US HB1223 | 2017-2018 | 115th Congress
Status
Spectrum: Slight Partisan Bill (Republican 28-16)
Status: Introduced on February 27 2017 - 25% progression, died in committee
Action: 2017-03-03 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]
Status: Introduced on February 27 2017 - 25% progression, died in committee
Action: 2017-03-03 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]
Summary
OPEN Act Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Department of Health and Human Services (HHS) to extend by six months the exclusivity period for a drug or biological product approved by the Food and Drug Administration (FDA) when the product is additionally approved to prevent, diagnose, or treat a new indication that is a rare disease or condition (also known as an orphan disease). HHS may revoke an extension if the application submitted to the FDA for the new indication contained an untrue material statement. HHS must notify the public of products that receive this extension and patents related to those products. Products may receive only one extension under this bill. Extensions under this bill are in addition to other extensions. The bill applies only to products approved after enactment of this bill for a new indication that is a rare disease or condition.
Title
OPEN Act Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017
Sponsors
History
| Date | Chamber | Action |
|---|---|---|
| 2017-03-03 | House | Referred to the Subcommittee on Health. |
| 2017-02-27 | House | Referred to the House Committee on Energy and Commerce. |
| 2017-02-27 | House | Introduced in House |
Same As/Similar To
SB1509 (Related) 2017-06-29 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Subjects
Administrative remedies
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Drug therapy
Food and Drug Administration (FDA)
Government information and archives
Health
Intellectual property
Prescription drugs
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Drug therapy
Food and Drug Administration (FDA)
Government information and archives
Health
Intellectual property
Prescription drugs
US Congress State Sources
| Type | Source |
|---|---|
| Summary | https://www.congress.gov/bill/115th-congress/house-bill/1223/all-info |
| Text | https://www.congress.gov/115/bills/hr1223/BILLS-115hr1223ih.pdf |
