Section 1 Short title
This Act may be cited as the “Comprehensive Addiction Reform, Education, and Safety Act of 2018” or the “CARES Act”.
Comprehensive Addiction Reform, Education, and Safety Act of 2018
A BILL
To combat the opioid epidemic by reforming existing laws and providing for the public's safety, and for other purposes.
Sec. 2 Opioid advertising and consumer safety
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—
in subsection (a), by striking “The Secretary” and inserting “Subject to subsection (f), the Secretary”;
in subsection (c), by inserting “or (f)” after “subsection (e)”;
by redesignating subsection (f) as subsection (g); and
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.”
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).”
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.
Sec. 3 Increasing civil and criminal penalties
Section 402(c) of the Controlled Substances Act (21 U.S.C. 842(c)) is amended—
in paragraph (1)(B), by striking “shall not exceed $10,000.” and inserting the following:
“(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.”
in paragraph (2)—
in subparagraph (A), by inserting “or (D)” after “subparagraph (B)”; and
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.”
Sec. 4 Opioid manufacturer accountability and combatting diversion
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)).
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.