[Federal Register Volume 89, Number 104 (Wednesday, May 29, 2024)]
[Notices]
[Pages 46404-46406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11727]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4805]


Maria Anzures-Camarena: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an 
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
permanently debarring Maria Anzures-Camarena 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. Anzures-
Camarena 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. 
Anzures-Camarena 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. Anzures-Camarena has not responded. Ms. Anzures-Camarena's failure 
to respond and request a hearing constitutes a waiver of her right to a 
hearing concerning this matter.

DATES: This order is applicable May 29, 2024.

ADDRESSES: Any application by Ms. Anzures-Camarena 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 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-4805. 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

[[Page 46405]]

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, 
[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 
March 17, 2023, Ms. Anzures-Camarena 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 approximately 
April 2014 and February 2021 Ms. Anzures-Camarena was involved in a 
conspiracy with drug traffickers to distribute misbranded and 
counterfeit cough syrup. Specifically, Ms. Anzures-Camarena worked for 
Woodfield Pharmaceutical LLC as a packaging specialist. Woodfield 
Pharmaceutical LLC was a part of a group of pharmaceutical companies 
that 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 syrup base 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. Anzures-Camarena assisted in 
the packaging and delivery of the counterfeit syrup. In addition, when 
the Marshall DTO exhausted its available supply of promethazine, Ms. 
Anzures-Camarena was videoed, along with her supervisor, removing 
controlled substances from Woodfield's vault to deliver to the Marshall 
DTO. Later, Ms. Anzures-Camarena agreed with other Woodfield employees 
to create additional syrup base supply not authorized by Woodfield in 
order to sell that additional supply to Marshall and DTO at a reduced 
price in order to split the fee with other Woodfield employees, a 
practice Ms. Anzures-Camarena and other employees called, ``double 
batching.'' No records of the ``double batching'' were created.
    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.
    FDA sent Ms. Anzures-Camarena, by certified mail, on January 25, 
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. Anzures-Camarena 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. Anzures-Camarena 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. Anzures-Camarena received the proposal and notice of 
opportunity for a hearing on February 5, 2024. Ms. Anzures-Camarena 
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 Maria 
Anzures-Camarena 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. Anzures-Camarena 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. Anzures-Camarena 
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. Anzures-
Camarena 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

[[Page 46406]]

FD&C Act). In addition, FDA will not accept or review any abbreviated 
new drug application from Ms. Anzures-Camarena 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 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-11727 Filed 5-28-24; 8:45 am]
BILLING CODE 4164-01-P