Notice2024-11727
Maria Anzures-Camarena: Final Debarment Order
Primary source
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Published
May 29, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 104 (Wednesday, May 29, 2024)</title>
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[Federal Register Volume 89, Number 104 (Wednesday, May 29, 2024)]
[Notices]
[Pages 46404-46406]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<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-4805. 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
[[Page 46405]]
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, 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,
<a href="/cdn-cgi/l/email-protection#a2c6c7c0c3d0cfc7ccd6d1e2c4c6c38ccacad18cc5cdd4"><span class="__cf_email__" data-cfemail="0f6b6a6d6e7d626a617b7c4f696b6e2167677c21686079">[email protected]</span></a>.
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
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