Short title

This Act may be cited as the

Comprehensive Addiction Reform, Education, and Safety Act of 2018

or the

CARES Act

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.

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.

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.

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.