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S 4918 117th Congress Senate Health Civil actions and liability Drug safety, medical device, and laboratory regulation Prescription drugs

Increasing Prescription Drug Competition Act

Introduced: September 22, 2022 Introduced by: Hassan, Margaret Wood Democratic · New Hampshire See on congress.gov
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 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Sep 22, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sep 22, 2022
Introduced in Senate
 Plain-English summary Congressional Research Service

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.

What's happening now September 22, 2022

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

 Committees of jurisdiction 1