Notice2024-06287
Phillip Leonowens: Final Debarment Order
Primary source
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Published
March 26, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 59 (Tuesday, March 26, 2024)</title>
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[Federal Register Volume 89, Number 59 (Tuesday, March 26, 2024)]
[Notices]
[Pages 20978-20979]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="/cdn-cgi/l/email-protection#b5d1d0d7d4c7d8d0dbc1c6f5d3d1d49bddddc69bd2dac3"><span class="__cf_email__" data-cfemail="3054555251425d555e4443705654511e5858431e575f46">[email protected]</span></a>.
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 <a href="http://www.ExpressPCT.com">www.ExpressPCT.com</a>, 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
<a href="http://www.ExpressPCT.com">www.ExpressPCT.com</a>. 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
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