118th Congress · HOUSE BILLBILL

H.R. 4692 — Increasing Prescription Drug Competition Act

“To amend the Federal Food, Drug, and Cosmetic Act to prevent the use of patents, trade secrets, or other intellectual property to inhibit competition.”

Health

Introduced Jul 17, 2023

Last action Jul 21, 2023

Pipeline · Bill → Law

Step 1

Introduced

Jul 17, 2023

Step 2

Referred

Jul 21, 2023

E&C

Step 3

Committee

Step 4

House floor

Step 5

Senate

Step 6

Resolve Changes

Step 7

Signed

SummaryCRS Summary

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...

Provisions · 2 sectionsIntroduced in House

Timeline · 3 actions

Jul 21, 2023

Referred to the Subcommittee on Health.

Jul 17, 2023

Introduced in House

Jul 17, 2023

Referred to the House Committee on Energy and Commerce.