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S. 1767: Combination Product Regulatory Fairness Act of 2016

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S. 1767: Combination Product Regulatory Fairness Act of 2016

114th Congress · introduced 2015-07-15 · Health · Latest: Placed on Senate Legislative Calendar under General Orders. Calendar No. 414.

federal

Follow this bill, step by step

  1. Where it came from: introduced 2015-07-15 · official record
  2. Who proposed it: Sen. Isakson, Johnny [R-GA] · what a sponsor is
  3. What happened next: no floor votes in our records yet. Why?
  4. Where it stands now: Placed on Senate Legislative Calendar under General Orders. Calendar No. 414. Not final yet: this can still change. We check for updates every day.
  5. If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

Combination Product Regulatory Fairness Act of 2016

Plain 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.

Congressional Research Service summary (Reported to Senate with amendment(s)), quoted unchanged (nonpartisan). Read the source.

What a vote does

A “Yea” vote

If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

PSI Sci description of the legislative step (not an opinion).

What does this mean? (plain words)

Official text

Combination Product Regulatory Fairness Act of 2016

Source: Congressional Research Service summary (Reported to Senate with amendment(s))

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The strongest published arguments

Arguments for (supporters)

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Arguments against (opponents)

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Alternatives

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Sen. Isakson, Johnny [R-GA] · 6 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Bill Cassidy (R-LA)

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (2)
Bill
A proposed law. It becomes law only if it passes the legislature and is signed by the president or governor (or a veto is overridden).
Rulemaking
The process agencies use to write regulations that carry out laws passed by Congress or a legislature. Usually an agency publishes a proposed rule, takes public comments, then publishes a final rule.

Plain meanings written from linked sources. All words.

Sources

Record fed-us-cong114-s1767 · catalog fed-us-congress-bills-cong114 · updated 2026-11-15 by psicol fed-bills-cong114