[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]


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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.

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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