FDA Accountability for Public Safety Act

Bill: 116-s-418
Sponsor: full_name: Sen. Manchin, Joe, III [D-WV]
Introduced: 2019-02-07
Policy area: Health
Subjects: 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
Latest action: action_date: 2019-02-07
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2019-02-07
action_desc: Introduced in Senate
text: <p><b>FDA Accountability for Public Safety Act</b></p> This bill establishes additional procedures related to the market approval process for opioids. <p>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. </p> <p>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.</p>

tv_txt: II 116th CONGRESS 1st Session S. 418 IN THE SENATE OF THE UNITED STATES February 7, 2019 Mr. Manchin (for himself, Mrs. Capito , and Mr. King ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To establish procedures regarding the approval of opioid drugs by the Food and Drug Administration.

1. Short title This Act may be cited as the FDA Accountability for Public Safety Act . 2. Approval against the recommendation of the FDA advisory committee on opioid drugs (a) In General Any approval of an application or supplement to an application under section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ) for a drug that is an opioid against the recommendation of the advisory committee pursuant to section 106 of the Comprehensive Drug and Recovery Act of 2016 ( Public Law 114–198 ) shall be made by the Commissioner of Food and Drugs (referred to in this section as the Commissioner ) and shall not be delegated. (b) Reports to Congress If the Commissioner approves a drug as described in subsection (a), the Commissioner shall— (1) submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and to any member of Congress that requests the report, that includes— (A) medical and scientific evidence regarding patient safety that clearly supports the Commissioner's decision to approve the opioid drug against the recommendation of the advisory committee; and (B) a disclosure of any potential conflicts of interest that may exist regarding any official of the Food and Drug Administration who was involved in the decision to approve the drug prior to the Commissioner's final decision under subsection (a); and (2) at the request of the Committee on Health, Education, Labor, and Pensions of the Senate or the Committee on Energy and Commerce of the House of Representatives, testify before that committee regarding the Commissioner's decision to approve the opioid drug against the recommendation of the advisory committee. (c) Prohibition on marketing A drug approved as described in subsection (a) shall not be introduced or delivered for introduction into interstate commerce until the report described in subsection (b)(1) has been submitted to Congress. (d) Scope of advisory committee review Section 106(a)(1)(A) of the Comprehensive Addiction and Recovery Act of 2016 ( Public Law 114–198 ) is amended— (1) by inserting , or supplement to an application, after application each place such term appears; and (2) by striking of a new and inserting for .