US Congress Senate Bill 1767 (Prior Session Legislation)

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Sponsorship: Slight Partisan Bill (Republican 5-2)
Status: Introduced on July 15 2015 - 25% progression, died in chamber
Action: 2016-04-05 - Placed on Senate Legislative Calendar under General Orders. Calendar No. 414.
Text: Latest bill text (Introduced) [PDF]

Combination Product Regulatory Fairness Act of 2016 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

Sen. Johnny Isakson [R-GA]	Sen. Robert Casey [D-PA]	Sen. Pat Roberts [R-KS]	Sen. Pat Toomey [R-PA]
Sen. Mark Kirk [R-IL]	Sen. Joe Donnelly [D-IN]	Sen. Bill Cassidy [R-LA]

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

Type	Source
Summary	https://www.congress.gov/bill/114th-congress/senate-bill/1767/all-info
Text	https://www.congress.gov/114/bills/s1767/BILLS-114s1767is.pdf
Text	https://www.congress.gov/114/bills/s1767/BILLS-114s1767rs.pdf