Barry J. Cadden: Final Debarment Order, 76582-76583 [2020-26255]
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76582
Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices
Chief Executive Officer (CEO). Insys
developed and owned a drug called
SUBSYS, a liquid formulation of
fentanyl to be applied under the tongue.
FDA approved SUBSYS for the
management of breakthrough pain in
adult cancer patients who are already
receiving and are already tolerant to
opioid therapy for their underlying
persistent cancer pain. From 2012 and
continuing through 2015, Mr. Kapoor
oversaw a conspiracy whereby
employees of Insys bribed medical
practitioners in various states to get
those practitioners to increase
prescribing SUBSYS to their patients.
Mr. Kapoor, along with his coconspirators, measured the effect of
these bribes on each practitioner’s
prescribing habits and on the revenue
that each bribed practitioner generated
for Insys. Mr. Kapoor, along with his coconspirators, reduced or eliminated
bribes paid to those practitioners who
failed to meet the minimum
prescription requirements or failed to
generate enough revenue to justify
additional bribes.
To further this conspiracy, Mr.
Kapoor oversaw a scheme whereby
Insys executives conspired to mislead
and defraud health insurance providers
to ensure those providers approved
payment for SUBSYS. Insys achieved
this goal by establishing the ‘‘Insys
Reimbursement Center,’’ which was
designed to shift the burden of seeking
prior authorization for SUBSYS from
practitioners to Insys. This allowed
Insys to determine what medical
information was presented to insurers.
Mr. Kapoor and his co-conspirators
directed Insys employees to mislead
insurers to obtain payment
authorization.
As a result of this conviction, FDA
sent Mr. Kapoor by certified mail on
July 16, 2020, 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.
Kapoor 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 also offered Mr.
Kapoor 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 request a hearing constituted
an election not to use the opportunity
for a hearing and a waiver of any
contentions concerning this action. Mr.
Kapoor received the proposal on July
27, 2020. Mr. Kapoor, through counsel,
submitted a letter to FDA dated August
VerDate Sep<11>2014
20:03 Nov 27, 2020
Jkt 253001
12, 2020, which commented on some of
the factual circumstances surrounding
the case. In the letter, he also stated that
he did not intend to request a hearing
nor, however, would he acquiesce to
debarment. Since he did not request a
hearing within the timeframe prescribed
by regulation, Mr. Kapoor has waived
his opportunity for a hearing and any
contentions concerning his debarment
(21 CFR part 12).
Publicly available submissions will be
placed in the docket and will be
viewable at https://www.regulations.gov
or at the Dockets Management Staff (see
ADDRESSES) between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
II. Findings and Order
BILLING CODE 4164–01–P
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. Kapoor
has been convicted of a felony under
Federal law for conduct otherwise
relating to the regulation of a drug
product under the FD&C Act.
As a result of the foregoing finding,
Mr. Kapoor, 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 (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 the services of Mr. Kapoor, in any
capacity 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. Kapoor 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
drug application from Mr. Kapoor
during his 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 section 306 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) (see section 201(dd)
of the FD&C Act (21 U.S.C. 321(dd))).
Any application by Mr. Kapoor for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2020–N–1337 and sent to the
Dockets Management Staff (see
ADDRESSES). The public availability of
information in these submissions is
governed by 21 CFR 10.20.
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Fmt 4703
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Dated: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–26262 Filed 11–27–20; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–4248]
Barry J. Cadden: Final Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 Barry J.
Cadden 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. Cadden was convicted
of a felony under Federal law for
conduct that relates to the regulation of
a drug product under the FD&C Act. Mr.
Cadden was given notice of the
proposed permanent debarment and an
opportunity to request a hearing to show
why he should not be debarred. As of
July 9, 2020 (30 days after receipt of the
notice), Mr. Cadden had not responded.
Mr. Cadden’s failure to respond and
request a hearing constitutes a waiver of
his right to a hearing concerning this
action.
DATES: This order is applicable
November 30, 2020.
ADDRESSES: Submit applications for
special termination of debarment to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852, 240–402–7500, or at https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of
Enforcement, Office of Strategic
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, debarments@
fda.hhs.gov, or at 240–402–8743.
SUPPLEMENTARY INFORMATION:
SUMMARY:
E:\FR\FM\30NON1.SGM
30NON1
TKELLEY on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices
I. Background
Section 306(a)(2)(B) of the FD&C Act
(21 U.S.C. 335a(a)(2)(B)) 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
June 27, 2017, Mr. Cadden was
convicted as defined in section 306(l)(1)
of the FD&C Act when judgment was
entered against him in the U.S. District
Court for the District of Massachusetts,
after a jury verdict, for one count of
racketeering in violation of 18 U.S.C.
1962(c), one count of racketeering
conspiracy in violation of 18 U.S.C.
1962(d), 52 counts of mail fraud in
violation of 18 U.S.C. 1341, and three
counts of introduction of misbranded
drugs into interstate commerce with the
intent to defraud and mislead-no
prescriptions in violation of 21 U.S.C.
353(b)(1), 331(a), and 333(a)(2).
As contained in counts 1–2, 4–39, 41–
56, 95, and 99–100 of the indictment,
filed on December 16, 2014, Mr. Cadden
was an owner and director of the New
England Compounding Center (NECC),
which held itself out as a compoundingonly pharmacy, and he served as
NECC’s president, head pharmacist, and
Manager of Record. In addition, Mr.
Cadden was an owner and director of
Medical Sales Management, Inc. (MSM),
and served as MSM’s Treasurer. MSM
provided sales and administrative
services to NECC for which MSM was
paid a service fee. MSM’s sales
representatives sold drugs on behalf of
NECC to customers throughout the
country. In those capacities, Mr. Cadden
instructed the MSM sales force to falsely
represent to customers that NECC was
providing the highest quality
compounded medications, when in fact
Mr. Cadden, among other things, failed
to properly sterilize drug products
consistent with applicable U.S.
Pharmacopeia standards, failed to test
purportedly sterile drugs, authorized the
shipping of drugs before test results
confirming their sterility were returned,
never notified customers of nonsterile
results, and compounded drugs with
expired ingredients. Additionally, Mr.
Cadden directed and authorized the
shipping and mailing, in interstate
commerce, of contaminated
methylprednisolone acetate to NECC
customers nationwide. Mr. Cadden also
caused drugs to be introduced and
delivered into interstate commerce
without the valid prescription of a
practitioner licensed by law to
VerDate Sep<11>2014
20:03 Nov 27, 2020
Jkt 253001
administer drugs, which act resulted in
the drugs being misbranded. Further,
Mr. Cadden defrauded the United States
by interfering with and obstructing the
lawful governmental functions of FDA
by claiming to be a pharmacy
dispensing drugs pursuant to valid,
patient-specific prescriptions. In fact,
NECC routinely dispensed drugs in bulk
without valid, patient-specific
prescriptions.
As a result of this conviction, FDA
sent Mr. Cadden, by certified mail on
June 2, 2020, 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.
Cadden was convicted of felonies under
Federal law for conduct relating to the
regulation of a drug product under the
FD&C Act. The proposal also offered Mr.
Cadden 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 request a hearing constituted
an election not to use the opportunity
for a hearing and a waiver of any
contentions concerning this action. Mr.
Cadden received the proposal on June 9,
2020. Mr. Cadden did not request a
hearing within the timeframe prescribed
by regulation 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 Barry J.
Cadden, has been convicted of a felony
under Federal law for conduct
otherwise relating to the regulation of a
drug product under the FD&C Act.
As a result of the foregoing finding,
Barry J. Cadden, 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 the services of Barry J.
Cadden, in any capacity 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.
Cadden provides services in any
capacity to a person with an approved
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
76583
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 drug applications
from Mr. Cadden during his 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
section 306 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, 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))).
Any application by Mr. Cadden for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2019–N–4248 and sent to the
Dockets Management Staff (see
ADDRESSES). The public availability of
information in these submissions is
governed by 21 CFR 10.20.
Publicly available submissions will be
placed in the docket and will be
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.
Dated: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–26255 Filed 11–27–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1255]
Tuan Anh Tran: 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) debarring
Tuan Anh Tran for a period of 5 years
from importing or offering for import
any drug into the United States. FDA
bases this order on a finding that Mr.
Tran engaged in a pattern of importing
or offering for import misbranded drugs
(i.e., in an amount, frequency, or dosage
that is inconsistent with his personal or
household use) that are not designated
in an authorized electronic data
interchange system as products
SUMMARY:
E:\FR\FM\30NON1.SGM
30NON1
]]>Agencies
[Federal Register Volume 85, Number 230 (Monday, November 30, 2020)]
[Notices]
[Pages 76582-76583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26255]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-4248]
Barry J. Cadden: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 Barry J. Cadden 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. Cadden was
convicted of a felony under Federal law for conduct that relates to the
regulation of a drug product under the FD&C Act. Mr. Cadden was given
notice of the proposed permanent debarment and an opportunity to
request a hearing to show why he should not be debarred. As of July 9,
2020 (30 days after receipt of the notice), Mr. Cadden had not
responded. Mr. Cadden's failure to respond and request a hearing
constitutes a waiver of his right to a hearing concerning this action.
DATES: This order is applicable November 30, 2020.
ADDRESSES: Submit applications for special termination of debarment to
the Dockets Management Staff (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement, Office of Strategic Planning and Operational Policy,
Office of Regulatory Affairs, Food and Drug Administration, 12420
Parklawn Dr., Rockville, MD 20857, [email protected], or at 240-
402-8743.
SUPPLEMENTARY INFORMATION:
[[Page 76583]]
I. Background
Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
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 June 27, 2017, Mr. Cadden was
convicted as defined in section 306(l)(1) of the FD&C Act when judgment
was entered against him in the U.S. District Court for the District of
Massachusetts, after a jury verdict, for one count of racketeering in
violation of 18 U.S.C. 1962(c), one count of racketeering conspiracy in
violation of 18 U.S.C. 1962(d), 52 counts of mail fraud in violation of
18 U.S.C. 1341, and three counts of introduction of misbranded drugs
into interstate commerce with the intent to defraud and mislead-no
prescriptions in violation of 21 U.S.C. 353(b)(1), 331(a), and
333(a)(2).
As contained in counts 1-2, 4-39, 41-56, 95, and 99-100 of the
indictment, filed on December 16, 2014, Mr. Cadden was an owner and
director of the New England Compounding Center (NECC), which held
itself out as a compounding-only pharmacy, and he served as NECC's
president, head pharmacist, and Manager of Record. In addition, Mr.
Cadden was an owner and director of Medical Sales Management, Inc.
(MSM), and served as MSM's Treasurer. MSM provided sales and
administrative services to NECC for which MSM was paid a service fee.
MSM's sales representatives sold drugs on behalf of NECC to customers
throughout the country. In those capacities, Mr. Cadden instructed the
MSM sales force to falsely represent to customers that NECC was
providing the highest quality compounded medications, when in fact Mr.
Cadden, among other things, failed to properly sterilize drug products
consistent with applicable U.S. Pharmacopeia standards, failed to test
purportedly sterile drugs, authorized the shipping of drugs before test
results confirming their sterility were returned, never notified
customers of nonsterile results, and compounded drugs with expired
ingredients. Additionally, Mr. Cadden directed and authorized the
shipping and mailing, in interstate commerce, of contaminated
methylprednisolone acetate to NECC customers nationwide. Mr. Cadden
also caused drugs to be introduced and delivered into interstate
commerce without the valid prescription of a practitioner licensed by
law to administer drugs, which act resulted in the drugs being
misbranded. Further, Mr. Cadden defrauded the United States by
interfering with and obstructing the lawful governmental functions of
FDA by claiming to be a pharmacy dispensing drugs pursuant to valid,
patient-specific prescriptions. In fact, NECC routinely dispensed drugs
in bulk without valid, patient-specific prescriptions.
As a result of this conviction, FDA sent Mr. Cadden, by certified
mail on June 2, 2020, 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. Cadden was
convicted of felonies under Federal law for conduct relating to the
regulation of a drug product under the FD&C Act. The proposal also
offered Mr. Cadden 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 request a hearing constituted
an election not to use the opportunity for a hearing and a waiver of
any contentions concerning this action. Mr. Cadden received the
proposal on June 9, 2020. Mr. Cadden did not request a hearing within
the timeframe prescribed by regulation 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 Barry J.
Cadden, has been convicted of a felony under Federal law for conduct
otherwise relating to the regulation of a drug product under the FD&C
Act.
As a result of the foregoing finding, Barry J. Cadden, 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 the services of Barry J. Cadden, in any capacity 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. Cadden
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
drug applications from Mr. Cadden during his 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
section 306 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, 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))).
Any application by Mr. Cadden for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2019-N-4248 and sent to the Dockets Management Staff
(see ADDRESSES). The public availability of information in these
submissions is governed by 21 CFR 10.20.
Publicly available submissions will be placed in the docket and
will be 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.
Dated: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26255 Filed 11-27-20; 8:45 am]
BILLING CODE 4164-01-P
