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.

Referred to the Subcommittee on Health.

Congressional Research Service

Official summary

Version 00 · Introduced in House · May 14, 2015

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data may submit initial research concepts for feedback; (2) the FDA may request or receive from such an entity draft guidance documents, data, and summaries and analyses of data; and (3) patient experience data may be considered in the risk-benefit assessment of a new drug.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

Read the summary on Congress.gov

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People & committees

Who introduced it

Rep. Pitts, Joseph R. [R-PA-16] · R–PA

Committees

Energy and Commerce Committee

0 cosponsorship records, including any withdrawals

Legislative record

Actions

A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.

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
May 14, 2015
Introduced in House

Primary sources

Bill text & related measures

Text links open the official source. We currently store references to these documents.

Introduced in House · May 14, 2015 Formatted Text PDF Formatted XML

Related bills identified by Congress.gov

HR 6 · 21st Century Cures Act

Source last updated: Jan 3, 2025. Consult Congress.gov for the current record.

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Objective

Analyze H.R.2338 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.

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Discuss H.R.2338, 114th Congress: 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.

Official record: https://www.congress.gov/bill/114th-congress/house-bill/2338

Text version to examine: Introduced in House · 2015-05-14.

Official full text: https://www.congress.gov/114/bills/hr2338/BILLS-114hr2338ih.htm

Imported record last updated by the source: 2025-01-03T00:09:08Z. Verify current status and distinguish any later version from the version above.

Read the official text before answering. If you cannot access it, say so and ask me to provide it; do not assume a link means you have read the document. Distinguish proposals from enacted law, cite sources, and separate facts, interpretation, and uncertain predictions. Include counterarguments even when using a particular perspective.

Analyze H.R.2338 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.

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Examine H.R.2338 through a progressive lens, focusing on fairness, access, economic inequality, and effects on vulnerable communities. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and distinguish stated goals from demonstrated outcomes.

View full prompt & sources

Discuss H.R.2338, 114th Congress: 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.

Official record: https://www.congress.gov/bill/114th-congress/house-bill/2338

Text version to examine: Introduced in House · 2015-05-14.

Official full text: https://www.congress.gov/114/bills/hr2338/BILLS-114hr2338ih.htm

Imported record last updated by the source: 2025-01-03T00:09:08Z. Verify current status and distinguish any later version from the version above.

Read the official text before answering. If you cannot access it, say so and ask me to provide it; do not assume a link means you have read the document. Distinguish proposals from enacted law, cite sources, and separate facts, interpretation, and uncertain predictions. Include counterarguments even when using a particular perspective.

Examine H.R.2338 through a progressive lens, focusing on fairness, access, economic inequality, and effects on vulnerable communities. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and distinguish stated goals from demonstrated outcomes.

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Examine H.R.2338 through a conservative lens, focusing on fiscal responsibility, institutional stability, federalism, and the scope of government. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and any provisions that challenge this perspective.

View full prompt & sources

Discuss H.R.2338, 114th Congress: 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.

Official record: https://www.congress.gov/bill/114th-congress/house-bill/2338

Text version to examine: Introduced in House · 2015-05-14.

Official full text: https://www.congress.gov/114/bills/hr2338/BILLS-114hr2338ih.htm

Imported record last updated by the source: 2025-01-03T00:09:08Z. Verify current status and distinguish any later version from the version above.

Read the official text before answering. If you cannot access it, say so and ask me to provide it; do not assume a link means you have read the document. Distinguish proposals from enacted law, cite sources, and separate facts, interpretation, and uncertain predictions. Include counterarguments even when using a particular perspective.

Examine H.R.2338 through a conservative lens, focusing on fiscal responsibility, institutional stability, federalism, and the scope of government. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and any provisions that challenge this perspective.

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Examine H.R.2338 through a civil-liberties and limited-government lens. Consider individual rights, privacy, voluntary choice, accountability, and government power. Explain tradeoffs, possible safeguards, and the strongest counterarguments without assuming the proposal is beneficial or harmful.

View full prompt & sources

Discuss H.R.2338, 114th Congress: 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.

Official record: https://www.congress.gov/bill/114th-congress/house-bill/2338

Text version to examine: Introduced in House · 2015-05-14.

Official full text: https://www.congress.gov/114/bills/hr2338/BILLS-114hr2338ih.htm

Imported record last updated by the source: 2025-01-03T00:09:08Z. Verify current status and distinguish any later version from the version above.

Read the official text before answering. If you cannot access it, say so and ask me to provide it; do not assume a link means you have read the document. Distinguish proposals from enacted law, cite sources, and separate facts, interpretation, and uncertain predictions. Include counterarguments even when using a particular perspective.

Examine H.R.2338 through a civil-liberties and limited-government lens. Consider individual rights, privacy, voluntary choice, accountability, and government power. Explain tradeoffs, possible safeguards, and the strongest counterarguments without assuming the proposal is beneficial or harmful.