SENATE 415117th CongressBecame Public Law No: 117-9.

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

Last Action: 4/23/2021

Actions

2021-04-23Became Public Law No: 117-9.
2021-04-23Became Public Law No: 117-9.
2021-04-23Signed by President.
2021-04-23Signed by President.
2021-04-20Presented to President.
2021-04-20Presented to President.
2021-04-14Motion to reconsider laid on the table Agreed to without objection.
2021-04-14On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H1755)
2021-04-14Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H1755)
2021-04-14DEBATE - The House proceeded with forty minutes of debate on S. 415.
2021-04-14Considered under suspension of the rules. (consideration: CR H1755-1756)
2021-04-14Mr. Pallone moved to suspend the rules and pass the bill.
2021-03-12Held at the desk.
2021-03-12Received in the House.
2021-03-11Message on Senate action sent to the House.

Showing 15 of 20 actions. Full history on Congress.gov.

CRS Summary

As of 2021-04-23 (49)

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.

Cosponsors (2)

Tina Smith (D-MN)
Roger Marshall (R-KS)

Subjects

Administrative law and regulatory procedures
Chemistry
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation

Became law: Pub. L. 117-9

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