I 

116TH CONGRESS 

2D SESSION H. R. 5668 

To amend the Federal Food, Drug, and Cosmetic Act to modernize the 

labeling of certain generic drugs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 24, 2020 

Ms. MATSUI (for herself and Mr. GUTHRIE) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

modernize the labeling of certain generic drugs, and for 

other purposes. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Making Objective Drug 

5 Evidence Revisions for New Labeling Act of 2020’’ or the 

6 ‘‘MODERN Labeling Act of 2020’’. 


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1 SEC. 2. MODERNIZING THE LABELING OF CERTAIN GE2 NERIC DRUGS. 

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

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

5 section 503C the following: 

6 ‘‘SEC. 503D. PROCESS TO UPDATE LABELING FOR CERTAIN 

7 DRUGS. 

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

9 ‘‘(1) The term ‘covered drug’ means a drug ap10 proved under section 505(c)— 

11 ‘‘(A) for which there are no unexpired pat12 ents included in the list under section 505(j)(7) 

13 and no unexpired period of exclusivity; 

14 ‘‘(B) for which the approval of the applica15 tion has been withdrawn for reasons other than 

16 safety or effectiveness; and 

17 ‘‘(C) for which, with respect to the label18 ing— 

19 ‘‘(i) new scientific evidence is available 

20 regarding the conditions of use of the 

21 drug; 

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

23 in clinical practice that is not reflected in 

24 the approved labeling; or 


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

2 not reflect current legal and regulatory re3 quirements. 

4 ‘‘(2) The term ‘period of exclusivity’, with re5 spect to a drug approved under section 505(c), 

6 means any period of exclusivity under clause (ii), 

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

8 or (iv) of section 505(j)(5)(F), or section 505A, 

9 505E, or 527. 

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

11 approved under section 505(j) whose reference drug 

12 is a covered drug. 

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

14 use for a drug in clinical practice that is supported 

15 by scientific evidence that appears to the Secretary 

16 to meet the standards for approval under section 

17 505. 

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

19 drug for which the Secretary has determined 

20 through the process under subsection (c) that the la21 beling should be changed. 

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

23 Secretary may identify covered drugs for which labeling 

24 updates would provide a public health benefit. To assist 


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

2 both of the following: 

3 ‘‘(1) Enter into cooperative agreements or con4 tracts with public or private entities to review the 

5 available scientific evidence concerning such drugs. 

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

7 including input on whether there is a relevant ac8 cepted use in clinical practice that is not reflected in 

9 the approved labeling of such drugs or whether new 

10 scientific evidence is available regarding the condi11 tions of use for such drug, by— 

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

13 ‘‘(B) opening a public docket for the sub14 mission of public comments; or 

15 ‘‘(C) other means, as the Secretary deter16 mines appropriate. 

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

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

19 the available scientific evidence meets the standards under 

20 section 505 for adding or modifying information to the 

21 labeling or providing supplemental information to the la22 beling regarding the use of the covered drug, the Secretary 

23 may initiate the process under subsection (d). 

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

25 If the Secretary determines that labeling changes are apVerDate Sep 11 2014 23:42 Jan 24, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5668.IH H5668

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1 propriate for a selected drug pursuant to subsection (c), 

2 the Secretary shall provide notice to the holders of ap3 proved applications for a generic version of such drug 

4 that— 

5 ‘‘(1) summarizes the findings supporting the 

6 determination of the Secretary that the available sci7 entific evidence meets the standards under section 

8 505 for adding or modifying information or pro9 viding supplemental information to the labeling of 

10 the covered drug pursuant to subsection (c); 

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

12 additional, modified, or supplemental information for 

13 such labeling, according to the determination by the 

14 Secretary (including, as applicable, modifications to 

15 add the relevant accepted use to the labeling of the 

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

17 ‘‘(3) states whether the statement under para18 graph (2) applies to the selected drug as a class of 

19 covered drugs or only to a specific drug product. 

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

21 of receipt of notification provided by the Secretary pursu22 ant to subsection (d), the holder of an approved applica23 tion for a generic version of the selected drug shall— 

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

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1 formation the Secretary has determined to be appro2 priate; or 

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

4 approved application does not believe that the re5 quested labeling changes are warranted and submit 

6 a statement detailing the reasons why such changes 

7 are not warranted. 

8 ‘‘(f) REVIEW OF APPLICATION HOLDER’S RE9 SPONSE.— 

10 ‘‘(1) IN GENERAL.—Upon receipt of the appli11 cation holder’s response, the Secretary shall prompt12 ly review each statement received under subsection 

13 (e)(2) and determine which labeling changes pursu14 ant to the Secretary’s notice under subsection (d) 

15 are appropriate, if any. If the Secretary disagrees 

16 with the reasons why such labeling changes are not 

17 warranted, the Secretary shall provide opportunity 

18 for discussions with the application holders to reach 

19 agreement on whether the labeling for the covered 

20 drug should be updated to reflect available scientific 

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

22 changes. 

23 ‘‘(2) CHANGES TO LABELING.—After consid24 ering all responses from the holder of an approved 

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


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

2 Secretary may order such holder to make the label3 ing changes the Secretary determines are appro4 priate and meet the standards under section 505 for 

5 adding or modifying information or providing sup6 plemental information to such labeling. Such holder 

7 of an approved application shall— 

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

9 at the next printing of that labeling; 

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

11 drug within 30 days of such order; and 

12 ‘‘(C) submit the revised labeling through 

13 the form, ‘Supplement—Changes Being Ef14 fected’. 

15 ‘‘(g) VIOLATION.—If the holder of an approved appli16 cation for the generic version of the selected drug does 

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

18 such generic version of the selected drug shall be deemed 

19 to be misbranded under section 502. 

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

21 ‘‘(1) IN GENERAL.—With respect to any label22 ing change required under this section, the generic 

23 version shall be deemed to have the same conditions 

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

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


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1 505(j)(2)(A). Any labeling change so required shall 

2 not have any legal effect for the applicant that is 

3 different than the legal effect that would have re4 sulted if a supplemental application had been sub5 mitted and approved to conform the labeling of the 

6 generic version to a change in the labeling of the ref7 erence drug. 

8 ‘‘(2) SUPPLEMENTAL APPLICATIONS.—Changes 

9 to labeling made in accordance with this section 

10 shall not be eligible for an exclusivity period under 

11 this Act. 

12 ‘‘(i) RULES OF CONSTRUCTION.— 

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

14 shall not be construed as altering the applicability of 

15 the standards for approval of an application under 

16 section 505. No order shall be issued under this sub17 section unless the scientific evidence supporting the 

18 changed labeling meets the standards for approval 

19 applicable to any change to labeling under section 

20 505. 

21 ‘‘(2) SECRETARY AUTHORITY.—Nothing in this 

22 section shall be construed to limit the authority of 

23 the Secretary to require labeling changes under sec24 tion 505(o). 


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1 ‘‘(j) REPORTS.—Not later than 4 years after the date 

2 of the enactment of the Making Objective Drug Evidence 

3 Revisions for New Labeling Act of 2020, and every 4 years 

4 thereafter, the Secretary shall prepare and submit to the 

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

6 the Senate and the Committee on Energy and Commerce 

7 of the House of Representatives, a report that— 

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

9 under this section, including— 

10 ‘‘(A) the number of covered drugs and de11 scription of the types of drugs the Secretary 

12 has selected for labeling changes and the ra13 tionale for such recommended changes; and 

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

15 entered into discussions concerning a disagree16 ment with an application holder or holders and 

17 a summary of the decision regarding a labeling 

18 change, if any; and 

19 ‘‘(2) includes any recommendations of the Sec20 retary for modifying the program under this sec21 tion.’’. 

Æ 


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