US Congress Senate Bill 415

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Completed Legislative Action
Spectrum: Slight Partisan Bill (Republican 2-1)
Status: Passed on April 23 2021 - 100% progression
Action: 2021-04-23 - Became Public Law No: 117-9. (TXT | PDF)
Text: Latest bill text (Enrolled) [PDF]

Provides statutory authority for the existing Food and Drug Administration (FDA) practice of defining active ingredient more narrowly as active moiety in certain situations, such as when determining whether a new drug is entitled to a market exclusivity period or providing priority review of drugs for treating rare pediatric diseases. Generally, the FDA defines active moiety as the core molecule or ion in a drug responsible for the relevant physiological or pharmacological action. By contrast, the FDA defines an active ingredient as a component in a drug that is intended to furnish pharmacological activity or other direct effect. The FDA's existing practice of interpreting active ingredient as active moiety in certain situations, as statutorily authorized by this bill, tends to exclude some drugs from market exclusivity. The bill replaces references to active ingredient with active moiety in various statutes authorizing FDA activities.

A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity.

Sen. Bill Cassidy [R-LA]

Sen. Tina Smith [D-MN]

Sen. Roger Marshall [R-KS]

Date	Chamber	Action
2021-04-23	Senate	Became Public Law No: 117-9. (TXT | PDF)
2021-04-23	Senate	Signed by President.
2021-04-20	Senate	Presented to President.
2021-04-14	House	Motion to reconsider laid on the table Agreed to without objection.
2021-04-14	House	On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H1755)
2021-04-14	House	DEBATE - The House proceeded with forty minutes of debate on S. 415.
2021-04-14	House	Considered under suspension of the rules. (consideration: CR H1755-1756)
2021-04-14	House	Mr. Pallone moved to suspend the rules and pass the bill.
2021-03-12	House	Held at the desk.
2021-03-12	House	Received in the House.
2021-03-11	Senate	Message on Senate action sent to the House.
2021-03-10	Senate	Passed Senate without amendment by Unanimous Consent. (text: CR S1435)
2021-03-10	Senate	Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. (consideration: CR S1435)
2021-02-24	Senate	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Type	Source
Summary	https://www.congress.gov/bill/117th-congress/senate-bill/415/all-info
Text	https://www.congress.gov/117/bills/s415/BILLS-117s415is.pdf
Text	https://www.congress.gov/117/bills/s415/BILLS-117s415es.pdf
Text	https://www.congress.gov/117/bills/s415/BILLS-117s415enr.pdf