To amend the Federal Food, Drug, and Cosmetic Act to provide for the development and use of patient experience data to enhance the structured risk-benefit assessment framework, and for other purposes.
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish processes under which: (1) an entity seeking to develop patient experience data may submit initial research concepts for feedback; (2) the FDA may request or receive from such an entity draft guidance documents, data, and summaries and analyses of data; and (3) patient experience data may be considered in the risk-benefit assessment of a new drug.
“Patient experience data” is data collected by patients or others that is intended to facilitate the FDA's risk-benefit assessments, including information about the impact of a disease or a therapy on patients' lives.
The FDA must convene workshops and publish guidance on the patient experience data processes described above.
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