HR 2338 — 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.

1 sponsors · 0 co-sponsors · 546 not signed on

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Frequently asked questions

What does HR 2338 do?

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data may submit initial research concepts for feedback; (2) the FDA may request or receive from such an entity draft guidance documents, data, and summaries and analyses of data; and (3) patient experience data may be considered in the risk-benefit assessment of a new drug.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.

Who sponsors HR 2338?

HR 2338 is sponsored by Joseph Pitts (R).

What is the current status of HR 2338?

This bill died with 114th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

Where can I track HR 2338?

Track HR 2338 free on One Click Politics — get push/email alerts when it moves.