US SB415 | 2021-2022 | 117th Congress


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.

Tracking Information

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



2021-04-23SenateBecame Public Law No: 117-9. (TXT | PDF)
2021-04-23SenateSigned by President.
2021-04-20SenatePresented to President.
2021-04-14HouseMotion to reconsider laid on the table Agreed to without objection.
2021-04-14HouseOn motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H1755)
2021-04-14HouseDEBATE - The House proceeded with forty minutes of debate on S. 415.
2021-04-14HouseConsidered under suspension of the rules. (consideration: CR H1755-1756)
2021-04-14HouseMr. Pallone moved to suspend the rules and pass the bill.
2021-03-12HouseHeld at the desk.
2021-03-12HouseReceived in the House.
2021-03-11SenateMessage on Senate action sent to the House.
2021-03-10SenatePassed Senate without amendment by Unanimous Consent. (text: CR S1435)
2021-03-10SenateSenate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. (consideration: CR S1435)
2021-02-24SenateRead twice and referred to the Committee on Health, Education, Labor, and Pensions.


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Bill Comments