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: H.R.6980 | Sponsor: Rep. Hudson, Richard (R-NC)
Policy area: Health

Summary:
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.

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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 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.
                                 <all>