Title: CARES Act
Policy area: Crime and Law Enforcement

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:

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2440 Introduced in Senate (IS)]

<DOC>






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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

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

SEC. 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.

SEC. 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.''.

SEC. 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.

SEC. 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.
                                 <all>