Opioid QuOTA Act

II 116TH CONGRESS 1ST SESSION S. 1366 To amend the Controlled Substances Act to require the Attorney General to make procurement quotas for opioid analgesics publicly available, and for other purposes. IN THE SENATE OF THE UNITED STATES MAY 8, 2019 Mr. MARKEY (for himself, Mrs. SHAHEEN, Mr. BROWN, Mr. DURBIN, Ms. HASSAN, and Mr. MANCHIN) introduced the following bill; which was read twice and referred to the Committee on the Judiciary A BILL To amend the Controlled Substances Act to require the At- torney General to make procurement quotas for opioid analgesics publicly available, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Opioid Quota Open- 4 ness, Transparency, and Awareness Act of 2019’’ or the 5 ‘‘Opioid QuOTA Act’’. 6 VerDate Sep 11 2014 01:20 May 15, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1366.IS S1366 pamtmann on DSKBFK8HB2PROD with BILLS 2 •S 1366 IS SEC. 2. PUBLIC REPORTING OF PROCUREMENT QUOTAS 1 FOR OPIOID ANALGESICS. 2 (a) IN GENERAL.—Section 306 of the Controlled 3 Substances Act (21 U.S.C. 826) is amended by adding at 4 the end the following: 5 ‘‘(j)(1) In this subsection, the term ‘opioid procure- 6 ment quota’ means a quota established by the Attorney 7 General for the quantity of opioid analgesics that a reg- 8 istered manufacturer may procure for purposes of manu- 9 facturing dosage forms or other substances. 10 ‘‘(2) The Attorney General shall make publicly avail- 11 able, including through the website of the Drug Enforce- 12 ment Administration— 13 ‘‘(A) the quantity of the opioid procurement 14 quota for each registered manufacturer for each 15 year; 16 ‘‘(B) the quantity of opioid analgesics procured 17 by each registered manufacturer for each year; and 18 ‘‘(C) except as provided under paragraph (3)— 19 ‘‘(i) a copy of the form or other applica- 20 tion, including any attachments or exhibits, 21 submitted by each registered manufacturer re- 22 questing an opioid procurement quota; and 23 ‘‘(ii) a copy of each year-end or annual re- 24 port relating to the procurement or use of 25 opioid analgesics submitted to the Attorney 26 VerDate Sep 11 2014 01:20 May 15, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1366.IS S1366 pamtmann on DSKBFK8HB2PROD with BILLS 3 •S 1366 IS General by a registered manufacturer to whom 1 the Attorney General has issued an opioid pro- 2 curement quota. 3 ‘‘(3) Upon a request by a registered manufacturer as- 4 serting that a document or information described in clause 5 (i) or (ii) of paragraph (2)(C) is exempt from disclosure 6 under section 552(b)(4) of title 5, United States Code, and 7 to the extent that the Attorney General determines that 8 the document or information is exempt from disclosure 9 under such section 552(b)(4), the document or informa- 10 tion may be excluded from public disclosure under para- 11 graph (2).’’. 12 (b) GAO REPORT.—The Comptroller General of the 13 United States shall submit to Congress a report that, for 14 the 1-year period beginning on the date of enactment of 15 this Act— 16 (1) details— 17 (A) the number of instances in which a 18 registered manufacturer made a request de- 19 scribed in section 306(j)(3) of the Controlled 20 Substances Act, as added by subsection (a), 21 with respect to a document or information; and 22 (B) the number of instances in which the 23 Attorney General determined such a document 24 or information was exempt from disclosure 25 VerDate Sep 11 2014 01:20 May 15, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1366.IS S1366 pamtmann on DSKBFK8HB2PROD with BILLS 4 •S 1366 IS under section 552(b)(4) of title 5, United 1 States Code; and 2 (2) evaluates the extent of the independent 3 evaluation conducted by the Attorney General of re- 4 quests described in section 306(j)(3) of the Con- 5 trolled Substances Act. 6 Æ VerDate Sep 11 2014 01:20 May 15, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\S1366.IS S1366 pamtmann on DSKBFK8HB2PROD with BILLS