Bill Activity

Bill Enacted

This bill was enacted into law on 2021-04-23

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Main Subject: Health

This bill 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.

Library of Congress Actions

President
Apr. 23 2021	Became Public Law No: 117-9. Signed by President.
Apr. 20 2021	Presented to President.

BecameLaw
Apr. 23 2021	Became Public Law No: 117-9. Signed by President.

Floor
Apr. 14 2021	Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H1755)
Mar. 10 2021	Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(text: CR S1435)

Committee
Mar. 10 2021	Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.(consideration: CR S1435)

House floor actions Actions

Floor
Apr. 20 2021	Presented to President.
Apr. 14 2021	Motion to reconsider laid on the table Agreed to without objection. On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H1755) DEBATE - The House proceeded with forty minutes of debate on S. 415. Considered under suspension of the rules. (consideration: CR H1755-1756) Mr. Pallone moved to suspend the rules and pass the bill.
Mar. 12 2021	Held at the desk. Received in the House.

Senate Actions

Floor
Mar. 11 2021	Message on Senate action sent to the House.
Mar. 10 2021	Passed Senate without amendment by Unanimous Consent. (text: CR S1435)

Discharge
Mar. 10 2021	Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. (consideration: CR S1435)

IntroReferral
Feb. 24 2021	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

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