Lower Drug Costs through Competition Act
Latest action · Mar 18, 2016 Referred to the Subcommittee on Health.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedMar 17, 2016
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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 FY2018, 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 end of FY2021.
The FDA must periodically report on generic drug applications filed before FY2017 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.Cosponsors 16
Members who signed on, in the order they did. Signatures ran from Mar 17, 2016 to Dec 8, 2016; 1 is an original cosponsor, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-FL | Gus M. Bilirakis | Original | Mar 17, 2016 |
| D-CA | Scott H. Peters | Sep 6, 2016 | |
| R-IL | Robert J. Dold | Sep 7, 2016 | |
| D-NY | Brian Higgins | Sep 12, 2016 | |
| R-ME | Bruce Poliquin | Sep 12, 2016 | |
| D-NE | Brad Ashford | Sep 13, 2016 | |
| I-AZ | Kyrsten Sinema | Sep 13, 2016 | |
| D-TN | Jim Cooper | Sep 19, 2016 | |
| D-MA | Seth Moulton | Sep 19, 2016 | |
| D-CA | Barbara Lee | Sep 21, 2016 | |
| D-MI | Brenda L. Lawrence | Sep 21, 2016 | |
| D-CT | James A. Himes | Sep 21, 2016 | |
| D-CA | Jim Costa | Sep 21, 2016 | |
| R-FL | Bill Posey | Sep 26, 2016 | |
| D-CA | Ami Bera | Sep 28, 2016 | |
| D-IL | Daniel Lipinski | Dec 8, 2016 |
Committees 1
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Energy and Commerce Committee | Referred Mar 17, 2016 |
| Health Subcommittee | Referred Mar 18, 2016 |
Actions 3
Everything that happened, newest first.
- Mar 18, 2016Referred to the Subcommittee on Health.
- Mar 17, 2016Introduced in House
- Mar 17, 2016Referred to the House Committee on Energy and Commerce.
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Constitutional authority
The sponsor’s statement, as printed in the Congressional Record, vol. 162, no. 43, March 17, 2016, page H1462.
Related bills 2
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 749 | Lower Drug Costs through Competition Act | Reintroduced Bill | Feb 3, 2017 |
| S 2615 | Increasing Competition in Pharmaceuticals Act | Related bill | Mar 1, 2016 |
Titles 2
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To increase competition in the pharmaceutical industry.
- Short Titles as Introduced
- Lower Drug Costs through Competition Act
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Mar 17, 2016Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
