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Bill114th CongressFiled Jul 15, 2015Health
S. 1767

Combination Product Regulatory Fairness Act of 2016

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Under committee review

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What it doesSummary 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.

What just happenedApr 5, 2016

Placed on Senate Legislative Calendar under General Orders. Calendar No. 414.

Who’s behind it

Sen. Isakson, Johnny [R-GA](R-GA)Sponsor
6 cosponsors2 D4 R
Read on Congress.gov
6cosponsors1committees6actions1related bills5subjects
  1. Apr 5, 2016Calendars

    Placed on Senate Legislative Calendar under General Orders. Calendar No. 414.

  2. Apr 5, 2016Committee

    Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.

    Health, Education, Labor, and Pensions Committee
  3. Apr 5, 2016Committee14000

    Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.

    Health, Education, Labor, and Pensions Committee
  4. Mar 9, 2016Committee

    Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.

    Health, Education, Labor, and Pensions Committee
  5. Jul 15, 2015IntroReferral

    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

    Health, Education, Labor, and Pensions Committee
  6. Jul 15, 2015IntroReferral10000

    Introduced in Senate

Reported to Senate with amendment(s)Apr 5, 20161

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.
Introduced in SenateJul 15, 2015

Combination Product Regulatory Fairness Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to provide the sponsor of a product the scientific rationale supporting a determination that the product is not a medical device before making that determination. If the FDA preliminarily determines that a product is not a medical device, the sponsor may propose a study to inform the product's classification.

The FDA is prohibited from determining that a combination product (a product that is a combination of drug, device, or biological product) is a drug solely because the product has a chemical action.

The FDA must provide the scientific rationale for deciding the primary mode of action (the most important therapeutic action) of a combination product if the FDA's decision disagrees with the conclusions of the product sponsor. (Combination products are regulated based on their primary mode of action.)

The sponsor of a combination product and the FDA may agree to a combination product review plan regarding the standards and requirements applicable to the product's premarket review, postmarket modification, or manufacturing.

The FDA may allow the sponsor of a combination product that contains an approved constituent product to omit information from the combination product application that is duplicative of information submitted regarding the approved constituent part.

The FDA must describe the responsibilities of each agency center regarding review of combination products.

The FDA's Office of Combination Products must resolve disputes regarding the premarket review of combination products within 90 days and annually report on disputes and meetings.
Combination Product Regulatory Fairness Act of 2016 — Informed