S. 1767 · 114th Congress
Combination Product Regulatory Fairness Act of 2015
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Never voted on. It didn't reach a floor vote before the 114th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
IsaksonSponsor6 cosponsors · 2 D, 4 R
2 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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.
What it does: CRS summary · Reported to Senate with amendment(s) · Apr 5, 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.Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Combination Product Regulatory Fairness Act of 2016
Latest action (Apr 5, 2016): Placed on Senate Legislative Calendar under General Orders. Calendar No. 414.
Policy area: Health · Origin: Senate · Introduced: Jul 15, 2015
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.