Improving the Nation's Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act
This bill modifies provisions relating to the inspection of foreign drug manufacturing facilities, including by incorporating the compliance history of facilities in foreign countries into inspections and requiring periodic assessments of whether additional agreements with foreign agencies are needed. The bill also requires the Government Accountability Office to report on inspections of foreign facilities.
To amend the Federal Food, Drug, and Cosmetic Act to improve 
inspections of foreign drug manufacturing establishments, and for other 
                               purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Improving the Nation's Safe 
Pharmaceuticals and Excipients by Creating Tools for Inspecting and 
Overseeing Needed Supplies Act'' or the ``INSPECTIONS Act''.

SEC. 2. IMPROVING FDA INSPECTIONS.

    (a) Risk Factors for Establishments.--Section 510(h)(4) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(h)(4)) is amended--
            (1) by redesignating subparagraph (F) as subparagraph (G); 
        and
            (2) by inserting after subparagraph (E) the following:
                    ``(F) The compliance history of establishments in 
                the country or region in which the establishment is 
                located that are subject to regulation under this Act, 
                including the history of violations related to products 
                exported from such country or region that are subject 
                to such regulation.''.
    (b) Use of Records.--Section 704(a)(4) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 374) is amended--
            (1) by redesignating subparagraph (C) as subparagraph (D); 
        and
            (2) by inserting after subparagraph (B) the following:
                    ``(C) The Secretary may use any records or other 
                information that the Secretary may inspect under this 
                section to satisfy requirements for a preapproval or 
                risk-based surveillance inspection, including resolving 
                the findings of such inspections, if applicable and 
                appropriate.''.
    (c) Recognition of Foreign Government Inspections.--Section 809 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384e) is amended--
            (1) in subsection (a)(1), by inserting ``preapproval or'' 
        before ``risk-based inspections''; and
            (2) by adding at the end the following:
    ``(c) Periodic Review.--
            ``(1) In general.--Beginning not later than 1 year after 
        the date of the enactment of the INSPECTIONS Act the Secretary 
        shall periodically assess whether additional arrangements and 
        agreements with a foreign government or an agency of a foreign 
        government, as allowed under this section, are appropriate.
            ``(2) Reports to congress.--Beginning not later than 4 
        years after the date of the enactment of the INSPECTIONS Act, 
        and every 4 years thereafter, the Secretary shall submit to the 
        Committee on Energy and Commerce of the House of 
        Representatives and the Committee on Health, Education, Labor 
        and Pensions a report describing the findings and conclusions 
        of each review conducted under paragraph (1).''.

SEC. 3. GAO REPORT ON INSPECTIONS OF FOREIGN ESTABLISHMENTS 
              MANUFACTURING DRUGS.

    (a) In General.--Not later than 18 months after the date of the 
enactment of this Act, the Comptroller General of the United States 
shall submit to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor and 
Pensions of the Senate a report on inspections of foreign 
establishments conducted by the Secretary of Health and Human Services 
pursuant to subsections (h) and (i) of section 510 and section 704 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360, 374) (or a 
foreign government or an agency of a foreign government pursuant to 
section 809 of such Act (21 U.S.C. 384e)). 
    (b) Contents.--The report conducted under subsection (a) shall 
include--
            (1) what alternative tools, including remote inspections, 
        other countries are utilizing to facilitate inspections of 
        foreign establishments;
            (2) how frequently trusted foreign regulators conduct 
        inspections of foreign facilities that could be useful to the 
        Food and Drug Administration to review in lieu of its own 
        inspections;
            (3) how frequently and under what circumstances, including 
        for what types of inspections, the Secretary utilizes existing 
        agreements or arrangements under section 809 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 384e) and whether the 
        use of such agreements could be appropriately expanded;
            (4) whether the Secretary has accepted reports of 
        inspections of facilities in China and India conducted by 
        entities with which they have entered into such an agreement or 
        arrangement;
            (5) what additional foreign governments or agencies of 
        foreign governments the Secretary has considered entering into 
        a mutual recognition agreement with and, if applicable, reasons 
        why the Secretary declined to enter into a mutual recognition 
        agreement with such foreign governments or agencies;
            (6) what tools, if any, the Secretary used to facilitate 
        inspections of domestic facilities that could also be 
        effectively utilized to appropriately inspect foreign 
        facilities;
            (7) what steps the Secretary has taken to identify and 
        evaluate tools and strategies the Secretary may use to continue 
        oversight with respect to inspections when in-person 
        inspections are disrupted;
            (8) how the Secretary is considering incorporating 
        alternative tools into the inspection activities conducted 
        pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        321 et seq.); and
            (9) what steps the Secretary has taken to identify and 
        evaluate how the Secretary may use alternative tools to address 
        workforce shortages to carry out such inspection activities.
                                 <all>
INSPECTIONS Act
To amend the Federal Food, Drug, and Cosmetic Act to improve inspections of foreign drug manufacturing establishments, and for other purposes.
INSPECTIONS Act
Improving the Nation’s Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act
Rep. Griffith, H. Morgan