Lower Insulin Costs Now Act

Summary

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  Such an application not approved after October 1, 2022, shall be deemed withdrawn.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

1. 17 December 2019

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 17 December 2019

   Introduced

   Introduced in House

   Source: IntroReferral

3. 17 December 2019

   Introduced

   Introduced in House

   Source: IntroReferral

4. 18 December 2019

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 17 December 2019 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 17 December 2019

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 17 December 2019

  ViewDownloadOpen at official source

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• Introduced in House

  summary · EN · 17 December 2019

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Rep. Underwood, Lauren [D-IL-14] · D · Sponsor
• Rep. Schakowsky, Janice D. [D-IL-9] · D · Sponsor
• Rep. Guthrie, Brett [R-KY-2] · R · Sponsor
• Rep. Kelly, Mike [R-PA-16] · R · Sponsor
• Rep. Levin, Andy [D-MI-9] · D · Sponsor
• Rep. Fitzpatrick, Brian K. [R-PA-1] · R · Cosponsor
• Rep. Perry, Scott [R-PA-10] · R · Cosponsor
• · hsif00 · Standing

Related records

• related to → Lower Costs, More Cures Act of 2019
• related to → Further Consolidated Appropriations Act, 2020