3.0.0 418 2022-11-01T15:47:44Z 2022-11-01T15:47:44Z Senate S 2019-02-07 116 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2019-02-07T21:45:34Z FDA Accountability for Public Safety Act 116 5632 HR 2020-01-16 Referred to the House Committee on Energy and Commerce. Identical bill CRS 2019-02-07 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2019-02-07 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 2019-02-07 True K000383 Sen. King, Angus S., Jr. [I-ME] Angus King I ME S. 2019-02-07 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 2019-02-07 Introduced in Senate 2021-09-02T15:44:03Z FDA Accountability for Public Safety Act

This bill establishes additional procedures related to the market approval process for opioids.

Under the bill, a Food and Drug Administration (FDA) advisory committee must make recommendations regarding supplemental applications for opioids. Current law requires only that an FDA committee make recommendations on new drug applications.

The bill specifies that only the Commissioner of Food and Drugs may approve an opioid-related application against the recommendation of the committee. If the Commissioner approves such an application against a committee recommendation, the Commissioner must submit a report to Congress that includes (1) the evidence regarding patient safety that supports the Commissioner's decision, and (2) a disclosure of any potential conflicts of interest of FDA officials involved in the decision. The Commissioner must also testify before Congress regarding the decision, upon request. The drug in question may not be sold until the Commissioner has submitted the required report.

]]> FDA Accountability for Public Safety Act Display Title FDA Accountability for Public Safety Act Short Title(s) as Introduced FDA Accountability for Public Safety Act Introduced in Senate IS 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 Introduced in Senate 2019-02-07T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s418is/xml/BILLS-116s418is.xml 2019-02-07 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.