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.

Patient-Focused Impact Assessment Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to require the package of information published by the Food and Drug Administration (FDA) upon approval of a new drug to include documentation of efforts to assess patient engagement. This documentation must include identification of patient-focused drug development tools and an explanation of whether certain information was reviewed or examined, including patient preferences and patient-reported or caregiver-reported outcomes. The FDA must annually summarize the data collected in this documentation.

The FDA must publish guidance on collaboration between patients, advocacy organizations, and industry for the purposes of developing patient-focused drug development tools and obtaining patient perspectives on medical products under development.