Protecting Access to Safe and Effective Medicines Act of 2019

Summary

Protecting Access to Safe and Effective Medicines Act of 2019 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. 31 October 2019

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 31 October 2019

   Introduced

   Introduced in House

   Source: IntroReferral

3. 31 October 2019

   Introduced

   Introduced in House

   Source: IntroReferral

4. 1 November 2019

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 31 October 2019 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 31 October 2019

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 31 October 2019

  ViewDownloadOpen at official source

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  Vertaal document

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• Introduced in House

  summary · EN · 31 October 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. Engel, Eliot L. [D-NY-16] · D · Sponsor
• Rep. Guthrie, Brett [R-KY-2] · R · Sponsor
• Rep. Schrader, Kurt [D-OR-5] · D · Sponsor
• Rep. Hudson, Richard [R-NC-8] · R · Sponsor
• · hsif00 · Standing

Related records

• related to → Ensuring Innovation Act
• related to → Lower Costs, More Cures Act of 2019
• related to → Lower Health Care Costs Act