115TH CONGRESS 

2D SESSION H. R. 5811 

AN ACT 

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

respect to postapproval study requirements for certain 

controlled substances, 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, 
2 

•HR 5811 EH

1 SECTION 1. POSTAPPROVAL STUDY REQUIREMENTS. 

2 (a) PURPOSES OF STUDY.—Section 505(o)(3)(B) of 

3 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

4 355(o)(3)(B)) is amended by adding at the end the fol5 lowing: 

6 ‘‘(iv) To assess a potential reduction 

7 in effectiveness of the drug for the condi8 tions of use prescribed, recommended, or 

9 suggested in the labeling thereof if— 

10 ‘‘(I) the drug involved— 

11 ‘‘(aa) is or contains a sub12 stance for which a listing in any 

13 schedule is in effect (on a tem14 porary or permanent basis) under 

15 section 201 of the Controlled 

16 Substances Act; or 

17 ‘‘(bb) is a drug that has not 

18 been approved under this section 

19 or licensed under section 351 of 

20 the Public Health Service Act, 

21 for which an application for such 

22 approval or licensure is pending 

23 or anticipated, and for which the 

24 Secretary provides notice to the 

25 sponsor that the Secretary in26 tends to issue a scientific and 
3 

•HR 5811 EH

1 medical evaluation and rec2 ommend controls under the Con3 trolled Substances Act; and 

4 ‘‘(II) the potential reduction in 

5 effectiveness could result in the bene6 fits of the drug no longer outweighing 

7 the risks.’’. 

8 (b) ESTABLISHMENT OF REQUIREMENT.—Section 

9 505(o)(3)(C) of the Federal Food, Drug, and Cosmetic 

10 Act (21 U.S.C. 355(o)(3)(C)) is amended by striking 

11 ‘‘such requirement’’ and all that follows through ‘‘safety 

12 information.’’ and inserting the following: ‘‘such require13 ment— 

14 ‘‘(i) in the case of a purpose described 

15 in clause (i), (ii), or (iii) of subparagraph 

16 (B), only if the Secretary becomes aware of 

17 new safety information; and 

18 ‘‘(ii) in the case of a purpose de19 scribed in clause (iv) of such subpara20 graph, if the Secretary determines that 

21 new effectiveness information exists.’’. 

22 (c) APPLICABILITY.—Section 505(o)(3) of the Fed23 eral Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)) 

24 is amended by adding at the end the following new sub25 paragraph: 
4 

•HR 5811 EH

1 ‘‘(G) APPLICABILITY.—The conduct of a 

2 study or clinical trial required pursuant to this 

3 paragraph for the purpose specified in subpara4 graph (B)(iv) shall not be considered a new 

5 clinical investigation for the purpose of a period 

6 of exclusivity under clause (iii) or (iv) of sub7 section (c)(3)(E) or clause (iii) or (iv) of sub8 section (j)(5)(F).’’. 

9 (d) NEW EFFECTIVENESS INFORMATION DE10 FINED.—Section 505(o)(2) of the Federal Food, Drug, 

11 and Cosmetic Act (21 U.S.C. 355(o)(2)) is amended by 

12 adding at the end the following new subparagraph: 

13 ‘‘(D) NEW EFFECTIVENESS INFORMA14 TION.—The term ‘new effectiveness informa15 tion’, with respect to a drug that is or contains 

16 a controlled substance for which a listing in any 

17 schedule is in effect (on a temporary or perma18 nent basis) under section 201 of the Controlled 

19 Substances Act, means new information about 

20 the effectiveness of the drug, including a new 

21 analysis of existing information, derived from— 

22 ‘‘(i) a clinical trial; an adverse event 

23 report; a postapproval study or clinical 

24 trial (including a study or clinical trial 

25 under paragraph (3)); 
5 

•HR 5811 EH

1 ‘‘(ii) peer-reviewed biomedical lit2 erature; 

3 ‘‘(iii) data derived from the 

4 postmarket risk identification and analysis 

5 system under subsection (k); or 

6 ‘‘(iv) other scientific data determined 

7 to be appropriate by the Secretary.’’. 

8 (e) CONFORMING AMENDMENTS WITH RESPECT TO

9 LABELING CHANGES.—Section 505(o)(4) of the Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(4)) is 

11 amended— 

12 (1) in subparagraph (A)— 

13 (A) in the heading, by inserting ‘‘OR NEW

14 EFFECTIVENESS’’ after ‘‘SAFETY’’; 

15 (B) by striking ‘‘safety information’’ and 

16 inserting ‘‘new safety information or new effec17 tiveness information such’’; and 

18 (C) by striking ‘‘believes should be’’ and 

19 inserting ‘‘believes changes should be made to’’; 

20 (2) in subparagraph (B)(i)— 

21 (A) by striking ‘‘new safety information’’ 

22 and by inserting ‘‘new safety information or 

23 new effectiveness information’’; and 

24 (B) by inserting ‘‘indications,’’ after 

25 ‘‘boxed warnings,’’; 
6 

•HR 5811 EH

1 (3) in subparagraph (C), by inserting ‘‘or new 

2 effectiveness information’’ after ‘‘safety informa3 tion’’; and 

4 (4) in subparagraph (E), by inserting ‘‘or new 

5 effectiveness information’’ after ‘‘safety informa6 tion’’. 

7 (f) RULE OF CONSTRUCTION.—Nothing in the 

8 amendments made by this section shall be construed to 

9 alter, in any manner, the meaning or application of the 

10 provisions of paragraph (3) of section 505(o) of the Fed11 eral Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)) 

12 with respect to the authority of the Secretary of Health 

13 and Human Services to require a postapproval study or 

14 clinical trial for a purpose specified in clauses (i) through 

15 (iii) of subparagraph (B) of such paragraph (3) or para16 graph (4) of such section 505(o) with respect to the Sec17 retary’s authority to require safety labeling changes. 

Passed the House of Representatives June 19, 2018. 

Attest: 

Clerk. 

115TH CONGRESS 

2D SESSION H. R. 5811 

AN ACT 

To amend the Federal Food, Drug, and Cosmetic 

other purposes. ments for certain controlled substances, and for Act with respect to postapproval study require-