S. 418: FDA Accountability for Public Safety Act
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S. 418: FDA Accountability for Public Safety Act
116th Congress · introduced 2019-02-07 · Health · Latest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
federal
Follow this bill, step by step
- Where it came from: introduced 2019-02-07 · official record
- Who proposed it: Sen. Manchin, Joe, III [D-WV] · what a sponsor is
- What happened next: no floor votes in our records yet. Why?
- Where it stands now: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Not final yet: this can still change. We check for updates every day.
- If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.
Official title
FDA Accountability for Public Safety Act
Plain summary
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.
Congressional Research Service summary (Introduced in Senate), quoted unchanged (nonpartisan). Read the source.
What a vote does
A “Yea” vote
If it passes both chambers and is signed, it becomes law.
A “Nay” vote
If it is not passed, current law stays as it is.
PSI Sci description of the legislative step (not an opinion).
What does this mean? (plain words)
Official text
FDA Accountability for Public Safety Act
Source: Congressional Research Service summary (Introduced in Senate)
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The strongest published arguments
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How did my representative vote? · This bill's floor votes
Officials and money
Sponsor: Sen. Manchin, Joe, III [D-WV] · 2 cosponsors
Cost estimate: No cost estimate published yet.
Cosponsors on this site
Shelley Moore Capito (R-WV), Angus S. King, Jr. (I-ME)
No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.
Words on this page, explained (1)
- Bill
- A proposed law. It becomes law only if it passes the legislature and is signed by the president or governor (or a veto is overridden).
Plain meanings written from linked sources. All words.
Sources
- Congressional Research Service summary (Introduced in Senate)
- Congress.gov
- Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-116s418.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/116/s>
Record fed-us-cong116-s418 · catalog fed-us-congress-bills-cong116 · updated 2026-11-15 by psicol fed-bills-cong116