To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to submit to Congress a report on barriers, including regulatory inefficiencies, to domestic manufacturing of active pharmaceutical ingredients, finished drug products, and devices, and for other purposes.

12/30/2022, 4:18 AM

This bill requires the Food and Drug Administration (FDA) to report to Congress on barriers to the domestic manufacturing of imported active pharmaceutical ingredients, finished drug products, and devices that are critical to public health.

The report must recommend strategies to overcome such barriers. The FDA may, to the extent appropriate, implement the strategies.

Bill 117 hr 6710, also known as the "Domestic Manufacturing and Regulatory Barriers Report Act," aims to address the challenges faced by domestic manufacturers of active pharmaceutical ingredients, finished drug products, and devices. The bill directs the Secretary of Health and Human Services, specifically through the Commissioner of Food and Drugs, to submit a report to Congress detailing the barriers hindering domestic manufacturing in these industries.

The report will specifically focus on regulatory inefficiencies that impede the ability of domestic manufacturers to compete in the global market. By identifying and addressing these barriers, the goal is to promote and support the growth of domestic manufacturing in the pharmaceutical and medical device sectors.

In addition to analyzing regulatory obstacles, the bill also aims to explore other factors that may be contributing to the decline in domestic manufacturing, such as supply chain vulnerabilities and reliance on foreign sources for critical medical products. Overall, the purpose of Bill 117 hr 6710 is to provide Congress with a comprehensive understanding of the challenges faced by domestic manufacturers in the pharmaceutical and medical device industries, in order to inform potential policy solutions that can support and strengthen domestic manufacturing capabilities.
Congress
117

Number
HR - 6710

Introduced on
2022-02-11

# Amendments
0

Sponsors
+5

Cosponsors
+5

Variations and Revisions

2/11/2022

Status of Legislation

Bill Introduced
Introduced to House
House to Vote
Introduced to Senate
Senate to Vote

Purpose and Summary

This bill requires the Food and Drug Administration (FDA) to report to Congress on barriers to the domestic manufacturing of imported active pharmaceutical ingredients, finished drug products, and devices that are critical to public health.

The report must recommend strategies to overcome such barriers. The FDA may, to the extent appropriate, implement the strategies.

Bill 117 hr 6710, also known as the "Domestic Manufacturing and Regulatory Barriers Report Act," aims to address the challenges faced by domestic manufacturers of active pharmaceutical ingredients, finished drug products, and devices. The bill directs the Secretary of Health and Human Services, specifically through the Commissioner of Food and Drugs, to submit a report to Congress detailing the barriers hindering domestic manufacturing in these industries.

The report will specifically focus on regulatory inefficiencies that impede the ability of domestic manufacturers to compete in the global market. By identifying and addressing these barriers, the goal is to promote and support the growth of domestic manufacturing in the pharmaceutical and medical device sectors.

In addition to analyzing regulatory obstacles, the bill also aims to explore other factors that may be contributing to the decline in domestic manufacturing, such as supply chain vulnerabilities and reliance on foreign sources for critical medical products. Overall, the purpose of Bill 117 hr 6710 is to provide Congress with a comprehensive understanding of the challenges faced by domestic manufacturers in the pharmaceutical and medical device industries, in order to inform potential policy solutions that can support and strengthen domestic manufacturing capabilities.
Alternative Names
Official Title as IntroducedTo direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to submit to Congress a report on barriers, including regulatory inefficiencies, to domestic manufacturing of active pharmaceutical ingredients, finished drug products, and devices, and for other purposes.

Policy Areas
Health

Potential Impact
Congressional oversight•
Drug safety, medical device, and laboratory regulation•
Emergency medical services and trauma care•
Infectious and parasitic diseases•
Manufacturing•
Trade restrictions

Comments

Recent Activity

Latest Summary9/6/2022

This bill requires the Food and Drug Administration (FDA) to report to Congress on barriers to the domestic manufacturing of imported active pharmaceutical ingredients, finished drug products, and devices that are critical to public health.

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Latest Action2/14/2022
Referred to the Subcommittee on Health.