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.

Bill: 117-hr-6980
Sponsor: full_name: Rep. Hudson, Richard [R-NC-8]
Introduced: 2022-03-08
Policy area: Health
Latest action: action_date: 2022-03-09
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2022-03-08
action_desc: Introduced in House
text: <p>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.</p>

tv_txt: 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.