[Federal Register Volume 69, Number 128 (Tuesday, July 6, 2004)]
[Notices]
[Pages 40653-40655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15152]


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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