[Federal Register Volume 75, Number 207 (Wednesday, October 27, 2010)]
[Notices]
[Pages 66138-66149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27094]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 06-8]


George Mathew, M.D.; Denial of Application

    On September 19, 2005, I, the Deputy Administrator of the Drug 
Enforcement Administration, issued an Order to Show Cause and Immediate 
Suspension of Registration to George Mathew, M.D. (Respondent), of 
Seattle, Washington. The Order proposed the revocation of Respondent's 
DEA Certificate of Registration, BM5009065, which authorized him to 
dispense controlled substances in schedules II through V as a 
practitioner, and the denial of any pending applications to renew or 
modify his registration on the ground that his ``continued registration 
is inconsistent with the public interest, as that term is used in 21 
U.S.C. 823(f) and 824(a)(4).'' Show Cause Order at 1.
    The Show Cause Order alleged that Respondent had participated in a 
criminal scheme run by Johar Saran, the owner of Carrington Healthcare 
Systems/Infiniti Services Group (CHS/ISG) of Arlington, Texas, which 
used numerous pharmacies owned by ``sham corporations'' to obtain the 
DEA registrations necessary to ``purchase and dispense large quantities 
of controlled substances via the Internet.'' Id. at 5. As for 
Respondent's involvement, the Order alleged that between May 1, 2005 
and June 17, 2005, Respondent, who was licensed in the State of 
Washington, had authorized 136 prescriptions for residents of ``at 
least 27 different states'' and that ``[n]inety-three percent of the 
[prescriptions] were for hydrocodone,'' a schedule III controlled 
substance. Id. at 6. The Order further alleged that Respondent ``did 
not see [the] customers, had no prior doctor-patient relationships with 
the Internet customers, did not conduct physical exams, * * * did [not] 
create or maintain patient records,'' and that ``[t]he only information 
usually reviewed prior to issuing [the] drug orders was the customer's 
online questionnaire.'' Id. The Order thus alleged that Respondent 
``participated'' in a scheme to ``facilitate [the] circumvention of 
legitimate medical practice'' by ``prescribing controlled substances to 
Internet customers despite never establishing a genuine doctor-patient 
relationship with the Internet customer.'' Id. at 5.
    Next, the Show Cause Order alleged that a DEA Diversion 
Investigator (DI) had accessed a Web site, http://www.heynowmeds.com, 
and, after providing his name, address, phone number, date of birth, 
gender, and filling out a brief medical questionnaire, purchased 
hydrocodone. Id. at 6. The Order further alleged that the DI received 
the drug three days later, that he had not been contacted by any one 
affiliated with the Web site, and that the bottle's label listed 
Respondent as the prescriber and Southwest Fusion, an entity in Fort 
Worth, Texas, as the dispensing pharmacy. Id.
    The Show Cause Order thus alleged that Respondent ``did not 
establish legitimate physician-patient relationships with the Internet 
customers to whom [he] prescribed controlled substances'' and that 
``such prescriptions [were] not [issued] for a legitimate medical 
purpose in the usual course of professional practice.'' Id. at 7. The 
Order thus alleged that the prescriptions violated 21 CFR 
1306.04(a).\1\
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    \1\ While I also immediately suspended Respondent's registration 
based on my conclusion that his continued registration during the 
pendency of the proceeding ``would constitute an immediate danger to 
public health and safety,'' Show Cause Order at 7, on October 14, 
2005, I subsequently stayed the suspension after Respondent 
maintained that he was the victim of identity theft. ALJ Ex. 4.
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    On September 22, 2005, Respondent requested a hearing on the 
allegations, which he denied, maintaining that he had been the victim 
of identity theft, ALJ Ex. 2; the matter was then placed on the docket 
of the Agency's Administrative Law Judges (ALJ). Moreover, on October 
7, 2005, Respondent requested a stay of the immediate suspension based 
on his contention of identity theft. See ALJ Ex. 4. On October 14, 
2005, I stayed the suspension pending resolution of his claim. Id.
    Thereafter, on October 19, 2005, the parties filed a Joint Motion 
to Stay the Proceedings, ALJ Ex. 3, and on October 26, 2005, the ALJ 
granted a stay. ALJ Ex. 5. On December 4, 2006, the parties filed a 
joint status report. ALJ Ex. 6. Therein, the parties notified the ALJ 
of their inability to reach a resolution of the matter and requested 
that the stay of the proceedings be lifted and that the hearing be held 
as soon as possible. Id.
    In its prehearing statement of January 5, 2007, the Government 
notified Respondent that it also intended to present evidence regarding 
statements he made during an interview with DEA Investigators on 
September 22, 2005. Gov. Prehearing Statement at 7. More specifically, 
the Government alleged that Respondent had contracted with EDrugs, an 
entity which operated a Web site (http://www.eDrugstore.com), and that 
``on a daily basis'' ``for about 6

[[Page 66139]]

months between July 2003 and February 2004,'' he would go to the 
``company webpage and review a list'' which ``contain[ed] patient names 
and suggested prescription drugs.'' Id. at 7-8. The Government also 
alleged that Respondent ``stated that he approved prescriptions for 
non-controlled substances and diet medications,'' that ``[h]e was paid 
$3.00 for each non-controlled prescription and $10.00 for each diet 
prescription,'' and that he ``received approximately $30,000 from 
EDrugs for his services.'' Id. at 8.
    After delays authorized by the ALJ, a hearing was held in Seattle, 
Washington on July 24-26, 2007. At the hearing, both parties called 
witnesses to testify and introduced documentary evidence. After the 
hearing, both parties submitted Proposed Findings of Fact, Conclusions 
of Law and Arguments.
    On September 22, 2008, the parties filed a Joint Motion to Stay the 
Administrative Proceedings until March 31, 2009. ALJ Ex. 12. The basis 
of the motion was that on July 8, 2008, the Washington Medical Quality 
Assurance Commission (MQAC) had summarily suspended Respondent's State 
medical license and that his hearing on that matter was not scheduled 
until March 6, 2009. ALJ Ex. 12. On September 26, 2008, the ALJ granted 
the motion and directed the parties to file a joint status report by 
March 31, 2009. ALJ Ex. 13.
    On March 30, 2009, the parties filed a Joint Status Report, Motion 
to Lift Stay of Proceedings and Motion to Reopen the Record. ALJ Ex. 
15. Therein, the parties noted that the MQAC had entered an Agreed 
Order which allowed Respondent to resume practicing medicine provided 
he satisfied various terms and conditions set forth therein; the 
parties also sought to supplement the record with various documents 
related to the MQAC proceeding and to file supplemental briefs. Id. On 
April 1, 2009, the ALJ lifted the stay, reopened the record to admit 
the MQAC documents, granted the parties additional time to file 
supplemental post-hearing briefs, and then closed the record. ALJ Ex. 
16. On July 22, 2009, the ALJ also reopened the record on Respondent's 
motion to admit an exhibit and then closed the record again. ALJ Ex. 
18. Finally, on July 29, 2009, the ALJ reopened the record sua sponte 
to admit various documents related to the matter's procedural history 
and then finally closed the record. ALJ Ex. 17.
    On October 2, 2009, the ALJ issued her recommended decision (ALJ). 
Therein, the ALJ concluded that the Government had made a prima facie 
showing that Respondent had committed acts which render his 
registration inconsistent with the public interest, finding that the 
evidence under factors two (Respondent's experience in dispensing 
controlled substances) and four (Respondent's compliance with State and 
Federal laws related to controlled substances) supported the revocation 
of Respondent's registration. ALJ at 29 & 31.
    The ALJ found that Respondent had contracted with eDrugstore, an 
internet pharmacy, and that from July 2003 through early 2004, 
Respondent had issued over 300 controlled substance prescriptions. Id. 
at 26. The ALJ also found that Respondent had issued prescriptions 
after reviewing online questionnaires and that he did not keep any 
medical records for the individuals to whom he prescribed the 
controlled substances. Id.
    With respect to these prescriptions, she further found that 
Respondent, who is only licensed to practice medicine in Washington, 
``prescribed controlled substances to individuals in other states, to 
include California, Indiana, Massachusetts, Texas, and Virginia,'' 
which require a physician to be licensed by them prior to issuing 
prescriptions to a State resident, and that this conduct violated the 
Controlled Substances Act (CSA) because he engaged in the unauthorized 
practice of medicine and thus acted outside of the usual course of 
professional practice. Id. at 27, 28 (collecting cases). She also 
concluded that Respondent violated the CSA in issuing these 
prescriptions because he did not have ``a face-to-face meeting'' with 
the patient and ``violate[d] the standard of care * * * for prescribing 
controlled substances'' and thus did not establish ``a valid doctor-
patient relationship.'' Id. at 29.
    Based on an undercover purchase, the ALJ found that ``Respondent's 
name and DEA number were used to authorize prescriptions through the 
Heynowmeds website.'' Id. While the ALJ acknowledged Respondent's 
contention that he did not issue prescriptions for this Web site, she 
concluded that because Respondent had ``allow[ed] such a website to 
gain access and to use his DEA registration number,'' he ``remains 
responsible for the outcome of that use.'' Id. She further reasoned 
that Respondent's failure to safeguard his registration from 
unauthorized use ``create[d] a risk of diversion'' and ``a risk to the 
public health and safety'' because it allowed persons ``without a 
legitimate need for * * * controlled substances'' to obtain them and 
thus was relevant conduct under factor five (such other conduct which 
may threaten public health and safety).\2\ Id. at 30.
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    \2\ With respect to factor one (the recommendation of the State 
board), the ALJ noted that the State Board ``has not made a direct 
recommendation concerning [his] DEA registration.'' ALJ at 25. The 
ALJ further found, however, that the State ``Board has engaged in 
considerable oversight of the Respondent's medical practice'' which 
included summarily suspending his license after finding that his 
``continued practice of medicine constitute an immediate danger to 
the public health and safety'' and that he had committed 
unprofessional conduct on two occasions (2007 and March 2009). Id. 
at 25-26. The ALJ did not, however, state whether this factor 
supported a finding that his continued registration is inconsistent 
with the public interest.
     With respect to factor three (Respondent's conviction record of 
offenses related to controlled substances), the ALJ found that there 
was ``no evidence of [his] having a conviction record.'' Id. at 30.
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    The ALJ then turned to other facts which she deemed relevant in the 
public interest determination. The ALJ found that ``Respondent was 
cooperative and truthful'' in his interview with DEA. Id. She also 
found significant the MQAC's 2007 finding ``that there was no evidence 
that the Respondent mishandled controlled substances during the 
Board's'' 2005 investigation. Id. at 30-31. She further found it 
``significant'' that, under the most recent MQAC order, Respondent is 
being supervised by a mentoring physician who is required to report to 
the Board. Id.
    While the ALJ concluded that the Government had made out its prima 
facie case, and that Respondent had violated both the CSA and State 
laws ``in prescribing controlled substances over the Internet'' and by 
his failure to safeguard his registration, she also noted that since 
the initiation of the proceedings, ``Respondent has had approximately 
four years to handle controlled substances without any adverse action 
being taken or evidence being seized by the DEA'' and that the 
``Medical Board is very diligent in monitoring [his] medical practice 
and will continue to do so in the future.'' Id. at 31-32. Believing 
that ``this proceeding has instilled in * * * Respondent a grave 
respect for the authority and responsibilities which attach to his DEA 
registration,'' the ALJ apparently recommended that I grant Respondent 
a new registration subject to the condition that he file his mentor's 
reports with this Agency and that he take the additional medical 
education courses order by the MQAC. Id. at 32.
    Neither party filed exceptions to the ALJ's decision. Thereafter, 
on November 3, 2009, the ALJ forwarded the record to me for final 
agency action.
    Having considered the record as a whole, I adopt the ALJ's findings 
of fact

[[Page 66140]]

and legal conclusions except as noted herein. However, I further find 
that Respondent prescribed controlled substances for Heynowmeds.com. 
While I also agree with the ALJ that the Government made out a prima 
facie case for revocation, I reject the ALJ's conclusion that the other 
facts and circumstances support granting him a new registration. As 
explained below, the ALJ ignored the extensive Agency precedent which 
holds that an applicant is not entitled to be registered unless he 
accepts responsibility for his misconduct. Because Respondent did not 
testify in this proceeding and continues to maintain that ``he ha[s] 
done nothing wrong,'' Tr. 645, he has not satisfied the Agency's rule 
for regaining his registration and his application must be denied. I 
make the following findings.

Findings of Fact

Respondent's Registration and License Status

    Respondent is a physician who previously held DEA Certificate of 
Registration, BM5009065, which authorized him to dispense controlled 
substances in schedules II through V as a practitioner; his registered 
location was in Seattle, Washington, and his registration expired on 
January 31, 2008. GX 1, at 1-2. Respondent did not, however, file a 
renewal application until January 24, 2008. ALJ Ex. 12, Appendix I, at 
1 (Joint Stipulation). The parties also agree that Respondent's 
registration ``did not continue in effect after January 31, 2008.'' Id. 
While Respondent no longer holds a registration, he does have an 
application for a new registration currently pending.
    Respondent is board-certified in internal medicine and holds a 
medical license issued by the State of Washington. RX 4, at 1. While 
Respondent has a current license, he has been the subject of two recent 
disciplinary proceedings before the Washington Medical Quality 
Assurance Commission (MQAC).
    On June 24, 2005, the MQAC filed a statement of charges which 
alleged that in July 2003, Respondent contracted with eDrugstore.md 
``to prescribe legend drugs to patients that were referred to him 
though the website,'' and was paid by the Web site and ``not the 
patients.'' GX 27, at 1-2. The MQAC alleged that its ``investigation 
included a portion of [his] prescriptions,'' and that ``[f]rom August 
2003, through approximately February 2004, Respondent authorized 
approximately 2,700 prescriptions in the sample obtained in the 
investigation.'' Id. at 2. The MQAC further alleged that:

    Respondent did not conduct a history and physical on any of 
these patients. He did not have face-to-face contact with any 
patient to evaluate them. Respondent did not have the patient's 
medical records available for review, and he did not have any way to 
verify any of the information provided to him via the online 
consultation form, nor did he attempt to do so. Respondent did not 
have a pre-existing physician-patient relationship with any of these 
patients. Respondent did not attempt to verify any pre-existing or 
underlying conditions, contraindications, or other medications that 
the patient was taking, other than via the online consultation form, 
filled out by the patient or through email. Nonetheless, Respondent 
undertook to provide diagnosis and treatment of every one of these 
patients.

Id. at 2.

    In addition, the MQAC alleged that Respondent had prescribed 
controlled substances to three State residents and that he had no 
medical records for these persons. Id. at 3-4. More specifically, the 
MQAC alleged that ``Respondent provided prescriptions for Percocet, 
Hydrocodone, and Amphetamine'' to Patient 1, that he ``prescribed 
Oxycodone and Alprazolam for Patient 2,'' and that he ``prescribed 
Hydrocodone and Cyclobenzaprine for Patient 3.'' Id. at 3. With respect 
to each of these three patients, the MQAC also alleged that Respondent 
``has no record of a history and physical for this patient, and no 
information to explain this patient's diagnosis and treatment. There 
are no medical records, no test results, or documentation of any kind 
to support this patient's diagnosis and treatment.'' Id. at 3-4.
    The MQAC thus alleged that Respondent's conduct with respect to 
both his prescribing over the Internet and his prescribing to the three 
patients constituted unprofessional conduct in violation of State law. 
Id. at 4. More specifically, the MQAC alleged that Respondent's 
prescribing violated Washington law prohibiting: (1) ``[i]ncompetence, 
negligence, or malpractice which results in injury to a patient or 
which creates an unreasonable risk that a patient may be harmed,'' id. 
(quoting Wash. Rev. Code Sec.  18.130.180(4)), and (2) ``[t]he 
possession, use, prescription for use, or distribution of controlled 
substances or legend drugs in any way other than for legitimate or 
therapeutic purposes, diversion of controlled substances or legend 
drugs, the violation of any drug law, or prescribing controlled 
substances for oneself.'' Id. (quoting Wash. Rev. Code Sec.  
18.130.180(6)).
    On January 18, 2007, following a hearing, the MQAC issued a Final 
Order on the allegations. GX 28. Therein, the MQAC found proved the 
allegations that Respondent had contracted with eDrugstore.md ``to 
prescribe legend drugs to patients that were referred to him through 
the web site'' and that he ``was compensated by eDrugstore.md [and] not 
by the patients.'' Id. at 5. The MQAC further found that Respondent 
used his DEA registration to prescribe medications and that ``[f]rom 
August 2003 through March 2004, [he] authorized approximately 2,700 
prescriptions.'' Id. at 6. The Board further found that:

    The Respondent did not conduct a history and physical on any of 
these patients. He did not have a face-to-fac[e] contact with any 
patient to evaluate them. The Respondent did not have the patient's 
medical records available for review, and he did not have any way to 
verify any of the information provided to him via the online 
consultation form, nor did he attempt to do so. The Respondent did 
not have pre-existing or underlying conditions, contraindications, 
or other medications that the patient was taking, other than via the 
online consultation form filled out by the patient or through email. 
Nonetheless, Respondent undertook to provide diagnosis and treatment 
of every one of these patients.

Id.

    The MQAC further found that, because ``Respondent did not 
physically see, interview, or examine the patients he treated through 
eDrugstore.md, [he] could not verify their identity and could not 
establish a diagnosis through the use of accepted medical practices to 
justify prescribing medications'' and that ``[t]hrough eDrugstore.md, 
[he] prescribed [p]hentermine, a diet medication to treat obesity.'' 
Id. at 7. Continuing, the MQAC found that ``[b]y prescribing'' 
phentermine ``over the Internet without proper counseling, follow up, 
and treatment plan, the Respondent failed to comply with standards of 
care from the perspective of managing obesity.'' Id. The MQAC also 
found that his prescribing of phentermine ``over the Internet was 
negligent and such conduct created [an] unreasonable risk that the 
patients may be harmed.'' Id.
    The MQAC further found that Respondent's internet prescribing ``was 
contrary to [its] Guidelines for the Appropriate Use of the Internet in 
Medical Practice,'' which it had issued on October 11, 2002. Id. at 6. 
See also GX 24. The MQAC noted that the Guidelines:

    Provide that treatment that is based solely on online 
questionnaires or online consultations do[es] not constitute an 
acceptable standard of care. Specifically, patient evaluation must 
be obtained prior to

[[Page 66141]]

providing treatment, including issuing prescriptions, electronically 
or otherwise. A patient evaluation includes a history and physical 
examination adequate to establish a diagnosis and to identify 
underlying conditions and/or contraindications to the treatment 
being recommended or provided.

GX 28, at 6; see also GX 24, at Sec.  5.\3\
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    \3\ On April 27, 2001, DEA published a guidance document, 
Dispensing and Purchasing Controlled Substances over the Internet, 
66 FR 21181. Therein, the Agency explained that ``Federal law 
requires that `[a] prescription for a controlled substance to be 
effective must be issued for a legitimate medical purpose by an 
individual practitioner acting in the usual course of his 
professional practice' '' and that ``[u]nder Federal and state law, 
for a doctor to be acting in the usual course of professional 
practice, there must be a bona fide doctor/patient relationship.'' 
Id. at 21182. The Agency further noted that ``many state 
authorities'' look to ``four elements as an indication that a 
legitimate doctor/patient relationship has been established.'' Id. 
These are: (1) ``[a] patient has a medical complaint''; (2) ``[a] 
medical history has been taken''; (3) ``[a] physical examination has 
been performed''; and (4) ``[s]ome logical connection exists between 
the medical complaint, the medical history, the physical 
examination, and the drug prescribed.'' Id. at 21182-83. The 
Document then noted that ``[c]ompleting a questionnaire that is then 
reviewed by a doctor hired by the Internet pharmacy could not be 
considered the basis for a doctor/patient relationship. * * * It is 
illegal to receive a prescription for a controlled substance without 
the establishment of a legitimate doctor/patient relationship, and 
it is unlikely for such a relationship to be formed through Internet 
correspondence alone.'' Id. at 21183.

    With respect to the three patients who were State residents, the 
MQAC found that Respondent had prescribed controlled substances to them 
and had ``failed to keep any medical records for these patients.'' GX 
28, at 7. The MQAC also found that Respondent ha[d] no record of a 
history and physical exam for these patients and no information to 
explain the patients' diagnosis and treatment. There are no medical 
records, no test results, or documentation of any kind to support the 
patient's diagnosis and treatment.'' Id. The MQAC further found that 
Respondent's treatment of these patients ``was below the standard of 
care for a physician in the state of Washington, and [that] his conduct 
created an unreasonable risk of harm.'' Id. at 8.
    The MQAC ultimately concluded that the State had ``proved by clear 
and convincing evidence that * * * Respondent's conduct constituted 
unprofessional conduct in violation of'' Wash. Rev. Code Sec.  
18.130.180(4). Id. at 9. However, apparently because the State produced 
no evidence showing that Respondent prescribed controlled substances 
``for use other than for therapeutic purposes,'' id. at 8, the MQAC 
concluded that the State had ``failed to prove by clear and convincing 
evidence that * * * Respondent's conduct constituted unprofessional 
conduct in violation of'' Wash. Rev. Code Sec.  18.130180(6).\4\ Id. at 
9.
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    \4\ Based on its findings that Respondent had committed 
unprofessional conduct, the MQAC imposed various sanctions on 
Respondent including a suspension (which was stayed), a restriction 
that he could only practice as an emergency medicine physician, and 
a fine of $2500. Id. at 10-119. The MQAC also ordered him to 
complete an approved education and assessment course and six hours 
of continuing medical education in ethics and professionalism, to 
file a declaration each quarter stating that he was in compliance 
with the Order, and to appear before the Commission for compliance 
hearings. Id. at 11-12.
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    On July 3, 2008, the MQAC filed another Statement of Charges 
against Respondent, alleging that he had committed unprofessional 
conduct in providing treatment (or lack thereof) of four emergency room 
patients. ALJ Ex. 15, at 2; Jt. Ex. 1, at 1, 4. However, none of the 
allegations involved the prescribing of controlled substances. Five 
days later, on July 8, 2008, the Commission entered an Ex Parte Order 
of Summary Suspension. ALJ Ex. 15, at 2; Jt. Ex. 2, at 1, 3.
    On March 5, 2009, Respondent entered into a Stipulated Findings of 
Fact, Conclusions of Law and Agreed Order with the Commission in which 
Respondent agreed that he had committed unprofessional conduct in his 
treatment of the patients in question in violation of Wash. Rev. Code 
Sec.  18.130.180(4). The Commission permitted Respondent to return to 
the practice of medicine pursuant to terms and conditions of the Agreed 
Order. ALJ Ex. 15, at 2; Jt. Ex. 3, at 1, 3. On the same date, finding 
that the Agreed Order superseded and appropriately incorporated all the 
outstanding terms and conditions of the January 2007 Final Order, the 
Commission released Respondent from that Order. ALJ Ex. 15, at 2; Jt. 
Ex. 4, at 2.
    Under the Agreed Order, which is to remain in effect for at least 
three years, Respondent is limited to ``office-based family and 
internal medicine group practice.'' Jt. Ex. 3, at 4. In addition to 
some continuing education and medical proficiency requirements, 
Respondent must ``arrange for another physician to serve as a mentor at 
all times prior to termination of these practice conditions.'' Id. at 
5. Among other matters, under the Agreed Order, the mentor must make 
periodic reports to the Commission, exercise oversight of the office-
based practice, and review all of Respondent's charts and entries 
``until otherwise directed by the Commission.'' \5\ Id. at 5-6.
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    \5\ By letter of June 15, 2009, Dr. David Lush indicated that he 
was Respondent's mentor physician for purposes of the Agreed Order. 
RX 37, at 1. Dr. Lush further indicated that Respondent had 
commenced to work under his supervision at his community clinic in 
Raymond, Washington. Id. at 1, 2. Dr. Lush requested that ``the DEA 
permit [Respondent] to hold a registration number so that he will be 
able to make the most constructive possible contribution to the 
operations of [the] clinic.'' Id. at 2. He averred that, given the 
Commission's restrictions on Respondent's license, ``there would be 
no danger to the public as a result of permitting [Respondent] to 
continue to hold a DEA registration number.'' Id.
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The DEA Investigation of Respondent

    In June 2004, DEA began investigating a criminal conspiracy run by 
Mr. Johar Saran and various associates, which among other crimes, 
unlawfully distributed controlled substances in violation of 21 U.S.C. 
841(a)(1)(a) & (b)(1)(D), 846. See generally GX 23. More specifically, 
the Saran conspiracy controlled more than twenty corporate entities 
(including Carrington Health Services (CHS) and Infiniti Services Group 
(ISG)) which were used to fraudulently obtain the DEA pharmacy 
registrations that are legally necessary to purchase controlled 
substances from registered manufacturers and distributors. GX 24, 
Factual Resume at 5-6; Tr. 24-25. Saran and his co-conspirators 
purchased the controlled substances and then distributed them to 
customers who sought them through over 100 Web sites. GX 24, Factual 
Resume at 8. As Johar Saran admitted in his plea agreement, he and his 
co-conspirators ``agreed to distribute and possess with the intent to 
distribute, controlled substances to Internet drug seeking customers 
without legitimate prescriptions. [He] knew that controlled substances 
would be distributed to Internet customers without the existence of a 
doctor patient relationship [and that] the Internet controlled 
substance distributions were outside the scope of professional practice 
and not for a legitimate medical purpose.'' Id.
    As part of the investigation, on December 9, 2004, DEA 
investigators conducted a ``trash run'' at CHS/ISG. Tr. 24. Among the 
evidence recovered were a dozen prescription labels for controlled 
substances (including phentermine, hydrocodone/apap, and alprazolam), 
which ``appear[ed] to be the portion of a multi-part printout that 
should have been filed by the pharmacy as a record of the transaction 
or the prescription being filed.'' Id. at 33-34; GX 37. The labels 
indicated that ``George Mathew, M.D.'' was the prescribing physician, 
gave his registered address in Seattle, Washington (albeit without the 
suite number and having a one-digit mistake in the zip code), and 
listed his DEA registration number. GXs 1 & 37. According to a DI, the 
pharmacy listed

[[Page 66142]]

on the labels (Anchor Services, Inc. of Fort Worth, Texas) was a Saran-
affiliated pharmacy; however, drug orders were not filled there but 
rather at the CHS location.\6\ Tr. 36; see GX 22, at 3-4.
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    \6\ The ALJ observed that the record contained no evidence that 
the medications reflected in the documents seized during the trash 
runs were actually sent to the individuals whose names appear on the 
seized documents. See also ALJ at 6. Ordinarily, a pharmacy would 
not go to the trouble of creating these documents unless it was 
dispensing a drug.
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    DEA Investigators also obtained a court order authorizing them to 
intercept electronic communications (including e-mail and downloads) to 
and from CHS/ISG from April 17, 2005 through the ensuing 90 days. Tr. 
50-51; GX 36, at 2. The intercept yielded 136 prescriptions for 
controlled substances which were filled between May and June 17, 2005 
by Southwest Infusion, one of Saran's sham pharmacies, and which bore 
Respondent's name as the prescribing doctor, his DEA number, and his 
signature. See generally GX 4. The prescriptions listed the same street 
address, suite number and city as Respondent's registered location but 
indicated the State as Massachusetts, rather than Washington, and a zip 
code of 98104, rather than 98121. See GXs 1 & 4.
    The vast majority of the prescriptions were for schedule III 
controlled substances containing hydrocodone (typically containing 10 
mg. of this controlled substance); other prescriptions were for the 
schedule IV controlled substances alprazolam and diazepam. See 
generally GX 4. The prescriptions were sent to patients throughout the 
United States (and outside of Washington State) and included the UPS 
shipping labels. Id.
    DEA also executed search warrants for Saran's business and the 
residence of Ted Solomon, one of Saran's co-conspirators, who ran 
several of his own Web sites. Among the items seized at both CHS/ISG 
and at Solomon's home was a spreadsheet which listed persons who were 
identified as the ``lead[s],'' \7\ the names of various companies and 
their Web sites, a contact for the companies, and various physician 
names. GX 33, at 3-4. Under the lead of ``Heather,'' the spreadsheet 
listed several companies and their Web sites including Pacific Blue Rx 
(PacifcBlueRx.com) and FMS (rxmetro.com); the spreadsheet also listed 
Heynowmeds.com.\8\ Tr. 98-100; GX 33, at 3-4. The spreadsheet listed 
Respondent as the Dr. for both PacificBlueRx and FMS. GX 33, at 3.
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    \7\ The testimony established that the ``lead'' was an employee 
of Saran who managed various companies' accounts.
    \8\ The document does not, however, list a physician for 
heynowmeds.com. See GX 33, at 4.
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    According to a DI, these three Web sites (as well as FMS) were 
owned by Michael Schwerdt, whose father-in-law was Abel Rodriguez.\9\ 
Tr. 100 & 111. Heather Elliot managed their accounts for Saran. Id. at 
102. According to the DI, Elliot would access the Internet and download 
approximately 50 prescriptions and print out their labels, which she 
then gave to people in the pharmacy who filled the vials and readied 
the drugs for shipping. Id. at 103. Elliot was eventually indicted and 
pled guilty to several Federal felony offenses. RX 27.
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    \9\ A July 6, 2005, ``Affidavit for Arrest'' for Abel Rodriguez 
identified Michael Schwerdt as Abel Rodriguez's son-in-law. RX 22, 
at 28. It also indicated that documents printed from Florida 
Corporations Online and seized at the time of a search warrant for 
certain business properties listed Abel Rodriguez as the registered 
agent for La Familia Pharmacy III, Inc. Id. at 32.
---------------------------------------------------------------------------

    On May 23, 2005, a DI went to Heynowmeds.com, which he selected 
because it was one of the busier Web sites, to purchase hydrocodone. 
Tr. 67; GX 3, at 1. The Web site listed various types of medicine 
available, and the DI clicked on ``pain relief.'' Id. at 73. The DI 
then ordered 90 tablets of hydrocodone/acetaminophen 10/325. Id. at 74. 
The DI selected this drug based on its popularity with drug abusers, 
which the DI explained was because ``you can get the strongest strength 
of hydrocodone and the smallest strength of additives, like 
acetaminophen.'' Id.
    While the Web site prompted the DI to provide some medical 
information, it did so only after asking for his contact and payment 
information. Id. at 77-78. The Web site also asked for contact 
information for his physician; the DI entered the name and cell phone 
of a DEA Special Agent. Id. at 79-80. The DI paid $265.84 for the drugs 
using a money order.\10\ GX 3, at 2 & 5.
---------------------------------------------------------------------------

    \10\ The instructions sent to the DI about payment for the 
shipment indicated that he should make his money order payable to 
Adserv, but the DI made the money order payable to SouthWest 
Infusion in order to track the payment back to the ``fill'' 
pharmacy. Tr. 86-87. Adserv employed Craig Schwerdt, the brother of 
Michael Schwerdt; the latter sent the former to Saran's headquarters 
``to make sure that [Heynowmed's] orders were going out in a timely 
fashion.'' Id. at 104; see also id. at 137; RX 24, at 47.
---------------------------------------------------------------------------

    Two days later, on May 25, the DI received the hydrocodone that he 
had ordered. Id. at 82. The label indicated that the filling pharmacy 
was SouthWest Infusion, one of Saran's pharmacies; \11\ the prescriber 
was listed as ``George Mathew, M.D.'' Id. at 61; GX 3, at 3.
---------------------------------------------------------------------------

    \11\ The DI testified that ``at one point'' Johar Saran had ``23 
pharmacies'' but that the number ``dwindled down to 19 by the end.'' 
Tr. at 61.
---------------------------------------------------------------------------

    The DI testified that Respondent was ``the contracting physician'' 
for Heynowmeds, PacificBlueRx, and Rx Metro, Tr. 100, in that he was 
``the physician that [wa]s approving the drug orders and [was]s being 
compensated by these websites for doing so.'' Id. at 102-03. The DI 
also testified that while he had ``no knowledge'' as to whether 
Respondent had personally approved his order for hydrocodone, id. at 
110, Respondent had ``entered into a contract with Abel Rodriguez'' and 
made both his DEA registration and his State license available to 
Rodriguez. Id. at 111.
    The DI then admitted that he had not found any contract between 
Respondent and the three Web sites. Id. at 114. Moreover, the DI 
further testified that during the Title III search, the Investigators 
found no evidence of personal contact between Respondent and the Saran 
pharmacies. Id. at 62-63. The DI explained, however, that ``when a 
physician enters into a contract with a Web site owner, the Web site 
owner arranges for the fill pharmacy'' and there is ``no reason for the 
physician to contact that fill pharmacy unless he's * * * following up 
on any questions or concerns that there might be about the drugs.'' Id. 
at 63. The DI further testified that because Respondent's case was an 
``administrative'' matter, the Investigators ``did not follow the money 
trail'' with respect to him. Id. Moreover, the Investigators did not 
have evidence of e-mails which Respondent may have sent to the three 
Web sites and which the Web sites may have sent to him.\12\ Id. at 158 
& 164.
---------------------------------------------------------------------------

    \12\ The ALJ noted that Government did not produce any testimony 
or statements from individuals associated with Saran including Johar 
Saran (and Heather Elliot) implicating Respondent. See ALJ at 5. 
However, this is hardly dispositive given that the Government did 
not allege that Respondent worked directly for a Saran-owned Web 
site. Moreover, given that this was a blatantly criminal scheme, it 
is not clear why Ms. Elliot would have needed to speak with 
Respondent rather than the Web site owners.
---------------------------------------------------------------------------

    On September 20, 2005, a Grand Jury indicted Johar Saran, 18 of his 
co-conspirators, and Saran's corporations for multiple felony offenses 
under Federal law. GX 22; Tr. 26. Thereafter, on September 22, 2005, 
DEA Investigators from the Seattle Division Office served the Order to 
Show Cause and Immediate Suspension on Respondent. Tr. 147, 149, 595, 
597-98.
    Later that day, the DIs met with Respondent and his attorney at the 
latter's office. Id. at 598. According to one of the DIs, during the 
interview Respondent told the DIs that ``everything'' in the Show Cause 
Order

[[Page 66143]]

was ``false.'' Id. at 599. Respondent admitted, however, that ``he had 
at one time * * * authorized some prescriptions on the Internet,'' 
which was between ``July 2003 and early 2004,'' when he had a 
``contract with a company called eDrugs or eDrugstore.'' Id. at 599, 
600.
    Respondent told Investigators that he approved drug orders for 
eDrugstore by reviewing an online questionnaire and a drug 
recommendation; if he agreed with the recommendation, he would 
authorize the drug order. Id. at 609. He further stated that the 
prescriptions he authorized were for ``mainly non-controlled 
substances'' and that, while he had authorized some prescriptions for 
``diet medications,'' he ``had not authorized any narcotic controlled 
substances.'' Id. at 599. Respondent further maintained ``that the 
quantity of the controlled substance prescriptions versus the non-
controlled substance prescriptions was very small.'' Id. at 606. 
Respondent did not have medical records pertinent to his prescribing 
for eDrugstore. Id. at 606-07.
    Respondent told the DIs that he had been paid $30,000 by eDrugstore 
during the six- month period he prescribed for it. Id. at 599-600, 605-
06. He also stated that he was paid $3 for non-controlled substances 
and $10 for the diet drugs, which he admitted were controlled 
substances. Id. at 606. While Respondent further told the DIs that he 
would provide them with bank records regarding the payments he received 
from eDrugstore, he never did. Id. at 606-07.
    However, his contention that he wrote only a ``very small'' number 
of controlled substance prescriptions cannot be reconciled with the 
MQAC's finding that Respondent authorized 2,700 prescriptions for 
eDrugstore, the total amount of the compensation ($30,000) he admitted 
to having received from eDrugstore, and the respective amounts 
eDrugstore paid him for the controlled ($10) and non-controlled 
prescriptions ($3). Indeed, this evidence suggests that the great 
majority of the prescriptions he wrote for eDrugstore were for 
controlled substances.\13\
---------------------------------------------------------------------------

    \13\ To demonstrate, even if half of the 2,700 prescriptions 
(1,350) were for controlled substances, he would have earned less 
than $18,000 based on the amounts he received for the controlled 
($10) and non-controlled ($3) prescriptions. Given the number of 
prescriptions, the only way that Respondent would have earned 
$30,000 was if nearly all the prescriptions were for controlled 
substances.
---------------------------------------------------------------------------

    With respect to the allegations of the Show Cause Order, Respondent 
stated that while he was prescribing for eDrugstore, he received a 
telephone call from Abel Rodriguez, who ``had obtained his name from a 
faxed prescription that he had received from eDrugstore.'' Id. at 602. 
Respondent told the DIs that eDrugstore used Rodriguez's pharmacy, La 
Familia Pharmacy, to fill some of its prescriptions, and that that was 
how Rodriguez received the prescription (which contained his DEA 
registration number).\14\ Id. at 624, 629. Rodriguez solicited 
Respondent to write prescriptions for his Web site; Respondent told the 
DIs that Rodriguez offered to pay him $30 to $35 for each controlled 
substance prescription. Id. at 611. After the phone call, Respondent 
went to Florida to visit Rodriguez and his pharmacy because he did not 
know Rodriguez, and Rodriguez came to Seattle. Id. at 612.
---------------------------------------------------------------------------

    \14\ Respondent denied having provided Rodriguez with his DEA 
number. Id. at 628.
---------------------------------------------------------------------------

    During the interview, Respondent maintained that he had written 
only about 100 prescriptions for non-controlled substances for 
Rodriguez's Web site. Id. at 614. He also denied having written any 
controlled substance prescriptions for him. Id. He denied receiving any 
money from Johar Saran. Id. at 601. He also denied knowing any of the 
individuals or entities listed in the Order to Show Cause and ``said 
that someone else had provided [his] DEA number to them because he had 
not provided anything to any of these people'' because he did not 
``know any of these people.'' Id. at 604.
    The Supervisory DI present at Respondent's interview testified that 
Respondent was cooperative, supportive of the DEA, and that ``[h]e 
appeared truthful.'' Id. at 604, 628. In a report submitted to the DEA 
Fort Worth office, she described Respondent's demeanor during the 
interview as candid and cooperative. Id. at 150.
    In support of his contention that Rodriguez had used his 
registration number without his permission, Respondent offered into 
evidence an affidavit prepared by Special Agents of the Florida 
Department of Law Enforcement in support of an application for a 
warrant to arrest Rodriguez. RX 22, at 12 et seq. According to 
Respondent, the affidavit stated that ``Rodriguez had forged the name 
of a physician, Miguel Mora, by `rubber-stamping' Dr. Mora's name to 
prescriptions filled by the La Familia group, even though he was not 
actually involved in prescribing the medications.'' Resp. Br. at 17 
(quoting RX 22, at 49). However, the affidavit does not identify 
Respondent as a physician whose name and registration were used to 
prescribe controlled substances without his authorization.\15\ See 
generally RX 22.
---------------------------------------------------------------------------

    \15\ Earlier, the affidavit noted that during a search, officers 
had found in a personnel file of one of Abel Rodriguez's associates 
``[a]n entry labeled `George Matthew, 121 Vine St, Seattle WA, 
98122,'' which also included his DEA number). RX 22, at 38. In 
parentheses, the affidavit stated that Respondent ``has previously 
been identified as a doctor writing prescriptions for the internet 
pharmacy operation.'' Id.
---------------------------------------------------------------------------

    Respondent did not testify in this proceeding. Instead, to bolster 
the credibility of his statement to the investigators that he did not 
authorize controlled prescriptions pursuant to his arrangement with 
Abel Rodriguez, he offered evidence that, in May 2007, he took and 
passed a polygraph examination which was arranged by his attorney. Tr. 
505-07; RXs 6 & 33. The ALJ admitted this evidence over the objection 
of the Government. Tr. 641.
    In United States v. Scheffer, 523 U.S. 303 (1998), the Supreme 
Court upheld a rule of evidence, which renders polygraph evidence 
inadmissible in a criminal proceeding, against a constitutional 
challenge. Fundamental to the Court's holding was its conclusion that 
polygraph evidence is not reliable. As the Court explained, ``there is 
simply no consensus that polygraph evidence is reliable,'' and ``[t]o 
this day, the scientific community remains extremely polarized about 
the reliability of polygraph techniques.'' Scheffer, 523 U.S. at 309 
(citations omitted).
    Under the Administrative Procedure Act (APA), the Agency's order 
must be ``supported by and in accordance with the reliable, probative, 
and substantial evidence.'' 5 U.S.C. 556(d) (emphasis added). 
Respondent has made no showing that the scientific community and the 
courts consider this evidence any more reliable today than they did 
when Scheffer was decided. While Respondent argues that several 
Agencies (including this one) use polygraphs for a variety of 
administrative and investigatory purposes, the Scheffer Court rejected 
the same argument, noting, most significantly, that these uses ``do not 
establish the reliability of polygraphs as trial evidence.'' 523 U.S. 
at 312 n.8.\16\ Accordingly, I conclude

[[Page 66144]]

that the evidence should not have been admitted and I decline to rely 
on it.\17\
---------------------------------------------------------------------------

    \16\ Even were I to hold Respondent's polygraph evidence 
admissible, I would give it no weight as each of the questions was 
compounded. More specifically, the examiner asked Respondent if he 
had: (1) ``ever done business with Johar Saran, CHS/HIS [sic], or 
http://www.heynowmeds.com,'' (2) ``ever personally prescribed 
controlled substances for customers of Johar Saran, CHS/HIS [sic], 
or http://www.heynowmeds.com, and (3) ``ever received any payment 
and/or money from Johar Saran, CHS/ISH [sic] or http://www.heynowmeds.com.'' Tr. 506-07.
    After the hearing, the Government submitted an affidavit by a 
DEA Supervisory Special Agent (SSA) who was also the Polygraph Staff 
Coordinator. GX 38. The SSA reviewed the testimony of Respondent's 
polygraph examiner as well as Respondent's Exhibits 33 (pre-
polygraph interview notes), 34 (Polygraph examination agreement), 
and 35 (Backster Zone Comparison Test Variations). Id. at 2. The SSA 
concluded that all three target questions in the polygraph exam were 
compounded, which ``could substantially diminish the accuracy of'' 
the exam results, as the questions could have been truthfully 
answered either yes or no. Id. (emphasis in original). To avoid this 
result, the questions should have been asked individually as to 
Johar Saran, CHS/ISG, and http://www.heynowmeds.com. Id. The SSA 
further stated that the Respondent's exam would be deemed an 
``Administrative Opinion,'' because the results were not based upon 
the physiological responses to applied stimuli. Id. at 3.
    \17\ Respondent also called an expert witness in information 
technology, who attempted to trace the source and destination 
Internet Protocol addresses identified in the intercepted 
prescriptions to show that Respondent did not have a connection 
with, or own, the addresses. Tr. 397-405. The witness, however, 
acknowledged that his ``research was inconclusive.'' Id. at 405; see 
also id. at 413. He further acknowledged that he was not asked to 
research whether Respondent had accessed the IP addresses and that 
his research did not establish that Respondent had not accessed 
them. Id. at 422.
---------------------------------------------------------------------------

    The Government also called Dr. George Van Komen, who was qualified 
as an expert witness in the prescribing of controlled substances 
including prescribing over the Internet. Tr. 284. Dr. Van Komen holds 
board certification in internal medicine, is a fellow of the American 
College of Physicians, and is an assistant professor of clinical 
medicine at the University of Utah School of Medicine, where he teaches 
a course in medical ethics and professionalism. GX 10, at 1; Tr. 261-
63. Previously, Dr. Van Komen was a member and chairman of the Utah 
Physicians Licensing Board as well as a member of the Board of 
Directors and President of the Federation of State Medical Boards 
(FSMB); currently, he is the chairman of the Utah Medical Association's 
Committee for Controlled Substances. GX 10, at 2-3. Dr. Van Komen was 
also a member of the committee which drafted the FSMB's Model 
Guidelines for the Appropriate Use of the Internet in Medical Practice 
(2002). Tr. 290; see also GX 18.
    Dr. Van Komen testified that there is ``a well defined standard of 
care'' for prescribing controlled substances and establishing a 
legitimate doctor patient relationship. Tr. 295. He further noted that 
the standards for Internet prescribing adopted by the MQAC (GX 24), 
closely follow the FSMB's guidelines and ``outline for physicians in 
very clear language what's appropriate and what's not appropriate.'' 
Tr. 297. Dr. Van Komen then testified that the standard of care for 
prescribing a controlled substance requires that a doctor-patient 
relationship be established. Id. at 304-05. More specifically, Dr. Van 
Komen testified that this begins with the patient presenting with an 
ailment or medical problem and that the physician must then: (1) Meet 
the patient face-to-face to take a history and perform a physical 
examination; (2) order appropriate tests to confirm or eliminate a 
potential diagnosis; (3) make a diagnosis; (4) discuss the diagnosis 
and treatment options with the patient; and (5) discuss the risks and 
benefits of specific treatment choices. Id. at 304-06. The standard of 
care for prescribing a controlled substance also requires that the 
physician maintain patient files documenting ``what has occurred in the 
doctor/patient relationship'' and following up with the patient to make 
sure that the treatment is having the intended effect and not causing 
side effects. Id. at 307-08, 344.
    Dr. Van Komen subsequently explained that reviewing an online 
questionnaire or engaging in a telephone consultation does not provide 
``the same information'' regarding a patient's potential drug 
dependency as does ``a face-to-face meeting.'' Tr. 334-35. Moreover, 
after writing a prescription, a doctor can reassess the patient when he 
comes back to the office. Id. at 334.
    Based on his review of the MQAC's 2005 Statement of Charges (GX 27) 
and its 2007 Final Order (GX 28), Dr. Van Komen opined that Respondent 
``prescribe[d] outside the standard of care usually accepted or as is 
accepted by the medical community.'' Tr. 328. He also opined that the 
DVD which showed how the DI obtained hydrocodone through the Heynowmeds 
Web site, as well as the prescriptions that were listed on the 
spreadsheet of intercepted data, supported his conclusion. Id. at 329-
30.
    The Government then asked Dr. Van Komen whether he had an opinion 
as to whether Respondent's prescriptions were issued for ``a legitimate 
medical purpose.'' Id. at 330. Dr. Van Komen explained that there was 
no ``way of knowing if any of the prescriptions are for a legitimate 
medical purpose because there's no contemporaneous medical records on 
any of the patients.'' Id. Continuing, Dr. Van Komen explained that the 
failure to maintain medical records is ``a huge breach of the 
responsibility of a physician when he's prescribing any medication * * 
* especially with controlled drugs.'' Id.
    As for the MQAC's finding that Respondent had violated State law in 
prescribing phentermine, Dr. Van Komen testified that this drug is a 
schedule IV controlled substance which ``can be abused and that the 
physician needs to [engage in] very close monitoring of patients,'' and 
that ``it makes no sense at all to prescribe phentermine without a 
doctor/patient relationship.'' Id. at 331. He further testified that 
phentermine is a stimulant, and that ``[o]f all of the drugs that we 
prescribe, stimulants are by far the most addictive.'' Id. at 343.
    With respect to hydrocodone, Dr. Van Komen testified that a 
physician has to have ``a real interaction'' with ``the patient 
before'' deciding to ``use opioid medication in the treatment of [the 
patient's] pain'' and that once the physician prescribes the drug, he 
has to ``have the patient come back'' to ``make sure that [the patient 
is] using the medication appropriately.'' Id. at 337. Dr. Van Komen 
also explained that hydrocodone is ``very abused'' and is ``one of the 
leading cause[s] of drug overdose deaths in the United States.'' Id. at 
338.
    On cross-examination, Dr. Van Komen further explained that even if 
he did not consider the evidence that the Government obtained in the 
Saran investigation, his ``opinion'' regarding the medical propriety of 
Respondent's prescribing ``would be the same as the [MQAC] found.'' Id. 
at 360. Continuing, Dr. Van Komen opined that Respondent ``abuse[d] his 
authority as a physician by prescribing on the Internet without 
bonafide doctor/patient relationships.'' Id. at 360-61. He further 
noted that Respondent ``did allow his DEA number and his medical 
license to remain with the Internet company'' and ``[h]e did very 
little after his initial stopping of prescribing in 2004 to try and get 
back the information from the Internet company.'' Id. at 361.

Discussion

    Pursuant to Section 303(f) of the Controlled Substances Act (CSA), 
``[t]he Attorney General may deny an application for [a practitioner's] 
registration if he determines that the issuance of such registration 
would be inconsistent with the public interest.'' Id. Sec.  823(f). 
With respect to a practitioner, the Act requires the consideration of 
the following factors in making the public interest determination:
    (1) The recommendation of the appropriate State licensing board or 
professional disciplinary authority.
    (2) The applicant's experience in dispensing * * * controlled 
substances.
    (3) The applicant's conviction record under Federal or State laws 
relating to the manufacture, distribution, or dispensing of controlled 
substances.

[[Page 66145]]

    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.

Id. Sec.  823(f).
    ``These factors are considered in the disjunctive.'' Robert A. 
Leslie, M.D., 68 FR 15227, 15230 (2003). I may rely on any one or a 
combination of factors, and may give each factor the weight I deem 
appropriate in determining whether to deny an application or revoke an 
existing registration. Id. Moreover, I am ``not required to make 
findings as to all of the factors.'' Hoxie v. DEA, 419 F.3d 477, 482 
(6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165, 173-74 (DC Cir. 
2005).
    With respect to a practitioner's registration, the Government bears 
the burden of proving (by a preponderance of the evidence) that 
granting the application would be inconsistent with the public 
interest. 21 CFR 1301.44(d). However, where the Government satisfies 
its prima facie burden, as for example, by showing that an applicant, 
who was previously registered, committed acts which are inconsistent 
with the public interest, the burden then shifts to the applicant to 
demonstrate why he can be entrusted with a registration.
    In this matter, I agree with the ALJ that the Government has 
satisfied its prima facie burden by showing that Respondent committed 
acts which render his registration inconsistent with the public 
interest. See ALJ at 31 (``The Government clearly met its burden of 
proving that justification exists for revoking the Respondent's DEA 
registration.''). However, I reject the ALJ's implicit conclusion that 
Respondent has rebutted the Government's prima facie case and her 
recommendation that Respondent ``be given an opportunity to 
demonstrate,'' while he is being mentored, ``his continuing ability and 
willingness to comply with the statutory and regulatory provisions that 
adhere to a DEA registration.'' Id. at 32.
    As explained below, the ALJ disregarded the extensive body of 
Agency precedent holding that an applicant must acknowledge his prior 
misconduct and accept responsibility for it. See, e.g., Medicine 
Shoppe-Jonesborough, 73 FR 364, 387 (2008) (collecting cases). 
Respondent did not testify in this proceeding and continues to assert 
that he has ``done nothing wrong.'' Tr. 645 (closing argument); see 
also Resp. Br. at 46. Accordingly, Respondent has not shown that he is 
entitled to a new registration.

Factor One--The Recommendation of the State Licensing Board

    Respondent has twice been subjected to disciplinary proceedings 
brought by the MQAC. The latter MQAC case, which included a summary 
suspension for his failure to properly treat emergency room patients, 
did not involve his prescribing of controlled substances.
    However, the first case was based on his internet prescribing of 
phentermine to patients he never physically examined, as well as his 
prescribings of controlled substances to three other patients on whom 
he did not maintain medical records. Based on this conduct, the MQAC 
found Respondent guilty of unprofessional conduct and imposed a 
suspension, which it stayed, as well as restrictions on his practice.
    Notably, in this matter, the MQAC has not made a recommendation 
that he retain his DEA registration. Respondent nonetheless argues that 
its decision reflects its conclusion that permitting him to continue to 
practice ``would not create a danger to public health and safety.'' 
Resp. Br. at 29. In his closing argument, Respondent further maintained 
that this Agency is required to defer to the MQAC's decision allowing 
him to continue to practice under conditions. Tr. 655.
    While the MQAC's reinstatement of his medical license (following 
the second proceeding) now makes him eligible to hold a DEA 
registration, see 21 U.S.C. 823(f), this Agency has repeatedly held 
that possessing a valid State license is not dispositive of the public 
interest inquiry. See Patrick W. Stodola, 74 FR 20727, 20730 n.16 
(2009); Robert A. Leslie, 68 FR at 15230. DEA has long held that ``the 
Controlled Substances Act requires that the Administrator * * * make an 
independent determination as to whether the granting of controlled 
substances privileges would be in the public interest.'' Mortimer 
Levin, 57 FR 8680, 8681 (1992).\18\ Accordingly, I am not required to 
defer to the MQAC's decision to allow Respondent to practice medicine, 
and I conclude that this factor is not dispositive either for, or 
against, granting Respondent's application.
---------------------------------------------------------------------------

    \18\ For reasons explained in my discussion of the sanction, I 
conclude that the conditions imposed by the MQAC do not adequately 
protect the public interest.
---------------------------------------------------------------------------

Factors Two and Four--Respondent's Experience in Dispensing Controlled 
Substances and His Record of Compliance With Laws Related to Controlled 
Substances

    Under a longstanding DEA regulation, a prescription for a 
controlled substance is not ``effective'' unless it is ``issued for a 
legitimate medical purpose by an individual practitioner acting in the 
usual course of his professional practice.'' 21 CFR 1306.04(a). This 
regulation further provides that ``an order purporting to be a 
prescription issued not in the usual course of professional treatment * 
* * is not a prescription within the meaning and intent of [21 U.S.C. 
829] and * * * the person issuing it, shall be subject to the penalties 
provided for violations of the provisions of law related to controlled 
substances.'' Id. See also 21 U.S.C. 802(10) (defining the term 
``dispense'' as meaning ``to deliver a controlled substance to an 
ultimate user by, or pursuant to the lawful order of, a practitioner, 
including the prescribing and administering of a controlled 
substance'') (emphasis added).
    As the Supreme Court recently explained, ``the prescription 
requirement * * * ensures patients use controlled substances under the 
supervision of a doctor so as to prevent addiction and recreational 
abuse. As a corollary, [it] also bars doctors from peddling to patients 
who crave the drugs for those prohibited uses.'' Gonzales v. Oregon, 
546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 
135, 143 (1975)).
    Under the CSA, it is fundamental that a practitioner must establish 
and maintain a bonafide doctor-patient relationship in order to act 
``in the usual course of * * * professional practice'' and to issue a 
prescription for a ``legitimate medical purpose.'' Laurence T. 
McKinney, 73 FR 43260, 43265 n.22 (2008); see also Moore, 423 U.S. at 
142-43 (noting that evidence established that physician ``exceeded the 
bounds of `professional practice,' '' when ``he gave inadequate 
physical examinations or none at all,'' ``ignored the results of the 
tests he did make,'' and ``took no precautions against * * * misuse and 
diversion''). At the time of the events at issue here, the CSA 
generally looked to State law to determine whether a doctor and patient 
had established a bonafide doctor-patient relationship. See Kamir 
Garces-Mejias, 72 FR 54931, 54935 (2007); United Prescription Services, 
Inc., 72 FR 50397, 50407 (2007).\19\
---------------------------------------------------------------------------

    \19\ On October 15, 2008, the President signed into law the Ryan 
Haight Online Pharmacy Consumer Protection Act of 2008, Public Law 
110-425, 122 Stat. 4820 (2008). Section 2 of the Act prohibits the 
dispensing of a prescription controlled substance ``by means of the 
Internet without a valid prescription,'' and defines, in relevant 
part, the ``[t]he term `valid prescription' [to] mean[] a 
prescription that is issued for a legitimate medical purpose in the 
usual course of professional practice by * * * a practitioner who 
has conducted at least 1 in-person medical evaluation of the 
patient.'' 122 Stat. 4820 (codified at 21 U.S.C. 829(e)(1) & (2)). 
Section 2 further defines ``[t]he term `in-person medical 
evaluation' [to] mean[] a medical evaluation that is conducted with 
the patient in the physical presence of the practitioner, without 
regard to whether portions of the evaluation are conducted by other 
health professionals.'' Id. (codified at 21 U.S.C. 829(e)(2)(B)). 
These provisions do not, however, apply to Respondent's conduct.

---------------------------------------------------------------------------

[[Page 66146]]

    It is undisputed that Respondent prescribed for the eDrugstore Web 
site and issued numerous prescriptions for phentermine, a schedule IV 
controlled substance, to persons located throughout the United States. 
As the MQAC found, Respondent did not take a medical history on any of 
these persons and did not perform physical examinations of them. As the 
MQAC further found, he did not obtain each person's medical records and 
did not attempt to verify (and had no way to verify) the information 
which these persons provided. Yet as the MQAC found, he diagnosed each 
person and prescribed to them. As the MQAC found, and as Dr. Van Komen 
testified, Respondent failed to comply with the standard of care for 
prescribing phentermine.\20\
---------------------------------------------------------------------------

    \20\ At the hearing, Respondent contended that the Government 
violated his right to Due Process by introducing the evidence 
regarding the MQAC's 2005 statement of charges and its 2007 order 
because the Government did not make any allegations in the Show 
Cause Order regarding the first MQAC proceeding. Tr. 322. Respondent 
did not dispute, however, that the documents were noticed in the 
Government's pre-hearing statement and that they were timely 
exchanged. Id. at 324-25. The ALJ properly overruled Respondent's 
objection in holding that the Government had complied with due 
process.
     One of the fundamental tenets of Due Process is that the Agency 
must provide a respondent with notice of those acts which the Agency 
intends to rely on in seeking the revocation of its registration so 
as to provide a full and fair opportunity to challenge the factual 
and legal basis for the Agency's action. See NLRB v. I.W.G., Inc., 
144 F.3d 685, 688-89 (10th Cir. 1998); Pergament United Sales, Inc., 
v. NLRB, 920 F.2d 130, 134 (2d Cir. 1990). See also 5 U.S.C. 554(b) 
(``Persons entitled to notice of an agency hearing shall be timely 
informed of * * * the matters of fact and law asserted.'').
     However, `` `[p]leadings in administrative proceedings are not 
judged by the standards applied to an indictment at common law.' '' 
Citizens State Bank of Marshfield v. FDIC, 751 F.2d 209, 213 (8th 
Cir. 1984) (quoting Aloha Airlines v. Civil Aeronautics Bd., 598 
F.2d 250, 262 (DC Cir. 1979)). See also Boston Carrier, Inc. v. ICC, 
746 F.2d 1555, 1560 (DC Cir. 1984) (quoted in Edmund Chein, 72 FR 
6580, 6592 n.21 (2007) (``an agency is not required `to give every 
[Respondent] a complete bill of particulars as to every allegation 
that [he] will confront' ''). Thus, the failure of the Government to 
disclose an allegation in the Order to Show Cause is not 
dispositive, and an issue can be litigated if the Government 
otherwise timely notifies a respondent of its intent to litigate the 
issue.
     The Agency has thus recognized that ``the parameters of the 
hearing are determined by the prehearing statements.'' Darrell 
Risner, D.M.D., 61 FR 728, 730 (1996). Accordingly, in Risner, the 
Agency held that where the Government has failed to disclose ``in 
its prehearing statements or indicate at any time prior to the 
hearing'' that an issue will be litigated, the issue cannot be the 
basis for a sanction. 61 FR at 730. See also Nicholas A. Sychak, d/
b/a Medicap Pharmacy, 65 FR 75959, 75961 (2000) (noting that the 
function of pre-hearing statements is to provide Due Process through 
``adequate * * * disclosure of the issues and evidence to be 
submitted in * * * proceedings''); cf. John Stafford Noell, 59 FR 
47359, 47361 (1994) (holding that notice was adequate where 
allegations were not included in Order to Show Cause but ``were set 
forth in the Government's Prehearing Statement'').
---------------------------------------------------------------------------

    It is acknowledged that the MQAC found that there was no evidence 
that Respondent ``diverted controlled substances * * * for illegitimate 
purpose in violation of any drug law.'' GX 28, at 8. However, the MQAC 
did not explain what legal standard it applied in making this finding. 
While the State of Washington can, of course, apply any standard it 
chooses in defining diversion for purposes of State law, the State has 
no authority to definitively interpret the CSA and determine what 
constitutes diversion under Federal law.
    Several Federal courts of appeals have held that conduct similar to 
what the MQAC found Respondent to have engaged in by prescribing 
phentermine over the Internet violates the prescription requirement of 
Federal law and constitutes an unlawful distribution under 21 U.S.C. 
841(a). See United States v. Nelson, 383 F.3d 1227, 1231-32 (10th Cir. 
2004) (upholding physician's conviction for conspiracy to distribute 
prescription controlled substances ``outside the usual course of 
professional practice'' through internet scheme when physician approved 
``prescription drug requests * * * without ever examining his purported 
patient''); see also United States v. Smith, 573 F.3d 639, 657-58 (8th 
Cir. 2009) (upholding conviction of operator of internet drug 
distribution scheme for violations of 21 U.S.C. 841(a)(1) where `` 
`[t]here was never an established doctor/patient relationship. There 
was never a face-to-face examination. There was never a history. There 
was no physical examination.' '' (citation omitted)); United States v. 
Fuchs, 467 F.3d 889 (5th Cir. 2006) (rejecting pharmacist's challenge 
to convictions for dispensing controlled substance ``not in the usual 
course of professional practice in violation of 21 U.S.C. 841(a);'' 
scheme involved customers going to pharmacist's Web site, completing an 
online profile and requesting medication, which was then forwarded to 
physician who ``reviewed the patient's profile and approved and signed 
the prescription without communicating with the patient either face to 
face or over the telephone'').
    As these decisions make plain, a physician acts outside of the 
usual course of professional practice and lacks a legitimate medical 
purpose when he issues a controlled substance prescription to a person 
with whom he has not established a legitimate doctor-patient 
relationship. As the MQAC's finding makes clear--and as Dr. Van Komen's 
testimony corroborates--by failing to take a medical history, review 
medical records and perform physical examinations, Respondent did not 
establish a legitimate doctor-patient relationship with any of the 
persons he prescribed phentermine to through eDrugstore. Tr. 330 & 360-
61.
    Respondent's conduct was not simply ``malpractice, or even 
intentional malpractice.'' United States v. Feingold, 454 F.3d 1001, 
1010 (9th Cir. 2006). Rather, he ``wantonly ignored the basic protocols 
of the medical profession'' and ``his actions completely betrayed any 
semblance of legitimate medical treatment.'' Id. Accordingly, I hold 
that Respondent, in issuing phentermine prescriptions for eDrugstore, 
acted outside of the usual course of professional practice and lacked a 
legitimate medical purpose and therefore violated Federal law. 21 
U.S.C. 841(a)(1); 21 CFR 1306.04(a). And to make clear for purposes of 
Federal law, where, as here, a physician violates the CSA's 
prescription requirement, the drug is deemed diverted.\21\
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    \21\ The MQAC also found that Respondent had prescribed 
controlled substances to three State residents and yet had ``failed 
to keep any medical records for these patients'' and thus lacked 
documentation of having taken the patient's history, physical exam, 
and had no ``documentation of any kind to support the patient's 
diagnosis and treatment.'' GX 28, at 7. Here again, the MQAC found 
that Respondent had committed unprofessional conduct and violated 
the standard of care applicable under Washington law. Id. However, 
the MQAC found that the State had failed to prove that Respondent 
lacked a therapeutic purpose in issuing these prescriptions.
    While the ALJ's opinion erroneously suggests that the CSA 
requires that a physician maintain patient records, see ALJ at 26-
27, the CSA requires only that a doctor maintain records showing the 
disposition of controlled substances which are dispensed and 
administered (but not prescribed) as a regular part of his 
professional practice. See 21 CFR 1304.04(d). However, a 
practitioner's failure to maintain records required under State law 
which relate to the prescribing of controlled substances is properly 
considered by the Agency under factors two, four, and five of the 
public interest standard.
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    I further find that the Government has proved by a preponderance of 
the

[[Page 66147]]

evidence that Respondent also wrote the prescriptions which were 
identified as having been ordered through the Heynowmeds Web site and 
which were filled by the Saran pharmacies. See GXs 2-5. Relatedly, I 
reject Respondent's affirmative defense that his name, signature and 
DEA registration number were ``stole[n] and misused'' by Abel 
Rodriguez.
    As found above, Respondent's name, registration number, and 
signature were found on more than 130 controlled substance 
prescriptions which were intercepted by the Government in its 
investigation of the Saran conspiracy; \22\ these prescriptions were 
clearly distributed as evidenced by the attached shipping labels. GX 3. 
The presence of Respondent's name, registration number, and signature 
on these prescriptions creates a rebuttable presumption that he 
authorized them. Moreover, during the execution of search warrants at 
both CHS/ISG and the home of one of Saran's co-conspirators, 
Investigators seized a document which listed Respondent as the 
prescribing physician for several Web sites whose prescriptions were 
filled at Saran's pharmacies. Finally, in an interview with 
investigators, Respondent admitted that he had travelled from 
Washington State to Florida to meet Abel Rodriguez and that he had 
written prescriptions for Rodriguez (although he denied writing 
controlled substance prescriptions for his Web site).
---------------------------------------------------------------------------

    \22\ The act of writing a prescription, by itself, constitutes 
the delivery of a controlled substance under Federal law even if the 
prescription is never dispensed by a pharmacy.
---------------------------------------------------------------------------

    Respondent did not testify in this proceeding. Instead, to support 
his defense, he put forward: (1) The results of a polygraph 
examination; (2) an affidavit submitted by Florida law enforcement 
officers in support of an arrest warrant for Abel Rodriguez, which 
stated that another physician's signature was used by an associate of 
Rodriguez to authorize prescriptions even though the physician was not 
involved in prescribing the drugs; and (3) the testimony of a DI who 
served the Show Cause Order and interviewed him later the same day 
during which he denied having written prescriptions for Heynowmeds.
    Respondent's evidence is not sufficient to rebut the presumption 
that he wrote the prescriptions. With respect to the polygraph 
evidence, even putting aside the criticism of the Government's expert 
regarding the manner in which the test was administered, there is no 
consensus among the scientific community and the courts that polygraph 
evidence is reliable. See United States v. Scheffer, 523 U.S. at 309. 
As explained above, this evidence does not meet the standard of 
reliability imposed by the APA.
    As for the affidavit's statement (which was based on the statement 
of one of Rodriguez's associates) that another physician's signature 
was used without his authority, all this establishes is that that 
physician's signature was misused. It does not prove that Respondent's 
registration was misused in writing the prescriptions.
    Finally, Respondent relies on his statement to the DIs in which he 
denied that he wrote the controlled substance prescriptions identified 
in the Order to Show Cause. Respondent also points to the testimony of 
the DI that she found him to be credible.
    However, Respondent's interview was not sworn. Moreover, the DI who 
did the interview was based in Seattle, had no previous role in the 
Saran investigation which was run by the Fort Worth, Texas office, and 
thus was not familiar with what the investigation had uncovered. 
Accordingly, the DI did not have the underlying knowledge of the facts 
of the investigation necessary to probe Respondent's story and to 
evaluate his credibility.
    Beyond this, there is no reason to give dispositive weight to this 
statement when Respondent could have testified (and subjected himself 
to cross-examination) at his hearing but chose not to. It is well 
established that the Agency can draw an adverse inference from a 
respondent's failure ``to testify in response to probative evidence 
offered against'' him. See Baxter v. Palmigiano, 425 U.S. 308, 316 
(1976); see also United States v. Solano-Godines, 120 F.3d 957, 962 
(9th Cir. 1997) (``In civil proceedings * * * the Fifth Amendment does 
not forbid fact finders from drawing adverse inferences against a party 
who refuses to testify.''). It is appropriate to draw an adverse 
inference here, where the Government produced evidence showing that his 
name, registration number and signature were used to authorize 
controlled substance prescriptions and Respondent failed to 
testify.\23\
---------------------------------------------------------------------------

    \23\ In his brief, Respondent argues that the Government has not 
met its evidentiary burden because it did not present additional 
evidence establishing his involvement with Heynowmeds such as 
``proof of payments'' to him from Heynowmeds or ``testimony from an 
undercover officer or from bona fide drug-seeking customers about 
direct contacts with'' him. Resp. Br. at 34-36. Respondent's 
position would have some merit if he had presented substantial, 
reliable and probative evidence that he was not involved with 
Heynowmeds. He did not.
     I further note that while Respondent promised to turn over his 
bank records, he never did.
---------------------------------------------------------------------------

    I thus find that Respondent authorized the intercepted 
prescriptions. And for the same reasons that I found that the 
phentermine prescriptions violated Federal law (i.e., he did not 
establish a legitimate doctor/patient relationship with those he 
prescribed for), I conclude that these prescriptions were also issued 
outside of the usual course of professional practice and lacked a 
legitimate medical purpose and thus violated Federal law. See 21 U.S.C. 
841(a)(1); 21 CFR 1306.04(a).
    The prescriptions violated Federal law for a further reason. As the 
Supreme Court explained shortly after the CSA's enactment, ``[i]n the 
case of a physician[,] [the Act] contemplates that he is authorized by 
the State to practice medicine and to dispense drugs in connection with 
his professional practice.'' United States v. Moore, 423 U.S. at 140-
41. See also 21 U.S.C. 802(21) (defining ``[t]he term `practitioner' 
[to] mean[] a physician * * * or other person licensed, registered, or 
otherwise permitted, by the United States or the jurisdiction in which 
he practices * * * to dispense * * * a controlled substance in the 
course of professional practice.''). Accordingly, DEA has held that 
``[a] physician who engages in the unauthorized practice of medicine 
under state law is not a `practitioner acting in the usual course of * 
* * professional practice,' '' and that ``[a] controlled-substance 
prescription issued by a physician who lacks the license necessary to 
practice medicine within a State is therefore unlawful under the CSA.'' 
United Prescription Services, Inc., 72 FR at 50407 (quoting 21 CFR 
1306.04(a)). Likewise, the MQAC's 2002 Guidelines clearly stated that 
``[p]hysicians who treat or prescribe through Internet Web sites are 
practicing medicine and must possess appropriate licensure in all 
jurisdictions where patients reside.'' GX 24, at 6. Because Respondent 
was licensed only in Washington State, the prescriptions identified in 
Government Exhibits 2-5 were unlawful under both Federal law and the 
laws of numerous States for this reason as well. See, e.g., Ala. Code 
Sec.  34-24-502 (2005); id. Sec.  34-24-51; Cal. Bus. & Prof. Code 
Sec.  2052 (2005) \24\; N.C. Gen.

[[Page 66148]]

Stat. Sec.  90-18; Tenn. Code Ann. Sec.  63-6-201; Tenn. Comp. R. & 
Regs. 0880-2.16; Tex. Occ. Code Ann. Sec. Sec.  151.056 & 155.001.
---------------------------------------------------------------------------

    \24\ See also Hageseth v. Superior Court, 59 Cal. Rptr. 3d 385 
(Ct. App. 2007) (upholding prosecution of out-of-State and 
unlicensed physician who prescribed drug to State resident over the 
Internet for the unauthorized practice of medicine); United 
Prescription Services, 72 FR at 50401 n.10 (discussing actions 
brought by Medical Board of California against out-of State 
physicians for prescribing to State residents).
---------------------------------------------------------------------------

    As the forgoing demonstrates, Respondent issued numerous controlled 
substance prescriptions in violation of both Federal and State laws. He 
also lacked the records required under Washington law to justify his 
prescribing of controlled substances. Accordingly, I conclude that the 
evidence presented by the Government on factors two and four satisfies 
its prima facie burden of showing that granting Respondent's 
application ``would be inconsistent with the public interest.'' 21 
U.S.C. 823(f).

Sanction

    Under Agency precedent, where, as here, ``the Government has proved 
that a registrant has committed acts inconsistent with the public 
interest, a registrant must ` ``present[] sufficient mitigating 
evidence to assure the Administrator that [he] can be entrusted with 
the responsibility carried by such a registration.'' ' '' Medicine 
Shoppe-Jonesborough, 73 FR 364, 387 (2008) (quoting Samuel S. Jackson, 
72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 
(1988))). ``Moreover, because `past performance is the best predictor 
of future performance,' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th 
Cir.1995), [DEA] has repeatedly held that where a registrant has 
committed acts inconsistent with the public interest, the registrant 
must accept responsibility for [his] actions and demonstrate that [he] 
will not engage in future misconduct.'' Medicine Shoppe, 73 FR at 387; 
see also Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 
(2006); Cuong Tron Tran, 63 FR 64280, 62483 (1998); Prince George 
Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v. DEA, 419 F.3d at 
483 (``admitting fault'' is ``properly consider[ed]'' by DEA to be an 
``important factor[]'' in the public interest determination).
    The ALJ did not acknowledge any of these cases in her recommended 
decision. See ALJ at 30-32. Instead, she noted that it was 
``appropriate to consider all of the facts and circumstances'' which, 
in her view, include that he ``was cooperative and truthful when 
working with DEA personnel,'' the Medical Board's 2007 finding that 
``there was no evidence that [he] mishandled controlled substances 
during the MQAC's'' June's 2005 investigation, and ``most 
significant[ly],'' that under the MQAC's 2009 Order, Respondent is now 
being supervised by another physician. Id. Apparently, the ALJ also 
deemed it significant that since the institution of the proceeding, the 
Agency had not found any evidence of Respondent's mishandling of 
controlled substances. Id. at 31-32. Expressing her belief that ``this 
proceeding has instilled in the Respondent a grave respect for the 
authority and responsibilities which attach to his DEA registration,'' 
the ALJ recommended that Respondent ``be given an opportunity to 
demonstrate, during his mentorship, his continuing ability and 
willingness to comply with the statutory and regulatory provisions that 
adhere to a * * * registration.'' Id. at 32.
    The ALJ's reasoning is unpersuasive. While it is true that the MQAC 
found no diversion in its 2005 investigation, as explained above, under 
Federal law, when prescriptions are issued outside of the usual course 
of professional practice and lack a legitimate medical purpose, 21 CFR 
1306.04(a), the drugs are deemed to have been diverted. Indeed, in 
other decisions involving practitioners who prescribed over the 
Internet, DEA has noted the egregious nature of this misconduct and the 
serious threat it poses to public health and safety. See William R. 
Lockridge, 71 FR 77791, 77800 (2006) (noting that internet prescriber 
``was a drug dealer'' and that conduct created ``imminent danger to 
public health and safety''); Mario Avello, 70 FR 11695, 11697 (2005); 
cf. Southwood Pharmaceuticals, Inc., 72 FR 36487, 36504 (2007) 
(discussing increase in the rates of prescription drug abuse and the 
Internet's ``role in facilitating the growth of prescription drug 
abuse''); see also National Center on Addiction and Substance Abuse, 
``You've Got Drugs!'' IV: Prescription Drug Pushers on the Internet 
(2007), at 11 (``[T]he wide availability of dangerous and addictive 
drugs on the Internet reveals a wide-open channel of distribution. This 
easy availability has enormous implications for public health, 
particularly the health of our children, since research has documented 
the tight connection between availability of drugs to young people and 
substance abuse and addiction.'') (GX 32).
    Moreover, as explained above, the Federal courts have recognized 
that prescribing controlled substances under these circumstances (i.e., 
without taking medical history, physically examining the patient, and 
maintaining patient records) constitutes drug dealing. See Nelson, 383 
F.3d at 1231-32 (``A practitioner has unlawfully distributed a 
controlled substance if she prescribes the substance either outside the 
usual course of medical practice or without a legitimate medical 
purpose.''); United States v. Quinones, 536 F.Supp.2d 267, 271 
(E.D.N.Y. 2008) (rejecting motion to dismiss indictment under 21 U.S.C. 
841; ``[t]hat the moving defendants allegedly carried out their 
activities through the Internet is of no consequence. Two circuit 
courts have approved the application of the Federal drugs laws to the 
operation of Internet pharmacies.'') (citing Nelson, 383 F.3d 1227, and 
Fuchs, 467 F.3d 889). Contrary to the ALJ's understanding, Respondent's 
internet prescribing does not involve minor regulatory violations, but 
rather egregious acts which go to the core of the CSA's statutory 
purpose of preventing diversion and abuse.
    As noted above, the ALJ did not even acknowledge the extensive 
Agency case law which holds that where a registrant has committed acts 
which render his registration inconsistent with the public interest, he 
must do two things: (1) Accept responsibility for his actions, and (2) 
demonstrate that he will not engage in future misconduct. Accordingly, 
the ALJ made no finding as to whether Respondent has accepted 
responsibility for his misconduct.
    However, the Agency is the ultimate fact finder so I do make a 
finding. Based on Respondent's failure to testify in this proceeding, 
as well as his maintaining that he has done nothing wrong, I find that 
he has not accepted responsibility for his misconduct. See, e.g., 
Hoxie, 419 F.3d at 483 (``admitting fault'' is ``properly considered'' 
to be an ``important factor''). Given the egregious nature of his 
misconduct, Respondent's failure to acknowledge his wrongdoing provides 
reason alone to hold that he has not rebutted the Government's prima 
facie case.\25\ Accordingly,

[[Page 66149]]

Respondent's application will be denied.
---------------------------------------------------------------------------

    \25\ None of the other circumstances identified by the ALJ is 
sufficient to overcome Respondent's failure to acknowledge his 
misconduct, and only one of them--his being monitored by a mentor--
would tend to establish that he can be entrusted with a new 
registration.
     If Respondent had accepted responsibility, the MQAC's 
limitation of his practice to an office-based setting, which is 
supervised by another physician who must report to the MQAC, would 
be entitled to some weight. However, the gravamen of this case 
involved Respondent's misconduct in prescribing over the Internet 
and not his prescribing in a clinical setting. Thus, it is not clear 
that Respondent's mentor has either the authority or the capability 
to properly monitor him to ensure that he does not engage in 
internet prescribing. Respondent has therefore also failed to carry 
his burden with respect to showing that he can be entrusted with a 
new registration.
     As for the ALJ's finding that he was ``cooperative,'' this 
ignores that during his interview with the DIs he agreed to provide 
them with his bank records but never did. While the ALJ also noted 
that Respondent was ``truthful,'' this finding was based on an 
opinion of an Investigator who lacked adequate information to 
properly assess his credibility. Moreover, the inconsistency between 
Respondent's claim that in prescribing for eDrugstore he only wrote 
a ``small minority'' of controlled substance prescriptions and the 
evidence regarding the total number of prescriptions, the amounts he 
was paid for the respective types of prescriptions, and his 
compensation, provides further reason to question the ALJ's 
conclusion.
     The ALJ also found it significant that the Agency had not 
produced any evidence that Respondent mishandled controlled 
substances since the institution of the proceeding. However, because 
Respondent failed to file a timely renewal application, thus 
allowing his registration to expire (and also had his State license 
suspended), he lacked authority to handle controlled substances for 
a substantial portion of this period. In addition, the weight to be 
given this circumstance is significantly diminished by the fact that 
he was then in the midst of a Show Cause Proceeding.
     Finally, the ALJ did not cite any evidence to support her 
belief that ``this proceeding has instilled in the Respondent a 
grave respect for the authority and responsibility which attach to 
his DEA registration.'' ALJ at 32. Given the egregious misconduct 
proved on this record, rather than take a leap of faith, I rely on 
the Agency's longstanding rule which requires that a registrant 
acknowledge his misconduct and the relevant evidence or, as in this 
case, the lack thereof.
---------------------------------------------------------------------------

Order

    Pursuant to the authority vested in me by 21 U.S.C. 824(a), as well 
as 28 CFR 0.100(b) & 0.104, I order that the pending application of 
George Mathew, M.D., for a DEA Certificate of Registration as a 
practitioner be, and it hereby is, denied. This Order is effective 
November 26, 2010.

    Dated: October 17, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-27094 Filed 10-26-10; 8:45 am]
BILLING CODE 4410-09-P