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HR 2338 114th Congress House

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.

Introduced: May 14, 2015 See on congress.gov
Health Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationHealth information and medical records
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Medical researchResearch administration and funding
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This bill died when the 114th Congress ended
It never became law before the 114th Congress (2015–2016) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
May 15, 2015
Referred to the Subcommittee on Health.
May 14, 2015
Referred to the House Committee on Energy and Commerce.
May 14, 2015
Introduced in House
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 Latest action May 15, 2015

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

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data may submit initial research concepts for feedback; (2) the FDA may request or receive from such an entity draft guidance documents, data, and summaries and analyses of data; and (3) patient experience data may be considered in the risk-benefit assessment of a new drug.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.
 Related & companion bills 1
  • HR 6 Related bill 21st Century Cures Act
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
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APA
U.S. Congress. (2026). 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. Open America. https://openamerica.io/bill/114-HR-2338/
MLA
"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, 2026, Open America, https://openamerica.io/bill/114-HR-2338/.
Bluebook (legal)
H.R. 2338, 114th Cong. (2026), https://openamerica.io/bill/114-HR-2338/.
Markdown link
[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.](https://openamerica.io/bill/114-HR-2338/)
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