I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Improving the Nation’s 

5 Safe Pharmaceuticals and Excipients by Creating Tools 

6 for Inspecting and Overseeing Needed Supplies Act’’ or 

7 the ‘‘INSPECTIONS Act’’. 


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1 SEC. 2. IMPROVING FDA INSPECTIONS. 

2 (a) RISK FACTORS FOR ESTABLISHMENTS.—Section 

3 510(h)(4) of the Federal Food, Drug, and Cosmetic Act 

4 (21 U.S.C. 360(h)(4)) is amended— 

5 (1) by redesignating subparagraph (F) as sub6 paragraph (G); and 

7 (2) by inserting after subparagraph (E) the fol8 lowing: 

9 ‘‘(F) The compliance history of establish10 ments in the country or region in which the es11 tablishment is located that are subject to regu12 lation under this Act, including the history of 

13 violations related to products exported from 

14 such country or region that are subject to such 

15 regulation.’’. 

16 (b) USE OF RECORDS.—Section 704(a)(4) of the 

17 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374) 

18 is amended— 

19 (1) by redesignating subparagraph (C) as sub20 paragraph (D); and 

21 (2) by inserting after subparagraph (B) the fol22 lowing: 

23 ‘‘(C) The Secretary may use any records 

24 or other information that the Secretary may in25 spect under this section to satisfy requirements 

26 for a preapproval or risk-based surveillance inVerDate Sep 11 2014 03:54 Mar 11, 2022 Jkt 029200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H7006.IH H7006

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1 spection, including resolving the findings of 

2 such inspections, if applicable and appro3 priate.’’. 

4 (c) RECOGNITION OF FOREIGN GOVERNMENT IN5 SPECTIONS.—Section 809 of the Federal Food, Drug, and 

6 Cosmetic Act (21 U.S.C. 384e) is amended— 

7 (1) in subsection (a)(1), by inserting 

8 ‘‘preapproval or’’ before ‘‘risk-based inspections’’; 

9 and 

10 (2) by adding at the end the following: 

11 ‘‘(c) PERIODIC REVIEW.— 

12 ‘‘(1) IN GENERAL.—Beginning not later than 1 

13 year after the date of the enactment of the IN14 SPECTIONS Act the Secretary shall periodically as15 sess whether additional arrangements and agree16 ments with a foreign government or an agency of a 

17 foreign government, as allowed under this section, 

18 are appropriate. 

19 ‘‘(2) REPORTS TO CONGRESS.—Beginning not 

20 later than 4 years after the date of the enactment 

21 of the INSPECTIONS Act, and every 4 years there22 after, the Secretary shall submit to the Committee 

23 on Energy and Commerce of the House of Rep24 resentatives and the Committee on Health, Edu25 cation, Labor and Pensions a report describing the 


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1 findings and conclusions of each review conducted 

2 under paragraph (1).’’. 

3 SEC. 3. GAO REPORT ON INSPECTIONS OF FOREIGN ESTAB4 LISHMENTS MANUFACTURING DRUGS. 

5 (a) IN GENERAL.—Not later than 18 months after 

6 the date of the enactment of this Act, the Comptroller 

7 General of the United States shall submit to the Com8 mittee on Energy and Commerce of the House of Rep9 resentatives and the Committee on Health, Education, 

10 Labor and Pensions of the Senate a report on inspections 

11 of foreign establishments conducted by the Secretary of 

12 Health and Human Services pursuant to subsections (h) 

13 and (i) of section 510 and section 704 of the Federal 

14 Food, Drug, and Cosmetic Act (21 U.S.C. 360, 374) (or 

15 a foreign government or an agency of a foreign govern16 ment pursuant to section 809 of such Act (21 U.S.C. 

17 384e)). 

18 (b) CONTENTS.—The report conducted under sub19 section (a) shall include— 

20 (1) what alternative tools, including remote in21 spections, other countries are utilizing to facilitate 

22 inspections of foreign establishments; 

23 (2) how frequently trusted foreign regulators 

24 conduct inspections of foreign facilities that could be 


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1 useful to the Food and Drug Administration to re2 view in lieu of its own inspections; 

3 (3) how frequently and under what cir4 cumstances, including for what types of inspections, 

5 the Secretary utilizes existing agreements or ar6 rangements under section 809 of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 384e) and 

8 whether the use of such agreements could be appro9 priately expanded; 

10 (4) whether the Secretary has accepted reports 

11 of inspections of facilities in China and India con12 ducted by entities with which they have entered into 

13 such an agreement or arrangement; 

14 (5) what additional foreign governments or 

15 agencies of foreign governments the Secretary has 

16 considered entering into a mutual recognition agree17 ment with and, if applicable, reasons why the Sec18 retary declined to enter into a mutual recognition 

19 agreement with such foreign governments or agen20 cies; 

21 (6) what tools, if any, the Secretary used to fa22 cilitate inspections of domestic facilities that could 

23 also be effectively utilized to appropriately inspect 

24 foreign facilities; 


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1 (7) what steps the Secretary has taken to iden2 tify and evaluate tools and strategies the Secretary 

3 may use to continue oversight with respect to inspec4 tions when in-person inspections are disrupted; 

5 (8) how the Secretary is considering incor6 porating alternative tools into the inspection activi7 ties conducted pursuant to the Federal Food, Drug, 

8 and Cosmetic Act (21 U.S.C. 321 et seq.); and 

9 (9) what steps the Secretary has taken to iden10 tify and evaluate how the Secretary may use alter11 native tools to address workforce shortages to carry 

12 out such inspection activities. 

Æ 


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