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To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes.

USA115th CongressHR-2051| House 
| Updated: 4/7/2017
David B. McKinley

David B. McKinley

Republican Representative

West Virginia

Cosponsors (13)
Steve Stivers (Republican)Michelle Lujan Grisham (Democratic)James B. Renacci (Republican)Ro Khanna (Democratic)Kurt Schrader (Democratic)Matt Cartwright (Democratic)David P. Joyce (Republican)Ami Bera (Democratic)Daniel Lipinski (Democratic)Diana DeGette (Democratic)Janice D. Schakowsky (Democratic)Jeff Fortenberry (Republican)Peter Welch (Democratic)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Fair Access for Safe and Timely Generics Act of 2017 or the FAST Generics Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the license holder of a Food and Drug Administration (FDA)-approved drug or biological product from restricting availability of the medication for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting availability with a risk evaluation and mitigation strategy (REMS). Upon request, the license holder of a medication that is not subject to a REMS must provide a product developer with the medication for testing. For a medication subject to a REMS, a product developer must have FDA authorization to obtain the medication before the license holder must provide it. The FDA may authorize a product developer to conduct testing and clinical trials with the medication. A wholesaler or specialty distributor who receives a request from a product developer for a medication for testing may not disclose to the license holder the identity of the product developer. The FDA may prohibit or limit transfer of a medication to a product developer if the transfer poses an imminent hazard to public health. License holders are not liable for claims arising from a product developer testing a medication. The FDA may waive the requirement that a medication use a single, shared system of elements to assure safe use with a comparable approved medication if the product developer is unable to finalize terms for a shared system with the license holder of the approved medication.
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Timeline
Apr 6, 2017
Introduced in House
Apr 6, 2017
Referred to the House Committee on Energy and Commerce.
Apr 7, 2017
Referred to the Subcommittee on Health.
  • April 6, 2017
    Introduced in House


  • April 6, 2017
    Referred to the House Committee on Energy and Commerce.


  • April 7, 2017
    Referred to the Subcommittee on Health.

Health

Competition and antitrustDrug safety, medical device, and laboratory regulationLicensing and registrationsPrescription drugs

To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes.

USA115th CongressHR-2051| House 
| Updated: 4/7/2017
Fair Access for Safe and Timely Generics Act of 2017 or the FAST Generics Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the license holder of a Food and Drug Administration (FDA)-approved drug or biological product from restricting availability of the medication for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting availability with a risk evaluation and mitigation strategy (REMS). Upon request, the license holder of a medication that is not subject to a REMS must provide a product developer with the medication for testing. For a medication subject to a REMS, a product developer must have FDA authorization to obtain the medication before the license holder must provide it. The FDA may authorize a product developer to conduct testing and clinical trials with the medication. A wholesaler or specialty distributor who receives a request from a product developer for a medication for testing may not disclose to the license holder the identity of the product developer. The FDA may prohibit or limit transfer of a medication to a product developer if the transfer poses an imminent hazard to public health. License holders are not liable for claims arising from a product developer testing a medication. The FDA may waive the requirement that a medication use a single, shared system of elements to assure safe use with a comparable approved medication if the product developer is unable to finalize terms for a shared system with the license holder of the approved medication.
View Full Text

Suggested Questions

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

Timeline
Apr 6, 2017
Introduced in House
Apr 6, 2017
Referred to the House Committee on Energy and Commerce.
Apr 7, 2017
Referred to the Subcommittee on Health.
  • April 6, 2017
    Introduced in House


  • April 6, 2017
    Referred to the House Committee on Energy and Commerce.


  • April 7, 2017
    Referred to the Subcommittee on Health.
David B. McKinley

David B. McKinley

Republican Representative

West Virginia

Cosponsors (13)
Steve Stivers (Republican)Michelle Lujan Grisham (Democratic)James B. Renacci (Republican)Ro Khanna (Democratic)Kurt Schrader (Democratic)Matt Cartwright (Democratic)David P. Joyce (Republican)Ami Bera (Democratic)Daniel Lipinski (Democratic)Diana DeGette (Democratic)Janice D. Schakowsky (Democratic)Jeff Fortenberry (Republican)Peter Welch (Democratic)

Health Subcommittee, Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Competition and antitrustDrug safety, medical device, and laboratory regulationLicensing and registrationsPrescription drugs