Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015

Hozzl · 2023-01-11T13:31:05Z

Explore the details of Senate Bill 1421 Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 currently in Congress. Get insights into its purpose, current status, sponsors, and potential impact on Health. Stay informed on legislative developments.

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.

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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

Democrat Sponsors

Republican Sponsors

Unaffiliated Sponsors

Total Number of Cosponsors

Democrat Cosponsors

Republican Cosponsors

Unaffiliated Cosponsors

Policy Area and Potential Impact of Bill S 1421

Primary Policy Focus

Health

Potential Impact Areas

Administrative remediesDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationDrug therapyFood and Drug Administration (FDA)Government information and archivesIntellectual propertyPrescription drugs

Alternate Title(s) of Bill S 1421

Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015A 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

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