S 954
114th 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: April 15, 2015
See on congress.gov
Everywhere this bill has been
2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Apr 15, 2015
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Apr 15, 2015
Introduced in Senate
Plain-English summary
FDA Accountability for Public Safety Act
This bill requires the Commissioner of Food and Drugs to ensure that an advisory committee of the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) evaluates each new drug application for an opioid (a drug with effects similar to opium, such as morphine) and issues a recommendation regarding approval of the drug. If the decision to approve the drug is inconsistent with the committee's recommendation, the Commissioner must make the final decision on approval.
If the committee recommends a drug not be approved but the Commissioner decides to approve the drug, 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 to approve the drug; and (2) testify before Congress regarding the decision, upon request. Such a drug cannot be sold until the Commissioner has submitted the required report.
What's happening now
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committees of jurisdiction
1