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To establish a process for updating the labeling of certain drugs with outdated 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drugs with outdated labeling. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. PROCESS TO UPDATE LABELING FOR DRUGS 

4 WITH OUTDATED LABELING. 

5 Chapter V of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 351 et seq.) is amended by inserting after 

7 section 503C the following: 

8 ‘‘SEC. 503D. PROCESS TO UPDATE LABELING FOR DRUGS 

9 WITH OUTDATED LABELING. 

10 ‘‘(a) DEFINITIONS.—For purposes of this section: 


pamtmann on DSKBFK8HB2PROD with BILLS
2 

•S 1897 IS

1 ‘‘(1) The term ‘covered drug’ means a drug ap2 proved under section 505(c)— 

3 ‘‘(A) for which there are no unexpired pat4 ents included in the list under section 505(j)(7) 

5 and no unexpired period of market exclusivity; 

6 ‘‘(B) for which the approval of the applica7 tion has been withdrawn for reasons other than 

8 safety or effectiveness; and 

9 ‘‘(C) for which, with respect to the label10 ing— 

11 ‘‘(i) new scientific evidence is available 

12 regarding the conditions of use of the 

13 drug; 

14 ‘‘(ii) there is a relevant accepted use 

15 in clinical practice that is not reflected in 

16 the approved labeling; or 

17 ‘‘(iii) the labeling of such drug does 

18 not reflect current legal and regulatory re19 quirements. 

20 ‘‘(2) The term ‘period of market exclusivity’, 

21 with respect to a drug approved under section 

22 505(c), means any period of market exclusivity 

23 under clause (ii), (iii), or (iv) of section 

24 505(c)(3)(E), clause (ii), (iii), or (iv) of section 

25 505(j)(5)(F), or section 505A, 505E, or 527. 


pamtmann on DSKBFK8HB2PROD with BILLS
3 

•S 1897 IS

1 ‘‘(3) The term ‘generic version’ means a drug 

2 approved under section 505(j) whose reference drug 

3 is a covered drug. 

4 ‘‘(4) The term ‘relevant accepted use’ means a 

5 use for a drug in clinical practice that is supported 

6 by scientific evidence that appears to the Secretary 

7 to meet the standards for approval under section 

8 505. 

9 ‘‘(5) The term ‘selected drug’ means a covered 

10 drug for which the Secretary has determined 

11 through the process under subsection (c) that the la12 beling should be changed. 

13 ‘‘(b) IDENTIFICATION OF COVERED DRUGS.—The 

14 Secretary may identify covered drugs for which labeling 

15 updates would provide a public health benefit. To assist 

16 in identifying covered drugs, the Secretary may do one or 

17 both of the following: 

18 ‘‘(1) Enter into cooperative agreements or con19 tracts with public or private entities to review the 

20 available scientific evidence concerning such drugs. 

21 ‘‘(2) Seek public input concerning such drugs, 

22 including input on whether there is a relevant ac23 cepted use in clinical practice that is not reflected in 

24 the approved labeling of such drugs or whether new 


pamtmann on DSKBFK8HB2PROD with BILLS
4 

•S 1897 IS

1 scientific evidence is available regarding the condi2 tions of use for such drug, by— 

3 ‘‘(A) holding one or more public meetings; 

4 ‘‘(B) opening a public docket for the sub5 mission of public comments; or 

6 ‘‘(C) other means, as the Secretary deter7 mines appropriate. 

8 ‘‘(c) SELECTION OF DRUGS FOR UPDATING.—If the 

9 Secretary determines, with respect to a covered drug, that 

10 the available scientific evidence meets the standards under 

11 section 505 for adding or modifying information to the 

12 labeling or providing supplemental information to the la13 beling regarding the use of the covered drug, the Secretary 

14 may initiate the process under subsection (d). 

15 ‘‘(d) INITIATION OF THE PROCESS OF UPDATING.— 

16 If the Secretary determines that labeling changes are ap17 propriate for a selected drug pursuant to subsection (c), 

18 the Secretary shall provide notice to the holders of ap19 proved applications for a generic version of such drug 

20 that— 

21 ‘‘(1) summarizes the findings supporting the 

22 determination of the Secretary that the available sci23 entific evidence meets the standards under section 

24 505 for adding or modifying information or proVerDate 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

1 viding supplemental information to the labeling of 

2 the covered drug pursuant to subsection (c); 

3 ‘‘(2) provides a clear statement regarding the 

4 additional, modified, or supplemental information for 

5 such labeling, according to the determination by the 

6 Secretary (including, as applicable, modifications to 

7 add the relevant accepted use to the labeling of the 

8 drug as an additional indication for the drug); and 

9 ‘‘(3) states whether the statement under para10 graph (2) applies to the selected drug as a class of 

11 covered drugs or only as to a specific drug product. 

12 ‘‘(e) RESPONSE TO NOTIFICATION.—Within 30 days 

13 of receipt of notification provided by the Secretary pursu14 ant to subsection (d), the holder of an approved applica15 tion for a generic version of the selected drug shall— 

16 ‘‘(1) agree to change the approved labeling to 

17 reflect the additional, modified, or supplemental in18 formation the Secretary has determined to be appro19 priate; or 

20 ‘‘(2) notify the Secretary that the holder of the 

21 approved application does not believe that the re22 quested labeling changes are warranted and submit 

23 a statement detailing the reasons why such changes 

24 are not warranted. 


pamtmann on DSKBFK8HB2PROD with BILLS
6 

•S 1897 IS

1 ‘‘(f) REVIEW OF APPLICATION HOLDER’S RE2 SPONSE.— 

3 ‘‘(1) IN GENERAL.—Upon receipt of the appli4 cation holder’s response, the Secretary shall prompt5 ly review each statement received under subsection 

6 (e)(2) and determine which labeling changes pursu7 ant to the Secretary’s notice under subsection (d) 

8 are appropriate, if any. If the Secretary disagrees 

9 with the reasons why such labeling changes are not 

10 warranted, the Secretary shall provide opportunity 

11 for discussions with the application holders to reach 

12 agreement on whether the labeling for the covered 

13 drug should be updated to reflect current scientific 

14 evidence, and if so, the content of such labeling 

15 changes. 

16 ‘‘(2) CHANGES TO LABELING.—After consid17 ering all responses from the holder of an approved 

18 application under paragraph (1) or (2) of subsection 

19 (e), and any discussion under paragraph (1), the 

20 Secretary may order such holder to make the label21 ing changes the Secretary determines are appro22 priate. Such holder of an approved application 

23 shall— 

24 ‘‘(A) update its paper labeling for the drug 

25 at the next printing of that labeling; 


pamtmann on DSKBFK8HB2PROD with BILLS
7 

•S 1897 IS

1 ‘‘(B) update any electronic labeling for the 

2 drug within 30 days; and 

3 ‘‘(C) submit the revised labeling through 

4 the form, ‘Supplement—Changes Being Ef5 fected’. 

6 ‘‘(g) VIOLATION.—If the holder of an approved appli7 cation for the generic version of the selected drug does 

8 not comply with the requirements of subsection (f)(2), 

9 such generic version of the selected drug shall be deemed 

10 to be misbranded under section 502. 

11 ‘‘(h) LIMITATIONS; GENERIC DRUGS.— 

12 ‘‘(1) IN GENERAL.—With respect to any label13 ing change required under this section, the generic 

14 version shall be deemed to have the same conditions 

15 of use and the same labeling as a reference drug for 

16 purposes of clauses (i) and (v) of section 

17 505(j)(2)(A). Any labeling change so required shall 

18 not have any legal effect for the applicant that is 

19 different than the legal effect that would have re20 sulted if a supplemental application had been sub21 mitted and approved to conform the labeling of the 

22 generic version to a change in the labeling of the ref23 erence drug. 

24 ‘‘(2) SUPPLEMENTAL APPLICATIONS.—Changes 

25 to labeling made in accordance with this paragraph 


pamtmann on DSKBFK8HB2PROD with BILLS
8 

•S 1897 IS

1 shall not be eligible for an exclusivity period under 

2 this Act. 

3 ‘‘(i) DRUG PRODUCT CLASSES.—In the case of a se4 lected drug for which the labeling changes ordered by the 

5 Secretary under subsection (d)(2) are required for a class 

6 of covered drugs, such labeling changes shall be made for 

7 generic versions of such drug in that class. 

8 ‘‘(j) RULES OF CONSTRUCTION.— 

9 ‘‘(1) APPROVAL STANDARDS.—This section 

10 shall not be construed as altering the applicability of 

11 the standards for approval of an application under 

12 section 505. No order shall be issued under this sub13 section unless the evidence supporting the changed 

14 labeling meets the standards for approval applicable 

15 to any change to labeling under section 505. 

16 ‘‘(2) REMOVAL OF INFORMATION.—Nothing in 

17 this section shall be construed to give the Secretary 

18 additional authority to remove approved indications 

19 for drugs, other than the authority to remove certain 

20 indications from the labels of certain covered drugs, 

21 as described in this section. 

22 ‘‘(k) REPORTS.—Not later than 4 years after the 

23 date of the enactment of this section and every 4 years 

24 thereafter, the Secretary shall prepare and submit to the 

25 Committee on Health, Education, Labor, and Pensions of 


pamtmann on DSKBFK8HB2PROD with BILLS
9 

•S 1897 IS

1 the Senate and the Committee on Energy and Commerce 

2 of the House of Representatives, a report that— 

3 ‘‘(1) describes the actions of the Secretary 

4 under this section, including— 

5 ‘‘(A) the number of covered drugs and de6 scription of the types of drugs the Secretary 

7 has selected for labeling changes and the ra8 tionale for such recommended changes; and 

9 ‘‘(B) the number of times the Secretary 

10 entered into discussions concerning a disagree11 ment with an application holder or holders and 

12 a summary of the decision regarding a labeling 

13 change, if any; and 

14 ‘‘(2) includes any recommendations of the Sec15 retary for modifying the program under this sec16 tion.’’. 

Æ 


pamtmann on DSKBFK8HB2PROD with BILLS