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S 1597 114th Congress Senate Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Government information and archives Prescription drugs

Patient-Focused Impact Assessment Act of 2015

Introduced: June 17, 2015 Introduced by: Wicker, Roger F. Republican · Mississippi See on congress.gov
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This bill died when the 114th Congress ended
It never became law before the 114th Congress (2015–2016) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 5 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Apr 5, 2016
Placed on Senate Legislative Calendar under General Orders. Calendar No. 413.
Apr 5, 2016
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
Mar 9, 2016
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Jun 17, 2015
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jun 17, 2015
Introduced in Senate
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 Plain-English summary Congressional Research Service

Patient-Focused Impact Assessment Act of 2016

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), after approving an application for a new medication, to publish a brief statement on any patient experience data or related information that was part of the application. Patient experience data is information about the impact of a medical condition or a related therapy on a patient's life and the patient's preferences for treatment.

(Sec. 3) The FDA must issue guidance on the collection of patient experience data and the use of that data in drug development.

(Sec. 4) The Paperwork Reduction Act does not apply to voluntary collection of patient experience data.

(Sec. 5) The FDA must report on its review of patient experience data as part of approving applications for new medications.
What's happening now April 5, 2016

Placed on Senate Legislative Calendar under General Orders. Calendar No. 413.

 Bill text 2 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Cosponsors 5
All 5 Democratic 2 Republican 3
R
Murkowski, Lisa
Alaska · Mar 9, 2016
 R
Cotton, Tom
Arkansas · Feb 29, 2016
 D
Bennet, Michael F.
Colorado · Jun 17, 2015
 R
Collins, Susan M.
Maine · Jun 17, 2015
 D
Klobuchar, Amy
Minnesota · Jun 17, 2015
Cite this page click to expand
APA
U.S. Congress. (2026). S. 1597: Patient-Focused Impact Assessment Act of 2016. 114th Congress. Open America. https://openamerica.io/bill/114-S-1597/
MLA
"S. 1597: Patient-Focused Impact Assessment Act of 2016." 114th Congress, 2026, Open America, https://openamerica.io/bill/114-S-1597/.
Bluebook (legal)
S. 1597, 114th Cong. (2026), https://openamerica.io/bill/114-S-1597/.
Markdown link
[S. 1597: Patient-Focused Impact Assessment Act of 2016](https://openamerica.io/bill/114-S-1597/)
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