[Federal Register Volume 89, Number 31 (Wednesday, February 14, 2024)]
[Notices]
[Pages 11296-11298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03036]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4094]


Kalpen D. Patel: 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 Kalpen D. Patel 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 Mr. Patel was convicted of a felony 
under Federal law for conduct that relates to the regulation of any 
drug product under the FD&C Act. Mr. Patel was given notice of the 
proposed permanent debarment and was given an opportunity to request a 
hearing to show why he should not be debarred within the timeframe 
prescribed by regulation. Mr. Patel responded to the notice by 
submitting correspondence to FDA, but he did not request a hearing. Mr. 
Patel's failure to request a hearing within the prescribed timeframe 
constitutes a waiver of his right to a hearing concerning this action.

DATES: This order is applicable February 14, 2024.

ADDRESSES: Any application by Mr. Patel 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 as follows:

Electronic Submissions

    [ssquf] 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.
    [ssquf] 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

    [ssquf] 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.
    [ssquf] 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-4094. 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.
    [ssquf] 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, 
[email protected].

SUPPLEMENTARY INFORMATION:

[[Page 11297]]

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 
September 7, 2023, Mr. Patel 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 his plea 
of guilty and entered a judgment against him 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 factual basis for this conviction is as follows: as contained 
in the Second Superseding Indictment and in the Factual Basis, between 
approximately April 2014 and February 2021, Mr. Patel conspired with 
drug traffickers to distribute misbranded and counterfeit cough syrup. 
Specifically, Mr. Patel worked for Pernix Manufacturing LLC (Pernix) as 
a product-development scientist. 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 would have revealed 
that he was not a licensed physician as he claimed. Marshall sought to 
copy Actavis Prometh VC with Codeine (Actavis). Actavis is a purple, 
peach-mint flavor 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. In his 
role at Pernix as a product-development scientist, Mr. Patel worked 
with Marshall and his associates to recreate Actavis without codeine 
and promethazine in order to recreate the syrup base, which is a 
necessary component of cough syrup. Mr. Patel referred to the new 
product as a ``placebo.'' Marshall and his associates would then add 
promethazine to this counterfeit ``placebo'' substance prior to 
bottling and distribution in order to create the street drug.
    On April 25, 2014, as Pernix was scaling-up production of the 
``placebo'' syrup base, Pernix was acquired by Woodfield Pharmaceutical 
LLC, a contract manufacturing company, and Woodfield Distribution LLC, 
a third-party logistics company (collectively, Woodfield). Mr. Patel 
was subsequently promoted to Woodfield's Research and Development 
Manager. In that role he supervised Woodfield's chemical formulation 
development, optimization, and scale-up for clients, and he worked with 
Marshall and his associates to develop and distribute the misbranded 
and counterfeit cough syrup. When Marshall and his DTO had difficulty 
dissolving promethazine into the ``placebo'' syrup base, Mr. Patel, 
along with others, worked to resolve that issue.
    In or about July 2017, Marshall and his DTO asked Mr. Patel to 
reformulate another cough syrup to use in their drug trafficking 
scheme: Hi-Tech Promethazine Hydrocholoride and Codeine Phosphate Oral 
Solution (Hi-Tech). Mr. Patel reformulated Hi-Tech without the 
promethazine and codeine, and Woodfield began producing it for Marshall 
and his DTO. Later, Mr. Patel was promoted to Woodfield's Director of 
Technical Operations, and in that role, he agreed with other Woodfield 
employees to create additional ``placebo'' syrup base supply not 
authorized by Woodfield's ownership in order to sell that additional 
supply to Marshall and DTO at a reduced price and split the fee with 
other Woodfield employees.
    On or about December 10, 2019, Marshall and his DTO asked Mr. Patel 
to reformulate another cough syrup to use in their drug trafficking 
scheme: Wockhardt Promethazine Syrup Plain (Wockhardt). Mr. Patel 
reformulated Wockhardt, and Woodfield eventually produced the 
``placebo'' syrup base for Marshall and his DTO.
    Initially, there were no batch records to document the production 
of the ``placebo'' cough syrups as required; Woodfield provided the 
syrup to Marshall and his DTO without any corresponding documentation 
that identified the ingredients of the syrup. This practice continued 
until February 2019, when Mr. Patel started creating paper records for 
some of the cough syrup batches Woodfield made for the DTO. Based on 
the records that do exist and Mr. Patel's own statements, from 2014 
through February 2021, the conspiracy with the Marshall DTO produced 
and distributed, or attempted to produce and distribute, approximately 
65,920 gallons of counterfeit cough syrup.
    Based on this conviction, FDA sent Mr. Patel by certified mail on 
October 30, 2023, a notice proposing to permanently debar him 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 Mr. Patel was 
convicted, as set forth in section 306(l)(1) of the FD&C Act, of a 
felony under Federal law for conduct relating to the regulation of a 
drug product under the FD&C Act. The proposal also offered Mr. Patel 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 file a timely request for a hearing would constitute an 
election not to use the opportunity for a hearing and a waiver of any 
contentions concerning this action. Mr. Patel received the proposal on 
November 8, 2023. On December 12, 2023, Mr. Patel submitted 
correspondence to FDA explaining the reasons why he believed he was not 
guilty of the offenses he pled guilty to in court. However, in his 
request he did not request a hearing and has, therefore, waived his 
opportunity for a hearing and 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(a)(2)(B) of the FD&C Act, under 
authority delegated to the Assistant Commissioner, finds that Mr. Patel 
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, Mr. Patel 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 Mr. Patel during his 
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 Mr. Patel provides services 
in any capacity to a person with an approved or pending drug product 
application during his period of debarment, he 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

[[Page 11298]]

drug application from Mr. Patel during his period of debarment, other 
than in connection with an audit under 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: February 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-03036 Filed 2-13-24; 8:45 am]
BILLING CODE 4164-01-P