Gina Acosta: Final Debarment Order, 42474-42476 [2024-10584]
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42474
Federal Register / Vol. 89, No. 95 / Wednesday, May 15, 2024 / Notices
Application Process (CAP), components
of the FDA Industry Systems, or by
contacting FDA for assistance. Health
certificates are the exception and are
requested via email. To facilitate the
application process, we have eliminated
paper-based forms. All information is
currently submitted electronically using
Forms FDA 3613d, 3613e, and 3613k.
The eCATS Module is Form 3613k,
where 3613e is the Certificate of Free
Sale (https://www.fda.gov/food/foodexport-certificates/online-applicationsexport-certificates-food). All ‘‘forms’’ are
electronic and part of the eCATS or CAP
portal accessed via https://
www.access.fda.gov. To view
representations of the forms,
instructions must be downloaded and
are accessible through the following
links: https://www.fda.gov/cosmetics/
cosmetics-exporters/onlineapplications-export-certificatescosmetics and https://www.fda.gov/
food/food-export-certificates/onlineapplications-export-certificates-food.
While burden attributable to activities
associated with export certificates
issued for other FDA regulated products
is accounted for and approved under
OMB control number 0910–0498, this
collection specifically supports
information collection activity
attributable to export certificates issued
for human food and cosmetic products.
Also, because we have eliminated
paper-based forms, respondents who
require assistance with completing
export certificate applications online
may contact FDA directly by email
(CFSANExportCertification@
fda.hhs.gov) or telephone (240–402–
2307). Instructions for requesting export
certificates for cosmetics (Form FDA
3613d) are available online at https://
www.fda.gov/cosmetics/cosmeticsexporters/online-applications-exportcertificates-cosmetics and instructions
for requesting export certificates for
food (Forms FDA 3613e and Form
3613k) are available online at https://
www.fda.gov/food/food-exportcertificates/online-applications-exportcertificates-food.
We are revising the information
collection to include a web-based
inquiry form, Form FDA 5077, entitled
‘‘U.S. Department of Health and Human
Services Food and Drug Administration
Export Certification Inquiry,’’ intended
to facilitate processing by crossreferencing the request with existing
Agency data. A mockup of the proposed
electronic form is posted to the docket
to solicit public comment. For food
products, respondents may identify
facilities using their Food Facility
Registration number, FDA
Establishment Identifier number, or a
Data Universal Numbering System
number. The system uses these
identifiers to locate and auto-populate
name and address information,
eliminating the need for users to
manually enter this information and
reducing the time to complete the
application. For some applications,
respondents can also upload product
information via a spreadsheet, which
reduces the time needed to enter
product information, particularly for
applications that include multiple
products.
Description of Respondents: The
respondents to this collection of
information are firms interested in
exporting U.S.-manufactured human
food and cosmetic products to foreign
countries that require export certificates.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Type of certificate
Form No. 2
Cosmetics ......................................
Food ..............................................
Export Certification Inquiry ............
FDA 3613d ...................................
FDA 3613e, 3613k .......................
FDA 5077 .....................................
66
454
520
3
10
18
198
4,540
9,360
0.5 (30 min.) ...............
0.5 (30 min.) ...............
0.25 (15 min.) .............
99
2,270
39
Total .......................................
.......................................................
........................
........................
........................
.....................................
2,408
Total hours
1 There
are no operating and maintenance costs associated with this collection of information.
2 All forms are submitted electronically via FDA Industry Systems.
Since our last review of the
information collection, we have
adjusted our estimate of the number of
respondents downward. At the same
time, we have increased the number of
responses per respondent and added
new Form FDA 5077. Cumulatively
these activities result in an estimated
burden increase of 39 hours and 9,360
responses annually.
Dated: May 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–10606 Filed 5–14–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–4785]
Gina Acosta: 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 (FD&C Act) permanently
debarring Gina Acosta from providing
services in any capacity to a person that
has an approved or pending drug
product application. FDA bases this
order on a finding that Ms. Acosta was
convicted of a felony under Federal law
for conduct that relates to the regulation
of a drug product under the FD&C Act.
Ms. Acosta was given notice of the
SUMMARY:
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proposed debarment and an opportunity
to request a hearing to show why she
should not be debarred. As of March 6,
2024 (30 days after receipt of the
notice), Ms. Acosta has not responded.
Ms. Acosta’s failure to respond and
request a hearing constitutes a waiver of
Ms. Acosta’s right to a hearing
concerning this matter.
DATES: This order is applicable May 15,
2024.
ADDRESSES: Any application by Ms.
Acosta for special termination of
debarment under section 306(d)(4) of
the FD&C Act (21 U.S.C. 335a(d)(4)) 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
E:\FR\FM\15MYN1.SGM
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Federal Register / Vol. 89, No. 95 / Wednesday, May 15, 2024 / Notices
lotter on DSK11XQN23PROD with NOTICES1
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–
4785. 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
VerDate Sep<11>2014
19:12 May 14, 2024
Jkt 262001
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-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.
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,
debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act
requires debarment of an individual
from providing services in any capacity
to a person that has an approved or
pending drug product application if
FDA finds that the individual has been
convicted of a felony under Federal law
for conduct relating to the regulation of
any drug product under the FD&C Act.
On October 5, 2023, Ms. Acosta was
convicted as defined in section 306(l)(1)
of the FD&C Act, in the U.S. District
Court for the Eastern District of TexasBeaumont Division, when the court
accepted her plea of guilty and entered
judgment against her for the felony
offense of Conspiracy to Traffick in
Drugs with Counterfeit Mark in
violation of 18 U.S.C. 371 and 18 U.S.C.
2320(a)(4). The underlying facts
supporting the conviction are as
follows: as contained in the Second
Superseding Indictment and the Factual
Basis, between April 2014 until
February 2021, Ms. Acosta was involved
in a conspiracy with drug traffickers to
distribute misbranded and counterfeit
cough syrup. Specifically, Ms. Acosta
worked for Woodfield Pharmaceutical,
LLC as a packaging supervisor.
Woodfield Pharmaceutical, LLC was a
part of a group of pharmaceutical
companies, which included Woodfield
Pharmaceutical, LLC, a contract
manufacturing company, and Woodfield
Distribution. LLC, a third-party logistics
company (collectively, ‘‘Woodfield’’).
On April 25, 2014, Woodfield acquired
Pernix Manufacturing, LLC (Pernix).
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Pernix had, in January 2014, entered
into an agreement with Byron A.
Marshall and his Drug Trafficking
Organization (DTO) to copy and
manufacture cough syrup according to
the directions of Marshall and his
associates.
Marshall was not licensed or
authorized to distribute cough syrup
and any background check of the
personal information provided by
Marshall to Pernix or later Woodfield
would have revealed that he was not a
licensed physician as he claimed.
Initially, Marshall sought to copy
Actavis Prometh VC with Codeine
(Actavis). Actavis is a purple, peachmint flavored prescription cough syrup
that was in demand as a street drug.
Marshall and his associates wanted to
mass produce and traffic a counterfeit
version of Actavis that contained
promethazine, but not codeine. On
April 24, 2014, Actavis Holdco US
discontinued production of Actavis due
to its widespread abuse by recreational
drug users. A Pernix productdevelopment scientist worked with
Marshall and his associates to re-create
the Actavis product without codeine
and promethazine in order to re-create
the syrup base, which is a necessary
component of cough syrup. Marshall
and his associates would add
promethazine to the counterfeit
substance prior to bottling and
distribution in order to create the street
drug. Marshall and his DTO also
obtained counterfeited commercialgrade pharmaceutical labels designed to
look exactly like the genuine labels for
the prescription cough syrup from
another supplier. Later in the
conspiracy, Marshall and his DTO asked
Woodfield employees to reformulate
other cough syrup to use in their drug
trafficking scheme to include Hi-Tech
Promethazine Hydrocholoride and
Codeine Phosphate Oral Solution (HiTech) and Wockhardt Promethazine
Syrup Plain (Wockhardt).
In her position within Woodfield, Ms.
Acosta assisted in the packaging and
delivery of the counterfeit cough syrup.
In addition, between February 2019
through March 2021, Ms. Acosta was
the principal point of contact between
the owner of Woodfield, Adam
Runsdorf, and the Marshall DTO. Ms.
Acosta also was the principal conduit
for cash from the Marshall DTO to
Runsdorf.
From 2014 through February 2021,
the conspiracy between the Marshall
DTO produced and distributed, or
attempted to produce and distribute,
approximately 65,920 gallons of
counterfeit cough syrup.
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Federal Register / Vol. 89, No. 95 / Wednesday, May 15, 2024 / Notices
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FDA sent Ms. Acosta, by certified
mail, on January 30, 2024, a notice
proposing to permanently debar her
from providing services in any capacity
to a person that has an approved or
pending drug product application. The
proposal was based on a finding, under
section 306(a)(2)(B) of the FD&C Act,
that Ms. Acosta was convicted of a
felony under Federal law for conduct
relating to the regulation of a drug
product under the FD&C Act. The
proposal informed Ms. Acosta of the
proposed debarment and offered her an
opportunity to request a hearing,
providing her 30 days from the date of
receipt of the letter in which to file the
request, and advised her that failure to
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. Ms.
Acosta received the proposal and notice
of opportunity for a hearing on February
5, 2024. Ms. Acosta failed to request a
hearing within the timeframe prescribed
by regulation and has, therefore, waived
her opportunity for a hearing and
waived any contentions concerning her
debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Ms. Gina
Acosta has been convicted of a felony
under Federal law for conduct relating
to the regulation of a drug product
under the FD&C Act.
As a result of the foregoing finding,
Ms. Acosta is permanently debarred
from providing services in any capacity
to a person with an approved or
pending drug product application,
effective (see DATES) (see sections
306(a)(2)(B) and 306(c)(2)(A)(ii) of the
FD&C Act). Any person with an
approved or pending drug product
application who knowingly employs or
retains as a consultant or contractor, or
otherwise uses in any capacity the
services of Ms. Acosta during her
debarment, will be subject to civil
money penalties (section 307(a)(6) of the
FD&C Act (21 U.S.C. 335b(a)(6))). If Ms.
Acosta provides services in any capacity
to a person with an approved or
pending drug product application
during her period of debarment, she will
be subject to civil money penalties
(section 307(a)(7) of the FD&C Act). In
addition, FDA will not accept or review
any abbreviated new drug application
from Ms. Acosta during her period of
debarment, other than in connection
with an audit under section 306 of the
FD&C Act (section 306(c)(1)(B) of the
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19:12 May 14, 2024
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FD&C Act). Note that, for purposes of
sections 306 and 307 of the FD&C Act,
a ‘‘drug product’’ is defined as a ‘‘drug
subject to regulation under section 505,
512, or 802 of the FD&C Act (21 U.S.C.
355, 360b, or 382) or under section 351
of the Public Health Service Act (42
U.S.C. 262)’’ (section 201(dd) of the
FD&C Act (21 U.S.C. 321(dd))).
Dated: May 8, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–10584 Filed 5–14–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Committee on
Training and Primary Care Medicine
and Dentistry
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Advisory
Committee on Training in Primary Care
Medicine and Dentistry (ACTPCMD or
Committee) will hold public meetings
for the 2024 calendar year (CY). This
notice supersedes the information about
ACTPCMD’s 2024 meetings found in the
Federal Register notice dated December
15, 2023, Meeting of the Advisory
Committee on Training and Primary
Care Medicine and Dentistry.
DATES: ACTPCMD meetings will be held
on:
• August 1, 2024, 8:00 a.m.–5:00 p.m.
Eastern Time and August 2, 2024, 8:00
a.m.–3:00 p.m. Eastern Time, and
• Another 2024 meeting will be
identified at a later date and announced
at least 30 days before the meeting date
through the Federal Register.
ADDRESSES: Meetings will be held inperson, by teleconference, and/or on a
video conference platform. In-person
meetings will be held at the HRSA
Headquarters located at 5600 Fishers
Lane, Rockville, Maryland, 20857 and
will also be broadcast virtually on a
video conference platform. For updates
on how the meetings will be held, visit
the ACTPCMD website 20 days before
the date of the meeting, where
instructions for joining meetings will be
posted. For meeting information
updates, go to the ACTPCMD website
meeting page at https://www.hrsa.gov/
SUMMARY:
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advisory-committees/primarycaredentist/meetings.
FOR FURTHER INFORMATION CONTACT:
Shane Rogers, Designated Federal
Officer, Division of Medicine and
Dentistry, Bureau of Health Workforce,
HRSA, 5600 Fishers Lane, Room
15N102, Rockville, Maryland 20857;
301–443–5260; or SRogers@hrsa.gov.
SUPPLEMENTARY INFORMATION:
ACTPCMD provides advice and
recommendations to the Secretary of
Health and Human Services on policy,
program development, and other
matters of significance concerning the
activities under Section 747 of Title VII
of the Public Health Service (PHS) Act,
as it existed upon the enactment of
Section 749 of the PHS Act in 1998.
ACTPCMD prepares an annual report
describing the activities of the
committee, including findings and
recommendations made by the
committee concerning the activities
under Section 747, as well as training
programs in oral health and dentistry.
The annual report is submitted to the
Secretary of Health and Human Services
as well as the Chair and ranking
members of the Senate Committee on
Health, Education, Labor and Pensions
and the House of Representatives
Committee on Energy and Commerce.
ACTPCMD also develops, publishes,
and implements performance measures
and guidelines for longitudinal
evaluations of programs authorized
under title VII, part C of the PHS Act,
and recommends appropriation levels
for programs under this Part.
Since priorities dictate meeting times,
be advised that start times, end times,
and agenda items are subject to change.
For CY 2024 meetings, agenda items
may include, but are not limited to, a
full review of the many programs
authorized under title VII, sections 747
and 748, of the PHS Act, discussions
pertaining to tribal health issues, and
potential recommendations updating
the authorizing legislations for the
programs. Refer to the ACTPCMD
website listed above for all current and
updated information concerning the CY
2024 ACTPCMD meetings, including
agendas and meeting materials that will
be posted 20 calendar days before the
meeting.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting(s). Oral comments will be
honored in the order they are requested
and may be limited as time allows.
Requests to submit a written statement
or make oral comments to ACTPCMD
should be sent to Shane Rogers using
E:\FR\FM\15MYN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 95 (Wednesday, May 15, 2024)]
[Notices]
[Pages 42474-42476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10584]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4785]
Gina Acosta: 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 (FD&C Act) permanently
debarring Gina Acosta from providing services in any capacity to a
person that has an approved or pending drug product application. FDA
bases this order on a finding that Ms. Acosta was convicted of a felony
under Federal law for conduct that relates to the regulation of a drug
product under the FD&C Act. Ms. Acosta was given notice of the proposed
debarment and an opportunity to request a hearing to show why she
should not be debarred. As of March 6, 2024 (30 days after receipt of
the notice), Ms. Acosta has not responded. Ms. Acosta's failure to
respond and request a hearing constitutes a waiver of Ms. Acosta's
right to a hearing concerning this matter.
DATES: This order is applicable May 15, 2024.
ADDRESSES: Any application by Ms. Acosta for special termination of
debarment under section 306(d)(4) of the FD&C Act (21 U.S.C.
335a(d)(4)) 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
[[Page 42475]]
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-4785. 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, 240-402-8743,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act requires debarment of an
individual from providing services in any capacity to a person that has
an approved or pending drug product application if FDA finds that the
individual has been convicted of a felony under Federal law for conduct
relating to the regulation of any drug product under the FD&C Act.
On October 5, 2023, Ms. Acosta was convicted as defined in section
306(l)(1) of the FD&C Act, in the U.S. District Court for the Eastern
District of Texas-Beaumont Division, when the court accepted her plea
of guilty and entered judgment against her for the felony offense of
Conspiracy to Traffick in Drugs with Counterfeit Mark in violation of
18 U.S.C. 371 and 18 U.S.C. 2320(a)(4). The underlying facts supporting
the conviction are as follows: as contained in the Second Superseding
Indictment and the Factual Basis, between April 2014 until February
2021, Ms. Acosta was involved in a conspiracy with drug traffickers to
distribute misbranded and counterfeit cough syrup. Specifically, Ms.
Acosta worked for Woodfield Pharmaceutical, LLC as a packaging
supervisor. Woodfield Pharmaceutical, LLC was a part of a group of
pharmaceutical companies, which included Woodfield Pharmaceutical, LLC,
a contract manufacturing company, and Woodfield Distribution. LLC, a
third-party logistics company (collectively, ``Woodfield''). On April
25, 2014, Woodfield acquired Pernix Manufacturing, LLC (Pernix). Pernix
had, in January 2014, entered into an agreement with Byron A. Marshall
and his Drug Trafficking Organization (DTO) to copy and manufacture
cough syrup according to the directions of Marshall and his associates.
Marshall was not licensed or authorized to distribute cough syrup
and any background check of the personal information provided by
Marshall to Pernix or later Woodfield would have revealed that he was
not a licensed physician as he claimed. Initially, Marshall sought to
copy Actavis Prometh VC with Codeine (Actavis). Actavis is a purple,
peach-mint flavored prescription cough syrup that was in demand as a
street drug. Marshall and his associates wanted to mass produce and
traffic a counterfeit version of Actavis that contained promethazine,
but not codeine. On April 24, 2014, Actavis Holdco US discontinued
production of Actavis due to its widespread abuse by recreational drug
users. A Pernix product-development scientist worked with Marshall and
his associates to re-create the Actavis product without codeine and
promethazine in order to re-create the syrup base, which is a necessary
component of cough syrup. Marshall and his associates would add
promethazine to the counterfeit substance prior to bottling and
distribution in order to create the street drug. Marshall and his DTO
also obtained counterfeited commercial-grade pharmaceutical labels
designed to look exactly like the genuine labels for the prescription
cough syrup from another supplier. Later in the conspiracy, Marshall
and his DTO asked Woodfield employees to reformulate other cough syrup
to use in their drug trafficking scheme to include Hi-Tech Promethazine
Hydrocholoride and Codeine Phosphate Oral Solution (Hi-Tech) and
Wockhardt Promethazine Syrup Plain (Wockhardt).
In her position within Woodfield, Ms. Acosta assisted in the
packaging and delivery of the counterfeit cough syrup. In addition,
between February 2019 through March 2021, Ms. Acosta was the principal
point of contact between the owner of Woodfield, Adam Runsdorf, and the
Marshall DTO. Ms. Acosta also was the principal conduit for cash from
the Marshall DTO to Runsdorf.
From 2014 through February 2021, the conspiracy between the
Marshall DTO produced and distributed, or attempted to produce and
distribute, approximately 65,920 gallons of counterfeit cough syrup.
[[Page 42476]]
FDA sent Ms. Acosta, by certified mail, on January 30, 2024, a
notice proposing to permanently debar her from providing services in
any capacity to a person that has an approved or pending drug product
application. The proposal was based on a finding, under section
306(a)(2)(B) of the FD&C Act, that Ms. Acosta was convicted of a felony
under Federal law for conduct relating to the regulation of a drug
product under the FD&C Act. The proposal informed Ms. Acosta of the
proposed debarment and offered her an opportunity to request a hearing,
providing her 30 days from the date of receipt of the letter in which
to file the request, and advised her that failure to request a hearing
constituted a waiver of the opportunity for a hearing and of any
contentions concerning this action. Ms. Acosta received the proposal
and notice of opportunity for a hearing on February 5, 2024. Ms. Acosta
failed to request a hearing within the timeframe prescribed by
regulation and has, therefore, waived her opportunity for a hearing and
waived any contentions concerning her debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Ms. Gina
Acosta has been convicted of a felony under Federal law for conduct
relating to the regulation of a drug product under the FD&C Act.
As a result of the foregoing finding, Ms. Acosta is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application, effective (see DATES)
(see sections 306(a)(2)(B) and 306(c)(2)(A)(ii) of the FD&C Act). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses in any capacity the services of Ms. Acosta during her
debarment, will be subject to civil money penalties (section 307(a)(6)
of the FD&C Act (21 U.S.C. 335b(a)(6))). If Ms. Acosta provides
services in any capacity to a person with an approved or pending drug
product application during her period of debarment, she will be subject
to civil money penalties (section 307(a)(7) of the FD&C Act). In
addition, FDA will not accept or review any abbreviated new drug
application from Ms. Acosta during her period of debarment, other than
in connection with an audit under section 306 of the FD&C Act (section
306(c)(1)(B) of the FD&C Act). Note that, for purposes of sections 306
and 307 of the FD&C Act, a ``drug product'' is defined as a ``drug
subject to regulation under section 505, 512, or 802 of the FD&C Act
(21 U.S.C. 355, 360b, or 382) or under section 351 of the Public Health
Service Act (42 U.S.C. 262)'' (section 201(dd) of the FD&C Act (21
U.S.C. 321(dd))).
Dated: May 8, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-10584 Filed 5-14-24; 8:45 am]
BILLING CODE 4164-01-P
