US SB1421 | 2015-2016 | 114th Congress
Status
Sponsorship: Bipartisan Bill
Status: Introduced on May 21 2015 - 25% progression, died in committee
Action: 2015-05-21 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Pending: Senate Health, Education, Labor, And Pensions Committee
Text: Latest bill text (Introduced) [PDF]
Status: Introduced on May 21 2015 - 25% progression, died in committee
Action: 2015-05-21 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Pending: Senate Health, Education, Labor, And Pensions Committee
Text: Latest bill text (Introduced) [PDF]
Summary
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 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”). Allows HHS to revoke an extension if the application submitted to the FDA for the new indication contained an untrue material statement. Requires the sponsor of a product receiving an extension to notify HHS one year prior to discontinuing production for commercial reasons. Requires HHS to notify the public of products that receive this extension and patents related to those products. Limits a product to one extension under this Act. Sets forth that extensions under this Act are in addition to other extensions. Applies only to products approved after enactment of this Act for a new indication that is a rare disease or condition.
Title
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Sponsors
| Sen. Orrin Hatch [R-UT] | Sen. Amy Klobuchar [D-MN] | Sen. Tim Scott [R-SC] | Sen. Mark Kirk [R-IL] |
| Sen. Robert Menendez [D-NJ] | Sen. Thom Tillis [R-NC] | Sen. Cory Booker [D-NJ] |
History
| Date | Chamber | Action |
|---|---|---|
| 2015-05-21 | Senate | Read twice and referred to the Committee on Health, Education, Labor, and Pensions. |
Same As/Similar To
HB6 (Related) 2015-07-13 - Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
HB971 (Related) 2015-02-20 - Referred to the Subcommittee on Health.
HB971 (Related) 2015-02-20 - Referred to the Subcommittee on Health.
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/114th-congress/senate-bill/1421/all-info |
| Text | https://www.congress.gov/114/bills/s1421/BILLS-114s1421is.pdf |
