US SB1509 | 2017-2018 | 115th Congress
Status
Spectrum: Bipartisan Bill
Status: Introduced on June 29 2017 - 25% progression, died in committee
Action: 2017-06-29 - 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 June 29 2017 - 25% progression, died in committee
Action: 2017-06-29 - 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 Products Extension Now Accelerating Cures and Treatments Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to extend by six months the exclusivity period for an approved drug or biological product 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). The FDA may revoke an extension if the application for the new indication contained an untrue material statement. The FDA must notify the public of products that receive this extension and patents related to those products. Products may receive only one of these extensions. This extension is in addition to other extensions. Only products approved after enactment of this bill for a new indication that is a rare disease or condition are eligible for an extension. For a medication to be approved as an orphan drug with seven years of marketing exclusivity when it is the same medication for the same condition as an already approved orphan drug, the sponsor of the new medication must demonstrate that the new medication is clinically superior to the approved medication. The bill expands to cover brand name drugs provisions that allow generic drugs to be approved and marketed without labeling for pediatric indications when the pediatric indications are protected by patent or marketing exclusivity.
Title
Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017
Sponsors
Sen. Orrin Hatch [R-UT] | Sen. Robert Menendez [D-NJ] | Sen. Tim Scott [R-SC] | Sen. Bill Nelson [D-FL] |
Sen. Marco Rubio [R-FL] | Sen. Joe Donnelly [D-IN] |
History
Date | Chamber | Action |
---|---|---|
2017-06-29 | Senate | Read twice and referred to the Committee on Health, Education, Labor, and Pensions. |
Same As/Similar To
HB1223 (Related) 2017-03-03 - Referred to the Subcommittee on Health.
Subjects
Administrative law and regulatory procedures
Administrative remedies
Child health
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
Licensing and registrations
Prescription drugs
Administrative remedies
Child health
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
Licensing and registrations
Prescription drugs
US Congress State Sources
Type | Source |
---|---|
Summary | https://www.congress.gov/bill/115th-congress/senate-bill/1509/all-info |
Text | https://www.congress.gov/115/bills/s1509/BILLS-115s1509is.pdf |