There are 2 versions of this bill. View text

Click the check-box to add or remove the section, click the text link to scroll to that section.
Titles Actions Overview All Actions Cosponsors Committees Related Bills Subjects Latest Summary All Summaries

Titles (3)

Short Titles

Short Titles - Senate

Short Titles as Reported to Senate

Combination Product Regulatory Fairness Act of 2016

Short Titles as Introduced

Combination Product Regulatory Fairness Act of 2015

Official Titles

Official Titles - Senate

Official Titles as Introduced

A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to combination products, and for other purposes.


Actions Overview (2)

Date
04/05/2016Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
07/15/2015Introduced in Senate

All Actions (4)

Date
04/05/2016Placed on Senate Legislative Calendar under General Orders. Calendar No. 414.
Action By: Senate
04/05/2016Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
03/09/2016Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
07/15/2015Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Action By: Senate

Cosponsors (6)

* = Original cosponsor
CosponsorDate Cosponsored
Sen. Casey, Robert P., Jr. [D-PA]* 07/15/2015
Sen. Roberts, Pat [R-KS]* 07/15/2015
Sen. Toomey, Pat [R-PA] 08/03/2015
Sen. Kirk, Mark Steven [R-IL] 09/25/2015
Sen. Donnelly, Joe [D-IN] 10/20/2015
Sen. Cassidy, Bill [R-LA] 12/14/2015

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
Senate Health, Education, Labor, and Pensions07/15/2015 Referred to
03/09/2016 Markup by
04/05/2016 Reported by

A related bill may be a companion measure, an identical bill, a procedurally-related measure, or one with text similarities. Bill relationships are identified by the House, the Senate, or CRS, and refer only to same-congress measures.


Latest Summary (2)

There are 2 summaries for S.1767. View summaries

Shown Here:
Reported to Senate with amendment(s) (04/05/2016)

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.