Legis Daily

A bill to amend the Federal Food, Drug, and Cosmetic Act to authorize an extension of exclusivity periods for certain drugs that are approved for a new indication for a rare disease or condition, and for other purposes.

USA115th CongressS-1509| Senate 
| Updated: 6/29/2017
Orrin G. Hatch

Orrin G. Hatch

Republican Senator

Utah

Cosponsors (5)
Joe Donnelly (Democratic)Tim Scott (Republican)Bill Nelson (Democratic)Robert Menendez (Democratic)Marco Rubio (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Mar 3, 2017

Latest Companion Bill Action

HR 115-1223
Referred to the Subcommittee on Health.
Jun 29, 2017
Introduced in Senate
Jun 29, 2017
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • March 3, 2017

    Latest Companion Bill Action

    HR 115-1223
    Referred to the Subcommittee on Health.


  • June 29, 2017
    Introduced in Senate


  • June 29, 2017
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Related Bills

  • HR 115-1223: To amend the Federal Food, Drug, and Cosmetic Act to authorize an extension of exclusivity periods for certain drugs that are approved for a new indication for a rare disease or condition, and for other purposes.
Administrative law and regulatory proceduresAdministrative remediesChild healthDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationDrug therapyFood and Drug Administration (FDA)Government information and archivesIntellectual propertyLicensing and registrationsPrescription drugs

A bill to amend the Federal Food, Drug, and Cosmetic Act to authorize an extension of exclusivity periods for certain drugs that are approved for a new indication for a rare disease or condition, and for other purposes.

USA115th CongressS-1509| Senate 
| Updated: 6/29/2017
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Mar 3, 2017

Latest Companion Bill Action

HR 115-1223
Referred to the Subcommittee on Health.
Jun 29, 2017
Introduced in Senate
Jun 29, 2017
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • March 3, 2017

    Latest Companion Bill Action

    HR 115-1223
    Referred to the Subcommittee on Health.


  • June 29, 2017
    Introduced in Senate


  • June 29, 2017
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Orrin G. Hatch

Orrin G. Hatch

Republican Senator

Utah

Cosponsors (5)
Joe Donnelly (Democratic)Tim Scott (Republican)Bill Nelson (Democratic)Robert Menendez (Democratic)Marco Rubio (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 115-1223: To amend the Federal Food, Drug, and Cosmetic Act to authorize an extension of exclusivity periods for certain drugs that are approved for a new indication for a rare disease or condition, and for other purposes.
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresAdministrative remediesChild healthDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationDrug therapyFood and Drug Administration (FDA)Government information and archivesIntellectual propertyLicensing and registrationsPrescription drugs