HR 3379 116th Congress House

PRICED Act

Official title: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years.

Introduced: October 11, 2019 Introduced by: Schakowsky, Janice D. Democratic · Illinois See on congress.gov

Health Drug safety, medical device, and laboratory regulationLicensing and registrationsMarketing and advertising

Everywhere this bill has been 3 steps

Introduced

In committee

Reported out

Passed House

Passed Senate

To President

Became law

Jun 21, 2019

Referred to the Subcommittee on Health.

Jun 20, 2019

Referred to the House Committee on Energy and Commerce.

Jun 20, 2019

Introduced in House

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Latest action June 21, 2019

Referred to the Subcommittee on Health.

Plain-English summary Congressional Research Service

Price Relief, Innovation, and Competition for Essential Drugs Act or the PRICED Act

This bill allows biosimilars to be marketed five years after the reference brand-name biological product is licensed. Currently, brand-name biological products are provided a 12-year marketing-exclusivity period.

This shortened marketing-exclusivity period applies only to biological products licensed by the Food and Drug Administration after enactment of this bill.

Related & companion bills 2