Bill
Bill > HR2452
US HR2452
US HR2452To amend the Federal Food, Drug, and Cosmetic Act with respect to facilitating dissemination of health care economic information.
summary
Introduced
05/19/2015
05/19/2015
In Committee
05/22/2015
05/22/2015
Crossed Over
Passed
Dead
01/03/2017
01/03/2017
Introduced Session
114th Congress
Bill Summary
To amend the Federal Food, Drug, and Cosmetic Act with respect to facilitating dissemination of health care economic information. This bill amends the Federal Food, Drug, and Cosmetic Act to revise the requirements for health care economic information that is provided to entities selecting drugs for coverage or reimbursement, such as formularies. The information must include a conspicuous and prominent statement describing the differences between the information and the labeling approved for the drug. "Health care economic information" is an analysis that describes the economic consequences of the use of a drug. Such an analysis is no longer required to compare the use of the drug to another intervention or no intervention. An analysis that relates only to an indication for which the drug is not approved is not health care economic information.
AI Summary
This bill amends the Federal Food, Drug, and Cosmetic Act to make it easier to share health care economic information, which is an analysis of a drug's economic impact, with entities that decide which drugs to cover or pay for, such as formulary committees. The changes clarify that such analyses no longer need to compare the drug to other treatments or no treatment, and that analyses solely about unapproved uses of a drug do not qualify as health care economic information. Importantly, any health care economic information shared must now include a clear statement highlighting any significant differences between the economic analysis and the drug's officially approved labeling, and these specific economic analyses are exempt from certain standard drug approval requirements.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (3)
Last Action
Referred to the Subcommittee on Health. (on 05/22/2015)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location | Created |
|---|---|---|
| State Bill Page | https://www.congress.gov/bill/114th-congress/house-bill/2452/all-info | 05/20/2015 |
| BillText | https://www.congress.gov/114/bills/hr2452/BILLS-114hr2452ih.pdf | 07/05/2016 |
| Bill | https://www.congress.gov/114/bills/hr2452/BILLS-114hr2452ih.pdf.pdf | 07/05/2016 |
| BillText | http://gpo.gov/fdsys/pkg/BILLS-114hr2452ih/pdf/BILLS-114hr2452ih.pdf | 05/28/2015 |
| Bill | http://gpo.gov/fdsys/pkg/BILLS-114hr2452ih/pdf/BILLS-114hr2452ih.pdf.pdf | 05/28/2015 |
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