Us Congress 2025-2026 Regular Session

Us Congress House Bill HB1051

Introduced

2/6/25

Refer

2/6/25

Caption

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.

Impact

If enacted, HB1051 would amend existing provisions on exclusivity rules under the Food, Drug, and Cosmetic Act. The most critical aspect of this legislation is the enforcement of a 180-day exclusivity period for the first applicant that is approved but does not initiate marketing within the prescribed timeline. Subsequently, this bill allows for other applicants to jump ahead in the approval line under specific conditions. The intention behind this amendment is to prevent stifling competition caused by delays in commercial marketing from initial applicants, thereby fostering quicker access to generic medications in the healthcare market.

Summary

House Bill 1051 seeks to amend the Federal Food, Drug, and Cosmetic Act, specifically addressing the protocol for approving abbreviated new drug applications (ANDAs). The bill is designed to streamline the process in cases where the first applicant fails to commence commercial marketing within a specific period, effectively allowing subsequent applicants to proceed without being held back by the initial applicant's inaction. This legislative move is significant as it attempts to enhance market responsiveness and availability of generic drugs, which could ultimately benefit consumers by increasing competition and lowering drug prices.

Contention

There could be potential contention surrounding the bill, particularly from stakeholders in the pharmaceutical industry. Proponents argue that the bill supports public health by promoting timely access to crucial medications, while critics may raise concerns about balancing the interests of patent holders and original drug manufacturers with the need for generic alternatives. Additionally, there may be discussions regarding the adequacy and fairness of regulatory review processes when multiple applicants vie for approval under revised exclusivity terms. These factors could influence both consumer markets and pharmaceutical innovations.

Congress_id

119-HR-1051

Policy_area

Health

Introduced_date

2025-02-06

Companion Bills

No companion bills found.

Previously Filed As

US HB10370

To amend the Federal Food, Drug, and Cosmetic Act to establish certain labeling requirements for caffeine, and for other purposes.

US HB3839

To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.

US HB10409

To address the high costs of health care services, prescription drugs, and health insurance coverage in the United States, and for other purposes.

US HB7974

To amend the Federal Food, Drug, and Cosmetic Act to require labeling of food products containing insects, and for other purposes.

US SB5638

A bill to secure the supply of drugs in the United States, and for other purposes.

US HB10406

To amend the Federal Food, Drug, and Cosmetic Act to authorize requiring the manufacturers of a covered device to disclose to a patient all patient-specific data that is recorded or transmitted by the device and accessible to the manufacturer, and for other purposes.

US HB8123

To amend the Federal Food, Drug, and Cosmetic Act to establish new prohibited acts relating to dietary supplements.

US HB10428

To support and fund the Federal procurement of clean energy products, and for other purposes.

US HB10550

To amend the Trademark Act of 1946 to clarify the applicability of Federal trademark law in the area of digital replicas of identifying characteristics of individuals, and for other purposes.

US HB8267

Old Drugs, New Cures Act

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