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To direct the Secretary of Health and Human Services to conduct a pilot program under which the Secretary increases the conduct of unannounced inspections of foreign human drug establishments and evaluates the differences between inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection.

3/8/2023, 7:58 PM

Summary of Bill HR 6980

Bill 117 HR 6980, also known as the Foreign Drug Inspection Pilot Program Act, aims to improve the oversight of foreign human drug establishments by directing the Secretary of Health and Human Services to conduct a pilot program. This program would involve increasing the frequency of unannounced inspections of foreign human drug establishments and evaluating the differences between inspections of domestic and foreign establishments.

The bill specifically focuses on the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance. By conducting unannounced inspections, the goal is to ensure that these establishments are meeting the same standards and regulations as domestic establishments.

The pilot program will allow for a comparison of the effectiveness of announced versus unannounced inspections in ensuring compliance with regulations. This information will be crucial in determining the best practices for oversight of foreign human drug establishments. Overall, the Foreign Drug Inspection Pilot Program Act seeks to strengthen the oversight of foreign human drug establishments to ensure the safety and efficacy of drugs imported into the United States.

Congressional Summary of HR 6980

This bill requires the Food and Drug Administration to conduct a pilot program to increase the number of unannounced inspections of foreign drug manufacturing facilities and evaluate the differences between inspections of domestic and foreign facilities.

Current Status of Bill HR 6980

Bill HR 6980 is currently in the status of Bill Introduced since March 8, 2022. Bill HR 6980 was introduced during Congress 117 and was introduced to the House on March 8, 2022.  Bill HR 6980's most recent activity was Referred to the Subcommittee on Health. as of March 9, 2022

Bipartisan Support of Bill HR 6980

Total Number of Sponsors
1
Democrat Sponsors
0
Republican Sponsors
1
Unaffiliated Sponsors
0
Total Number of Cosponsors
2
Democrat Cosponsors
2
Republican Cosponsors
0
Unaffiliated Cosponsors
0

Policy Area and Potential Impact of Bill HR 6980

Primary Policy Focus

Health

Alternate Title(s) of Bill HR 6980

To direct the Secretary of Health and Human Services to conduct a pilot program under which the Secretary increases the conduct of unannounced inspections of foreign human drug establishments and evaluates the differences between inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection.
To direct the Secretary of Health and Human Services to conduct a pilot program under which the Secretary increases the conduct of unannounced inspections of foreign human drug establishments and evaluates the differences between inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection.

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