Raymond Sean Brown: Debarment Order, 11044-11045 [2017-03173]
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11044
Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices
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Dated: February 13, 2017.
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[FR Doc. 2017–03176 Filed 2–16–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2191]
Raymond Sean Brown: Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The U.S. Food and Drug
Administration (FDA or Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) permanently debarring Dr.
Raymond Sean Brown 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 Dr. Brown was
convicted of a felony under Federal law
for conduct relating to the regulation of
a drug product under the FD&C Act. Dr.
Brown was given notice of the proposed
permanent debarment and an
opportunity to request a hearing within
the timeframe prescribed by regulation.
Dr. Brown failed to request a hearing.
Dr. Brown’s failure to request a hearing
constitutes a waiver of his right to a
hearing concerning this action.
DATES: This order is effective February
17, 2017.
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:38 Feb 16, 2017
Jkt 241001
Submit applications for
special termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade (ELEM–4144), Division of
Enforcement, Office of Enforcement and
Import Operations, Office of Regulatory
Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD
20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
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 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
April 2, 2015, the U.S. District Court for
the Eastern District of Tennessee
entered judgment against Dr. Brown for
one count of receiving and distributing
misbranded drugs in interstate
commerce with intent to defraud and
mislead in violation of section 301(a) of
the FD&C Act (21 U.S.C. 331(c)), which
according to section 303(a)(2) of the
FD&C Act (21 U.S.C. 333(a)(2))
constitutes a felony.
FDA’s finding that the debarment is
appropriate based on the felony
conviction referenced herein. The
factual basis for this conviction is as
follows: Dr. Brown was a licensed
medical doctor in the state of Tennessee
with a practice address listed in
Cleveland, TN. The Tennessee
Department of Health also lists Bradley
PM&R as a licensed health care facility.
Dr. Brown was the medical director of
Bradley PM&R, and Dr. Brown’s medical
practice was listed at the same address.
As a part of the treatment of patients for
pain management, Bradley PM&R
purchased assorted prescription drugs,
including Botulinum Toxin Type A,
also known as Botox
Onabotulinumtoxin A (hereinafter
referred to as ‘‘Botox’’), which was
prescribed by Dr. Brown and was
administered and dispensed through
Bradley PM&R. Prior to 2009, Botox®/
Botox® Cosmetic, a product
manufactured by Allergan, Inc., was the
only Botulinum Toxin Type A product
licensed by FDA for use in humans for
any indication, including pain
management.
Axon Medical Supplies was a
business operating in Surry, BC,
Canada. Axon offered for sale to
physicians and other health care
providers in the United States drugs that
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
had been obtained from foreign sources
and that had not been approved by FDA
for distribution or use in the United
States.
From May 2008 until December 2012,
Dr. Brown received $7,482,968 in
reimbursement from Medicare for Botox
injections alone, with none of these
payments resulting from properly
payable claims for FDA approved Botox
injections.
Beginning in or about January 2007
and continuing through in or about
December 2012, Dr. Brown ordered 254
vials (25,400 units) of Botox from Axon
Medical Supplies that were misbranded
within the meaning of the FD&C Act in
that the drug’s labeling failed to bear
adequate directions for use and all
words, statements, or other information
required by or under authority of the
FD&C Act to appear on the label and
labeling were not present, in fact many
of the words were not in the English
language. These misbranded drugs were
sent to Bradley PM&R clinic and Dr.
Brown injected these drugs into his
patients, while purporting them to be
FDA-approved drugs.
Dr. Brown billed Medicare for all of
these Botox units as if they were FDAapproved drugs. Dr. Brown also
provided diluted Botox injections and
billed as if they were full doses. Dr.
Brown billed Medicare for an additional
15,865 vials that he did not inject into
patients. Dr. Brown admitted that he
received the Botox in interstate
commerce for delivery that was
misbranded and he acted with intent to
defraud and/or mislead. Dr. Brown’s
conduct constituted a violation of
section 303(c) of the FD&C Act, which
according to section 303(a)(2)
constitutes a felony.
As a result of this conviction, FDA
sent Dr. Brown by certified mail on
October 28, 2016, 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 Dr.
Brown was convicted of a felony under
Federal law for conduct relating to the
regulation of a drug product under the
FD&C Act. FDA determined that Dr.
Brown’s felony conviction was related
to the regulation of drug products
because the conduct underlying his
conviction undermined FDA’s
regulatory oversight over drug products
marketed in the United States—Dr.
Brown knowingly received and
distributed misbranded drugs in
interstate commerce with intent to
defraud and mislead. The proposal also
offered Dr. Brown an opportunity to
E:\FR\FM\17FEN1.SGM
17FEN1
Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
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 a waiver of the opportunity
for a hearing and of any contentions
concerning this action. The proposal
was received on October 31, 2016. Dr.
Brown 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 Director, Office of
Enforcement and Import Operations,
Office of Regulatory Affairs, under
section 306(a)(2)(B) of the FD&C Act,
under authority delegated to him (Staff
Manual Guide 1410.35), finds that Dr.
Raymond Sean Brown has been
convicted of a felony under Federal law
for conduct relating to the regulation of
a drug product under the FD&C Act.
Section 306(c)(2)(A)(ii) of the FD&C Act
requires that Dr. Brown’s debarment be
permanent.
As a result of the foregoing finding,
Dr. Raymond Sean Brown 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), effective (see DATES) (see section
201(dd), 306(c)(1)(B), and
306(c)(2)(A)(ii) of the FD&C Act (21
U.S.C. 321(dd), 335a(c)(1)(B), and
335a(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 the services of Dr.
Brown, 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 Dr.
Brown 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 Dr. Brown during his period of
debarment (section 306(c)(1)(B) of the
FD&C Act).
Any application by Dr. Brown for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2016–N–2191 and sent to the
Division of Dockets Management (see
ADDRESSES). All such submissions are to
be filed in four copies. The public
VerDate Sep<11>2014
17:38 Feb 16, 2017
Jkt 241001
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 Division of Dockets
Management (see ADDRESSES) between 9
a.m. and 4 p.m., Monday through
Friday.
Dated: February 13, 2017.
Armando Zamora,
Deputy Director, Office of Enforcement and
Import Operations, Office of Regulatory
Affairs.
[FR Doc. 2017–03173 Filed 2–16–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1677]
Karis Copper Delong: 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 (the
FD&C Act) debarring Karis Copper
Delong for a period of 12 years 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. Delong
was convicted of four misdemeanor
counts under the FD&C Act for
introducing, delivering for introduction,
and causing the introduction and
delivery for introduction of a
misbranded drug into interstate
commerce, which relates to the
regulation of drug products under the
FD&C Act. In addition, FDA determined
that the type of conduct that served as
the basis for the conviction undermines
the process for the regulation of drugs.
Ms. Delong was given notice of the
proposed debarment and an opportunity
to request a hearing within the
timeframe prescribed by regulation. Ms.
Delong failed to request a hearing. Ms.
Delong’s failure to request a hearing
constitutes a waiver of her right to a
hearing concerning this action.
DATES: This order is effective February
17, 2017.
ADDRESSES: Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
SUMMARY:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
11045
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Division of Enforcement,
Office of Regulatory Affairs (ELEM–
4144), Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD
20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(2)(B)(i)(I) of the FD&C
Act (21 U.S.C. 335a(b)(2)(B)(i)(I))
permits debarment of an individual if
FDA finds that the individual has been
convicted of a misdemeanor under
federal law for conduct relating to the
regulation of drug products under the
FD&C Act, and if FDA finds that the
type of conduct that served as the basis
for the conviction undermines the
process for the regulation of drugs.
On June 9, 2015, in the U.S. District
Court for the Eastern District of
Washington, judgment was entered
against Ms. Delong after she entered a
plea of guilty to four counts of shipment
of misbranded drugs in interstate
commerce, in violation of section 301(a)
of the FD&C Act (21 U.S.C. 331(a)),
which according to section 303(a)(1) of
the FD&C Act (21 U.S.C. 333(a)(1))
constitutes a misdemeanor.
FDA’s finding that debarment is
appropriate is based on the
misdemeanor convictions referenced
herein. The factual basis for these
convictions is as follows: Beginning as
early as April 2008, Ms. Delong assisted
Louis Daniel Smith and others in the
operation of Project Green Life (PGL).
PGL was a Nevada corporation with
physical operations at various locations
in Spokane, WA. PGL marketed and
sold various health-related products
over the Internet. PGL’s flagship product
was the Miracle Mineral Solution
(MMS), a mixture of sodium chlorite
and water.
Although Ms. Delong acted primarily
at the direction of Louis Daniel Smith,
she had access to PGL’s operations. On
various occasions, she handled shipping
for PGL, including the delivery of
packages containing MMS for shipment
in interstate commerce to PGL
customers nationwide and
internationally. Although at times PGL
marketed MMS as a water purification
product, Ms. Delong knew that MMS
was also used by consumers to treat
disease. At times, PGL provided
instructions to consumers that directed
consumers to mix MMS with a citric
acid solution and consume orally to
treat various diseases. Ms. Delong knew
that PGL provided such instructions to
consumers.
E:\FR\FM\17FEN1.SGM
17FEN1
Agencies
[Federal Register Volume 82, Number 32 (Friday, February 17, 2017)]
[Notices]
[Pages 11044-11045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03173]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2191]
Raymond Sean Brown: Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The U.S. Food and Drug Administration (FDA or Agency) is
issuing an order under the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) permanently debarring Dr. Raymond Sean Brown 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 Dr.
Brown was convicted of a felony under Federal law for conduct relating
to the regulation of a drug product under the FD&C Act. Dr. Brown was
given notice of the proposed permanent debarment and an opportunity to
request a hearing within the timeframe prescribed by regulation. Dr.
Brown failed to request a hearing. Dr. Brown's failure to request a
hearing constitutes a waiver of his right to a hearing concerning this
action.
DATES: This order is effective February 17, 2017.
ADDRESSES: Submit applications for special termination of debarment to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kenny Shade (ELEM-4144), Division of
Enforcement, Office of Enforcement and Import Operations, Office of
Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, 301-796-4640.
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 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 April 2,
2015, the U.S. District Court for the Eastern District of Tennessee
entered judgment against Dr. Brown for one count of receiving and
distributing misbranded drugs in interstate commerce with intent to
defraud and mislead in violation of section 301(a) of the FD&C Act (21
U.S.C. 331(c)), which according to section 303(a)(2) of the FD&C Act
(21 U.S.C. 333(a)(2)) constitutes a felony.
FDA's finding that the debarment is appropriate based on the felony
conviction referenced herein. The factual basis for this conviction is
as follows: Dr. Brown was a licensed medical doctor in the state of
Tennessee with a practice address listed in Cleveland, TN. The
Tennessee Department of Health also lists Bradley PM&R as a licensed
health care facility. Dr. Brown was the medical director of Bradley
PM&R, and Dr. Brown's medical practice was listed at the same address.
As a part of the treatment of patients for pain management, Bradley
PM&R purchased assorted prescription drugs, including Botulinum Toxin
Type A, also known as Botox Onabotulinumtoxin A (hereinafter referred
to as ``Botox''), which was prescribed by Dr. Brown and was
administered and dispensed through Bradley PM&R. Prior to 2009,
Botox[supreg]/Botox[supreg] Cosmetic, a product manufactured by
Allergan, Inc., was the only Botulinum Toxin Type A product licensed by
FDA for use in humans for any indication, including pain management.
Axon Medical Supplies was a business operating in Surry, BC,
Canada. Axon offered for sale to physicians and other health care
providers in the United States drugs that had been obtained from
foreign sources and that had not been approved by FDA for distribution
or use in the United States.
From May 2008 until December 2012, Dr. Brown received $7,482,968 in
reimbursement from Medicare for Botox injections alone, with none of
these payments resulting from properly payable claims for FDA approved
Botox injections.
Beginning in or about January 2007 and continuing through in or
about December 2012, Dr. Brown ordered 254 vials (25,400 units) of
Botox from Axon Medical Supplies that were misbranded within the
meaning of the FD&C Act in that the drug's labeling failed to bear
adequate directions for use and all words, statements, or other
information required by or under authority of the FD&C Act to appear on
the label and labeling were not present, in fact many of the words were
not in the English language. These misbranded drugs were sent to
Bradley PM&R clinic and Dr. Brown injected these drugs into his
patients, while purporting them to be FDA-approved drugs.
Dr. Brown billed Medicare for all of these Botox units as if they
were FDA-approved drugs. Dr. Brown also provided diluted Botox
injections and billed as if they were full doses. Dr. Brown billed
Medicare for an additional 15,865 vials that he did not inject into
patients. Dr. Brown admitted that he received the Botox in interstate
commerce for delivery that was misbranded and he acted with intent to
defraud and/or mislead. Dr. Brown's conduct constituted a violation of
section 303(c) of the FD&C Act, which according to section 303(a)(2)
constitutes a felony.
As a result of this conviction, FDA sent Dr. Brown by certified
mail on October 28, 2016, 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 Dr. Brown
was convicted of a felony under Federal law for conduct relating to the
regulation of a drug product under the FD&C Act. FDA determined that
Dr. Brown's felony conviction was related to the regulation of drug
products because the conduct underlying his conviction undermined FDA's
regulatory oversight over drug products marketed in the United States--
Dr. Brown knowingly received and distributed misbranded drugs in
interstate commerce with intent to defraud and mislead. The proposal
also offered Dr. Brown an opportunity to
[[Page 11045]]
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 a waiver of the opportunity for a
hearing and of any contentions concerning this action. The proposal was
received on October 31, 2016. Dr. Brown 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 Director, Office of Enforcement and Import
Operations, Office of Regulatory Affairs, under section 306(a)(2)(B) of
the FD&C Act, under authority delegated to him (Staff Manual Guide
1410.35), finds that Dr. Raymond Sean Brown has been convicted of a
felony under Federal law for conduct relating to the regulation of a
drug product under the FD&C Act. Section 306(c)(2)(A)(ii) of the FD&C
Act requires that Dr. Brown's debarment be permanent.
As a result of the foregoing finding, Dr. Raymond Sean Brown 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), effective (see DATES) (see section 201(dd), 306(c)(1)(B), and
306(c)(2)(A)(ii) of the FD&C Act (21 U.S.C. 321(dd), 335a(c)(1)(B), and
335a(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 the services of Dr. Brown, 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 Dr.
Brown 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 Dr. Brown during his period of debarment
(section 306(c)(1)(B) of the FD&C Act).
Any application by Dr. Brown for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2016-N-2191 and sent to the Division of Dockets
Management (see ADDRESSES). All such submissions are to be filed in
four copies. 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 Division of
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: February 13, 2017.
Armando Zamora,
Deputy Director, Office of Enforcement and Import Operations, Office of
Regulatory Affairs.
[FR Doc. 2017-03173 Filed 2-16-17; 8:45 am]
BILLING CODE 4164-01-P