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.

1/11/2023, 1:27 PM

Congressional Summary of HR 2338

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data may submit initial research concepts for feedback; (2) the FDA may request or receive from such an entity draft guidance documents, data, and summaries and analyses of data; and (3) patient experience data may be considered in the risk-benefit assessment of a new drug.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

Formatted Text PDF Formatted XML

Current Status of Bill HR 2338

Bill HR 2338 is currently in the status of Bill Introduced since May 14, 2015. Bill HR 2338 was introduced during Congress 114 and was introduced to the House on May 14, 2015. Bill HR 2338's most recent activity was Referred to the Subcommittee on Health. as of May 15, 2015

Bipartisan Support of Bill HR 2338

Total Number of Sponsors

Democrat Sponsors

Republican Sponsors

Unaffiliated Sponsors

Total Number of Cosponsors

Democrat Cosponsors

Republican Cosponsors

Unaffiliated Cosponsors

Policy Area and Potential Impact of Bill HR 2338

Primary Policy Focus

Health

Potential Impact Areas

Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationHealth information and medical recordsMedical researchResearch administration and funding

Alternate Title(s) of Bill 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.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.

Start holding our government accountable!