82 FR 11044 - Raymond Sean Brown: Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 32 (February 17, 2017)

Page Range		11044-11045
FR Document		2017-03173

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.

Federal Register, Volume 82 Issue 32 (Friday, February 17, 2017)

[Federal Register Volume 82, Number 32 (Friday, February 17, 2017)]
[Notices]
[Pages 11044-11045]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-03173]


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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

11044 Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices

TABLE 1—REGISTRATION FEES 1— ADDRESSES: Submit applications for had been obtained from foreign sources
Continued special termination of debarment to the and that had not been approved by FDA
Division of Dockets Management (HFA– for distribution or use in the United
Standard 305), Food and Drug Administration, States.
Attendee type rate 5630 Fishers Lane, Rm. 1061, Rockville, From May 2008 until December 2012,
MD 20852. Dr. Brown received $7,482,968 in
Government .............................. Free reimbursement from Medicare for Botox
FOR FURTHER INFORMATION CONTACT:
1 The fourth registration from the same com- Kenny Shade (ELEM–4144), Division of injections alone, with none of these
pany is free. Payment for the three paying Enforcement, Office of Enforcement and payments resulting from properly
registrants must be made prior to registering payable claims for FDA approved Botox
the fourth person free. Import Operations, Office of Regulatory
Affairs, Food and Drug Administration, injections.
The following forms of payment will be 12420 Parklawn Dr., Rockville, MD Beginning in or about January 2007
accepted: American Express, Visa, 20857, 301–796–4640. and continuing through in or about
Mastercard, and company checks. December 2012, Dr. Brown ordered 254
Attendees are responsible for their SUPPLEMENTARY INFORMATION: vials (25,400 units) of Botox from Axon
own accommodations. The conference I. Background Medical Supplies that were misbranded
headquarter hotel is the Downtown within the meaning of the FD&C Act in
Cincinnati Hilton Netherlands Plaza, 35 Section 306(a)(2)(B) of the FD&C Act that the drug’s labeling failed to bear
West 5th St., Cincinnati, OH 45202, (21 U.S.C. 335a(a)(2)(B)) requires adequate directions for use and all
513–421–9100. To make reservations debarment of an individual if FDA finds words, statements, or other information
online, please visit the ‘‘Venue & that the individual has been convicted required by or under authority of the
Logistics’’ link at http://www.Xavier of a felony under Federal law for FD&C Act to appear on the label and
PharmaLink.com. The hotel is expected conduct relating to the regulation of any labeling were not present, in fact many
to sell out during this timeframe, so drug product under the FD&C Act. On of the words were not in the English
early reservation in the conference April 2, 2015, the U.S. District Court for language. These misbranded drugs were
room-block is encouraged. the Eastern District of Tennessee sent to Bradley PM&R clinic and Dr.
entered judgment against Dr. Brown for Brown injected these drugs into his
Dated: February 13, 2017. one count of receiving and distributing
Leslie Kux, patients, while purporting them to be
misbranded drugs in interstate FDA-approved drugs.
Associate Commissioner for Policy. commerce with intent to defraud and Dr. Brown billed Medicare for all of
[FR Doc. 2017–03176 Filed 2–16–17; 8:45 am] mislead in violation of section 301(a) of these Botox units as if they were FDA-
BILLING CODE 4164–01–P the FD&C Act (21 U.S.C. 331(c)), which approved drugs. Dr. Brown also
according to section 303(a)(2) of the provided diluted Botox injections and
FD&C Act (21 U.S.C. 333(a)(2)) billed as if they were full doses. Dr.
DEPARTMENT OF HEALTH AND constitutes a felony. Brown billed Medicare for an additional
HUMAN SERVICES FDA’s finding that the debarment is 15,865 vials that he did not inject into
appropriate based on the felony patients. Dr. Brown admitted that he
Food and Drug Administration conviction referenced herein. The received the Botox in interstate
[Docket No. FDA–2016–N–2191] factual basis for this conviction is as commerce for delivery that was
follows: Dr. Brown was a licensed misbranded and he acted with intent to
Raymond Sean Brown: Debarment medical doctor in the state of Tennessee defraud and/or mislead. Dr. Brown’s
Order with a practice address listed in conduct constituted a violation of
AGENCY: Food and Drug Administration, Cleveland, TN. The Tennessee section 303(c) of the FD&C Act, which
HHS. Department of Health also lists Bradley according to section 303(a)(2)
ACTION: Notice. PM&R as a licensed health care facility. constitutes a felony.
Dr. Brown was the medical director of As a result of this conviction, FDA
SUMMARY: The U.S. Food and Drug Bradley PM&R, and Dr. Brown’s medical sent Dr. Brown by certified mail on
Administration (FDA or Agency) is practice was listed at the same address. October 28, 2016, a notice proposing to
issuing an order under the Federal As a part of the treatment of patients for permanently debar him from providing
Food, Drug, and Cosmetic Act (the pain management, Bradley PM&R services in any capacity to a person that
FD&C Act) permanently debarring Dr. purchased assorted prescription drugs, has an approved or pending drug
Raymond Sean Brown from providing including Botulinum Toxin Type A, product application. The proposal was
services in any capacity to a person that also known as Botox based on a finding, under section
has an approved or pending drug Onabotulinumtoxin A (hereinafter 306(a)(2)(B) of the FD&C Act, that Dr.
product application. FDA bases this referred to as ‘‘Botox’’), which was Brown was convicted of a felony under
order on a finding that Dr. Brown was prescribed by Dr. Brown and was Federal law for conduct relating to the
convicted of a felony under Federal law administered and dispensed through regulation of a drug product under the
for conduct relating to the regulation of Bradley PM&R. Prior to 2009, Botox®/ FD&C Act. FDA determined that Dr.
a drug product under the FD&C Act. Dr. Botox® Cosmetic, a product Brown’s felony conviction was related
Brown was given notice of the proposed manufactured by Allergan, Inc., was the to the regulation of drug products
permanent debarment and an only Botulinum Toxin Type A product because the conduct underlying his
opportunity to request a hearing within licensed by FDA for use in humans for conviction undermined FDA’s
mstockstill on DSK3G9T082PROD with NOTICES

the timeframe prescribed by regulation. any indication, including pain regulatory oversight over drug products
Dr. Brown failed to request a hearing. management. marketed in the United States—Dr.
Dr. Brown’s failure to request a hearing Axon Medical Supplies was a Brown knowingly received and
constitutes a waiver of his right to a business operating in Surry, BC, distributed misbranded drugs in
hearing concerning this action. Canada. Axon offered for sale to interstate commerce with intent to
DATES: This order is effective February physicians and other health care defraud and mislead. The proposal also
17, 2017. providers in the United States drugs that offered Dr. Brown an opportunity to

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Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices 11045

request a hearing, providing him 30 availability of information in these 5630 Fishers Lane, Rm. 1061, Rockville,
days from the date of receipt of the letter submissions is governed by 21 CFR MD 20852.
in which to file the request, and advised 10.20. FOR FURTHER INFORMATION CONTACT:
him that failure to request a hearing Publicly available submissions will be Kenny Shade, Division of Enforcement,
constituted a waiver of the opportunity placed in the docket, and will be Office of Regulatory Affairs (ELEM–
for a hearing and of any contentions viewable at https://www.regulations.gov 4144), Food and Drug Administration,
concerning this action. The proposal or at the Division of Dockets 12420 Parklawn Dr., Rockville, MD
was received on October 31, 2016. Dr. Management (see ADDRESSES) between 9 20857, 301–796–4640.
Brown did not request a hearing and a.m. and 4 p.m., Monday through SUPPLEMENTARY INFORMATION:
has, therefore, waived his opportunity Friday.
for a hearing and any contentions Dated: February 13, 2017.
I. Background
concerning his debarment (21 CFR part Section 306(b)(2)(B)(i)(I) of the FD&C
Armando Zamora,
12). Act (21 U.S.C. 335a(b)(2)(B)(i)(I))
Deputy Director, Office of Enforcement and
II. Findings and Order Import Operations, Office of Regulatory permits debarment of an individual if
Therefore, the Director, Office of Affairs. FDA finds that the individual has been
Enforcement and Import Operations, [FR Doc. 2017–03173 Filed 2–16–17; 8:45 am] convicted of a misdemeanor under
Office of Regulatory Affairs, under BILLING CODE 4164–01–P federal law for conduct relating to the
section 306(a)(2)(B) of the FD&C Act, regulation of drug products under the
under authority delegated to him (Staff FD&C Act, and if FDA finds that the
Manual Guide 1410.35), finds that Dr. DEPARTMENT OF HEALTH AND type of conduct that served as the basis
Raymond Sean Brown has been HUMAN SERVICES for the conviction undermines the
convicted of a felony under Federal law process for the regulation of drugs.
Food and Drug Administration On June 9, 2015, in the U.S. District
for conduct relating to the regulation of
a drug product under the FD&C Act. [Docket No. FDA–2016–N–1677] Court for the Eastern District of
Section 306(c)(2)(A)(ii) of the FD&C Act Washington, judgment was entered
requires that Dr. Brown’s debarment be Karis Copper Delong: Debarment against Ms. Delong after she entered a
permanent. Order plea of guilty to four counts of shipment
As a result of the foregoing finding, of misbranded drugs in interstate
AGENCY: Food and Drug Administration, commerce, in violation of section 301(a)
Dr. Raymond Sean Brown is
HHS. of the FD&C Act (21 U.S.C. 331(a)),
permanently debarred from providing
services in any capacity to a person with ACTION: Notice. which according to section 303(a)(1) of
an approved or pending drug product the FD&C Act (21 U.S.C. 333(a)(1))
SUMMARY: The Food and Drug constitutes a misdemeanor.
application under sections 505, 512, or Administration (FDA or Agency) is
802 of the FD&C Act (21 U.S.C. 355, FDA’s finding that debarment is
issuing an order under the Federal appropriate is based on the
360b, or 382), or under section 351 of Food, Drug, and Cosmetic Act (the
the Public Health Service Act (42 U.S.C. misdemeanor convictions referenced
FD&C Act) debarring Karis Copper herein. The factual basis for these
262), effective (see DATES) (see section Delong for a period of 12 years from
201(dd), 306(c)(1)(B), and convictions is as follows: Beginning as
providing services in any capacity to a early as April 2008, Ms. Delong assisted
306(c)(2)(A)(ii) of the FD&C Act (21 person that has an approved or pending
U.S.C. 321(dd), 335a(c)(1)(B), and Louis Daniel Smith and others in the
drug product application. FDA bases operation of Project Green Life (PGL).
335a(c)(2)(A)(ii)). Any person with an
this order on a finding that Ms. Delong PGL was a Nevada corporation with
approved or pending drug product
was convicted of four misdemeanor physical operations at various locations
application who knowingly employs or
counts under the FD&C Act for in Spokane, WA. PGL marketed and
retains as a consultant or contractor, or
introducing, delivering for introduction, sold various health-related products
otherwise uses the services of Dr.
and causing the introduction and over the Internet. PGL’s flagship product
Brown, in any capacity during his
delivery for introduction of a was the Miracle Mineral Solution
debarment, will be subject to civil
misbranded drug into interstate (MMS), a mixture of sodium chlorite
money penalties (section 307(a)(6) of the
commerce, which relates to the and water.
FD&C Act (21 U.S.C. 335b(a)(6))). If Dr.
regulation of drug products under the Although Ms. Delong acted primarily
Brown provides services in any capacity
FD&C Act. In addition, FDA determined at the direction of Louis Daniel Smith,
to a person with an approved or
that the type of conduct that served as she had access to PGL’s operations. On
pending drug product application
the basis for the conviction undermines various occasions, she handled shipping
during his period of debarment he will
the process for the regulation of drugs. for PGL, including the delivery of
be subject to civil money penalties
Ms. Delong was given notice of the packages containing MMS for shipment
(section 307(a)(7) of the FD&C Act). In
proposed debarment and an opportunity in interstate commerce to PGL
addition, FDA will not accept or review
to request a hearing within the customers nationwide and
any abbreviated new drug applications
timeframe prescribed by regulation. Ms. internationally. Although at times PGL
from Dr. Brown during his period of
Delong failed to request a hearing. Ms. marketed MMS as a water purification
debarment (section 306(c)(1)(B) of the
Delong’s failure to request a hearing product, Ms. Delong knew that MMS
FD&C Act).
Any application by Dr. Brown for constitutes a waiver of her right to a was also used by consumers to treat
mstockstill on DSK3G9T082PROD with NOTICES

special termination of debarment under hearing concerning this action. disease. At times, PGL provided
section 306(d)(4) of the FD&C Act DATES: This order is effective February instructions to consumers that directed
should be identified with Docket No. 17, 2017. consumers to mix MMS with a citric
FDA–2016–N–2191 and sent to the ADDRESSES: Submit applications for acid solution and consume orally to
Division of Dockets Management (see termination of debarment to the treat various diseases. Ms. Delong knew
ADDRESSES). All such submissions are to Division of Dockets Management (HFA– that PGL provided such instructions to
be filed in four copies. The public 305), Food and Drug Administration, consumers.

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Document Created: 2017-02-17 00:29:07
Document Modified: 2017-02-17 00:29:07

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		This order is effective February 17, 2017.
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.
FR Citation		82 FR 11044

82 FR 11044 - Raymond Sean Brown: Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 32 (February 17, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration