CARES Act

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 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 (1) in subsection (a), by striking The Secretary Subject to subsection (f), the Secretary (2) in subsection (c), by inserting or (f) 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 (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) (1) in paragraph (1)(B), by striking shall not exceed $10,000. 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) subparagraph (B) (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.

Summary: Comprehensive Addiction Reform, Education, and Safety Act of 2018 or the CARES Act This bill establishes new requirements related to the marketing and distribution of controlled substances. Among other things, the bill does the following: requires predissemination review of television advertisements for controlled substances, increases penalties for drug manufacturers who commit certain violations involving opioids, and requires the prior conviction records of opioid manufacturers to be made publicly available.