Competition Prescription Act of 2019

Summary

Competition Prescription Act of 2019 This bill revises various requirements related to the development, production, and sale of prescription drugs and biological products. First, the bill permits the developer of a drug or biological product to bring a civil action against the license holder of an approved product if the license holder has declined to make available sufficient quantities of the approved product for the developer's testing. The bill also requires the Food and Drug Administration (FDA) to establish a process for developers of generic complex drugs to request and receive expedited development and priority review. Further, upon request by a drug sponsor, a drug that treats a life-threatening disease or condition must be designated for expedited review if there are fewer than three drugs currently available for such treatment. States are prohibited from placing restrictions on dispensing substitute biological products that have been determined to be interchangeable with another product by the FDA. Additionally, the bill prohibits sponsors of Medicare Part D prescription drug plans from reducing a payment to a pharmacy after a claim without defect has been submitted by such pharmacy. The bill establishes requirements for pricing standards for pharmacy benefits managers under Medicare and other federal prescription drug benefits programs. Starting in 2025, the bill removes the cap on rebates paid by manufacturers of outpatient prescription drugs under Medicaid. Further, the bill requires the publication of specified information regarding licensed biological products, exempts from antitrust prohibitions specified drug-price negotiation strategies, and establishes a Chief Pharmaceutical Negotiator in the Office of the U.S. Trade Representative.

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

Timeline

1. 24 July 2019

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

2. 24 July 2019

   Introduced

   Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, the Judiciary, Armed Services, and Oversight and Reform, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

   Source: IntroReferral

3. 24 July 2019

   Introduced

   Introduced in House

   Source: IntroReferral

4. 24 July 2019

   Introduced

   Introduced in House

   Source: IntroReferral

5. 25 July 2019

   Referred

   Referred to the Subcommittee on Military Personnel.

   Source: Committee

6. 28 August 2019

   Referred

   Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 24 July 2019 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 24 July 2019

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 24 July 2019

  ViewDownloadOpen at official source

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• Introduced in House

  summary · EN · 24 July 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. Meadows, Mark [R-NC-11] · R · Sponsor
• · hsju00 · Standing
• · hsif00 · Standing
• · hsas00 · Standing
• · hswm00 · Standing
• · hsgo00 · Standing

Related records

• related to → Fixing Global Freeloading Act
• related to → CREATES Act of 2019
• related to → Fair Care Act of 2019
• related to ← Securing America’s Medical Supply Chain and Advancing the Production of Life Saving Medicines Act