IN THE SENATE OF THE UNITED STATES
December 7, 2021
Mr. Markey (for himself, Mr. Manchin, Mr. Brown, and Mr. Durbin) introduced the following bill; which was read twice and referred to the Committee on the Judiciary
To amend the Controlled Substances Act to require the Attorney General to make procurement quotas for opioid analgesics publicly available, and for other purposes.
This Act may be cited as the
Opioid Quota Openness, Transparency, and Awareness Act of 2021 or the
Opioid QuOTA Act of 2021.
Public reporting of procurement quotas for opioid analgesics
Section 306 of the Controlled Substances Act (21 U.S.C. 826) is amended by adding at the end the following:
In this subsection, the term opioid procurement quota means a quota established by the Attorney General for the quantity of opioid analgesics that a registered manufacturer may procure for purposes of manufacturing dosage forms or other substances.
The Attorney General shall make publicly available, including through the website of the Drug Enforcement Administration—
the quantity of the opioid procurement quota for each registered manufacturer for each year;
the quantity of opioid analgesics procured by each registered manufacturer for each year; and
except as provided under paragraph (3)—
a copy of the form or other application, including any attachments or exhibits, submitted by each registered manufacturer requesting an opioid procurement quota; and
a copy of each year-end or annual report relating to the procurement or use of opioid analgesics submitted to the Attorney General by a registered manufacturer to whom the Attorney General has issued an opioid procurement quota.
Upon request by a registered manufacturer, the Attorney General may redact information identified in clause (i) or (ii) of paragraph (2)(C) from the publication required under paragraph (2) if the Attorney General determines that public disclosure of that information is likely to cause substantial harm to the competitive position of the registered manufacturer. For purposes of a determination under this subparagraph, adverse publicity or embarrassment shall not constitute competitive harm.
A determination of the Attorney General under subparagraph (A) shall be subject to judicial review in accordance with chapter 7 of title 5, United States Code.
The Attorney General shall annually publish a report on the website of the Department of Justice containing an accounting of each declination determination made under subparagraph (A), including the reason for the declination, during the time period covered by the report.
The Comptroller General of the United States shall submit to Congress a report that, for the 1-year period beginning on the date of enactment of this Act—
the number of instances in which a registered manufacturer made a request described in section 306(j)(3) of the Controlled Substances Act, as added by subsection (a), with respect to a document or information; and
the number of instances in which the Attorney General redacted information described in clause (i) or (ii) of subsection (j)(2)(C) of the Controlled Substances Act, as added by subsection (a), from the publication required under such subsection (j)(2); and
evaluates, in a fair, compliant, and transparent manner, the extent of the independent evaluation conducted by the Attorney General of requests described in section 306(j)(3) of the Controlled Substances Act, as added by subsection (a).