II 

115TH CONGRESS 

2D SESSION S. 2440 

To combat the opioid epidemic by reforming existing laws and providing 

for the public’s safety, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 15, 2018 

Ms. CANTWELL (for herself and Ms. HARRIS) introduced the following bill; 

which was read twice and referred to the Committee on the Judiciary 

A BILL 

To combat the opioid epidemic by reforming existing laws 

and providing for the public’s safety, 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 ‘‘Comprehensive Addic5 tion Reform, Education, and Safety Act of 2018’’ or the 

6 ‘‘CARES Act’’. 

7 SEC. 2. OPIOID ADVERTISING AND CONSUMER SAFETY. 

8 (a) REQUIRING FDA REVIEW OF TELEVISION AD9 VERTISEMENTS FOR CONTROLLED SUBSTANCES.—SecVerDate Sep 11 2014 23:51 Feb 20, 2018 Jkt 079200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2440.IS S2440

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1 tion 503C of the Federal Food, Drug, and Cosmetic Act 

2 (21 U.S.C. 353c) is amended— 

3 (1) in subsection (a), by striking ‘‘The Sec4 retary’’ and inserting ‘‘Subject to subsection (f), the 

5 Secretary’’; 

6 (2) in subsection (c), by inserting ‘‘or (f)’’ after 

7 ‘‘subsection (e)’’; 

8 (3) by redesignating subsection (f) as sub9 section (g); and 

10 (4) by inserting after subsection (e) the fol11 lowing: 

12 ‘‘(f) ADVERTISEMENTS FOR CONTROLLED SUB13 STANCES.— 

14 ‘‘(1) IN GENERAL.—In the case of a television 

15 advertisement for a controlled substance (as defined 

16 in section 102 of the Controlled Substances Act)— 

17 ‘‘(A) the Secretary shall require the sub18 mission of such advertisement under subsection 

19 (a); and 

20 ‘‘(B) the sponsor of such advertisement 

21 may not disseminate the advertisement until the 

22 Secretary has conducted the review under this 

23 section. 

24 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 

25 There is authorized to be appropriated $5,000,000 


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1 for the period of fiscal years 2019 through 2023 to 

2 increase the proficiency and speed of the Secretary 

3 in conducting and reviewing television advertise4 ments for controlled substances (as so defined) 

5 under this section.’’. 

6 (b) ENFORCEMENT.—Section 301 of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend8 ed by adding at the end the following: 

9 ‘‘(eee) The failure to comply with the requirements 

10 under section 503C(f).’’. 

11 (c) RULE OF CONSTRUCTION.—No amendment made 

12 by this section shall preclude the enforcement, under any 

13 relevant civil or other enforcement authority, of a State 

14 consumer protection statute. 

15 SEC. 3. INCREASING CIVIL AND CRIMINAL PENALTIES. 

16 Section 402(c) of the Controlled Substances Act (21 

17 U.S.C. 842(c)) is amended— 

18 (1) in paragraph (1)(B), by striking ‘‘shall not 

19 exceed $10,000.’’ and inserting the following: ‘‘shall 

20 not exceed— 

21 ‘‘(i) except as provided in clause (ii), 

22 $10,000; and 

23 ‘‘(ii) if the violation is committed by a 

24 manufacturer of opioids and relates to the 

25 reporting of suspicious orders for opioids 


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1 or failing to maintain effective controls 

2 against diversion of opioids, $100,000.’’; 

3 and 

4 (2) in paragraph (2)— 

5 (A) in subparagraph (A), by inserting ‘‘or 

6 (D)’’ after ‘‘subparagraph (B)’’; and 

7 (B) by adding at the end the following: 

8 ‘‘(D) In the case of a violation referred to in subpara9 graph (A) that was a violation of paragraph (5) or (10) 

10 of subsection (a) committed by a manufacturer of opioids 

11 that relates to the reporting of suspicious orders for 

12 opioids or failing to maintain effective controls against di13 version of opioids, the criminal fine under title 18, United 

14 States Code, shall not exceed $500,000.’’. 

15 SEC. 4. OPIOID MANUFACTURER ACCOUNTABILITY AND 

16 COMBATTING DIVERSION. 

17 (a) PUBLICATION OF CERTAIN RECORDS.—Not later 

18 than 1 year after the date of enactment of this Act, and 

19 every year thereafter, the Administrator of the Drug En20 forcement Administration shall publish in the Federal 

21 Register and on the Internet website of the Drug Enforce22 ment Administration the prior conviction records under 

23 Federal and State law of manufacturers of opioids, as de24 scribed in section 303(a)(4) of the Controlled Substances 

25 Act (21 U.S.C. 823(a)(4)). 


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1 (b) AUTHORIZATION OF APPROPRIATIONS.—There 

2 are authorized to be appropriated to the Administrator of 

3 the Drug Enforcement Administration for diversion inves4 tigators and tactical diversion squads of the Drug En5 forcement Administration such sums as may be necessary 

6 for each of fiscal years 2019 through 2023, which shall 

7 be in addition to any amounts otherwise made available 

8 to the Administrator. 

9 SEC. 5. HEROIN ENFORCEMENT GROUPS. 

10 (a) IN GENERAL.—The Attorney General shall estab11 lish heroin enforcement groups within the Drug Enforce12 ment Administration to target and dismantle illicit heroin 

13 trafficking organizations. 

14 (b) FUNDING.—There is authorized to be appro15 priated to carry out this section $50,000,000 for fiscal 

16 year 2019. 

Æ 


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