S.1597 - Patient-Focused Impact Assessment Act of 2016114th Congress (2015-2016)
|Sponsor:||Sen. Wicker, Roger F. [R-MS] (Introduced 06/17/2015)|
|Committees:||Senate - Health, Education, Labor, and Pensions|
|Latest Action:||Senate - 04/05/2016 Placed on Senate Legislative Calendar under General Orders. Calendar No. 413. (All Actions)|
This bill has the status Introduced
Here are the steps for Status of Legislation:
Summary: S.1597 — 114th Congress (2015-2016)All Information (Except Text)
Reported to Senate with amendment(s) (04/05/2016)
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.