Legis Daily

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 CongressHR-1223| House 
| Updated: 3/3/2017
Gus M. Bilirakis

Gus M. Bilirakis

Republican Representative

Florida

Cosponsors (43)
Donald Norcross (Democratic)Daniel M. Donovan (Republican)Mo Brooks (Republican)Markwayne Mullin (Republican)Jared Huffman (Democratic)Steven M. Palazzo (Republican)Pete Olson (Republican)Steve Stivers (Republican)Kathleen M. Rice (Democratic)Darren Soto (Democratic)John Abney Culberson (Republican)Tim Murphy (Republican)Carol Shea-Porter (Democratic)Eric Swalwell (Democratic)Leonard Lance (Republican)David Young (Republican)Wm. Lacy Clay (Democratic)Billy Long (Republican)Michelle Lujan Grisham (Democratic)Luke Messer (Republican)Don Bacon (Republican)Christopher H. Smith (Republican)Fred Upton (Republican)G. K. Butterfield (Democratic)Ted Poe (Republican)Peter J. Roskam (Republican)David E. Price (Democratic)David G. Reichert (Republican)Anna G. Eshoo (Democratic)Peter J. Visclosky (Democratic)Daniel Webster (Republican)Bonnie Watson Coleman (Democratic)Michael T. McCaul (Republican)Jeff Fortenberry (Republican)Albio Sires (Democratic)Brian K. Fitzpatrick (Republican)Rodney P. Frelinghuysen (Republican)Bill Posey (Republican)Zoe Lofgren (Democratic)Cathy McMorris Rodgers (Republican)Alcee L. Hastings (Democratic)Barbara Comstock (Republican)Francis Rooney (Republican)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017 or the OPEN Act This bill 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). HHS may revoke an extension if the application submitted to the FDA for the new indication contained an untrue material statement. HHS must notify the public of products that receive this extension and patents related to those products. Products may receive only one extension under this bill. Extensions under this bill are in addition to other extensions. The bill applies only to products approved after enactment of this bill for a new indication that is a rare disease or condition.
View Full Text

Suggested Questions

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

Timeline
Feb 27, 2017
Introduced in House
Feb 27, 2017
Referred to the House Committee on Energy and Commerce.
Mar 3, 2017
Referred to the Subcommittee on Health.
Jun 29, 2017

Latest Companion Bill Action

S 115-1509
Introduced in Senate
  • February 27, 2017
    Introduced in House


  • February 27, 2017
    Referred to the House Committee on Energy and Commerce.


  • March 3, 2017
    Referred to the Subcommittee on Health.


  • June 29, 2017

    Latest Companion Bill Action

    S 115-1509
    Introduced in Senate

Health

Related Bills

  • S 115-1509: 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.
Administrative remediesDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationDrug therapyFood and Drug Administration (FDA)Government information and archivesIntellectual propertyPrescription drugs

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 CongressHR-1223| House 
| Updated: 3/3/2017
Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017 or the OPEN Act This bill 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). HHS may revoke an extension if the application submitted to the FDA for the new indication contained an untrue material statement. HHS must notify the public of products that receive this extension and patents related to those products. Products may receive only one extension under this bill. Extensions under this bill are in addition to other extensions. The bill applies only to products approved after enactment of this bill for a new indication that is a rare disease or condition.
View Full Text

Suggested Questions

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

Timeline
Feb 27, 2017
Introduced in House
Feb 27, 2017
Referred to the House Committee on Energy and Commerce.
Mar 3, 2017
Referred to the Subcommittee on Health.
Jun 29, 2017

Latest Companion Bill Action

S 115-1509
Introduced in Senate
  • February 27, 2017
    Introduced in House


  • February 27, 2017
    Referred to the House Committee on Energy and Commerce.


  • March 3, 2017
    Referred to the Subcommittee on Health.


  • June 29, 2017

    Latest Companion Bill Action

    S 115-1509
    Introduced in Senate
Gus M. Bilirakis

Gus M. Bilirakis

Republican Representative

Florida

Cosponsors (43)
Donald Norcross (Democratic)Daniel M. Donovan (Republican)Mo Brooks (Republican)Markwayne Mullin (Republican)Jared Huffman (Democratic)Steven M. Palazzo (Republican)Pete Olson (Republican)Steve Stivers (Republican)Kathleen M. Rice (Democratic)Darren Soto (Democratic)John Abney Culberson (Republican)Tim Murphy (Republican)Carol Shea-Porter (Democratic)Eric Swalwell (Democratic)Leonard Lance (Republican)David Young (Republican)Wm. Lacy Clay (Democratic)Billy Long (Republican)Michelle Lujan Grisham (Democratic)Luke Messer (Republican)Don Bacon (Republican)Christopher H. Smith (Republican)Fred Upton (Republican)G. K. Butterfield (Democratic)Ted Poe (Republican)Peter J. Roskam (Republican)David E. Price (Democratic)David G. Reichert (Republican)Anna G. Eshoo (Democratic)Peter J. Visclosky (Democratic)Daniel Webster (Republican)Bonnie Watson Coleman (Democratic)Michael T. McCaul (Republican)Jeff Fortenberry (Republican)Albio Sires (Democratic)Brian K. Fitzpatrick (Republican)Rodney P. Frelinghuysen (Republican)Bill Posey (Republican)Zoe Lofgren (Democratic)Cathy McMorris Rodgers (Republican)Alcee L. Hastings (Democratic)Barbara Comstock (Republican)Francis Rooney (Republican)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • S 115-1509: 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.
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative remediesDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationDrug therapyFood and Drug Administration (FDA)Government information and archivesIntellectual propertyPrescription drugs