3.0.0 1584 2022-11-01T05:47:44Z 2022-11-01T05:47:44Z Senate S 2019-05-21 116 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2019-05-21T22:28:23Z Opioid Crisis Accountability Act of 2019 116 2917 HR 2019-05-23 Referred to the Subcommittee on Health. Identical bill CRS 2019-05-21 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2019-05-21 Introduced in Senate IntroReferral 10000 9 Library of Congress S000033 Sen. Sanders, Bernard [I-VT] Bernard Sanders I VT N B001267 Sen. Bennet, Michael F. [D-CO] Michael Bennet D CO 2019-05-21 True H001075 Sen. Harris, Kamala D. [D-CA] Kamala Harris D CA D. 2019-05-21 True B001277 Sen. Blumenthal, Richard [D-CT] Richard Blumenthal D CT 2019-05-21 True Health Child health Civil actions and liability Consumer affairs Corporate finance and management Criminal procedure and sentencing Drug safety, medical device, and laboratory regulation Drug trafficking and controlled substances Drug, alcohol, tobacco use Government studies and investigations Government trust funds Health care coverage and access Health programs administration and funding Marketing and advertising Prescription drugs Securities Wages and earnings Health 00 2019-05-21 Introduced in Senate 2020-01-25T19:55:49Z Opioid Crisis Accountability Act of 2019

This bill establishes a series of restrictions and requirements relating to opioid marketing and distribution practices.

Specifically, the bill prohibits (1) knowingly making false advertising or marketing claims regarding the addictive nature of opioids; (2) knowingly supplying communities with quantities of opioids that are not medically reasonable; or (3) failing to report distribution orders, or patterns of orders, while knowing that the orders are not being dispensed in a medically reasonable manner. Employees of opioid manufacturers and distributors are subject to civil penalties and imprisonment for violations; corporations and executives are subject to civil penalties. Manufacturers shall also lose their period of market exclusivity.

Additionally, the Department of Health and Human Services must assess a fee against each corporation that, between January 1, 1993, and the date of enactment of this bill, manufactured or distributed opioids, if such opioids were covered under a federal health program at least once during this period. Manufacturers that fail to pay the fee shall lose associated drug approval until the fee is paid in full.

The bill authorizes collected civil penalties and fees to be used for activities that address opioid misuse and abuse, including family and educational programs.

]]> Opioid Crisis Accountability Act of 2019 Display Title Opioid Crisis Accountability Act of 2019 Short Title(s) as Introduced Opioid Crisis Accountability Act of 2019 Introduced in Senate IS Official Title as Introduced A bill to hold pharmaceutical companies accountable for dubious marketing and distribution of opioid products and for their role in creating and exacerbating the opioid epidemic in the United States. Introduced in Senate IS Introduced in Senate 2019-05-21T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s1584is/xml/BILLS-116s1584is.xml 2019-05-21 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.