H.R. 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.

H.R. 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.

114th Congress · introduced 2015-05-14 · Health · Latest: Referred to the Subcommittee on Health.

federal

Follow this bill, step by step

Where it came from: introduced 2015-05-14 · official record
Who proposed it: Rep. Pitts, Joseph R. [R-PA-16] · what a sponsor is
What happened next: no floor votes in our records yet. Why?
Where it stands now: Referred to the Subcommittee on Health. Not final yet: this can still change. We check for updates every day.
If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

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.

Plain summary

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data may submit initial research concepts for feedback; (2) the FDA may request or receive from such an entity draft guidance documents, data, and summaries and analyses of data; and (3) patient experience data may be considered in the risk-benefit assessment of a new drug.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

Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.

What a vote does

A “Yea” vote

If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

PSI Sci description of the legislative step (not an opinion).

What does this mean? (plain words)

Official text

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.

Source: Congressional Research Service summary (Introduced in House)

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Rep. Pitts, Joseph R. [R-PA-16] · 0 cosponsors

Cost estimate: No cost estimate published yet.

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (1)

Bill: A proposed law. It becomes law only if it passes the legislature and is signed by the president or governor (or a veto is overridden).

Plain meanings written from linked sources. All words.

Sources

Congressional Research Service summary (Introduced in House)
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-114hr2338.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/114/hr>

Record fed-us-cong114-hr2338 · catalog fed-us-congress-bills-cong114 · updated 2026-11-15 by psicol fed-bills-cong114