Ryan Stabile: Final Debarment Order, 66413-66415 [2024-18268]
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Federal Register / Vol. 89, No. 158 / Thursday, August 15, 2024 / Notices
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[FR Doc. 2024–18309 Filed 8–14–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3028]
Cubist Pharmaceuticals LLC;
Withdrawal of Approval of a New Drug
Application for ENTEREG (Alvimopan)
Capsules, 12 Milligrams
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Cubist has
informed FDA that ENTEREG
(alvimopan) Capsules, 12 mg is no
longer marketed and has requested that
FDA withdraw approval of NDA 021775
under the process in § 314.150(c) (21
CFR 314.150(c)). Cubist has also, by its
request, waived its opportunity for a
hearing. Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.
Therefore, approval of NDA 021775,
and all amendments and supplements
thereto, is hereby withdrawn as of
September 16, 2024. Approval of the
entire application is withdrawn,
including any strengths and dosage
forms included in the application but
inadvertently missing from this notice.
Introduction or delivery for introduction
into interstate commerce of ENTEREG
(alvimopan) Capsules, 12 mg without an
approved NDA violates sections 505(a)
and 301(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(a) and
331(d)). Any ENTEREG (alvimopan)
Capsules, 12 mg, that is in inventory on
September 16, 2024 may continue to be
dispensed until the inventories have
been depleted or the drug products have
SUPPLEMENTARY INFORMATION:
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reached their expiration dates or
otherwise become violative, whichever
occurs first.
Dated: August 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–18269 Filed 8–14–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of a new drug
application (NDA) for ENTEREG
(alvimopan) Capsules, 12 milligrams
(mg), held by Cubist Pharmaceuticals
LLC, 126 East Lincoln Ave., Rahway, NJ
07065 (Cubist). Cubist notified the
Agency in writing that the drug product
was no longer marketed and requested
that the approval of the application be
withdrawn.
DATES: Approval is withdrawn as of
September 16, 2024.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
SUMMARY:
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[Docket No. FDA–2024–N–1090]
Ryan Stabile: Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) debarring
Ryan Stabile for a period of 15 years
from importing or offering for import
any drug into the United States. FDA
bases this order on a finding that Mr.
Stabile was convicted of three felony
counts under Federal law: one count of
conspiracy and two counts of
introduction of misbranded drugs with
intent to defraud/mislead. The factual
basis supporting Mr. Stabile’s
conviction, as described below, is
conduct relating to the importation into
the United States of a drug or controlled
substance. Mr. Stabile 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 June 7, 2024 (30 days
after receipt of the notice), Mr. Stabile
had not responded. Mr. Stabile’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 August
15, 2024.
ADDRESSES: Any application by Mr.
Stabile for termination of debarment
under section 306(d)(1) of the FD&C Act
(21 U.S.C. 335a(d)(1)) may be submitted
at any time as follows:
SUMMARY:
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
E:\FR\FM\15AUN1.SGM
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66414
Federal Register / Vol. 89, No. 158 / Thursday, August 15, 2024 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
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–2024–N–
1090. 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
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FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/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,
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, 240–402–8743, or
debarments@fda.hhs.gov.
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 February 14, 2024, Mr. Stabile was
convicted as defined in section 306(l)(1)
of the FD&C Act in the U.S. District
Court for the District of Massachusetts
when the court accepted his plea of
guilty and entered judgment against him
for the offenses of conspiracy in
violation of 18 U.S.C. 371, and two
counts of introduction of misbranded
drugs with intent to defraud/mislead in
violation of 21 U.S.C 331(a) and
333(a)(2) (sections 301(a) and 303(a)(2)
of the FD&C Act). The underlying facts
supporting the conviction are as
follows: As contained in the indictment
and plea agreement, Mr. Stabile owned
the companies Ultra Vulgar Media, LLC
and Supplements for Work (S4W). S4W
sold nootropics, a class of drugs and
supplements claiming to enhance mood
and cognitive functioning. Tianeptine,
when sold as a mood enhancer or as a
nootropic, or when otherwise intended
to treat or mitigate a disease or to affect
the structure or any function of the
human body, is a drug within the
meaning of section 201(g)(1) of the
FD&C Act (21 U.S.C. 321(g)(1)), and a
prescription drug within the meaning of
section 503(b)(1) of the FD&C Act (21
U.S.C. 353(b)(1)). A drug is misbranded
under section 503(b)(1) of the FD&C Act
if it is a prescription drug dispensed
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without the prescription of a
practitioner licensed by law to
administer such drugs. A drug is also
misbranded under section 502(f)(1) of
the FD&C Act (21 U.S.C. 352(f)(1)) if its
labeling does not bear adequate
directions for use.
Mr. Stabile and S4W operated several
websites where Mr. Stabile knowingly
sold various forms of tianeptine, which
were not approved by the FDA.
Although Mr. Stabile’s websites
displayed statements that the tianeptine
being sold was for research purposes
only, and not intended for human
consumption, Mr. Stabile sold it to
customers for those customers’ personal
use. Mr. Stabile sold tianeptine without
requiring the prescription of a
practitioner licensed by law to
administer prescription drugs. In
addition, the tianeptine Mr. Stabile sold
was not labeled with adequate
directions for use. Mr. Stabile and his
coconspirators smuggled the tianeptine
into the United States from a supplier in
China and had the supplier send
shipments to Mr. Stabile or his
coconspirators at several post office
boxes Mr. Stabile controlled. Mr. Stabile
and his coconspirators gave his supplier
in China instructions on steps they
could take to mislabel packages of
tianeptine in order to evade U.S.
Customs and Border Protection (CBP)
detection. Through Mr. Stabile’s illegal
smuggling and distribution of
tianeptine, he earned at least
$1,833,922.13.
Beginning in December 2017, some of
the packages of tianeptine Mr. Stabile
and his coconspirators imported were
intercepted and seized by CBP. In an
effort to have CBP release the packages,
Mr. Stabile and his coconspirators filed
a petition to have a package of
tianeptine released, which falsely
represented that the package was
mislabeled and that the tianeptine was
for research and development only.
FDA sent Mr. Stabile, by certified
mail, on May 3, 2024, a notice
proposing to debar him for a 15-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. Stabile’s felony convictions
under Federal law for conspiracy in
violation of 18 U.S.C. 371, and two
counts of introduction of misbranded
drugs with intent to defraud/mislead in
violation of sections 301(a) and
303(a)(2) of the FD&C Act, were for
conduct relating to the importation of
any drug or controlled substance into
the United States because Mr. Stabile
illegally imported tianeptine from China
and then distributed tianeptine in
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interstate commerce. 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. Stabile’s
offense and concluded that the offense
warranted the imposition of a 15-year
period of debarment.
The proposal informed Mr. Stabile 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.
Stabile received the proposal and notice
of opportunity for a hearing on May 8,
2024. Mr. Stabile 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. Ryan
Stabile 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 15 years
as provided by section 306(c)(2)(A)(iii)
of the FD&C Act.
As a result of the foregoing finding,
Mr. Stabile is debarred for a period of
15 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, the
importing or offering for import into the
United States of any drug by, with the
assistance of, or at the direction of Mr.
Stabile is a prohibited act.
Dated: August 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–18268 Filed 8–14–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2024–E–0187, FDA–
2024–E–0188, FDA–2024–E–0189, FDA–
2024–E–0190, and FDA–2024–E–0191]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; MIEBO
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for MIEBO and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of a patent which claims that
human drug product.
DATES: Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by October 15, 2024.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
February 11, 2025. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
October 15, 2024. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
PO 00000
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66415
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
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• 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 written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket Nos. FDA–
2024–E–0187, FDA–2024–E–0188,
FDA–2024–E–0189, FDA–2024–E–0190,
and FDA–2024–E–0191 for
‘‘Determination of Regulatory Review
Period for Purposes of Patent Extension;
MIEBO.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), 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 a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments 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 comments. 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
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]]>Agencies
[Federal Register Volume 89, Number 158 (Thursday, August 15, 2024)]
[Notices]
[Pages 66413-66415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18268]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-1090]
Ryan Stabile: 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
Ryan Stabile for a period of 15 years from importing or offering for
import any drug into the United States. FDA bases this order on a
finding that Mr. Stabile was convicted of three felony counts under
Federal law: one count of conspiracy and two counts of introduction of
misbranded drugs with intent to defraud/mislead. The factual basis
supporting Mr. Stabile's conviction, as described below, is conduct
relating to the importation into the United States of a drug or
controlled substance. Mr. Stabile 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 June 7, 2024 (30 days after receipt of
the notice), Mr. Stabile had not responded. Mr. Stabile'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 August 15, 2024.
ADDRESSES: Any application by Mr. Stabile for termination of debarment
under section 306(d)(1) of the FD&C Act (21 U.S.C. 335a(d)(1)) may be
submitted at any time 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
[[Page 66414]]
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-
2024-N-1090. 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, 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, 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 February 14, 2024, Mr. Stabile was convicted as defined in
section 306(l)(1) of the FD&C Act in the U.S. District Court for the
District of Massachusetts when the court accepted his plea of guilty
and entered judgment against him for the offenses of conspiracy in
violation of 18 U.S.C. 371, and two counts of introduction of
misbranded drugs with intent to defraud/mislead in violation of 21
U.S.C 331(a) and 333(a)(2) (sections 301(a) and 303(a)(2) of the FD&C
Act). The underlying facts supporting the conviction are as follows: As
contained in the indictment and plea agreement, Mr. Stabile owned the
companies Ultra Vulgar Media, LLC and Supplements for Work (S4W). S4W
sold nootropics, a class of drugs and supplements claiming to enhance
mood and cognitive functioning. Tianeptine, when sold as a mood
enhancer or as a nootropic, or when otherwise intended to treat or
mitigate a disease or to affect the structure or any function of the
human body, is a drug within the meaning of section 201(g)(1) of the
FD&C Act (21 U.S.C. 321(g)(1)), and a prescription drug within the
meaning of section 503(b)(1) of the FD&C Act (21 U.S.C. 353(b)(1)). A
drug is misbranded under section 503(b)(1) of the FD&C Act if it is a
prescription drug dispensed without the prescription of a practitioner
licensed by law to administer such drugs. A drug is also misbranded
under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) if its
labeling does not bear adequate directions for use.
Mr. Stabile and S4W operated several websites where Mr. Stabile
knowingly sold various forms of tianeptine, which were not approved by
the FDA. Although Mr. Stabile's websites displayed statements that the
tianeptine being sold was for research purposes only, and not intended
for human consumption, Mr. Stabile sold it to customers for those
customers' personal use. Mr. Stabile sold tianeptine without requiring
the prescription of a practitioner licensed by law to administer
prescription drugs. In addition, the tianeptine Mr. Stabile sold was
not labeled with adequate directions for use. Mr. Stabile and his
coconspirators smuggled the tianeptine into the United States from a
supplier in China and had the supplier send shipments to Mr. Stabile or
his coconspirators at several post office boxes Mr. Stabile controlled.
Mr. Stabile and his coconspirators gave his supplier in China
instructions on steps they could take to mislabel packages of
tianeptine in order to evade U.S. Customs and Border Protection (CBP)
detection. Through Mr. Stabile's illegal smuggling and distribution of
tianeptine, he earned at least $1,833,922.13.
Beginning in December 2017, some of the packages of tianeptine Mr.
Stabile and his coconspirators imported were intercepted and seized by
CBP. In an effort to have CBP release the packages, Mr. Stabile and his
coconspirators filed a petition to have a package of tianeptine
released, which falsely represented that the package was mislabeled and
that the tianeptine was for research and development only.
FDA sent Mr. Stabile, by certified mail, on May 3, 2024, a notice
proposing to debar him for a 15-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. Stabile's
felony convictions under Federal law for conspiracy in violation of 18
U.S.C. 371, and two counts of introduction of misbranded drugs with
intent to defraud/mislead in violation of sections 301(a) and 303(a)(2)
of the FD&C Act, were for conduct relating to the importation of any
drug or controlled substance into the United States because Mr. Stabile
illegally imported tianeptine from China and then distributed
tianeptine in
[[Page 66415]]
interstate commerce. 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. Stabile's offense and concluded that the
offense warranted the imposition of a 15-year period of debarment.
The proposal informed Mr. Stabile 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. Stabile received the proposal and notice of opportunity for
a hearing on May 8, 2024. Mr. Stabile 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. Ryan
Stabile 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 15 years as provided by section 306(c)(2)(A)(iii)
of the FD&C Act.
As a result of the foregoing finding, Mr. Stabile is debarred for a
period of 15 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, the importing or offering for import into the United
States of any drug by, with the assistance of, or at the direction of
Mr. Stabile is a prohibited act.
Dated: August 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-18268 Filed 8-14-24; 8:45 am]
BILLING CODE 4164-01-P
