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Titles (2)

Short Titles

Short Titles - House of Representatives

Short Titles as Introduced

Lower Drug Costs through Competition Act

Official Titles

Official Titles - House of Representatives

Official Title as Introduced

To increase competition in the pharmaceutical industry.

Actions Overview (1)

01/30/2017Introduced in House

All Actions (3)

02/03/2017Referred to the Subcommittee on Health.
Action By: Committee on Energy and Commerce
01/30/2017Referred to the House Committee on Energy and Commerce.
Action By: House of Representatives
01/30/2017Introduced in House
Action By: House of Representatives

Committees (1)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Reports
House Energy and Commerce01/30/2017 Referred to
House Energy and Commerce Subcommittee on Health02/03/2017 Referred to

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Latest Summary (1)

There is one summary for H.R.749. View summaries

Shown Here:
Introduced in House (01/30/2017)

Lower Drug Costs through Competition Act

This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs: (1) for which there is a shortage, or (2) that have not been recently introduced to the market by more than one manufacturer and for which tentative approval has not been granted to more than two applications.

The Food and Drug Administration (FDA) must prioritize the review of such submissions and act on them within 180 days. The FDA may expedite the inspection of a facility proposed to manufacture such a drug.

Beginning FY2019, the FDA must award a transferrable generic drug priority review voucher to the sponsor of such an application once the drug has a sustained market presence. A voucher may be used to have the FDA review and take action upon a generic drug application within 180 days of submission. The FDA must establish an additional user fee for applications subject to a voucher. This voucher program is terminated at the start of FY2024.

The FDA must periodically report on generic drug applications filed before FY2018 that are still pending.

For a new drug application to be eligible for a priority review voucher as a tropical disease product application, the application must include new, essential clinical investigations.

The Government Accountability Office must study the FDA's program for drug risk evaluation and mitigation strategies.