3.0.0 1078 2023-01-11T13:36:29Z 2023-01-11T13:36:29Z Senate S 2017-05-09 115 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2017-05-09T20:07:14Z 2017-05-09 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2017-05-09 Introduced in Senate IntroReferral 10000 9 Library of Congress M001183 Sen. Manchin, Joe, III [D-WV] Joseph Manchin D WV N C001047 Sen. Capito, Shelley Moore [R-WV] Shelley Capito R WV Moore 2017-05-09 True M001170 Sen. McCaskill, Claire [D-MO] Claire McCaskill D MO 2017-05-09 True K000383 Sen. King, Angus S., Jr. [I-ME] Angus King I ME S. 2017-05-09 True Health Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug trafficking and controlled substances Federal officials Food and Drug Administration (FDA) Government ethics and transparency, public corruption Marketing and advertising Prescription drugs Health 00 2017-05-09 Introduced in Senate 2018-05-08T20:53:42Z FDA Accountability for Public Safety Act

This bill amends the Comprehensive Addiction and Recovery Act of 2016 to expand the scope of the Food and Drug Administration (FDA) advisory committee to make recommendations regarding supplemental applications for opioids. Currently, the committee only makes recommendations on new drug applications.

Only the Commissioner of Food and Drugs may approve a new drug application or supplement to an application for an opioid against the recommendation of the committee. If the Commissioner approves a drug against the recommendation of the committee, the Commissioner must: (1) submit a report to Congress that includes the evidence regarding patient safety that supports the Commissioner's decision and a disclosure of any potential conflicts of interest of FDA officials involved in the decision; and (2) testify before Congress regarding the decision, upon request. Such a drug cannot be sold until the Commissioner has submitted the report.

]]> FDA Accountability for Public Safety Act Display Title FDA Accountability for Public Safety Act Official Title as Introduced A bill to establish procedures regarding the approval of opioid drugs by the Food and Drug Administration. Introduced in Senate IS Short Titles as Introduced FDA Accountability for Public Safety Act Introduced in Senate 2017-05-09T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115s1078is/xml/BILLS-115s1078is.xml 2017-05-09 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.