[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>