Bill Sponsor
Senate Bill 1636
116th Congress(2019-2020)
Ensuring Innovation Act
Active
Amendments
Active
Passed Senate on Dec 14, 2020
Overview
Text
Introduced
May 23, 2019
Latest Action
Dec 15, 2020
Origin Chamber
Senate
Type
Bill
Bill
The primary form of legislative measure used to propose law. Depending on the chamber of origin, bills begin with a designation of either H.R. or S. Joint resolution is another form of legislative measure used to propose law.
Bill Number
1636
Congress
116
Policy Area
Health
Health
Primary focus of measure is science or practice of the diagnosis, treatment, and prevention of disease; health services administration and funding, including such programs as Medicare and Medicaid; health personnel and medical education; drug use and safety; health care coverage and insurance; health facilities. Measures concerning controlled substances and drug trafficking may fall under Crime and Law Enforcement policy area.
Sponsorship by Party
Republican
Kansas
Republican
Louisiana
Democrat
Minnesota
Senate Votes (1)
House Votes (0)
checkPassed on December 14, 2020
Status
Passed
Type
Unanimous Consent
Unanimous Consent
A senator may request unanimous consent on the floor to set aside a specified rule of procedure so as to expedite proceedings. If no Senator objects, the Senate permits the action, but if any one senator objects, the request is rejected. Unanimous consent requests with only immediate effects are routinely granted, but ones affecting the floor schedule, the conditions of considering a bill or other business, or the rights of other senators, are normally not offered, or a floor leader will object to it, until all senators concerned have had an opportunity to inform the leaders that they find it acceptable.
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(text of amendment in the nature of a substitute: CR S7470)
Summary

Ensuring Innovation Act

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.

Text (2)
December 14, 2020
Amendments (1)
Dec 14, 2020
Agreed to in Senate
1
Sponsorship
Senate Amendment 2707
In the nature of a substitute.
Agreed To
Actions (9)
12/15/2020
Held at the desk.
12/15/2020
Received in the House.
12/15/2020
Message on Senate action sent to the House.
12/14/2020
Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S7470)
12/14/2020
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(text of amendment in the nature of a substitute: CR S7470)
12/14/2020
Measure laid before Senate by unanimous consent. (consideration: CR S7470)
12/14/2020
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
05/23/2019
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
05/23/2019
Introduced in Senate
Public Record
Record Updated
Jan 11, 2023 1:43:53 PM