Food and Drug Amendments of 2022

Bill: 117-hr-7667
Sponsor: Rep. Eshoo, Anna G. [D-CA-18]
Introduced: 2022-05-06 in the House
Policy area: Health
Subjects: Advanced technology and technological innovations
Advisory bodies
Animal protection and human-animal relationships
Blood and blood diseases
Business records
Cardiovascular and respiratory health
Child health
Computer security and identity theft
Congressional oversight
Criminal investigation, prosecution, interrogation
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Emergency medical services and trauma care
Employee hiring
Evidence and witnesses
Executive agency funding and structure
Food and Drug Administration (FDA)
Genetics
Government employee pay, benefits, personnel management
Government information and archives
Government studies and investigations
Health care coverage and access
Health programs administration and funding
Health technology, devices, supplies
Industrial facilities
Infectious and parasitic diseases
Inflation and prices
Licensing and registrations
Manufacturing
Marketing and advertising
Medical research
Minority health
Musculoskeletal and skin diseases
Organ and tissue donation and transplantation
Performance measurement
Photography and imaging
Prescription drugs
Product development and innovation
Public participation and lobbying
Public-private cooperation
Radiation
Research and development
Small business
User charges and fees

Summary:
action_date: 2022-05-06
text: 

Food and Drug Amendments of 2022

 
This bill reauthorizes Food and Drug Administration (FDA) user fee programs for certain drugs and devices, establishes requirements to increase diversity in clinical trials, and modifies requirements relating to the overall supply chain for drugs and devices.
 
Specifically, the bill reauthorizes through FY2027 the FDA user fee programs for prescription drugs, medical devices, generic drugs, and biosimilars.
 
The bill also requires the development of action plans and related reporting to increase the diversity of participants in clinical trials.
 
In addition, the bill requires the FDA to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why). 
 
The bill also (1) establishes requirements and reauthorizes programs to support the development of specific categories of drugs and devices (e.g., pediatric drugs) and inspections of drug manufacturing facilities; and (2) establishes and revises requirements relating to the approval of drugs and devices, including requirements for postapproval studies and guidance about using real-world evidence to support drug and device applications.

action_date: 2022-06-07
text: 

Food and Drug Amendments of 2022

 
This bill reauthorizes Food and Drug Administration (FDA) user fee programs for certain drugs and devices, establishes requirements to increase diversity in clinical trials, and modifies requirements relating to the overall supply chain for drugs and devices.
 
Specifically, the bill reauthorizes through FY2027 the FDA user fee programs for prescription drugs, medical devices, generic drugs, and biosimilars.
 
The bill also requires the development of action plans and related reporting to increase the diversity of participants in clinical trials.
 
In addition, the bill requires the FDA to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why). 
 
The bill also (1) establishes requirements and reauthorizes programs to support the development of specific categories of drugs and devices (e.g., pediatric drugs) and inspections of drug manufacturing facilities; and (2) establishes and revises requirements relating to the approval of drugs and devices, including requirements for postapproval studies and guidance about using real-world evidence to support drug and device applications.

action_date: 2022-06-08
text: 

Food and Drug Amendments of 2022

 
This bill reauthorizes Food and Drug Administration (FDA) user fee programs for certain drugs and devices, establishes requirements to increase diversity in clinical trials, and modifies requirements relating to the overall supply chain for drugs and devices.
 
Specifically, the bill reauthorizes through FY2027 the FDA user fee programs for prescription drugs, medical devices, generic drugs, and biosimilars.
 
The bill also requires the development of action plans and related reporting to increase the diversity of participants in clinical trials.
 
In addition, the bill requires the FDA to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why). 
 
The bill also (1) establishes requirements and reauthorizes programs to support the development of specific categories of drugs and devices (e.g., pediatric drugs) and inspections of drug manufacturing facilities; and (2) establishes and revises requirements relating to the approval of drugs and devices, including requirements for postapproval studies and guidance about using real-world evidence to support drug and device applications.


Legislative actions:
action_date: 2022-06-09
text: Received in the Senate.
action_date: 2022-06-08
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2022-06-08
text: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 392 - 28 (Roll no. 254). (text: 06/07/2022 CR H5298-5319)
action_date: 2022-06-08
text: Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 392 - 28 (Roll no. 254).
action_date: 2022-06-08
text: Considered as unfinished business. (consideration: CR H5402-5403)
action_date: 2022-06-07
text: At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.
action_date: 2022-06-07
text: DEBATE - The House proceeded with forty minutes of debate on H.R. 7667.
action_date: 2022-06-07
text: Considered under suspension of the rules. (consideration: CR H5298-5321)
action_date: 2022-06-07
text: Mr. Pallone moved to suspend the rules and pass the bill, as amended.
action_date: 2022-06-07
text: Placed on the Union Calendar, Calendar No. 262.
action_date: 2022-06-07
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-348.
action_date: 2022-06-07
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-348.
action_date: 2022-05-18
text: Ordered to be Reported (Amended) by the Yeas and Nays: 55 - 0.
action_date: 2022-05-18
text: Committee Consideration and Mark-up Session Held.
action_date: 2022-05-11
text: Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 30 - 0 .
action_date: 2022-05-11
text: Subcommittee Consideration and Mark-up Session Held.
action_date: 2022-05-09
text: Referred to the Subcommittee on Health.
action_date: 2022-05-06
text: Referred to the House Committee on Energy and Commerce.
action_date: 2022-05-06
text: Introduced in House
action_date: 2022-05-06
text: Introduced in House