[Federal Register: July 6, 2004 (Volume 69, Number 128)]
[Notices]
[Page 40653-40655]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06jy04-68]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Robert Brehm d/b/a Infinite Pills; Denial of Application
On October 15, 2003, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Robert Brehm (Mr. Brehm), proposing to deny his
application for DEA Certificate of Registration as a distributor. The
Order to Show Cause alleged that granting Mr. Brehm's application would
be inconsistent with the public interest as that term is used in 21
U.S.C. 823(b) and (e). The show cause order also notified Mr. Brehm
that should no request for a hearing be filed within 30 days, his
hearing right would be deemed waived.
The Order to Show Cause was sent by certified mail to Mr. Brehm at
his address of record and DEA received a signed receipt indicating that
it was received on October 20, 2003. DEA has not received a request for
hearing or any other reply from Mr. Brehm or anyone purporting to
represent him in this matter.
Therefore, the Deputy Administrator, finding that (1) 30 days have
passed since the receipt of the Order to Show Cause, and (2) no request
for a hearing having been received, concludes that Mr. Brehm is deemed
to have waived his hearing right. After considering material from the
investigative file in this matter, the Deputy Administrator now enters
her final order without a hearing pursuant to 21 CFR 1301.43(d) and (e)
and 1301.46.
The Deputy Administrator finds that Mr. Brehm submitted a DEA
registration application dated May 30, 2000, under the business name
``Infinite Pills'' at a location in Sellersville, Pennsylvania. Mr.
Brehm sought a DEA registration to handle controlled substances in
Schedules I through V as a distributor.
On June 21, 2000, a diversion investigator from DEA's Philadelphia
Field Division (the Philadelphia Division) conducted an on-site pre-
registration inspection of the applicant's proposed business location.
The inspection revealed the proposed registered location to be a
private, residential townhouse owned by the mother of Mr. Brehm. DEA's
investigation further revealed that at the time he submitted an
application for DEA registration, Mr. Brehm was a 20-year old male who
had never operated a business and had no working experience or
knowledge about the pharmaceutical (controlled substance) industry.
DEA's inspection further revealed that at the time of DEA's pre-
registration inspection, Mr. Brehm had yet to determine what controlled
substance products he would be handling, or from whom he would purchase
them. Mr. Brehm was unable to distinguish products that are controlled
substances (i.e., narcotics, barbiturates, etc.) as opposed to non-
controlled drugs. In addition, Mr. Brehm had no potential customers and
had not surveyed local pharmacies or practitioners in his area to
determine whether or not he could establish a customer base. Finally,
DEA's inspection revealed that Mr. Brehm had not developed a
recordkeeping/invoicing system for his proposed business.
As a result of its inspection, on July 20, 2000, the Philadelphia
Division sent a letter to Mr. Brehm notifying him that DEA would seek
the denial of his application, and further requested that Mr. Brehm
voluntarily withdraw his application. Mr. Brehm informed the
Philadelphia Field Division through a subsequent telephone message of
his intention not to withdraw his application.
In late August 2000, the Philadelphia Division received information
from the agency's Pittsburgh (Pennsylvania) office that a DEA
registration number belonging to a physician from western Pennsylvania
had been transferred to an address in Sellersville, Pennsylvania in
mid-July 2000. According to the investigative file, someone using this
registration number and claiming to be the doctor was attempting to
obtain controlled substances from a drug manufacturer located in
Aurora, Colorado. DEA's investigation revealed that the physician had
not requested a transfer of his DEA registration and was unaware of any
such transfer. It was later determined that the Sellersville address
from which an attempt was made to obtain controlled substances was the
same address that appeared on Mr. Brehm's May 30, 2000, application for
DEA registration.
On August 28, 2000, a DEA diversion investigator spoke with a
representative of the Colorado drug manufacturer. The company
representative stated that on July 28, 2000, she received a call from a
man identifying himself as a physician by the name of ``Louis
Nichamin.'' Several days later, the company received an order from
``Dr. Nichamin'' on a Kinko's letterhead fax. When the drug company
representative subsequently called the telephone number provided to her
by ``Dr. Nichamin,'' she was told by the person answering the call that
``* * * he (Dr. Nichamin) doesn't live here anymore.'' On August 18,
2000, the company representative received another call from a man
purportedly on Dr. Nichamin's behalf, who asked the status of an
earlier order. The man was described as speaking with an ``Indian
accent.'' When the company representative asked the name of the person
placing the call, the caller identified himself as ``Bob Brehm.''
On September 1, 2000, the drug company representative called the
Philadelphia Division informing that office that she had just received
another call from a person representing himself as ``Dr. Nichamin.''
This time the caller spoke with no discernable accent. When the caller
asked about the order placed by ``Dr. Nichamin'', the drug company
representative again asked the caller to identify himself. The caller
identified himself as Robert Brehm. When the drug company
representative stated her unfamiliarity with the caller, the caller
stated he was ``Bob Brehm'', the same person that she (the drug company
representative) had spoken to on an earlier occasion.
The drug company representative then asked the caller for a number
[[Page 40654]]
where he could be reached. Mr. Brehm again provided that same number
that was purportedly provided on behalf of Dr. Nichamin on a prior
occasion. When the drug company representative told Mr. Brehm of her
earlier unsuccessful attempt at reaching Dr. Nichamin at the number
provided, Mr. Breham stated that he and the doctor had been
``roommates'', but the doctor had moved into a house. It is unclear
from the investigative file whether any controlled substances were
distributed to Mr. Brehm pursuant to the orders that were placed.
On September 5, 2000, the drug company representative informed DEA
that a second order for controlled substances was received on behalf of
Dr. Nichamin, and originating from Mr. Brehm's address of record in
Sellersville. The controlled substances were ordered, in varying
quantities, via unsigned DEA Order Forms. Among the controlled
substances ordered were Morphine Sulfate, Hydromorphone, OxyCodone,
Hydrocodone Bitartrate, Meperidine, Testosterone Micro, Testosterone
Cypionate, Testosterone Propionate and Ketamine.
DEA's investigation further revealed that on September 1, 2000, the
Pennridge Regional Police received a complaint from Robert Brehm that
his father had stolen his (Mr. Brehm's) gun. It was later determined by
law enforcement authorities that Mr. Brehm attempted to shoot his
father with the gun. According to the police investigative report,
Robert Brehm had an altercation with his father inside the family's
residential address (the same address used for application purposes
with DEA), where Mr. Brehm fired six rounds from his .380 pistol at his
father. At the time the police arrived at the townhouse, it was noted
that Robert Brehm was ``* * * sweating profusely, had a blank stare,
and was displaying a difficult time with balance.'' The report further
described Mr. Brehm as ``* * * very withdrawn while in the holding
cell. He was sweating, holding his head between his legs, rocking back
and forth. He also was [observed] mumbling and sticking his finger down
his throat.''
Mr. Brehm was later taken to a local hospital for treatment, and a
warrant was issued for his arrest. Pursuant to a search warrant which
was subsequently executed at the Brehm residence, police found, among
other things, .380 caliber ammunition, a water pipe, and plastic jugs
with rubber tubes attached. Following his release from the hospital,
Robert Brehm was processed at the Pennridge Police Department. At that
time, he advised the police to be careful with the jugs taken during
the search warrant because he didn't know what they contained, and the
jugs were a part of what Mr. Brehm described to police as his ``old
meth lab.''
According to the investigative file, on September 11, 2000, Mr.
Brehm was arraigned in Pennsylvania state court on charges of
aggravated assault; simple assault; recklessly endangering another
person; terroristic threats; possessing an instrument of crime; and,
possession with intent to use drug paraphernalia. His $25,000 bail was
not initially posted, and Mr. Brehm was sent for detention to the Bucks
County Prison, where he was placed under a severe suicide watch due to
depression.
The investigative file also recounts the Philadelphia Division
receiving information from a detective in nearby Perkasie
(Pennsylvania) that Mr. Brehm, then 19 years of age, had been arrested
by Perkasie Police Department on possession of marijuana charges. The
arresting officer is quoted by a DEA diversion investigator as saying
that Mr. Brehm had been at a house where ``* * * just about every drug
imaginable was in the house.'' There is no information in the
investigative file on the disposition of these charges against Mr.
Brehm.
The investigative file further recounts that shortly after his
arrest, Mr. Brehm's bail was paid by his mother. Later that same night,
Mr. Brehm, who was driving his mother's car, hit a parked truck and
then veered the vehicle into a garage, where it hit two antique Harley
Davidson motorcycles. Mr. Brehm was the only person involved in the
accident and was apparently unhurt. Nevertheless, he was subsequently
arrested by local police, charged with misdemeanor offenses, and
released the same night.
The investigative file further reveals that on September 6, 2000,
the Philadelphia Division received information from the Pennsylvania
Department of Health (Department of Health), advising that a complaint
had been received from a manufacturer of medical gases located in
Allentown, Pennsylvania. The complaint alleged that Mr. Brehm was
``stockpiling nitrous oxide.'' DEA learned that Mr. Brehm was not
licensed as a distributor by Department of Health to engage in this
activity. DEA also received information that between March 31 and
August 18, 2000, Mr. Brehm made ten purchases of nitrous oxide totaling
$2,474.32, as well as medical oxygen at a cost of $28.54.
According to the investigative file, on October 16, 2000, the
Philadelphia Division learned that Mr. Brehm attempted to place an
order for some unspecified product with the Colorado drug manufacturer,
again, purportedly on behalf of Dr. Nichamin. In his faxed order, Mr.
Brehm also left instructions with the drug manufacturer to deliver the
ordered product to his residential address and Mr. Brehm provided the
name of an individual who would accept the order on behalf of Dr.
Nicamin. It turned out that the name of the individual left by Mr.
Brehm to accept the order was same as the Bucks County Assistant
District Attorney whose name was listed on the search warrant served at
the Brehm residence in September of 2000. A copy of the warrant had
been left at the premises at the time it was executed.
The investigative file further reveals that in a Bucks County court
proceeding on March 13, 2001, Mr. Brehm waived a jury trial and entered
a plea of not guilty due to mental health reasons, to charges arising
from the assault on his father. The docket of that proceeding showed
that on that same date, the presiding judge found Mr. Brehm not guilty
on all counts, and under the state Mental Health Act, committed Mr.
Brehm to mental health evaluation, to be reviewed yearly. As part of
the judge's order, Mr. Brehm was to report to the Lenape Valley
Foundation on March 16, 2001. It appears from the investigative file
that on April 2, 2001, a subsequent court order was entered pursuant to
Section 304(g) of the state Mental Health Procedures Act, committing
Mr. Brehm to a partial hospitalization program at the Penn Foundation
for up to one year.
The investigative file further describes the issuance of an
unspecified order dated July 6, 2001, ordering Mr. Brehm to take
medication as directed by his doctors and a subsequent request by the
state that Mr. Brehm be held in contempt for failure to comply with
Penn Foundation treatment recommendations as ordered by the court. The
investigative file further describes a court finding that Mr. Brehm was
in contempt of an earlier commitment order of the court, and on April
5, 2002, was recommitted to the partial program at the Penn Foundation
for a period of up to one year, apparently for further observation.
The Deputy Administrator may deny an application under 21 U.S.C.
823(b) and (e), if she determines that the registration would be
inconsistent with the public interest. Associated Pharmaceutical Group,
Ins., 58 FR 58181 (1993).
Pursuant to 21 U.S.C. 823(b) and (e), [i]n determining the public
interest, the following factors shall be considered:
(1) Maintenance of effective controls against diversion of
particular
[[Page 40655]]
controlled substances into other than legitimate medical, scientific
and industrial channels;
(2) Compliance with applicable State and local law;
(3) Prior conviction record of the applicant under federal or state
laws relating to the manufacture, distribution, or dispensing of
controlled substances;
(4) Past experience in the distribution of controlled substances;
(5) Such other factors as may be relevant to and consistent with
the public health or safety.''
It is well estabilised that these factors are to be considered in
the disjunctive; the Deputy Administrator may rely on any one or a
combination of factors and may give each factor the weight she deems
appropriate in determining whether a registration should be revoked or
an application for registration denied. See Henry J. Schwartz, Jr.,
M.D., 54 FR 16422 (1989).
Of the stated factors, the Deputy Administrator finds that there is
no evidence in the investigative file that Mr. Brehm or his company is
licensed under the State of Pennsylvania to handle controlled
substances, or that his company was not in compliance with applicable
state law, as contemplated by factor two. In addition, there is not
evidence in the record that Mr. Brehm or his company have ever been
convicted under controlled substance laws, or ever actually distributed
controlled substances, as described under factors three and four.
Accordingly, the Deputy Administrator finds factors one and five
relevant to this proceeding.
It is clear that granting the application for DEA Certificate of
Registration of Mr. Brehm d/b/a Infinite Pills would be inconsistent
with the public interest. Under the first factor, maintenance of
effective controls against diversion of particular controlled
substances into other than legitimate medical scientific and industrial
channels, the Deputy Administrator finds this factor relevant to the
findings of DEA's investigation that Mr. Brehm had not developed a
record keeping or invoicing system for his proposed business.
Factor one is further relevant to Mr. Brehm's attempts at obtaining
various controlled substances from a drug manufacturer under the name
and DEA registration of a physician without the latter's knowledge.
Given the dishonest methods employed to obtain these drugs, the Deputy
Administrator is left to conclude that Mr. Brehm's actions were an
attempt to divert controlled substances to his personal use. Therefore,
the maintenance of effective controls as contemplated under factor one,
are not present with respect to Mr. Brehm's pending application for
registration, and support the denial of his pending application.
With regard to factor five, such other factors as may be relevant
to and consistent with the public health or safety, Mr. Brehm's
proposed registered location is a residential townhouse which he shares
with his mother and other family members. At the time of the submission
of his application, Mr. Brehm was a 20-year old with no known
experience working with controlled substances. He had no potential
customers, nor had he made any visible efforts to establish a customer
base.
Factor five is further relevant to Mr. Brehm's use of several
artifices to obtain controlled substances from a Colorado drug
manufacturer, including the unauthorized use of the name and DEA number
of a physician; his apparent attempt to disguise his accent; his
apparent misrepresentation to the drug company representative that he
and the physician were roommates; and his apparent unauthorized use of
the name of yet another individual as the contact person for delivery
of controlled substances. In addition, Mr. Brehm attempted to have a
physician's DEA number transferred to a different address, without the
knowledge or authorization of the physician. This factor is also
relevant to Mr. Brehm's fraudulent submission to a drug manufacturer of
unsigned DEA order forms in a further attempt to obtain various
controlled substances.
Also given consideration under factor five is the reference in the
investigative file to an altercation involving Mr. Brehm and his
father, resulting in the firing of a loaded weapon by Mr. Brehm. This
altercation took place at the same address proposed by Mr. Brehm as a
DEA registered location. Mr. Brehm was later charged with various
assault, weapon, and drug charges. Following his arrest, and the
execution of a search warrant at his residential address, Mr. Brehm
advised law enforcement officers to exercise care in their handling of
certain materials at the residence because they were part of a
methamphetamine lab. The DEA investigative file also recounts the
arrest of Mr. Brehm on a charge of possessing marijuana.
In addition to his legal woes, Mr. Brehm has exhibited behavior
which can best be described as unstable. Such conduct raises further
questions about his ability to adequately discharge the
responsibilities of a DEA registrant.
Following his arrest in September of 2000, Mr. Brehm was placed
under a suicide watch after exhibiting erratic behavior while in
custody. Following his release from police custody, the automobile in
which he was driving struck three parked vehicles, and he was later
charged with a misdemeanor offense apparently related to the incident.
Pursuant to a subsequent court order, Mr. Brehm was committed to an
institution for a mental health evaluation, and was found to be in
violation of the court's order for noncompliance. Mr. Brehm's failure
to comply resulted in his being recommitted for further mental health
evaluation. Finally, DEA received information from the Pennsylvania
Department of Health which alleged that Mr. Brehm stockpiled nitrous
oxide without state authorization to do so.
It is clear that Mr. Brehm and the firm that he represents, does
not possess the requisite qualifications for DEA registration as a
distributor. Moreover, in reviewing the instant request for DEA
registration, and in light of Mr. Brehm's failure to request a hearing
in this matter, the Deputy Administrator has only the benefit of the
DEA investigative file in making her determination. No evidence has
been submitted on behalf of the applicant in support of his pending
application. Based on the above, the Deputy Administrator reiterates
that the applicant's registration would be inconsistent with the public
interest and therefore, his application for registration must be
denied.
Accordingly, the Deputy Administrator of the Drug Enforcement
Administration, pursuant to the authority vested in her by 21 U.S.C.
823 and 28 CFR 0.100(b), hereby orders that the application for DEA
Certificate of Registration as a distributor submitted by Robert Brehm
d/b/a Infinite Pills, be, and it hereby is, denied. This order is
effective August 5, 2004.
Dated: June 21, 2004.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 04-15152 Filed 7-2-04; 8:45 am]
BILLING CODE 4410-09-M