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Lower Insulin Costs Now Act

USA116th CongressHR-5444| House 
| Updated: 12/18/2019
Lauren Underwood

Lauren Underwood

Democratic Representative

Illinois

Cosponsors (6)
Brett Guthrie (Republican)Andy Levin (Democratic)Scott Perry (Republican)Mike Kelly (Republican)Janice D. Schakowsky (Democratic)Brian K. Fitzpatrick (Republican)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Lower Insulin Costs Now Act This bill requires the Food and Drug Administration (FDA) to continue to review applications for certain biological products under an earlier review process, notwithstanding recent FDA guidance. (A 2009 law established a new procedure for approving biological products but allowed certain products in an already approved product class to receive approval under the earlier procedure until March 23, 2020; subsequently, in December 2018, the FDA issued guidance stating that an application filed under the earlier procedure that is not approved by March, 23, 2020, will not be approved.) The bill requires the FDA to continue reviewing an application filed not later than March 23, 2019, under the earlier procedure, even if it was not approved as of March 23, 2020. Such an application not approved after October 1, 2022, shall be deemed withdrawn. Such an approved application shall be deemed a biological product license.
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Timeline
Dec 17, 2019
Introduced in House
Dec 17, 2019
Referred to the House Committee on Energy and Commerce.
Dec 18, 2019
Referred to the Subcommittee on Health.
  • December 17, 2019
    Introduced in House


  • December 17, 2019
    Referred to the House Committee on Energy and Commerce.


  • December 18, 2019
    Referred to the Subcommittee on Health.

Health

Related Bills

  • HR 116-1865: Further Consolidated Appropriations Act, 2020
  • HR 116-19: Lower Costs, More Cures Act of 2019
Biological and life sciencesDigestive and metabolic diseasesDrug safety, medical device, and laboratory regulationDrug therapyIntellectual propertyLicensing and registrationsPrescription drugs

Lower Insulin Costs Now Act

USA116th CongressHR-5444| House 
| Updated: 12/18/2019
Lower Insulin Costs Now Act This bill requires the Food and Drug Administration (FDA) to continue to review applications for certain biological products under an earlier review process, notwithstanding recent FDA guidance. (A 2009 law established a new procedure for approving biological products but allowed certain products in an already approved product class to receive approval under the earlier procedure until March 23, 2020; subsequently, in December 2018, the FDA issued guidance stating that an application filed under the earlier procedure that is not approved by March, 23, 2020, will not be approved.) The bill requires the FDA to continue reviewing an application filed not later than March 23, 2019, under the earlier procedure, even if it was not approved as of March 23, 2020. Such an application not approved after October 1, 2022, shall be deemed withdrawn. Such an approved application shall be deemed a biological product license.
View Full Text

Suggested Questions

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

Timeline
Dec 17, 2019
Introduced in House
Dec 17, 2019
Referred to the House Committee on Energy and Commerce.
Dec 18, 2019
Referred to the Subcommittee on Health.
  • December 17, 2019
    Introduced in House


  • December 17, 2019
    Referred to the House Committee on Energy and Commerce.


  • December 18, 2019
    Referred to the Subcommittee on Health.
Lauren Underwood

Lauren Underwood

Democratic Representative

Illinois

Cosponsors (6)
Brett Guthrie (Republican)Andy Levin (Democratic)Scott Perry (Republican)Mike Kelly (Republican)Janice D. Schakowsky (Democratic)Brian K. Fitzpatrick (Republican)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • HR 116-1865: Further Consolidated Appropriations Act, 2020
  • HR 116-19: Lower Costs, More Cures Act of 2019
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Biological and life sciencesDigestive and metabolic diseasesDrug safety, medical device, and laboratory regulationDrug therapyIntellectual propertyLicensing and registrationsPrescription drugs