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HR 5632 116th Congress House 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

FDA Accountability for Public Safety Act

Introduced: January 16, 2020 Introduced by: Kim, Andy Democratic · New Jersey See on congress.gov
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 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jan 16, 2020
Referred to the House Committee on Energy and Commerce.
Jan 16, 2020
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now January 16, 2020

Referred to the House Committee on Energy and Commerce.

 Committees of jurisdiction 1