Combination Product Regulatory Fairness Act of 2016
Latest action · Apr 5, 2016 Placed on Senate Legislative Calendar under General Orders. Calendar No. 414.
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.
- IntroducedJul 15, 2015
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Combination Product Regulatory Fairness Act of 2016
(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding products that are a combination of a drug, medical device, or biological product.
The primary mode of action of a combination product must be the mode of action that makes the greatest contribution to the product's therapeutic effect. (Combination products are regulated based on their primary mode of action.) The FDA is prohibited from determining that a combination product is a drug or biological product solely because the product has a chemical action. If the sponsor of a combination product disagrees with the FDA's determination of the primary mode of action of the product, the FDA must provide the rationale for its determination and the sponsor and the FDA may agree to studies to inform a reevaluation of the product.
After the primary mode of action of a product is determined, the sponsor and the FDA may agree to a combination product review plan that may address the standards and requirements applicable to the product's review, postmarket modification, or manufacturing. The plan must remain in effect unless the sponsor and the FDA agree otherwise or an issue essential to determining the safety or effectiveness of the product is identified.
The FDA may require the sponsor of a combination product that contains an approved constituent part to submit to the FDA only information that is necessary to assess the safety and effectiveness of the combination product, taking into account prior findings regarding the approved constituent part. If the approved constituent part is a drug, the application for the combination product must comply with specified requirements for drug applications.
The FDA Office of Combination Products must coordinate reviews of combination products and oversee feedback regarding such reviews. The office must review FDA agreements, guidance, and practices regarding combination products.
The FDA must: (1) issue guidance that describes the process and best practices for review of combination products, and (2) propose that certain types of combination products may adopt good manufacturing practices that vary from requirements in regulations.Cosponsors 6
Members who signed on, in the order they did. Signatures ran from Jul 15, 2015 to Dec 14, 2015, with 2 there on the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-KS | Pat Roberts | Original | Jul 15, 2015 |
| D-PA | Robert P. Casey Jr. | Original | Jul 15, 2015 |
| R-PA | Patrick J. Toomey | Aug 3, 2015 | |
| R-IL | Mark Kirk | Sep 25, 2015 | |
| D-IN | Joe Donnelly | Oct 20, 2015 | |
| R-LA | Bill Cassidy | Dec 14, 2015 |
Actions 5
Everything that happened, newest first.
- Apr 5, 2016Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
- Apr 5, 2016Placed on Senate Legislative Calendar under General Orders. Calendar No. 414.
- Mar 9, 2016Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- Jul 15, 2015Introduced in Senate
- Jul 15, 2015Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 34 | 21st Century Cures Act | Related bill | Dec 13, 2016 |
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 2
Each version as it was printed, newest first.
- Apr 5, 2016Reported to Senate
- Jul 15, 2015Introduced in Senate
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.