S. 2440Senate115th Congress (2017-2019)In Committee

CARES Act

Introduced February 15, 2018

AI-Generated Summary

Updated April 15, 2026 at 8:19 PM UTC

The Comprehensive Addiction Reform, Education, and Safety (CARES) Act of 2018 aims to curb the opioid crisis by tightening regulations, increasing penalties, and boosting enforcement resources. It requires the FDA to review television ads for controlled substances, holds opioid manufacturers more accountable, and creates new DEA heroin‑targeted enforcement groups. The bill primarily affects drug manufacturers, advertisers, and law‑enforcement agencies, while seeking to protect the public from opioid misuse.

Key Provisions

  • The FDA must review any television advertisement for a controlled substance before it can be aired, with $5 million appropriated for 2019‑2023 to support this review process.
  • Civil fines for opioid manufacturers that fail to report suspicious orders or maintain diversion controls can rise to $100,000, and criminal fines for related violations can reach $500,000.
  • The DEA Administrator must annually publish federal and state conviction records of opioid manufacturers, and additional funding is authorized for diversion investigators and tactical squads for fiscal years 2019‑2023.
  • The Attorney General must establish DEA heroin enforcement groups to target illicit heroin trafficking, with $50 million appropriated for FY 2019.

Legislative Activity

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SenateIntro Referral Latest Action

Read twice and referred to the Committee on the Judiciary.

February 15, 2018

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SenateIntro Referral

Introduced in Senate

February 15, 2018

SenateIntro Referral

Read twice and referred to the Committee on the Judiciary.

February 15, 2018

Floor Debate

1 member

What members said about S. 2440 on the floor

1 Democrat
Maria Cantwell
Sen. Maria CantwellD-WA · Jun 11, 2018

Mr. President, today I wish to thank my colleague from California, Senator Feinstein, for including provisions from my legislation, the Comprehensive Addiction Reform, Education, and Safety, CARES,…

Bill Text

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Introduced in SenateIssued February 15, 2018

II

115th CONGRESS

2d Session

S. 2440

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.

Short title

This Act may be cited as the Comprehensive Addiction Reform, Education, and Safety Act of 2018 or the CARES Act.

2.

Opioid advertising and consumer safety

(a)

Requiring FDA review of television advertisements for controlled substances

Section 503C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353c) is amended—

(1)

in subsection (a), by striking The Secretary and inserting Subject to subsection (f), the Secretary;

(2)

in subsection (c), by inserting or (f) after subsection (e);

(3)

by redesignating subsection (f) as subsection (g); and

(4)

by inserting after subsection (e) the following:

(f)

Advertisements for controlled substances

(1)

In general

In the case of a television advertisement for a controlled substance (as defined in section 102 of the Controlled Substances Act)—

(A)

the Secretary shall require the submission of such advertisement under subsection (a); and

(B)

the sponsor of such advertisement may not disseminate the advertisement until the Secretary has conducted the review under this section.

(2)

Authorization of appropriations

There is authorized to be appropriated $5,000,000 for the period of fiscal years 2019 through 2023 to increase the proficiency and speed of the Secretary in conducting and reviewing television advertisements for controlled substances (as so defined) under this section.

.

(b)

Enforcement

Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:

(eee)

The failure to comply with the requirements under section 503C(f).

.

(c)

Rule of construction

No amendment made by this section shall preclude the enforcement, under any relevant civil or other enforcement authority, of a State consumer protection statute.

3.

Increasing civil and criminal penalties

Section 402(c) of the Controlled Substances Act (21 U.S.C. 842(c)) is amended—

(1)

in paragraph (1)(B), by striking shall not exceed $10,000. and inserting the following:

shall not exceed—

(i)

except as provided in clause (ii), $10,000; and

(ii)

if the violation is committed by a manufacturer of opioids and relates to the reporting of suspicious orders for opioids or failing to maintain effective controls against diversion of opioids, $100,000.

; and

(2)

in paragraph (2)—

(A)

in subparagraph (A), by inserting or (D) after subparagraph (B); and

(B)

by adding at the end the following:

(D)

In the case of a violation referred to in subparagraph (A) that was a violation of paragraph (5) or (10) of subsection (a) committed by a manufacturer of opioids that relates to the reporting of suspicious orders for opioids or failing to maintain effective controls against diversion of opioids, the criminal fine under title 18, United States Code, shall not exceed $500,000.

.

4.

Opioid manufacturer accountability and combatting diversion

(a)

Publication of certain records

Not later than 1 year after the date of enactment of this Act, and every year thereafter, the Administrator of the Drug Enforcement Administration shall publish in the Federal Register and on the Internet website of the Drug Enforcement Administration the prior conviction records under Federal and State law of manufacturers of opioids, as described in section 303(a)(4) of the Controlled Substances Act (21 U.S.C. 823(a)(4)).

(b)

Authorization of appropriations

There are authorized to be appropriated to the Administrator of the Drug Enforcement Administration for diversion investigators and tactical diversion squads of the Drug Enforcement Administration such sums as may be necessary for each of fiscal years 2019 through 2023, which shall be in addition to any amounts otherwise made available to the Administrator.

5.

Heroin enforcement groups

(a)

In general

The Attorney General shall establish heroin enforcement groups within the Drug Enforcement Administration to target and dismantle illicit heroin trafficking organizations.

(b)

Funding

There is authorized to be appropriated to carry out this section $50,000,000 for fiscal year 2019.