To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes.

Summary

Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 This bill makes significant changes to the regulation by the Food and Drug Administration (FDA) of nonprescription (i.e., over-the-counter or OTC) drugs. The bill establishes a new approval process for OTC medications. Specifically, it creates an FDA administrative order process for the evaluation of OTC products, replacing the present notice and comment rulemaking approach. Under the new process, the FDA may issue an administrative order determining that a specific OTC drug, class of drugs, or combination is generally regarded as safe and effective and not subject to the new drug application process. The FDA may also use the administrative order process to (1) determine that a drug, class of drugs, or combination poses an imminent hazard to the public health; or (2) require labeling changes to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug. The bill provides for market exclusivity under certain circumstances. For drugs determined to be generally regarded as safe and effective pursuant to an administrative order requested by a sponsor (rather than initiated by the FDA), the requestor is granted 18 months of market exclusivity. This market exclusivity applies to an OTC drug with a new active ingredient or if the requestor conducted new human studies to get approval. The bill allows a sponsor of a nonprescription sunscreen active ingredient or a combination of such ingredients that was subject to a proposed sunscreen order to transition to the administrative order process. Market exclusivity provisions also apply to new sunscreen active ingredients. The FDA must establish a user fee program for OTC drugs.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

1. 24 June 2019

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 24 June 2019

   Introduced

   Introduced in House

   Source: IntroReferral

3. 24 June 2019

   Introduced

   Introduced in House

   Source: IntroReferral

4. 25 June 2019

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

5. 24 July 2019

   Introduced

   Sponsor introductory remarks on measure. (CR E971)

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in House · 24 June 2019 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 24 June 2019

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 24 June 2019

  ViewDownloadOpen at official source

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• Introduced in House

  summary · EN · 24 June 2019

  Open at official source

  Leesvertaling

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  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. DeGette, Diana [D-CO-1] · D · Sponsor
• Rep. Latta, Robert E. [R-OH-5] · R · Sponsor
• Rep. Dingell, Debbie [D-MI-6] · D · Sponsor
• Rep. Guthrie, Brett [R-KY-2] · R · Sponsor
• · hsif00 · Standing

Related records

• related to → Lower Costs, More Cures Act of 2019
• related to → CARES Act
• related to → Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019
• related to ← Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019