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Bill > HR2338


US HR2338

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.


summary

Introduced
05/14/2015
In Committee
05/15/2015
Crossed Over
Passed
Dead
01/03/2017

Introduced Session

114th Congress

Bill Summary

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data may submit initial research concepts for feedback; (2) the FDA may request or receive from such an entity draft guidance documents, data, and summaries and analyses of data; and (3) patient experience data may be considered in the risk-benefit assessment of a new drug.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

Committee Categories

Business and Industry, Health and Social Services

Sponsors (1)

Last Action

Referred to the Subcommittee on Health. (on 05/15/2015)

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