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H.R. 6980House117th Congress (2021-2023)In Committee

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.

Sponsored by Richard HudsonRep. Richard Hudson (R-NC)
Introduced March 8, 2022

AI-Generated Summary

Updated February 8, 2026 at 9:54 AM UTC

The bill directs the Secretary of Health and Human Services to start a pilot program that expands unannounced inspections of foreign facilities that make human drugs. It requires the program to compare those inspections with domestic ones, looking at violations, costs, barriers, and the effect of giving advance notice. The findings will be reported publicly and aim to improve oversight of foreign drug manufacturers.

Key Provisions

  • The Secretary must launch the pilot program within 180 days of the bill becoming law.
  • The program will increase unannounced inspections of foreign human drug establishments and assess differences versus announced inspections and domestic inspections.
  • It will evaluate violations, cost‑benefit impacts, barriers, and ways to mitigate any negative effects of announced inspections.
  • A final report with findings and recommendations must be posted on the FDA website within 180 days after the pilot ends, including suggestions for achieving parity between domestic and foreign inspections and data on inspections that would have been announced under current rules.

Legislative Activity

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2 earlier actions
HouseCommittee Latest Action

Referred to the Subcommittee on Health.

Health Subcommittee

March 9, 2022

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HouseIntro Referral

Introduced in House

March 8, 2022

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

March 8, 2022

HouseCommittee

Referred to the Subcommittee on Health.

Health Subcommittee

March 9, 2022

Bill Text

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Introduced in HouseIssued March 8, 2022

I

117th CONGRESS

2d Session

H. R. 6980

IN THE HOUSE OF REPRESENTATIVES

March 8, 2022

Mr. Hudson (for himself and Ms. Eshoo) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

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.

1.

Unannounced foreign facility inspections pilot program

(a)

In general

The Secretary of Health and Human Services (referred to in this section as the Secretary) shall 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. Such pilot program shall evaluate—

(1)

differences in the number and type of violations of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(B)) identified during unannounced and announced inspections of foreign human drug establishments and any other significant differences between each type of inspection;

(2)

costs and benefits associated with conducting announced and unannounced inspections of foreign human drug establishments;

(3)

barriers to conducting unannounced inspections of foreign human drug establishments and any challenges to achieving parity between domestic and foreign human drug establishment inspections; and

(4)

approaches for mitigating any negative effects of conducting announced inspections of foreign human drug establishments.

(b)

Pilot program initiation

The Secretary shall initiate the pilot program under this section not later than 180 days after the date of enactment of this Act.

(c)

Report

The Secretary shall, not later than 180 days following the completion of the pilot program, make available on the website of the Food and Drug Administration a final report on the pilot program under this section, including—

(1)

findings and any associated recommendations with respect to the evaluation under subsection (a), including any recommendations to address identified barriers to conducting unannounced inspections of foreign human drug establishments;

(2)

findings and any associated recommendations regarding how the Secretary may achieve parity between domestic and foreign human drug inspections; and

(3)

the number of unannounced inspections during the pilot that would not be unannounced under existing practices.