[Federal Register Volume 89, Number 59 (Tuesday, March 26, 2024)]
[Notices]
[Pages 20978-20979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06287]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2179]


Phillip Leonowens: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring 
Phillip Leonowens 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. Leonowens was convicted of one felony count under 
Federal law for conspiracy to smuggle goods into the United States. The 
factual basis supporting Mr. Leonowens' conviction, as described below, 
is conduct relating to the importation into the United States of a drug 
or controlled substance. Mr. Leonowens 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 December 31, 2023 (30 days after 
receipt of the notice), Mr. Leonowens had not responded. Mr. 
Leonowens's failure to respond and request a hearing constitutes a 
waiver of his right to a hearing concerning this matter.

DATES: This order is applicable March 26, 2024.

ADDRESSES: Any application by Mr. Leonowens 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-2179. 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,

[[Page 20979]]

Rockville, MD 20852 between 9 a.m. and 4 p.m., Monday through Friday, 
240-402-7500. 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 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 March 2, 2023, Mr. Leonowens was convicted, as defined in 
section 306(l)(1) of FD&C Act, in the U.S. District Court for the 
Western District of Michigan, when the court entered judgment against 
him for the offense of conspiracy to smuggle goods into the United 
States in violation of 18 U.S.C. 371 and 545. FDA's finding that 
debarment is appropriate is based on the felony conviction referenced 
herein.
    The factual basis for this conviction is as follows: As contained 
in the Information and Plea Agreement from Mr. Leonowens' case, filed 
on April 27, 2022, and April 28, 2022, respectively, Brendon Gagne 
owned and operated www.ExpressPCT.com, which sold misbranded 
prescription drugs, obtained from overseas suppliers, to customers in 
the United States without requiring a prescription. In exchange for 
obtaining Modafinil for himself, Mr. Leonowens conspired with Brendon 
Gagne and agreed to receive, repackage, and reship prescription drugs 
that Mr. Leonowens would receive from co-conspirators outside of the 
United States that were purchased by customers on the website 
www.ExpressPCT.com. Mr. Leonowens received approximately four packages 
containing bulk quantities of prescription drugs which were all shipped 
from overseas, including from Germany, India, and Singapore. Each time 
Mr. Leonowens received a package, he removed some Modafinil for himself 
and then sent the rest of the drugs to others. In his plea agreement, 
Mr. Leonowens acknowledged that he knew that receiving and reshipping 
prescription drugs in this manner was illegal. Mr. Leonowens also 
recruited others to join in the scheme by also receiving and reshipping 
misbranded prescription drugs from overseas suppliers. In exchange for 
his participation in the scheme, Mr. Leonowens received free or 
discounted prescription drugs.
    As a result of this conviction, FDA sent Mr. Leonowens, by United 
Parcel Service, 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. Leonowens' 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 for conduct relating 
to the importation into the United States of any drug or controlled 
substance because he 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. Leonowens' offense and concluded that the offense warranted the 
imposition of a 5-year period of debarment.
    The proposal informed Mr. Leonowens 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. Leonowens received the proposal and notice of opportunity 
for a hearing at his residence on December 1, 2023. Mr. Leonowens 
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. 
Leonowens 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. Leonowens 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. Leonowens is a prohibited act.

    Dated: March 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-06287 Filed 3-25-24; 8:45 am]
BILLING CODE 4164-01-P