FDA Accountability for Public Safety Act
Latest action · Jan 16, 2020 Referred to the House Committee on Energy and Commerce.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedJan 16, 2020
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
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.
Cosponsors
Members who signed on, in the order they did.
Actions 2
Everything that happened, newest first.
- Jan 16, 2020Introduced in House
- Jan 16, 2020Referred to the House Committee on Energy and Commerce.
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 418 | FDA Accountability for Public Safety Act | Identical bill | Feb 7, 2019 |
Subjects
Assigned by the Library of Congress. Policy area: 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
- Health
- Marketing and advertising
- Prescription drugs
Text 1
Each version as it was printed, newest first.
- Jan 16, 2020Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.