I 

115TH CONGRESS 

2D SESSION H. R. 5803 

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

Secretary of Health and Human Services to consider the potential for 

misuse and abuse when determining whether to approve certain drugs, 

and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 15, 2018 

Mr. GENE GREEN of Texas 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 

authorize the Secretary of Health and Human Services 

to consider the potential for misuse and abuse when 

determining whether to approve certain 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 ‘‘Saving American Fam5 ilies through Efficacy and Trusted Ways Act of 2018’’ or 

6 the ‘‘SAFETY Act of 2018’’. 


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•HR 5803 IH

1 SEC. 2. CONSIDERATION OF POTENTIAL FOR MISUSE AND 

2 ABUSE REQUIRED FOR DRUG APPROVAL. 

3 (a) IN GENERAL.—Section 505(d) of the Federal 

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

5 amended— 

6 (1) in the first sentence— 

7 (A) by striking ‘‘or (7)’’ and inserting 

8 ‘‘(7)’’; and 

9 (B) by inserting ‘‘; or (8) if the drug is or 

10 contains a controlled substance for which a list11 ing in any schedule is in effect under the Con12 trolled Substances Act or that is permanently 

13 scheduled pursuant to section 201 of such Act, 

14 on the basis of information submitted to him as 

15 part of the application, or upon the basis of any 

16 other information before him with respect to 

17 such drug, the drug is unsafe for use due to the 

18 risks of abuse or misuse or there is insufficient 

19 information to show that the drug is safe for 

20 use considering such risks;’’ before ‘‘he shall 

21 issue an order refusing to approve the applica22 tion’’; and 

23 (2) in the second sentence, by striking ‘‘(6)’’ 

24 and inserting ‘‘(8)’’. 


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•HR 5803 IH

1 (b) WITHDRAWAL AUTHORITY.—Section 505(e) of 

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

3 355(e)) is amended in the first sentence— 

4 (1) by striking ‘‘or (5)’’ and inserting ‘‘(5)’’; 

5 and 

6 (2) by inserting the following: ‘‘; or (6) that, in 

7 the case of a drug that is or contains a controlled 

8 substance for which a listing in any schedule is in 

9 effect under the Controlled Substances Act or that 

10 is permanently scheduled pursuant to section 201 of 

11 such Act, on the basis of new information before him 

12 with respect to such drug, evaluated together with 

13 the information available to him when the applica14 tion was approved, that the drug is unsafe for use 

15 due to the risks of abuse or misuse’’ after ‘‘of a ma16 terial fact’’. 

17 (c) RULE OF CONSTRUCTION.—Nothing in the 

18 amendments made by this section shall be construed to 

19 limit or narrow, in any manner, the meaning or applica20 tion of the provisions of paragraphs (1), (2), (3), (4), (5), 

21 and (7) of section 505(d) of the Federal Food, Drug, and 

22 Cosmetic Act (21 U.S.C. 355(d)) or paragraphs (1) and 

23 (2) of section 505(e) of such Act (21 U.S.C. 355(e)). 

Æ 


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