[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]


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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.

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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) 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