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. 

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


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1 SECTION 1. SHORT TITLE. 

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

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

4 ‘‘MODERN Labeling Act of 2020’’. 

5 SEC. 2. MODERNIZING THE LABELING OF CERTAIN GE6 NERIC DRUGS. 

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

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

9 section 503C the following: 

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

11 DRUGS. 

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

13 ‘‘(1) The term ‘covered drug’ means a drug ap14 proved under section 505(c)— 

15 ‘‘(A) for which there are no unexpired pat16 ents included in the list under section 505(j)(7) 

17 and no unexpired period of exclusivity; 

18 ‘‘(B) for which the approval of the applica19 tion has been withdrawn for reasons other than 

20 safety or effectiveness; and 

21 ‘‘(C) for which— 

22 ‘‘(i)(I) there is new scientific evidence 

23 available pertaining to the existing condi24 tions of use that is not reflected in the la25 beling; 


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1 ‘‘(II) the approved labeling does not 

2 reflect current legal and regulatory re3 quirements for content or format; or 

4 ‘‘(III) there is a relevant accepted use 

5 in clinical practice that is not reflected in 

6 the approved labeling; and 

7 ‘‘(ii) updating the labeling would ben8 efit the public health. 

9 ‘‘(2) The term ‘period of exclusivity’, with re10 spect to a drug approved under section 505(c), 

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

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

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

14 505E, or 527. 

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

16 approved under section 505(j) whose reference listed 

17 drug is a covered drug. 

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

19 use for a drug in clinical practice that is supported 

20 by scientific evidence that appears to the Secretary 

21 to meet the standards for approval under section 

22 505. 

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

24 drug for which the Secretary has determined 


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1 through the process under subsection (c) that the la2 beling should be changed. 

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

4 Secretary may identify covered drugs for which labeling 

5 updates would provide a public health benefit. To assist 

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

7 both of the following: 

8 ‘‘(1) Enter into cooperative agreements or con9 tracts with public or private entities to review the 

10 available scientific evidence concerning such drugs. 

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

12 including input on whether there is a relevant ac13 cepted use in clinical practice that is not reflected in 

14 the approved labeling of such drugs or whether new 

15 scientific evidence is available regarding the condi16 tions of use for such drug, by— 

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

18 ‘‘(B) opening a public docket for the sub19 mission of public comments; or 

20 ‘‘(C) other means, as the Secretary deter21 mines appropriate. 

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

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

24 the available scientific evidence meets the standards under 

25 section 505 for adding or modifying information to the 


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1 labeling or providing supplemental information to the la2 beling regarding the use of the covered drug, the Secretary 

3 may initiate the process under subsection (d). 

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

5 If the Secretary determines that labeling changes are ap6 propriate for a selected drug pursuant to subsection (c), 

7 the Secretary shall provide notice to the holders of ap8 proved applications for a generic version of such drug 

9 that— 

10 ‘‘(1) summarizes the findings supporting the 

11 determination of the Secretary that the available sci12 entific evidence meets the standards under section 

13 505 for adding or modifying information or pro14 viding supplemental information to the labeling of 

15 the covered drug pursuant to subsection (c); 

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

17 additional, modified, or supplemental information for 

18 such labeling, according to the determination by the 

19 Secretary (including, as applicable, modifications to 

20 add the relevant accepted use to the labeling of the 

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

22 ‘‘(3) states whether the statement under para23 graph (2) applies to the selected drug as a class of 

24 covered drugs or only to a specific drug product. 


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

2 of receipt of notification provided by the Secretary pursu3 ant to subsection (d), the holder of an approved applica4 tion for a generic version of the selected drug shall— 

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

6 reflect the additional, modified, or supplemental in7 formation the Secretary has determined to be appro8 priate; or 

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

10 approved application does not believe that the re11 quested labeling changes are warranted and submit 

12 a statement detailing the reasons why such changes 

13 are not warranted. 

14 ‘‘(f) REVIEW OF APPLICATION HOLDER’S RE15 SPONSE.— 

16 ‘‘(1) IN GENERAL.—Upon receipt of the appli17 cation holder’s response, the Secretary shall prompt18 ly review each statement received under subsection 

19 (e)(2) and determine which labeling changes pursu20 ant to the Secretary’s notice under subsection (d) 

21 are appropriate, if any. If the Secretary disagrees 

22 with the reasons why such labeling changes are not 

23 warranted, the Secretary shall provide opportunity 

24 for discussions with the application holders to reach 

25 agreement on whether the labeling for the covered 


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1 drug should be updated to reflect available scientific 

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

3 changes. 

4 ‘‘(2) CHANGES TO LABELING.—After consid5 ering all responses from the holder of an approved 

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

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

8 Secretary may order such holder to make the label9 ing changes the Secretary determines are appro10 priate. Such holder of an approved application 

11 shall— 

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

13 at the next printing of that labeling; 

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

15 drug within 30 days of such order; and 

16 ‘‘(C) submit the revised labeling through 

17 the form, ‘Supplement—Changes Being Ef18 fected’. 

19 ‘‘(g) VIOLATION.—If the holder of an approved appli20 cation for the generic version of the selected drug does 

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

22 such generic version of the selected drug shall be deemed 

23 to be misbranded under section 502. 

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


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1 ‘‘(1) IN GENERAL.—With respect to any label2 ing change required under this section, the generic 

3 version shall be deemed to have the same conditions 

4 of use and the same labeling as its reference listed 

5 drug for purposes of clauses (i) and (v) of section 

6 505(j)(2)(A). Any labeling change so required shall 

7 not have any legal effect for the applicant that is 

8 different than the legal effect that would have re9 sulted if a supplemental application had been sub10 mitted and approved to conform the labeling of the 

11 generic version to a change in the labeling of the ref12 erence drug. 

13 ‘‘(2) SUPPLEMENTAL APPLICATIONS.—Changes 

14 to labeling made in accordance with this section 

15 shall not be eligible for an exclusivity period under 

16 this Act. 

17 ‘‘(3) SELECTION OF DRUGS.—Nothing in this 

18 section shall be construed to give the Secretary the 

19 authority to identify a drug as a covered drug or se20 lect a drug label for updating solely based on the 

21 availability of new safety information. Upon identi22 fication of a drug as a covered drug, the Secretary 

23 may then consider the availability of new, additional, 

24 or different safety information in determining 


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1 whether the drug is a selected drug and in deter2 mining what labeling changes are appropriate. 

3 ‘‘(4) MAINTENANCE OF LABELING.—Nothing in 

4 this section shall be construed to affect the responsi5 bility of the holder of an approved application under 

6 section 505(j) to maintain its labeling in accordance 

7 with existing requirements, including subpart B of 

8 part 201 and sections 314.70 and 314.97 of title 21, 

9 Code of Federal Regulations (or any successor regu10 lations). 

11 ‘‘(i) RULES OF CONSTRUCTION.— 

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

13 shall not be construed as altering the applicability of 

14 the standards for approval of an application under 

15 section 505. No order shall be issued under this sub16 section unless the scientific evidence supporting the 

17 changed labeling meets the standards for approval 

18 applicable to any change to labeling under section 

19 505. 

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

21 section shall be construed to limit the authority of 

22 the Secretary to require labeling changes under sec23 tion 505(o). 

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

25 of the enactment of the Making Objective Drug Evidence 


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

2 thereafter, the Secretary shall prepare and submit to the 

3 Committee on Energy and Commerce of the House of 

4 Representatives and the Committee on Health, Education, 

5 Labor, and Pensions of the Senate, a report that— 

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

7 under this section, including— 

8 ‘‘(A) the number of covered drugs and de9 scription of the types of drugs the Secretary 

10 has selected for labeling changes and the ra11 tionale for such recommended changes; and 

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

13 entered into discussions concerning a disagree14 ment with an application holder or holders and 

15 a summary of the decision regarding a labeling 

16 change, if any; and 

17 ‘‘(2) includes any recommendations of the Sec18 retary for modifying the program under this sec19 tion.’’. 

Passed the House of Representatives November 17, 

2020. 

Attest: CHERYL L. JOHNSON, 

Clerk. 


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