S. 1597 · 114th Congress
Patient-Focused Impact Assessment Act of 2015
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Never voted on. It didn't reach a floor vote before the 114th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
WickerSponsor8 cosponsors · 4 D, 4 R
5 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
What it does: CRS summary · Reported to Senate with amendment(s) · Apr 5, 2016
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.Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Patient-Focused Impact Assessment Act of 2016
Latest action (Apr 5, 2016): Placed on Senate Legislative Calendar under General Orders. Calendar No. 413.
Policy area: Health · Origin: Senate · Introduced: Jun 17, 2015
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.