IB 

Union Calendar No. 471 

116TH CONGRESS 

2D SESSION H. R. 5668 

[Report No. 116–573] 

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 

NOVEMBER 16, 2020 

Additional sponsor: Mr. TAYLOR

NOVEMBER 16, 2020 

Reported with an amendment; committed to the Committee of the Whole 

House on the State of the Union and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on January 24, 2020] 


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A BILL 

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

modernize the labeling of certain generic drugs, and for 

other purposes. 


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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’’. 

7 SEC. 2. MODERNIZING THE LABELING OF CERTAIN GE8 NERIC DRUGS. 

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

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

11 section 503C the following: 

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

13 DRUGS. 

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

15 ‘‘(1) The term ‘covered drug’ means a drug ap16 proved under section 505(c)— 

17 ‘‘(A) for which there are no unexpired pat18 ents included in the list under section 505(j)(7) 

19 and no unexpired period of exclusivity; 

20 ‘‘(B) for which the approval of the applica21 tion has been withdrawn for reasons other than 

22 safety or effectiveness; and 

23 ‘‘(C) for which— 

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

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1 tions of use that is not reflected in the label2 ing; 

3 ‘‘(II) the approved labeling does not re4 flect current legal and regulatory require5 ments for content or format; or 

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

7 in clinical practice that is not reflected in 

8 the approved labeling; and 

9 ‘‘(ii) updating the labeling would ben10 efit the public health. 

11 ‘‘(2) The term ‘period of exclusivity’, with respect 

12 to a drug approved under section 505(c), means any 

13 period of exclusivity under clause (ii), (iii), or (iv) of 

14 section 505(c)(3)(E), clause (ii), (iii), or (iv) of sec15 tion 505(j)(5)(F), or section 505A, 505E, or 527. 

16 ‘‘(3) The term ‘generic version’ means a drug ap17 proved under section 505(j) whose reference listed 

18 drug is a covered drug. 

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

20 use for a drug in clinical practice that is supported 

21 by scientific evidence that appears to the Secretary to 

22 meet the standards for approval under section 505. 

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

24 drug for which the Secretary has determined through 


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1 the process under subsection (c) that the labeling 

2 should be changed. 

3 ‘‘(b) IDENTIFICATION OF COVERED DRUGS.—The Sec4 retary may identify covered drugs for which labeling up5 dates would provide a public health benefit. To assist in 

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

7 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 accept13 ed use in clinical practice that is not reflected in the 

14 approved labeling of such drugs or whether new sci15 entific evidence is available regarding the conditions 

16 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 

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1 beling or providing supplemental information to the label2 ing regarding the use of the covered drug, the Secretary may 

3 initiate the process under subsection (d). 

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

5 the Secretary determines that labeling changes are appro6 priate for a selected drug pursuant to subsection (c), the 

7 Secretary shall provide notice to the holders of approved 

8 applications for a generic version of such drug that— 

9 ‘‘(1) summarizes the findings supporting the de10 termination of the Secretary that the available sci11 entific evidence meets the standards under section 505 

12 for adding or modifying information or providing 

13 supplemental information to the labeling of the cov14 ered drug pursuant to subsection (c); 

15 ‘‘(2) provides a clear statement regarding the ad16 ditional, 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 para22 graph (2) applies to the selected drug as a class of 

23 covered drugs or only to a specific drug product. 

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

25 receipt of notification provided by the Secretary pursuant 


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1 to subsection (d), the holder of an approved application for 

2 a generic version of the selected drug shall— 

3 ‘‘(1) agree to change the approved labeling to re4 flect the additional, modified, or supplemental infor5 mation the Secretary has determined to be appro6 priate; or 

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

8 approved application does not believe that the re9 quested labeling changes are warranted and submit a 

10 statement detailing the reasons why such changes are 

11 not warranted. 

12 ‘‘(f) REVIEW OF APPLICATION HOLDER’S RE13 SPONSE.— 

14 ‘‘(1) IN GENERAL.—Upon receipt of the applica15 tion holder’s response, the Secretary shall promptly 

16 review each statement received under subsection (e)(2) 

17 and determine which labeling changes pursuant to the 

18 Secretary’s notice under subsection (d) are appro19 priate, if any. If the Secretary disagrees with the rea20 sons why such labeling changes are not warranted, the 

21 Secretary shall provide opportunity for discussions 

22 with the application holders to reach agreement on 

23 whether the labeling for the covered drug should be 

24 updated to reflect available scientific evidence, and if 

25 so, the content of such labeling changes. 


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1 ‘‘(2) CHANGES TO LABELING.—After considering 

2 all responses from the holder of an approved applica3 tion under paragraph (1) or (2) of subsection (e), and 

4 any discussion under paragraph (1), the Secretary 

5 may order such holder to make the labeling changes 

6 the Secretary determines are appropriate. 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 the 

13 form, ‘Supplement—Changes Being Effected’. 

14 ‘‘(g) VIOLATION.—If the holder of an approved appli15 cation for the generic version of the selected drug does not 

16 comply with the requirements of subsection (f)(2), such ge17 neric version of the selected drug shall be deemed to be mis18 branded under section 502. 

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

20 ‘‘(1) IN GENERAL.—With respect to any labeling 

21 change required under this section, the generic version 

22 shall be deemed to have the same conditions of use 

23 and the same labeling as its reference listed drug for 

24 purposes of clauses (i) and (v) of section 505(j)(2)(A). 

25 Any labeling change so required shall not have any 


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1 legal effect for the applicant that is different than the 

2 legal effect that would have resulted if a supplemental 

3 application had been submitted and approved to con4 form the labeling of the generic version to a change 

5 in the labeling of the reference drug. 

6 ‘‘(2) SUPPLEMENTAL APPLICATIONS.—Changes to 

7 labeling made in accordance with this section shall 

8 not be eligible for an exclusivity period under this 

9 Act. 

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

11 section shall be construed to give the Secretary the au12 thority to identify a drug as a covered drug or select 

13 a drug label for updating solely based on the avail14 ability of new safety information. Upon identification 

15 of a drug as a covered drug, the Secretary may then 

16 consider the availability of new, additional, or dif17 ferent safety information in determining whether the 

18 drug is a selected drug and in determining what la19 beling changes are appropriate. 

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

21 this section shall be construed to affect the responsi22 bility of the holder of an approved application under 

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

24 with existing requirements, including subpart B of 

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


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1 Code of Federal Regulations (or any successor regula2 tions). 

3 ‘‘(i) RULES OF CONSTRUCTION.— 

4 ‘‘(1) APPROVAL STANDARDS.—This section shall 

5 not be construed as altering the applicability of the 

6 standards for approval of an application under sec7 tion 505. No order shall be issued under this sub8 section unless the scientific evidence supporting the 

9 changed labeling meets the standards for approval ap10 plicable to any change to labeling under section 505. 

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

12 section shall be construed to limit the authority of the 

13 Secretary to require labeling changes under section 

14 505(o). 

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

16 of the enactment of the Making Objective Drug Evidence 

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

18 thereafter, the Secretary shall prepare and submit to the 

19 Committee on Energy and Commerce of the House of Rep20 resentatives and the Committee on Health, Education, 

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

22 ‘‘(1) describes the actions of the Secretary under 

23 this section, including— 

24 ‘‘(A) the number of covered drugs and de25 scription of the types of drugs the Secretary has 


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1 selected for labeling changes and the rationale for 

2 such recommended changes; and 

3 ‘‘(B) the number of times the Secretary en4 tered into discussions concerning a disagreement 

5 with an application holder or holders and a 

6 summary of the decision regarding a labeling 

7 change, if any; and 

8 ‘‘(2) includes any recommendations of the Sec9 retary for modifying the program under this sec10 tion.’’. 


pamtmann on DSKBC07HB2PROD with BILLS
Union Calendar No. 471 

116TH CONGRESS 

2D SESSION H. R. 5668 

[Report No. 116–573] 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

drugs, and for other purposes. Act to modernize the labeling of certain generic 

NOVEMBER 16, 2020 

Reported with an amendment; committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union 


pamtmann on DSKBC07HB2PROD with BILLS