[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7006 Introduced in House (IH)]
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117th CONGRESS
2d Session
H. R. 7006
To amend the Federal Food, Drug, and Cosmetic Act to improve
inspections of foreign drug manufacturing establishments, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 9, 2022
Mr. Griffith (for himself and Mr. Welch) introduced the following bill;
which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
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.
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