[Federal Register Volume 89, Number 28 (Friday, February 9, 2024)]
[Notices]
[Pages 9158-9160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-02706]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4717]


Brendon Gagne: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring 
Brendon Gagne for a period of 5 years from importing or offering for 
import any drug into the United States. FDA bases this order on a 
finding that Mr. Gagne was convicted of one felony

[[Page 9159]]

count under Federal law for conspiracy to smuggle goods into the United 
States. The factual basis supporting Mr. Gagne's conviction, as 
described below, is conduct relating to the importation into the United 
States of a drug or controlled substance. Mr. Gagne was given notice of 
the proposed debarment and was given an opportunity to request a 
hearing to show why he should not be debarred. As of January 5, 2024 
(30 days after receipt of the notice), Mr. Gagne had not responded. Mr. 
Gagne's failure to respond and request a hearing constitutes a waiver 
of his right to a hearing concerning this matter.

DATES: This order is effective February 9, 2024.

ADDRESSES: Any application by Mr. Gagne for termination of debarment 
under section 306(d)(1) of the FD&C Act (21 U.S.C. 335a(d)(1)) may be 
submitted as follows:

Electronic Submissions

     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. An application 
submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because 
your application will be made public, you are solely responsible for 
ensuring that your application does not include any confidential 
information that you or a third party may not wish to be posted, such 
as medical information, your or anyone else's Social Security number, 
or confidential business information, such as a manufacturing process. 
Please note that if you include your name, contact information, or 
other information that identifies you in the body of your application, 
that information will be posted on https://www.regulations.gov.
     If you want to submit an application with confidential 
information that you do not wish to be made available to the public, 
submit the application as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For a written/paper application submitted to the Dockets 
Management Staff, FDA will post your application, as well as any 
attachments, except for information submitted, marked, and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All applications must include the Docket No. FDA-
2023-N-4717. Received applications will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit an application with 
confidential information that you do not wish to be made publicly 
available, submit your application only as a written/paper submission. 
You should submit two copies total. One copy will include the 
information you claim to be confidential with a heading or cover note 
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The 
Agency will review this copy, including the claimed confidential 
information, in its consideration of your application. The second copy, 
which will have the claimed confidential information redacted/blacked 
out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management 
Staff. Any information marked as ``confidential'' will not be disclosed 
except in accordance with 21 CFR 10.20 and other applicable disclosure 
law. For more information about FDA's posting of comments to public 
dockets, see 80 FR 56469, September 18, 2015, or access the information 
at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket, go to https://www.regulations.gov 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852 between 9 a.m. and 4 p.m., Monday through Friday. Publicly 
available submissions may be seen in the docket.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Compliance 
and Enforcement, Office of Policy, Compliance, and Enforcement, Office 
of Regulatory Affairs, Food and Drug Administration, at 240-402-8743, 
or [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 306(b)(1)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D)) 
permits debarment of an individual from importing or offering for 
import any drug into the United States if FDA finds, as required by 
section 306(b)(3)(C) of the FD&C Act, that the individual has been 
convicted of a felony for conduct relating to the importation into the 
United States of any drug or controlled substance.
    On August 31, 2023, Mr. Gagne was convicted as defined in section 
306(l)(1) of the FD&C Act in the U.S. District Court for Western 
District of Michigan when the court accepted his plea of guilty and 
entered judgment against him for two offenses, one of which was for 
conspiracy to smuggle goods into the United States in violation of 18 
U.S.C. 371 and 545. The underlying facts supporting the conviction are 
as follows: As contained in the indictment from Mr. Gagne's case, filed 
on March 1, 2022, in the transcript from his guilty plea proceeding 
which was held on February 27, 2023, and from the Defendant's 
sentencing brief filed on August 15, 2023, beginning in or about 2018 
and continuing until in or about October 2021, several individuals ran 
a website, www.ExpressPCT.com, which sold misbranded prescription 
drugs, as well as some Schedule III and Schedule IV controlled 
substances, in the United States without requiring a prescription. The 
drugs were manufactured overseas and then shipped in bulk to the United 
States to domestic redistributors. The packages did not declare their 
illicit contents and instead took steps to conceal their true nature. 
Once the packages entered the United States, the redistributors sent 
the bulk orders to second tier U.S.-based distributors who then finally 
shipped the drugs to the customers, making the purchasers think their 
drugs came from the United States and not from overseas. Part of Mr. 
Gagne's role in the scheme was to receive, repackage, and reship 
prescription drugs he received from other co-conspirators outside of 
the United States that were purchased by customers on the website 
www.ExpressPCT.com. In addition, Mr. Gagne recruited, managed and, 
using the profits from the sale of the misbranded prescription drugs, 
paid others engaged in the scheme who also received, repackaged, and 
reshipped prescription drugs they received from other co-conspirators 
outside of the United States.
    As a result of this conviction, FDA sent Mr. Gagne, by certified 
mail, on November 30, 2023, a notice proposing to debar him for a 5-
year period from importing or offering for import any drug into the 
United States. The proposal was based on a finding under section 
306(b)(3)(C) of the FD&C Act that Mr. Gagne's felony conviction under 
Federal law for conspiracy to smuggle goods into the United States in 
violation of 18 U.S.C. 371 and 545, was

[[Page 9160]]

for conduct relating to the importation of any drug or controlled 
substance into the United States because Mr. Gagne was involved in a 
scheme to illegally import and introduce misbranded prescription drugs 
into the United States. In proposing a debarment period, FDA weighed 
the considerations set forth in section 306(c)(3) of the FD&C Act that 
it considered applicable to Mr. Gagne's offense and concluded that the 
offense warranted the imposition of a 5-year period of debarment.
    The proposal informed Mr. Gagne of the proposed debarment and 
offered him an opportunity to request a hearing, providing him 30 days 
from the date of receipt of the letter in which to file the request, 
and advised him that failure to request a hearing constituted a waiver 
of the opportunity for a hearing and of any contentions concerning this 
action. Mr. Gagne received the proposal and notice of opportunity for a 
hearing on December 6, 2023. Mr. Gagne failed to request a hearing 
within the timeframe prescribed by regulation and has, therefore, 
waived his opportunity for a hearing and waived any contentions 
concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal 
Food Operations, under section 306(b)(3)(C) of the FD&C Act, under 
authority delegated to the Assistant Commissioner, finds that Mr. 
Brendon Gagne has been convicted of a felony under Federal law for 
conduct relating to the importation into the United States of any drug 
or controlled substance. FDA finds that the offense should be accorded 
a debarment period of 5 years as provided by section 306(c)(2)(A)(iii) 
of the FD&C Act.
    As a result of the foregoing finding, Mr. Gagne is debarred for a 
period of 5 years from importing or offering for import any drug into 
the United States, effective (see DATES). Pursuant to section 301(cc) 
of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for 
import into the United States of any drug by, with the assistance of, 
or at the direction of Mr. Gagne is a prohibited act.

    Dated: February 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-02706 Filed 2-8-24; 8:45 am]
BILLING CODE 4164-01-P