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S 1078 115th Congress Senate 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: May 9, 2017 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
May 9, 2017
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
May 9, 2017
Introduced in Senate
 Plain-English summary Congressional Research Service

FDA Accountability for Public Safety Act

This bill amends the Comprehensive Addiction and Recovery Act of 2016 to expand the scope of the Food and Drug Administration (FDA) advisory committee to make recommendations regarding supplemental applications for opioids. Currently, the committee only makes recommendations on new drug applications.

Only the Commissioner of Food and Drugs may approve a new drug application or supplement to an application for an opioid against the recommendation of the committee. If the Commissioner approves a drug against the recommendation of the committee, the Commissioner must: (1) submit a report to Congress that includes the evidence regarding patient safety that supports the Commissioner's decision and a disclosure of any potential conflicts of interest of FDA officials involved in the decision; and (2) testify before Congress regarding the decision, upon request. Such a drug cannot be sold until the Commissioner has submitted the report.

What's happening now May 9, 2017

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

 Committees of jurisdiction 1
 Cosponsors 2
All 2 Republican 1 Independent 1