To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. | ChamberLight

IN COMMITTEE· 119TH CONGRESS

House BillHR 1051Drug safety, medical device, and laboratory regulationPrescription drugs

To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes.

INTRO FEB 6· LAST ACTION FEB 6

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Passed Senate

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Became Law

WHAT THE BILL DOES

AI-written

This bill matters because it tackles a problem known as 'parking' the 180-day exclusivity period. Currently, if a generic drug company wins the right to be the first to sell a generic version of a patented drug, they get 180 days where no other generic can launch. Sometimes, this first company doesn't actually sell the drug, effectively blocking all other cheaper generic options from reaching the market for an extended period, which keeps drug prices higher. If this bill becomes law, it would create an incentive for generic drug companies to use their exclusivity efficiently or risk losing their market advantage. This could lead to more timely access to affordable generic medications, which could save consumers money and improve public health by increasing the availability of cheaper drug alternatives. If it doesn't become law, the 'parking' issue could continue, potentially prolonging higher drug prices and limiting generic availability.

KEY PROVISIONS

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PROVISION 01

Allows the FDA to approve a subsequent generic drug applicant even if a first generic applicant is eligible for 180-day exclusivity.

This provision creates an exception to the existing 180-day exclusivity rule, preventing indefinite delays in generic drug availability.

PROVISION 02

Sets conditions for subsequent approval, including that 33 months must have passed since the first applicant's submission and no first applicant is effectively marketing the drug.

These conditions define when the FDA can intervene, balancing incentives for first applicants with public access to generics.

PROVISION 03

Requires a subsequent applicant approved under these new rules to certify that they will commence commercial marketing within 75 days of approval.

This ensures that subsequent approvals actually lead to drugs reaching the market quickly, preventing a new form of market delay.

PROVISION 04

Establishes a forfeiture rule where a subsequent applicant loses effective approval if they fail to market the drug within the promised 75-day period.

This rule adds accountability, ensuring companies uphold their commitment to timely market entry and preventing misuse of the new pathway.

SPONSORSHIP

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ACTION TIMELINE

2 EVENTS

FEB 6

Introduced in House

INTROREFERRAL

FEB 6

Referred to the House Committee on Energy and Commerce.

HOUSE · INTROREFERRAL

BILL INFO

TypeHouse Bill

NumberHR 1051

Congress119th

StatusIn Committee

IntroducedFeb 6, 2025

Last actionFeb 6, 2025

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IN COMMITTEE· 119TH CONGRESS · ENERGY AND COMMERCE COMMITTEE · INTRODUCED FEB 6, 2025

House BillHR 1051Drug safety, medical device, and laboratory regulationPrescription drugs

To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes.

INTRODUCED FEB 6, 2025· LAST ACTION FEB 6, 2025

PASSAGE CHANCES

—%

READING

5 min

COSPONSORS

COMPLEXITY

Moderate

LEGISLATIVE PROGRESS

STEP 2 OF 8

Introduced

In Committee

Reported

Passed House

Passed Senate

Conference

To President

Became Law

Introduced
In Committee
Reported
Passed House
Passed Senate
Conference
To President
Became Law

WHAT THE BILL DOES

AI-written

KEY PROVISIONS

AI-extracted

high

Allows the FDA to approve a subsequent generic drug applicant even if a first generic applicant is eligible for 180-day exclusivity.

This provision creates an exception to the existing 180-day exclusivity rule, preventing indefinite delays in generic drug availability.

high

Sets conditions for subsequent approval, including that 33 months must have passed since the first applicant's submission and no first applicant is effectively marketing the drug.

These conditions define when the FDA can intervene, balancing incentives for first applicants with public access to generics.

med

Requires a subsequent applicant approved under these new rules to certify that they will commence commercial marketing within 75 days of approval.

This ensures that subsequent approvals actually lead to drugs reaching the market quickly, preventing a new form of market delay.

med

Establishes a forfeiture rule where a subsequent applicant loses effective approval if they fail to market the drug within the promised 75-day period.

This rule adds accountability, ensuring companies uphold their commitment to timely market entry and preventing misuse of the new pathway.

DEADLINES & DATES

AI-extracted

An AI model extracted this from the bill’s official record and can make mistakes. Check the official text ↗ (opens in new tab)

Within 75 days after the date of approval

Subsequent applicant must commence commercial marketing of the drug.

At least 33 months

Period before subsequent applicant can be approved under this bill, measured from the date of submission of an application by at least one first applicant.

Not later than one business day after commencing marketing

Applicant must submit notification to the abbreviated new drug application confirming commencement of commercial marketing (if initially failed to market and later 'cured').

PENALTIES & ENFORCEMENT

AI-extracted

An AI model extracted this from the bill’s official record and can make mistakes. Check the official text ↗ (opens in new tab)

TYPE	AMOUNT	WHO
administrative	Loss of effective approval (application reverts to tentatively approved status)	Subsequent applicant approved under subclause (III) of subparagraph (B)(iv) who fails to commence commercial marketing within 75 days
administrative	Ineligibility for subsequent effective approval under subclause (III) unless specific 'cure' conditions are met (unforeseeable event, issue resolution)	Subsequent applicant who failed to commence commercial marketing within 75 days

GLOSSARY

AI-written

Abbreviated New Drug Application (ANDA): An application submitted to the FDA for approval of a generic drug. It shows that the generic drug is the same as a previously approved brand-name drug in terms of dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.
180-day exclusivity period: A limited period (180 days) granted by the FDA to the first generic drug manufacturer to challenge a brand-name drug's patent. During this time, the FDA cannot approve other generic versions of the same drug, giving the 'first applicant' a temporary head start in the market.
Paragraph IV certification: Part of a generic drug application where the applicant certifies that a brand-name drug's patent is either invalid, unenforceable, or will not be infringed by the generic drug. This certification often triggers a patent infringement lawsuit.
Commercial marketing: The act of actively selling and distributing a drug in the marketplace.
Tentatively approved: An FDA status for a drug application indicating that it meets all scientific and regulatory requirements for approval, but cannot yet be effectively approved or marketed due to legal or regulatory barriers, such as patent exclusivity.
First applicant: The first generic drug manufacturer to submit an Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification, potentially entitling them to 180-day exclusivity.

ACTION TIMELINE

2 EVENTS

FEB 6, 25

Introduced in House

INTROREFERRAL

FEB 6, 25

Referred to the House Committee on Energy and Commerce.

INTROREFERRAL

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To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes.

LEGISLATIVE PROGRESS

WHAT THE BILL DOES

KEY PROVISIONS

SPONSORSHIP

ACTION TIMELINE

BILL INFO

READER REACTIONS

Discussion

To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes.

LEGISLATIVE PROGRESS

WHAT THE BILL DOES

KEY PROVISIONS

DEADLINES & DATES

PENALTIES & ENFORCEMENT

GLOSSARY

ACTION TIMELINE

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