Title: Creating Efficiency in Foreign Facility Inspections Act
Policy area: Health

Summary:
Creating Efficiency in Foreign Facility Inspections Act
This bill prohibits, with some exceptions, the Food and Drug Administration (FDA) from providing notification in advance of a planned inspection of an establishment located outside of the United States that is engaged in drug manufacturing, processing, packing, or holding.
Specifically, the FDA may not provide such an establishment advance notification of a planned inspection unless (1) advance notification is required by the laws of the country where the establishment is located; (2) providing advance notification is needed to protect the public health; or (3) the inspection in question is a preapproval, prelicensure, or for-cause inspection. If the FDA must provide advance notification, it must minimize the time between the notification and the inspection.
If an establishment is located in a country that, on or after the date this bill is enacted, enacts a law requiring advance notification of inspections, the drug manufacturer must agree to waive the right to enforce the requirement, to the extent expressly permitted by the law.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3509 Introduced in Senate (IS)]

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117th CONGRESS
  2d Session
                                S. 3509

 To strengthen the authority of the Food and Drug Administration with 
             respect to foreign drug facility inspections.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

             January 13 (legislative day, January 10), 2022

 Mr. Braun (for himself and Ms. Ernst) introduced the following 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 Administration with 
             respect to foreign drug facility inspections.

    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 ``Creating Efficiency in Foreign 
Facility Inspections Act''.

SEC. 2. STRENGTHENING FOREIGN DRUG FACILITY INSPECTIONS.

    Section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
374) is amended by adding at the end the following:
    ``(i)(1) When the Secretary, and officers or employees duly 
designated by the Secretary, conduct inspections under this section of 
establishments engaged in the manufacturing, processing, packing, or 
holding of drugs that are located outside of the United States, the 
Secretary shall not notify the owner or operator of such establishment 
of the planned inspection before the inspection occurs unless--
            ``(A) notification to the establishment owner or operator 
        in advance of an inspection is mandated under the laws of the 
        country where the establishment is located, in which case, the 
        Secretary shall provide not more than the minimum advanced 
        notice so mandated; or
            ``(B) the Secretary determines that notification to the 
        establishment owner or operator in advance of an inspection is 
        needed to protect the public health.
    ``(2)(A) With respect to all inspections described in paragraph 
(1), the Secretary shall attempt to minimize the time between advance 
notification to an establishment owner or operator and the conduct of a 
surveillance inspection.
    ``(B) If the Secretary determines that notification to an owner or 
operator of a foreign establishment of an inspection in advance of a 
surveillance inspection pursuant to paragraph (1)(B) is needed, the 
Secretary shall provide such notification only as far in advance as is 
needed to protect the public health.
    ``(3) If an establishment is located in a country that, on or after 
the date of enactment of this subsection, enacts a law that prevents 
the Secretary from carrying out inspections as described in this 
subsection, the manufacturer shall agree to waive any right to enforce 
any advanced-notice requirement pursuant to such a law, to the extent 
expressly permitted under applicable local law. If the manufacturer 
does not agree to such a waiver, the manufacturer shall be deemed to 
have refused to permit entry or inspection in violation of section 
301(f).
    ``(4) The requirement of paragraph (1) shall not apply to 
preapproval, prelicensure, or for-cause inspections.''.
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