0
0
0
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
1/11/2023, 1:31 PM
Congressional Summary of S 1421
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.Read the Full Bill
Current Status of Bill S 1421
Bill S 1421 is currently in the status of Bill Introduced since May 21, 2015. Bill S 1421 was introduced during Congress 114 and was introduced to the Senate on May 21, 2015. Bill S 1421's most recent activity was Read twice and referred to the Committee on Health, Education, Labor, and Pensions. as of May 21, 2015
Bipartisan Support of Bill S 1421
Total Number of Sponsors
1Democrat Sponsors
0Republican Sponsors
1Unaffiliated Sponsors
0Total Number of Cosponsors
6Democrat Cosponsors
3Republican Cosponsors
3Unaffiliated Cosponsors
0Policy Area and Potential Impact of Bill S 1421
Primary Policy Focus
HealthPotential Impact Areas
- 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
- Intellectual property
- Prescription drugs
Alternate Title(s) of Bill S 1421
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
A bill to amend the Federal Food, Drug, and Cosmetic Act to authorize a 6-month extension of certain exclusivity periods in the case of approved drugs that are subsequently approved for a new indication to prevent, diagnose, or treat a rare disease or condition, and for other purposes.
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Comments
Sponsors and Cosponsors of S 1421
Latest Bills
Energy and Water Development and Related Agencies Appropriations Act, 2027
Bill HR 9022June 24, 2026
National Security, Department of State, and Related Programs Appropriations Act, 2027
Bill HR 8595June 24, 2026
To authorize an extension and expansion of the reimbursable screening services program of the Transportation Security Administration, and for other purposes.
Bill HR 9391June 24, 2026
Protecting Kids from Creeps Act
Bill HR 9131June 24, 2026
To amend title XVIII of the Social Security Act to require the inclusion of certain information in Medicare Advantage encounter data.
Bill HR 9392June 24, 2026
Providing for consideration of the bill (H.R. 1181) to prohibit payment card networks and covered entities from requiring the use of or assigning merchant category codes that distinguish a firearms retailer from general-merchandise retailer or sporting-goods retailer, and for other purposes; providing for consideration of the bill (H.R. 9022) making appropriations for energy and water development and related agencies for the fiscal year ending September 30, 2027, and for other purposes; providing for consideration of the bill (H.R. 8595) making appropriations for national security, Department of State, and related programs for the fiscal year ending September 30, 2027, and for other purposes; and providing for consideration of the bill (H.R. 9237) to amend titles 10 and 38, United States Code, and other Federal laws, to improve benefits for veterans and the administration of the Department of Veterans Affairs.
Bill HRES 1377June 24, 2026
Protecting Privacy in Purchases Act
Bill HR 1181June 24, 2026
To authorize the Secretary of Education to award grants to create evidence-based student success programs designed to increase participation, retention, and completion rates of high-need students.
Bill HR 9300June 24, 2026
Directing the President pursuant to section 5(c) of the War Powers Resolution to remove United States Armed Forces from hostilities in Lebanon.
Bill HCONRES 108June 24, 2026
To improve the retirement security of American families by increasing Social Security benefits for current and future beneficiaries while making Social Security stronger for future generations.
Bill HR 9415June 24, 2026
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015
Bill HR 971January 11, 2023
21st Century Cures Act
Bill HR 6January 11, 2023