, the Secretary shall prepare and submit to the 24 Committee on Health, Education, Labor, and Pensions of 25 VerDate Sep 11 2014 02:02 Jun 21, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1897.IS S1897 pamtmann on DSKBFK8HB2PROD with BILLS 9 •S 1897 IS the Senate and the Committee on Energy and Commerce 1 of the House of Representatives, a report that— 2 ‘‘(1) describes the actions of the Secretary 3 under this section, including— 4 ‘‘(A) the number of covered drugs and de- 5 scription of the types of drugs the Secretary 6 has selected for labeling changes and the ra- 7 tionale for such recommended changes; and 8 ‘‘(B) the number of times the Secretary 9 entered into discussions concerning a disagree- 10 ment with an application holder or holders and 11 a summary of the decision regarding a labeling 12 change, if any; and 13 ‘‘(2) includes any recommendations of the Sec- 14 retary for modifying the program under this sec- 15 tion.’’. 16 Æ VerDate Sep 11 2014 02:02 Jun 21, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6301 E:\BILLS\S1897.IS S1897 pamtmann on DSKBFK8HB2PROD with BILLS