Brenda Elise Edwards: Final Debarment Order, 15791-15792 [2020-05717]
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Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices
be introduced in interstate commerce
were misbranded because the drugs
were dangerous to health when used as
labeled and because the labeling on the
drugs regarding use by dates and the
strength of the ingredients were false
and misleading. Mr. Tighe assured
healthcare providers that they were
receiving drug products from Med Prep
that were produced in full compliance
with the law, were compounded and
packaged in compliance with chapter
797 of the United States Pharmacopeia
(USP 797) and would be safe for
patients. Mr. Tighe also told healthcare
providers that the beyond use dates that
Mr. Tighe assigned to sterile drug
products were supported by sterility
testing that satisfied the requirements of
USP 797. These representations were
made in, among other places, quarterly
reports that were sent by email to
healthcare providers and on Med Prep’s
website. Mr. Tighe did not inform
healthcare providers of failures to
comply with USP 797 and basic sterility
practices, and breaches of aseptic
technique in Med Prep’s cleanroom,
which occurred repeatedly at Med
Prep’s facility.
By engaging in this conduct, Mr.
Tighe violated Federal and State law
applicable to drug preparation and
created serious risks for patients who
were being treated for cancer and other
illnesses. Mr. Tighe misrepresented the
quality of Med Prep’s drug processing
and repackaging operations to increase
market share, and he engaged in
substandard practices to save money
and increase his profits. Relying on
these misrepresentations and omissions,
healthcare providers paid Med Prep
approximately $34,970,881 for its
services between approximately 2007
and 2012.
Based on his conviction, FDA sent
Mr. Tighe by certified mail on October
25, 2019, 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.
Tighe 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. Tighe 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
constituted a waiver of the opportunity
for a hearing and of any contentions
concerning this action. Mr. Tighe
VerDate Sep<11>2014
17:05 Mar 18, 2020
Jkt 250001
15791
received the proposal on October 31,
2019. Mr. Tighe did not request a
hearing and has, therefore, waived his
opportunity for a hearing and any
contentions concerning his debarment
(21 CFR part 12).
Dated: March 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
II. Findings and Order
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 Gerald Tighe
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,
Gerald Tighe is permanently debarred
from providing services in any capacity
to a person with an approved or
pending drug product application under
sections 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), applicable
(see DATES) (see sections 201(dd) and
306(c)(1)(B) and (c)(2)(A)(ii) of the FD&C
Act (21 U.S.C. 321(dd) and 335a(c)(1)(B)
and (c)(2)(A)(ii))). 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 Gerald Tighe 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.
Tighe 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. Tighe during his period of
debarment (section 306(c)(1)(B) of the
FD&C Act).
Any application by Mr. Tighe for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2019–N–3591 and sent to the
Dockets Management Staff (see
ADDRESSES). You can submit only one
copy for all such submissions. The
public availability of information in
these submissions is governed by 21
CFR 10.20.
Publicly available submissions may
be seen in the Dockets Management
Staff between 9 a.m. and 4 p.m.,
Monday through Friday.
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
[FR Doc. 2020–05714 Filed 3–18–20; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2019–N–4054]
Brenda Elise Edwards: 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 Brenda
Elise Edwards 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 Mrs. Edwards was
convicted of a felony under Federal law
for conduct that relates to the regulation
of a drug product under the FD&C Act.
Mrs. Edwards was given notice of the
proposed permanent debarment and
was given an opportunity to request a
hearing to show why she should not be
debarred. As of January 2, 2020 (30 days
after receipt of the notice), Mrs.
Edwards had not responded. Mrs.
Edwards’s failure to respond and
request a hearing constitutes a waiver of
her right to a hearing concerning this
action.
SUMMARY:
This order is applicable March
19, 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.
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, 240–402–8743.
SUPPLEMENTARY INFORMATION:
DATES:
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
E:\FR\FM\19MRN1.SGM
19MRN1
jbell on DSKJLSW7X2PROD with NOTICES
15792
Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices
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
January 28, 2019, Mrs. Edwards was
convicted as defined in section
306(l)(1)(A) of the FD&C Act when
judgment was entered against her in the
U.S. District Court for the Middle
District of Tennessee, Nashville
Division, after her plea of guilty, to one
count of conspiracy to commit mail
fraud in violation of 18 U.S.C. 371.
The factual basis for this conviction is
as follows: As contained in count 1 of
the indictment, filed on January 17,
2013, to which Mrs. Edwards pleaded
guilty, from December 2006 through
August 2009, Mrs. Edwards, along with
others, through Cumberland
Distribution, Inc. (Cumberland), a
company Mrs. Edwards was an
employee of, was engaged in wholesale
distribution of prescription drugs as
defined by section 505(e) of the FD&C
Act (21 U.S.C. 355(e)). Cumberland
purchased millions of dollars of
prescription drugs from unlicensed drug
suppliers who were not authorized to
distribute drugs under section 503 of the
FD&C Act (21 U.S.C. 353). Mrs. Edwards
knew that these unlicensed suppliers
often procured drugs from street level
drug diverters who had obtained the
drugs from persons with legitimate
prescriptions. On many occasions, Mrs.
Edwards, along with others, had drugs
shipped to shell companies, which
Cumberland used as pass-throughs to
create the appearance that Cumberland
was purchasing drugs from licensed
suppliers when in fact Cumberland was
purchasing drugs from unlicensed
suppliers. Afterwards, Mrs. Edwards,
along with others, had these drugs
shipped to Cumberland’s Nashville
warehouse where they were re-packaged
and shipped to independent pharmacies
around the country.
Mrs. Edwards also directed
Cumberland employees to take steps to
make it appear that the diverted drugs
were purchased from authorized sellers,
such as by: (1) Cleaning pharmaceutical
bottles to remove evidence of glue, dirt
or hair; (2) inspecting bottles for signs
of diversion, such as scratches in the
label, glue residue, broken seal, expired
product, or illegible lot numbers; and (3)
attaching patient information pamphlets
to bottles that did not have them. The
diverted drugs included drugs used to
combat human immunodeficiency virus
(HIV)/acquired immunodeficiency
syndrome (AIDS), antipsychotic
medications, anti-depressants, blood
pressure medications, and diabetes
medications, among others. Through the
VerDate Sep<11>2014
17:05 Mar 18, 2020
Jkt 250001
course of this scheme, Cumberland had
gross proceeds of approximately
$58,984,912. Mrs. Edwards and two
others obtained profits of approximately
$14,689,782.
As a result of this conviction, FDA
sent Mrs. Edwards by certified mail on
November 18, 2019, 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 Mrs.
Edwards 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 Mrs. Edwards 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 file a timely request
for a hearing constituted an election not
to use the opportunity for a hearing and
a waiver of any contentions concerning
this action. Mrs. Edwards received the
proposal on December 2, 2019. Mrs.
Edwards did not request a hearing
within the timeframe prescribed by
regulation and has, therefore, waived
her opportunity for a hearing and 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 Brenda Elise
Edwards 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,
Brenda Elise Edwards is permanently
debarred from providing services in any
capacity to a person with an approved
or pending drug product application,
applicable (see DATES) (see section
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 Brenda Elise
Edwards, in any capacity 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 Mrs.
Edwards 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
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
any abbreviated new drug applications
from Mrs. Edwards during her 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 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 Mrs. Edwards for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2019–N–4054 and sent to the
Dockets Management Staff (see
ADDRESSES). All such submissions are to
be filed in four copies (21 CFR 10.20(a)).
The public availability of information in
these submissions is governed by 21
CFR 10.20.
Publicly available submissions may
be seen in the Dockets Management
Staff between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: March 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–05717 Filed 3–18–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3608]
Stephen Kalinoski: 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 Stephen
Kalinoski 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. Kalinoski was
convicted of a felony for conduct that
relates to the regulation of a drug
product under the FD&C Act. Mr.
Kalinoski was given notice of the
proposed permanent debarment and an
opportunity to request a hearing within
the timeframe prescribed by regulation.
Mr. Kalinoski failed to respond. Mr.
Kalinoski’s failure to request a hearing
within the prescribed timeframe
SUMMARY:
E:\FR\FM\19MRN1.SGM
19MRN1
]]>Agencies
[Federal Register Volume 85, Number 54 (Thursday, March 19, 2020)]
[Notices]
[Pages 15791-15792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05717]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-4054]
Brenda Elise Edwards: 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 Brenda Elise Edwards 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 Mrs. Edwards was
convicted of a felony under Federal law for conduct that relates to the
regulation of a drug product under the FD&C Act. Mrs. Edwards was given
notice of the proposed permanent debarment and was given an opportunity
to request a hearing to show why she should not be debarred. As of
January 2, 2020 (30 days after receipt of the notice), Mrs. Edwards had
not responded. Mrs. Edwards's failure to respond and request a hearing
constitutes a waiver of her right to a hearing concerning this action.
DATES: This order is applicable March 19, 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.
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], 240-402-
8743.
SUPPLEMENTARY INFORMATION:
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
[[Page 15792]]
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 January 28, 2019,
Mrs. Edwards was convicted as defined in section 306(l)(1)(A) of the
FD&C Act when judgment was entered against her in the U.S. District
Court for the Middle District of Tennessee, Nashville Division, after
her plea of guilty, to one count of conspiracy to commit mail fraud in
violation of 18 U.S.C. 371.
The factual basis for this conviction is as follows: As contained
in count 1 of the indictment, filed on January 17, 2013, to which Mrs.
Edwards pleaded guilty, from December 2006 through August 2009, Mrs.
Edwards, along with others, through Cumberland Distribution, Inc.
(Cumberland), a company Mrs. Edwards was an employee of, was engaged in
wholesale distribution of prescription drugs as defined by section
505(e) of the FD&C Act (21 U.S.C. 355(e)). Cumberland purchased
millions of dollars of prescription drugs from unlicensed drug
suppliers who were not authorized to distribute drugs under section 503
of the FD&C Act (21 U.S.C. 353). Mrs. Edwards knew that these
unlicensed suppliers often procured drugs from street level drug
diverters who had obtained the drugs from persons with legitimate
prescriptions. On many occasions, Mrs. Edwards, along with others, had
drugs shipped to shell companies, which Cumberland used as pass-
throughs to create the appearance that Cumberland was purchasing drugs
from licensed suppliers when in fact Cumberland was purchasing drugs
from unlicensed suppliers. Afterwards, Mrs. Edwards, along with others,
had these drugs shipped to Cumberland's Nashville warehouse where they
were re-packaged and shipped to independent pharmacies around the
country.
Mrs. Edwards also directed Cumberland employees to take steps to
make it appear that the diverted drugs were purchased from authorized
sellers, such as by: (1) Cleaning pharmaceutical bottles to remove
evidence of glue, dirt or hair; (2) inspecting bottles for signs of
diversion, such as scratches in the label, glue residue, broken seal,
expired product, or illegible lot numbers; and (3) attaching patient
information pamphlets to bottles that did not have them. The diverted
drugs included drugs used to combat human immunodeficiency virus (HIV)/
acquired immunodeficiency syndrome (AIDS), antipsychotic medications,
anti-depressants, blood pressure medications, and diabetes medications,
among others. Through the course of this scheme, Cumberland had gross
proceeds of approximately $58,984,912. Mrs. Edwards and two others
obtained profits of approximately $14,689,782.
As a result of this conviction, FDA sent Mrs. Edwards by certified
mail on November 18, 2019, 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 Mrs.
Edwards 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 Mrs. Edwards 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 file a timely
request for a hearing constituted an election not to use the
opportunity for a hearing and a waiver of any contentions concerning
this action. Mrs. Edwards received the proposal on December 2, 2019.
Mrs. Edwards did not request a hearing within the timeframe prescribed
by regulation and has, therefore, waived her opportunity for a hearing
and 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 Brenda
Elise Edwards 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, Brenda Elise Edwards is
permanently debarred from providing services in any capacity to a
person with an approved or pending drug product application, applicable
(see DATES) (see section 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 Brenda Elise Edwards, in any capacity
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 Mrs. Edwards
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 applications from Mrs. Edwards during her 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 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 Mrs. Edwards for special termination of
debarment under section 306(d)(4) of the FD&C Act should be identified
with Docket No. FDA-2019-N-4054 and sent to the Dockets Management
Staff (see ADDRESSES). All such submissions are to be filed in four
copies (21 CFR 10.20(a)). The public availability of information in
these submissions is governed by 21 CFR 10.20.
Publicly available submissions may be seen in the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Dated: March 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05717 Filed 3-18-20; 8:45 am]
BILLING CODE 4164-01-P
