Federal

Creating Efficiency in Foreign Facility Inspections Act

Source: Congress.gov · 613 words in original text

What This Bill Does

This bill strengthens the Food and Drug Administration's power to inspect drug manufacturing facilities located outside the United States. The bill changes when and how the FDA must notify foreign drug facilities before conducting inspections.

Who It Affects

- The Food and Drug Administration and its designated officers and employees - Owners and operators of drug manufacturing, processing, packing, and holding facilities located outside the United States - Drug manufacturers operating foreign facilities

Key Provisions

- The FDA does not have to notify foreign drug facility owners or operators before planned inspections, except when required by the country's laws or needed to protect public health. (Sec. 2) - When advance notification to a foreign facility is required by local law, the FDA must provide only the minimum notice that law requires. (Sec. 2) - When the FDA determines advance notification is needed to protect public health, it must provide notice only as far in advance as needed to protect public health. (Sec. 2) - If a country passes a new law after this bill is enacted that prevents the FDA from conducting inspections as described, the drug manufacturer must agree to waive any right to enforce that country's advance-notice requirement. If the manufacturer refuses, they are considered to have refused entry or inspection. (Sec. 2) - The rules about advance notification do not apply to preapproval inspections, prelicensure inspections, or for-cause inspections. (Sec. 2)

What Changes

The FDA gains new authority to conduct unannounced inspections at foreign drug facilities. Currently, drug manufacturers can use foreign country laws to require advance notice before inspections. This bill allows the FDA to bypass those requirements unless local law mandates notification or public health protection requires it.

Important Definitions

- Surveillance inspection: A routine inspection to check compliance with regulations

Effective Date

Not specified in bill text

II 118TH CONGRESS 1ST SESSION S. 1134 To strengthen the authority of the Food and Drug Administration with respect to foreign drug facility inspections. IN THE SENATE OF THE UNITED STATES MARCH 30, 2023 Mr. BRAUN (for himself, Mr. HAWLEY, and Ms. ERNST) introduced the fol- lowing bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To strengthen the authority of the Food and Drug Adminis- tration with respect to foreign drug facility inspections. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Creating Efficiency 4 in Foreign Facility Inspections Act’’. 5 SEC. 2. STRENGTHENING FOREIGN DRUG FACILITY IN- 6 SPECTIONS. 7 Section 704 of the Federal Food, Drug, and Cosmetic 8 Act (21 U.S.C. 374) is amended by adding at the end the 9 following: 10 VerDate Sep 11 2014 23:56 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1134.IS S1134 kjohnson on DSK79L0C42PROD with BILLS 2 •S 1134 IS ‘‘(i)(1) When the Secretary, and officers or employees 1 duly designated by the Secretary, conduct inspections 2 under this section of establishments engaged in the manu- 3 facturing, processing, packing, or holding of drugs that 4 are located outside of the United States, the Secretary 5 shall not notify the owner or operator of such establish- 6 ment of the planned inspection before the inspection oc- 7 curs unless— 8 ‘‘(A) notification to the establishment owner or 9 operator in advance of an inspection is mandated 10 under the laws of the country where the establish- 11 ment is located, in which case, the Secretary shall 12 provide not more than the minimum advanced notice 13 so mandated; or 14 ‘‘(B) the Secretary determines that notification 15 to the establishment owner or operator in advance of 16 an inspection is needed to protect the public health. 17 ‘‘(2)(A) With respect to all inspections described in 18 paragraph (1), the Secretary shall attempt to minimize the 19 time between advance notification to an establishment 20 owner or operator and the conduct of a surveillance in- 21 spection. 22 ‘‘(B) If the Secretary determines that notification to 23 an owner or operator of a foreign establishment of an in- 24 spection in advance of a surveillance inspection pursuant 25 VerDate Sep 11 2014 23:56 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1134.IS S1134 kjohnson on DSK79L0C42PROD with BILLS 3 •S 1134 IS to paragraph (1)(B) is needed, the Secretary shall provide 1 such notification only as far in advance as is needed to 2 protect the public health. 3 ‘‘(3) If an establishment is located in a country that, 4 on or after the date of enactment of this subsection, enacts 5 a law that prevents the Secretary from carrying out in- 6 spections as described in this subsection, the manufacturer 7 shall agree to waive any right to enforce any advanced- 8 notice requirement pursuant to such a law, to the extent 9 expressly permitted under applicable local law. If the man- 10 ufacturer does not agree to such a waiver, the manufac- 11 turer shall be deemed to have refused to permit entry or 12 inspection in violation of section 301(f). 13 ‘‘(4) The requirement of paragraph (1) shall not 14 apply to preapproval, prelicensure, or for-cause inspec- 15 tions.’’. 16 Æ VerDate Sep 11 2014 23:56 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\S1134.IS S1134 kjohnson on DSK79L0C42PROD with BILLS

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