Ensuring Innovation Act

Summary

Ensuring Innovation Act This bill provides statutory authority for the existing Food and Drug Administration (FDA) practice of defining active ingredient more narrowly as active moiety in certain situations, such as when determining whether a new drug is entitled to a market exclusivity period or providing priority review of drugs for treating rare pediatric diseases. Generally, the FDA defines active moiety as the core molecule or ion in a drug responsible for the relevant physiological or pharmacological action. By contrast, the FDA defines an active ingredient as a component in a drug that is intended to furnish pharmacological activity or other direct effect. The FDA's existing practice of interpreting active ingredient as active moiety in certain situations, as statutorily authorized by this bill, tends to exclude some drugs from market exclusivity. The bill replaces references to active ingredient with active moiety in various statutes authorizing FDA activities.

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Timeline

1. 23 May 2019

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

   Source: IntroReferral

2. 23 May 2019

   Introduced

   Introduced in Senate

   Source: IntroReferral

3. 14 December 2020

   Floor

   Measure laid before Senate by unanimous consent. (consideration: CR S7470)

   Source: Floor

4. 14 December 2020

   Passed

   Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(text of amendment in the nature of a substitute: CR S7470)

   Source: Floor

5. 14 December 2020

   Discharge

   Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.

   Source: Discharge

6. 14 December 2020

   Committee

   Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.

   Source: Committee

7. 15 December 2020

   Floor

   Held at the desk.

   Source: Floor

8. 15 December 2020

   Floor

   Received in the House.

   Source: Floor

9. 15 December 2020

   Floor

   Message on Senate action sent to the House.

   Source: Floor

Votes

No vote records are attached yet.

Versions

• Engrossed in Senate · 14 December 2020 · Download file
• Introduced in Senate · 23 May 2019 · Download file

Documents

6 official files

• Engrossed in Senate (text)

  Engrossed in Senate · EN · 14 December 2020

  ViewDownloadOpen at official source

• Engrossed in Senate (PDF)

  Engrossed in Senate · EN · 14 December 2020

  ViewDownloadOpen at official source

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• Passed Senate

  summary · EN · 14 December 2020

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  Vertaal document

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• Introduced in Senate (text)

  Introduced in Senate · EN · 23 May 2019

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  Vertaal document

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 23 May 2019

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  Vertaal document

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

• Introduced in Senate

  summary · EN · 23 May 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

• Sen. Roberts, Pat [R-KS] · R · Sponsor
• Sen. Smith, Tina [D-MN] · D · Sponsor
• Sen. Cassidy, Bill [R-LA] · R · Sponsor
• · sshr00 · Standing

Related records

• related to → Lower Costs, More Cures Act of 2019
• related to ← Lower Health Care Costs Act
• related to ← Protecting Access to Safe and Effective Medicines Act of 2019
• amends ← In the nature of a substitute.