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

Bill: 117-s-415
Sponsor: Sen. Cassidy, Bill [R-LA]
Introduced: 2021-02-24 in the Senate
Policy area: Health
Subjects: Administrative law and regulatory procedures
Chemistry
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation

Summary:
action_date: 2021-02-24
text: 
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.

action_date: 2021-03-10
text: 
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.

action_date: 2021-04-14
text: 
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.

action_date: 2021-04-23
text: 
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.


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

Enacted as: number: 117-9