Increasing Prescription Drug Competition Act

Summary

Increasing Prescription Drug Competition Act This bill provides that certifications in generic drug applications of certain patents involved in Risk Evaluation and Mitigation Strategy (REMS) programs have no effect upon the drug's approval. (The Food and Drug Administration sometimes requires a REMS program for certain drugs with safety risks, which may include restrictions on a drug's distribution through elements to ensure safe use (ETASU), such as special requirements for pharmacies that dispense the drug.) Specifically, certifications in generic drug applications with respect to patents that involve an ETASU for REMS requirements have no effect on the effective date of the drug's approval, notwithstanding any other provisions that allow for a stay of approval pending litigation outcomes (i.e., 30-month stay). The bill also specifies that in a civil action alleging patent infringement with respect to REMS requirements, the sponsor of the approved brand-name drug may only seek damages from (rather than an injunction against) the generic drug applicant.

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Timeline

1. 1 March 2023

   Introduced

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

   Source: IntroReferral

2. 1 March 2023

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 1 March 2023 · Official file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 1 March 2023

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 1 March 2023

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 1 March 2023

  Open at official source

Sponsors

• Maggie Hassan · D · Sponsor
• Sen. Braun, Mike [R-IN] · R · Sponsor
• · sshr00 · Standing

Related records

• related to ← Increasing Prescription Drug Competition Act