[Federal Register Volume 75, Number 241 (Thursday, December 16, 2010)]
[Notices]
[Pages 78745-78754]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31650]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 08-43]


Ronald Lynch, M.D.; Revocation of Registration

    On April 4, 2008, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Ronald Lynch, M.D. (Respondent), of Sanford, 
Florida. The Show Cause Order proposed the revocation of Respondent's 
DEA Certificate of Registration, BL6686541, and the denial of any 
pending applications to renew or modify his registration, on the ground 
that Respondent's ``continued registration is inconsistent with the 
public interest, as that term is defined in 21 U.S.C. Sec. Sec.  
823(f), 824(a)(4).'' ALJ Ex. 1, at 1.
    The Show Cause Order alleged that Respondent ``authorized 
controlled substance prescriptions for Internet customers throughout 
the United States from approximately June 2002, through September 2004, 
on the basis of online questionnaires and/or telephone consultations.'' 
Id. The Order alleged that Respondent ``issued these prescriptions 
without a legitimate medical purpose and outside the usual course of 
professional practice, in violation of 21 CFR 1306.04(a) and 21 U.S.C. 
841(a)(1).'' Id. The Order further alleged that, while Respondent 
authorized controlled substance ``drug orders'' for ``online customers 
throughout the United States,'' he is only licensed to practice 
medicine in the State of Florida and that he ``violated state laws that 
prohibit the unauthorized practice of medicine, including unlicensed, 
out-of-state physicians issuing controlled substance prescriptions to 
state residents.'' Id. at 2 (citations omitted). Finally, the Order 
alleged that Respondent ``violated Florida law and regulation 
prohibiting licensed physicians from issuing controlled substance 
prescriptions in excessive or inappropriate quantities, and from 
issuing prescriptions via the Internet without a documented patient 
evaluation and discussion between the physician and patient regarding 
treatment options.'' Id. (citing Fla. Stat. Sec.  458.331(q) and Fla. 
Admin. Code Ann. r. 64B8-9.014).
    On May 7, 2008, Respondent's counsel requested a hearing on 
allegations, ALJ Ex. 2, and the matter was placed on the docket of the 
Agency's Administrative Law Judges (ALJs). On March 24-25, 2009, a 
hearing was held in Arlington, Virginia.
    At the hearing, the Government called several witnesses (including 
the Respondent) to testify and introduced documentary evidence. 
Respondent also testified on his own behalf. Following the hearing, 
both parties filed briefs containing their proposed findings of fact, 
conclusions of law, and argument.
    On September 18, 2009, the ALJ issued her recommended decision 
(also ALJ). Therein, the ALJ, after considering the five public 
interest factors, see 21 U.S.C. 823(f), concluded that ``Respondent has 
misused his DEA registration [in] the past and has not shown any 
indication that he will not do so in the future.'' ALJ at 46. The ALJ 
thus recommended that Respondent's ``registration be revoked and that 
any pending applications be denied.'' Id.
    As to the first factor--the recommendation of the appropriate state 
licensing board--the ALJ found that Respondent's continued licensure by 
the State of Florida ``throughout the relevant time period'' weighed 
``in favor of a finding that his continued registration would not be 
inconsistent with the public interest.'' Id. at 34. However, the ALJ 
also noted that ``state licensure is a necessary but not sufficient 
condition for [holding a] DEA registration'' so that ``this factor is 
not dispositive.'' Id.
    Examining factors two and four together--Respondent's experience in 
handling controlled substances and his compliance with applicable 
Federal, State or local laws--the ALJ determined that ``both the 
Controlled Substances Act and the Florida telemedicine standards 
require that the prescribing physician or a provider under his 
supervision personally conduct a physical examination.'' Id. at 38-39. 
The ALJ found that because Respondent failed to perform such 
examinations, ``he did not establish a proper doctor-patient

[[Page 78746]]

relationship'' and, as a result, ``was not a practitioner `acting in 
the usual course of his professional practice' '' and thus ``violated 
21 U.S.C. 841(a)(2).'' \1\ Id. at 39. The ALJ also concluded that 
Respondent's ``failure to review medical records prior to prescribing 
controlled substances was a violation of Florida standards for 
telemedicine'' and that he therefore ``failed to satisfy the 
requirements for a doctor-patient relationship; did not act in the 
usual course of his professional practice; and thereby violated the 
Controlled Substances Act.'' Id. at 40.
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    \1\ This appears to be a typographical error given that there is 
no evidence that Respondent was unlawfully distributing or 
dispensing ``a counterfeit substance.'' 21 U.S.C. 841(a)(2). The 
correct provision is section 841(a)(1).
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    The ALJ further found that Respondent had permitted ``Ken Drugs to 
use a rubber stamp bearing his signature to issue prescriptions for 
controlled substances'' and that this constituted a violation of 21 CFR 
1306.05(a), which generally requires that prescriptions ``be manually 
signed by the practitioner.'' Id. at 40-41; 21 CFR 1306.05(a). Next, 
the ALJ found that ``Respondent authorized refills for controlled 
substance prescriptions without a legitimate purpose'' such that ``the 
decision whether or not to dispense these refills was made by Ken Drugs 
personnel, and not by Respondent,'' thereby violating Florida 
Administrative Code r. 64B8-9.014. ALJ at 41. The ALJ therefore 
concluded that ``factors two and four weigh in favor of a finding that 
Respondent's continued registration would be inconsistent with the 
public interest.'' Id. at 43.
    With respect to the third factor--Respondent's conviction record 
under Federal or state laws relating to controlled substances--the ALJ 
found that ``Respondent has never been convicted'' of an offense 
related to the manufacture, distribution or dispensing of controlled 
substances. Id. However, the ALJ also noted that this factor was not 
dispositive. Id.
    As for factor five--other conduct which may threaten public health 
and safety--the ALJ found that ``Respondent maintained throughout the 
hearing . . . that any shortcomings involving Ken Drugs' Internet 
patients were due largely to the system set up by the Kennedee Group, 
and not to any irresponsibility on his part.'' Id. Noting that ``[a]s a 
DEA registrant, Respondent bears full responsibility for understanding 
his obligations under the Controlled Substances Act and related Federal 
regulations,'' the ALJ found that Respondent's ``claims merely 
demonstrate [his] unwillingness to accept his responsibilities as a DEA 
registrant'' and that his ``refusal or inability to acknowledge 
outright that he acted improperly in basing prescriptions on these 
telephone conversations suggests an unwillingness to recognize that he 
abrogated his responsibilities as a DEA registrant.'' Id. at 43 & 44.
    The ALJ thus found that Respondent had failed ``to accept 
responsibility for his actions'' and that his continued registration 
``poses a threat to the public health and safety.'' Id. at 45. She thus 
concluded that factor five also supported ``a finding that Respondent's 
continued registration would be inconsistent with the public 
interest.'' Id.
    Neither party filed exceptions to the ALJ's recommended decision. 
Thereafter, the ALJ forwarded the record to me for final agency action.
    Having considered the entire record in this matter, I adopt the 
ALJ's findings of fact including those related to the credibility of 
the witnesses. I also adopt her conclusions of law except for her 
conclusion that under the Florida telemedicine rule, Respondent, as the 
prescribing physician, was required to conduct the physical examination 
or to direct another health care provider in the performance of the 
examination. See ALJ at 38. However, I agree with the ALJ's conclusion 
that Respondent violated the Florida telemedicine rule in those 
instances when he prescribed without having obtained a documented 
patient evaluation, id., and that Respondent has failed to accept 
responsibility for his misconduct. I further conclude that Respondent 
violated various state laws and the Controlled Substances Act by 
prescribing controlled substances to residents of States where he was 
not authorized to practice medicine, as well as by prescribing 
controlled substances without having performed a physical exam on the 
residents of various States, whose laws require a prescribing physician 
to have personally performed a physical exam of his patient. I 
therefore adopt the ALJ's recommendation to revoke Respondent's 
registration and to deny any pending applications. I make the following 
factual findings.

Findings

    Respondent is a physician who is board-certified in family practice 
and holds a medical license issued by the State of Florida.\2\ Tr. 191 
& 279. In 1999, Respondent also obtained a license to practice medicine 
in the State of New York; however, he believes that this authority has 
now expired. Id. at 191-92. He is not, and never has been, licensed in 
any other State. Id. at 193.
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    \2\ Respondent testified that he is a member of the American 
Academy of Environmental Physicians. Tr. 282.
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    Respondent currently holds DEA Certificate of Registration 
BL6686541, which was last renewed on March 8, 2006 and was due to 
expire on March 31, 2009. GX 1. However, on February 9, 2009, 
Respondent submitted an application to renew his registration. 
Accordingly, because Respondent's application was timely submitted in 
accordance with the Agency's rule, his registration has remained in 
effect pending the issuance of this Decision and Final Order. See 5 
U.S.C. 558(c); 21 CFR 1301.36(i).
    In 2002, Respondent began working for the Kennedy Medical Clinic, 
Inc.,\3\ as a family physician.\4\ Id. at 194. On April 8, 2002, 
Kenneth Shobola, a Florida-registered pharmacist, incorporated Kennedy 
Medical Clinic, Inc., under the laws of the State of Florida; Shobola 
is the president and registered agent of the corporation, which 
operated two medical clinics in Tampa, Florida. GX 2, at 8.
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    \3\ Throughout this proceeding, the clinic was referred to 
simply as the ``Kennedy Clinic.''
    \4\ At some point while he was working for the Kennedy Clinic, 
Respondent also started his own practice, Integrative Natural 
Solutions. Id. at 68, 73, 194. Integrative Natural Solutions 
occupied one floor of an office building at the same address as the 
Kennedy Clinic in Kissimmee, Florida when, on September 21, 2004, a 
search warrant was executed at both offices, as well as at other 
locations. Id. at 16, 68.
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    On the same date, Shobola also incorporated Ken Drugs, Inc. Id. at 
7. Shobola also served as president of this entity and was its sole 
shareholder. Id. This entity owned four pharmacies, three of which were 
located in Tampa, the other in Kissimmee, Florida. Id. at 7-8.
    Shobola also incorporated and was the president of the Kennedee 
Group, Inc.\5\ Id. at 8. Two websites, medsviaweb.com and 
medsviaweb.net, were registered to the Kennedee Group at the address of 
1612 W. Waters Ave., Tampa, Florida; this was also the address of one 
of the Ken Drugs pharmacies. Id. at 7.
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    \5\ This entity was previously named Kenadee Group, Inc., and 
was also known as the Kenaday Group. GX 2, at 8.
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    In September 2002, the DEA Tampa Diversion Group received 
information that prescriptions for hydrocodone, a schedule III 
controlled substance, were being sent to another pharmacy through the 
medsviaweb.com website and that refills of these prescriptions were 
being filled by the Ken Drugs pharmacy

[[Page 78747]]

located on W. Waters Ave. in Tampa. Id. at 9-10. Moreover, ``the vast 
majority of clients seeking hydrocodone were from states other than 
Florida.'' Id. at 10.
    Based on this information, DEA opened an investigation. During the 
investigation, DEA, along with personnel from the Florida Department of 
Law Enforcement, the Florida Department of Health, the Kentucky State 
Police, and the Tampa Police Department made seventeen undercover 
purchases through either the medsviaweb.com website or through Ken 
Drugs of such drugs as hydrocodone and Xanax (a schedule IV controlled 
substance). Id. at 11.
    The Investigators obtained the drugs by filling out an online 
questionnaire, giving names, addresses, credit card information, dates 
of birth and purported medical conditions. Tr. 15; GX 2, at 10; see 
also GXs 6 & 10. After providing this information, a clerk from Ken 
Drugs' Tampa, Florida headquarters would call the Investigator and 
shortly thereafter, connect him/her with one of five different 
physicians employed by the Kennedee Group. Tr. 15; GX 2, at 11. A brief 
telephone consultation would occur with a physician who then issued a 
prescription for a controlled substance. Tr. 15; see also GX 2, at 11 
(``After the receipt of consultation payment * * *. the undercover 
purchaser would talk by telephone to an employee of Kennedee Group * * 
* who advised that the purchaser would have to telefax a medical record 
accompanied by a photocopy of his or her driver's license. Regardless 
of these requirements, the employee of Kennedee Group * * * customarily 
resumed telephonic contact with the aspirant purchaser immediately 
after payment of the $120 or $125 fee to advise that a doctor was 
available for an expeditious medical consultation soon after which, 
according to the employee, the controlled substances prescribed would 
be delivered to the purchaser by UPS or FedEx.'').
    According to a DEA Diversion Investigator (DI), 97 percent of the 
prescriptions were for hydrocodone, with the other 3 percent being for 
the schedule IV controlled substances alprazolam (generic for Xanax), 
and occasionally, diazepam (generic for Valium). See 21 CFR 1308.14(c); 
Tr. 15; see also GX 2, at 23 (``Between June 17 and September 9, 2004, 
a review of the Ken Drugs pharmacy records revealed that 4,842 
prescriptions were written for Schedule[] II, III, and IV controlled 
substances.\6\ The vast majority of the prescriptions were for 
hydrocodone and only a small number were for other controlled 
substances such as diazepam (Valium) and alprazolam (Xanax)''). The 
prescriptions were filled at one of Shobola's Ken Drug pharmacies in 
either Tampa or Kissimmee and then shipped to the customer. Tr. 16.
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    \6\ According to an affidavit prepared by an IRS Special Agent 
who participated in the investigation, ``[a] review of the 
prescriptions filled by the KEN DRUGS pharmacy on Waters Avenue in 
Tampa, Florida, from June of 2002 through of 2003, reveals that 
50,237 Schedule II, III, and IV prescriptions were filled. Further, 
that 48,793 prescriptions were written by Hameed, Lynch, Oluwole, 
Osuji, and Shyngle, and the vast majority were for hydrocodone.'' GX 
2, at 23.
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    In February 2004, the DI, using the undercover name ``Michael 
Patrick,'' made an undercover purchase from Ken Drugs. Id. at 39 & 44. 
Upon accessing http://www.medsviaweb.com, the DI registered as a 
patient and provided ``biographical data, credit card data, address 
data, information about allergies, [and] medical conditions.'' Id. at 
49-50; see GX 6 (screens printed out from medsviaweb.com). Next, 
because he lacked an undercover credit card, the DI called Ken Drugs in 
Tampa to ask whether he could purchase the controlled substance he was 
seeking with a postal money order; an employee of Ken Drugs approved 
this arrangement. Tr. 50.
    On February 6, the DI purchased the money order for $125 and sent 
it to Ken Drugs; several days later, the DI received a telephone call 
from Ken Drugs during which he was told that a medical consultation 
would follow if he would send a copy of his driver's license and 
medical records. Id.; see GX 8, at 1. While the DI could not remember 
whether he sent in a copy of his undercover driver's license, he did 
not send in any medical records. Tr. 50.
    The Government then played into the record Government Exhibit 7, an 
audio recording of the DI's telephone consultation with a Kennedee 
Group physician. A speaker, who identified herself as Jennifer, 
arranged for the consultation once she had confirmed that the DI's 
money order had been received. Tr. 31-32. Jennifer then asked the DI 
whether he had faxed his driver's license and medical records; the DI 
answered, ``Yes.'' Id. at 34. Jennifer then put the DI through to an 
individual who identified himself as Respondent. Id.
    The DI stated that he suffered ``back pain from an automobile 
crash'' and requested ``Vicodin extra strength.'' Id. He further 
explained that several years earlier another physician had 
``recommended'' Vicodin and that it had ``helped.'' Id. at 35. He also 
stated that he had not used Vicodin in several months. Id.
    Respondent recommended Lortab because it was something with less 
``Tylenol.'' \7\ Id. He then inquired as to the extent of the DI's back 
pain. Id. at 35-36. The DI stated that the back pain ``interfere[d] 
with [his] sleeping, can last for hours some days and for minutes in 
[sic] other days,'' and amounted to ``a little bit of interference.'' 
Id. at 36. The DI further offered that prior x-rays indicated that 
there was no structural damage. Id. Respondent then asked the DI how 
many pills he thought he would need per day; the DI responded two to 
three per day. Id. at 37. Respondent then stated: ``Let's say two, two 
would be fine,'' and indicated that the DI would be sent ``something 
that's actually a little safer for you and better than what you were 
asking for.'' Id. at 37-38.
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    \7\ Respondent testified that the voice on this recording 
sounded like his own. Tr. 223. As indicated infra, the prescription 
label on the vial identified the prescribing physician as Dr. Ronald 
Lynch. I therefore find that the individual identifying himself as 
Dr. Lynch in the telephone conversation recorded in Government 
Exhibit 7 is Respondent.
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    On February 12, 2004, the DI picked up the Lortab in person at Ken 
Drugs 3, which was located at 4730 North Havana Avenue in 
Tampa. Id. at 44. He received sixty tablets of hydrocodone/apap (10/
500), a drug which combines 10 mgs. of hydrocodone with 500 mgs. of 
acetaminophen in each tablet. Id. at 46; GX 8, at 2, 4. Laboratory 
testing confirmed that the tablets contained hydrocodone. Tr. 47. The 
label identified the prescribing physician as Respondent. GX 8 at 2, 4.
    The DI further testified that no physical examination was 
performed, that he did not know whether Respondent had a copy of the 
online questionnaire in front of him when he prescribed the Lortab, and 
that Respondent did not take a medical ``history'' or give him a 
``treatment plan.'' Tr. 41, 77-78.
    At DEA's request, on July 20, 2004, a Medical Quality Assurance 
Investigator with the Florida Department of Health (DOH) made an 
undercover purchase of hydrocodone through the website 
modernlifestylemeds.com; this prescription was also authorized by 
Respondent. Tr. 148; GX 9. According to the DOH Investigator, he 
registered as a customer, giving his undercover name of ``Donald 
Huntley,'' date of birth, home address, telephone number, and a medical 
complaint; he then requested Percodan. Tr. 149, 152-53; GX 9, at 1. On 
July 29, the DOH Investigator filled out a medical history form and 
received an e-mail confirming his name, date of birth, phone number, 
and his medical complaint. Tr. 150-152; GX 9, at 1. The

[[Page 78748]]

following day he received a telephone call from ``Jasmine at Modern 
Lifestyles,'' who asked ``what type of medication [he] was trying to 
obtain.'' Tr. 152; GX 9, at 1. After the DOH Investigator told her that 
he wanted Percodan, Jasmine replied that he could not get this drug 
(which is a schedule II controlled substance), but that he would be 
able to get Lortab at a cost of $177 for a thirty-day supply; she also 
instructed him to send in a copy of his driver's license and his 
medical records. Tr. 152; GX 9, at 1.
    On August 1, the DOH Investigator faxed a copy of his undercover 
driver's license but not his medical records, and on August 2, Jasmine 
called again to confirm that he wanted Lortab. Tr. 153; GX 9, at 1. 
Jasmine told the Investigator that he could not personally pick up the 
medication and that he would need to pay by credit card; he then gave 
her his undercover credit card information. GX 9, at 1. Jasmine did not 
ask about the medical records which the Investigator had failed to 
provide; she then put the Investigator through to an individual who 
identified himself as Respondent. GX 9, at 1; Tr. 154, 157.
    Respondent \8\ asked the Investigator his age and the cause of his 
pain. Tr. 154; GX 9, at 1. The Investigator responded that he was sixty 
years old and that he had injured his back some four to five years 
earlier while helping his son move furniture. Tr. 155; GX 9, at 1. 
Respondent further asked about other medications that the Investigator 
was taking and about whether he had any liver damage; the latter 
responded that he was taking Vicodin and Lortab and did not have liver 
damage. Tr. 155; GX 9, at 1. Respondent then asked the Investigator to 
provide the name of the physician he was currently seeing; the 
Investigator named a Dr. Cichon. Tr. 155; GX 9, at 1. After some three 
to five minutes, the conversation ended with Respondent stating that he 
would prescribe Lortab with three refills. Tr. 156; GX 9, at 1.
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    \8\ At this point in the hearing, counsel for Respondent 
objected to the witness referring to this individual as Dr. Lynch, 
the Respondent. Tr. 155. The ALJ overruled this objection. Id. In 
his testimony, Respondent did not dispute that he had prescribed to 
either the DEA or DOH Investigators. Moreover, the prescription 
label for the medication that was dispensed to the Investigator 
indicated that the prescribing physician was Dr. Ronald Lynch. GX 
10, at 2-3. I therefore find that Respondent was the individual who 
identified himself as Dr. Lynch.
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    In his testimony, the Investigator stressed that he never sent the 
required medical records, never met Respondent in person, and never 
underwent a physical examination by Respondent or anyone associated 
with the website he had accessed to obtain the medication. Tr. 157-158; 
see also GX 9, at 1-2.
    On August 4, the Investigator received a vial which contained 
hydrocodone/apap 10/500. Tr. 156; GX 9, at 2. The prescription was 
dispensed by Ken Drugs, Inc.'s pharmacy 3, which was located 
at 4730 North Habana Avenue in Tampa, Florida. Tr. 158; GX 9, at 2. The 
label on the vial indicated that it contained ninety pills and that 
Respondent was the prescribing physician. Tr. 159-60; GX 9, at 2; GX 
10, at 2, 3.
    On September 21, 2004, DEA executed a search warrant at seven 
locations associated with Ken Shobola and his Ken Drugs enterprise, two 
in Kissimmee and five in Tampa, including Respondent's Integrative 
Natural Solutions business, which was located at the same address as 
one of the Kennedy Clinic's offices. Tr. 16, 68, 73. As part of the 
search, the Investigators ``imaged [and] downloaded'' the files on 
thirty-three computers; they also seized another computer and sent it 
to the DEA forensics laboratory for analysis. Id. at 17.
    Among the items seized were records of ten controlled substance 
prescriptions which Respondent issued to residents of California, Ohio 
and Tennessee. Id. at 67; GX 18. Only one prescription bore 
Respondent's actual signature; this prescription was clearly faxed to 
the Kennedee Group. Tr. 226, GX 18, at 6. The other prescriptions bore 
a stamped signature and were electronically transmitted by Respondent. 
Tr. 226; GX 18, at 5-6.
    Three of the prescriptions were dispensed to residents of 
California; all of these prescriptions were for 90 tablets of 
hydrocodone/apap, containing either 7.5 or 10 mgs. of hydrocodone per 
tablet. GX 18, at 1-6. Six prescriptions were dispensed to residents of 
Tennessee; four of these were for 90 tablets of hydrocodone/apap 
containing 10 mgs. of hydrocodone, one was for 90 tablets of 
alprazolam, and one was for 60 tablets of diazepam. Id. at 7-10, 13-18. 
The remaining prescription, which was dispensed to a customer in Ohio, 
was for 90 hydrocodone/apap (10/500). Id. at 11-12.
    At least three physicians who worked for Shobola's scheme were 
interviewed by DEA Investigators. The lead DI testified that on October 
20, 2004, he interviewed a Dr. Ladapo Shyngle at his Tampa residence. 
Tr. 23; GX 2, at 9. During the interview, Dr. Shyngle stated that he 
did not have face-to-face meetings with the Ken Drugs customers he 
prescribed hydrocodone to; he also admitted that he did not review the 
customers' medical records in every case before prescribing controlled 
substances to them. Tr. 24; GX 5, at 15-16, 20; GX 17, at 2.
    Dr. Shyngle further admitted that as the number of Ken Drugs' 
customers increased, he saw their medical records before prescribing 
only approximately thirty percent of the time. GX 5, at 20-21; GX 17, 
at 1-2. According to Shyngle, Ken Drugs ``hired an institution'' that 
performed physical examinations for them. GX 5, at 25. Shyngle 
admitted, however, that the physicians were ``not always'' ``actually 
able to look at the information'' documenting those physical exams 
before they prescribed. Id.
    The DI also testified that on November 17, 2004, he interviewed a 
Dr. Chuma Osuji, Director of Medicine for Ken Drugs.\9\ Tr. 19-20, 82; 
GX 2, at 8; GX 4, at 5. The Government entered into evidence a 
transcript of the taped 2-hour interview of Dr. Osuji; the DI also 
testified as to the substance of the interview. Tr. 20-22; GX 4.
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    \9\ According to Dr. Osuji, although he was to be the medical 
director from the initial plans with Ken Shobola, there turned out 
to be ``many medical directors'' so that Dr. Osuji ultimately was 
not in charge of ``oversee[ing]'' the operation. GX 4, at 7. 
Apparently, there were a total of six medical directors. Id. at 42.
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    In the interview, Dr. Osuji admitted that he did not see the 
patients to whom he prescribed controlled substances; \10\ that most of 
the prescriptions he wrote were for hydrocodone; that, while he 
sometimes saw the medical records prior to, or at the time of 
prescribing, he ``frequently'' did not; and that all of the 
prescriptions authorized by the physicians retained by the Kennedee 
Group were filled at pharmacies owned by Ken Shobola. Tr. 20-21; GX 4, 
at 9-10, 30.
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    \10\ According to Dr. Osuji, the customers were supposedly seen 
by ``doctors, nurses, and [physicians assistants]'' before he spoke 
with them. GX 4, at 8.
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    Dr. Osuji also stated that he issued prescriptions by completing a 
form authorizing the prescription and faxing it to one of the Ken Drugs 
pharmacies for filling; the authorization was not ``manually'' signed. 
Tr. 88-89; GX 4, at 29-30. Dr. Osuji stated that Ken Drugs contracted 
with another company which was supposed to provide physical 
examinations of patients so Dr. Osuji assumed that the customers had 
undergone physical examinations prior to his prescribing to them. GX 4, 
at 25, 38. Also according to Dr. Osuji, one or two months earlier, he 
had learned that patients were not getting physical examinations 
(apparently after someone complained that he had paid for a physical 
and not received one). Tr. 21; GX 4, at 38-40, 47.

[[Page 78749]]

    Another DI testified that she participated in an interview of 
Respondent on the day the search warrant was executed. Tr. 168-69. She 
testified that Respondent conducted two different kinds of medical 
practice, the first an ``individual practice, which involved holistic 
medicine'' and was named Integrative Natural Solutions; the other was 
an ``internet pharmacy business, which was connected to the Ken Drugs 
business.'' Id. at 169.
    Respondent was hired by Shobola to write prescriptions for the 
Kennedee Group and was paid $30 per telephone consultation. Id. at 173. 
However, Respondent admitted that he was not paid if he did not 
authorize a prescription. Id. at 198. Respondent stated that he 
conducted approximately fifty consultations per week, ``usually no more 
than about 10 a [sic] day.'' Id. Respondent primarily prescribed 
hydrocodone. Id. at 171. The prescriptions were always filled by Ken 
Drugs. Id.
    Respondent contacted the customers by accessing the website 
``through the Kenned[ee] Group Corporation'' and then did telephone 
consultations with them. Id. at 170, 172-73. Respondent stated that he 
``talk[ed] with the patient [sic] regarding their medical concern, 
their medical need, if they had any problems, liver damage, if they had 
been taking medication, [and] what drugs or medication in particular 
they were seeking.'' Id.
    Respondent maintained that the customers' medical records were 
filed at the corporate offices of the Kennedee Group and that he would 
``periodically'' look at the records to determine patients' medical 
needs. Id. Respondent admitted, however, that his examination of the 
records did not ``necessarily'' occur ``before he dispensed the 
medication.'' Id. Respondent allowed the corporate office to ``use a 
rubber stamp with his signature, a custom stamp,'' to complete 
prescription authorizations. Id. at 172. He also told the Investigators 
that he was electronically transmitting the prescriptions to the 
pharmacy. Id. at 181.
    During the interview, Respondent stated that he ``believed that 
what he was doing was in line, because he thought that the Kenned[ee] 
Group were [sic] known. They [sic] had a big business and he felt he 
was doing what he thought was appropriate.'' Id. at 177. Respondent 
also stated that he believed that Shobola ``had looked into the 
legalities of the business[;] and he felt that with the size of the 
business, surely, what they were doing could not be wrong. He trusted 
the insight of Ken Shobola.'' Id. at 185.
    The Government also called Respondent to testify. The ALJ found, 
however, that Respondent's ``testimony was frequently at odds with that 
of the [other] Government witnesses'' and that he ``displayed a lack of 
candor and appeared to shade his testimony to support his position on 
the issues.'' ALJ at 32. She accordingly found ``the [other] Government 
witnesses more credible.'' Id.
    According to Respondent, the Ken Drugs corporate center was 
designed for telemedicine and not for the physical receiving and 
treating of patients. Id. at 202. He described the business as ``a 
nation-wide endeavor'' in which patients were serviced by regional 
staff which conducted home visits to ascertain such matters as whether 
the customers were minors. Id. at 203-04.
    In his testimony, Respondent admitted that the Ken Drugs scheme 
``[o]bviously[] did not lend itself to do[ing] any physical 
examination.'' Id. at 212-13. He further maintained that ``[v]ery 
often, the majority of the time * * * [a]t least 75 to 85 percent of 
the time'' he conducted his telephone consultations with the customers' 
medical records in front of him. Id. at 206. The ALJ did not find this 
testimony credible in light of his admission during the September 21, 
2004 interview that he did not necessarily review the records before he 
prescribed. ALJ at 39. Moreover, both the DEA and DOH Investigators 
testified that they did not send in their medical records prior to 
Respondent's prescribing hydrocodone to them. For the same reason, the 
ALJ did not credit Respondent's testimony that he would have to turn 
away Internet patients who did not provide medical records.\11\
    As to the potential for fraud in prescribing to persons he never 
met, Respondent admitted that ``the real doctor/patient relationship is 
based upon honesty,'' and that if the patients ``were liars'' ``they 
could break through.'' Id. at 206-07. Respondent then testified that 
the Shobola scheme used ``the team approach'' and that other employees 
were responsible for confirming the customers' identities and screening 
the required medical records and physical examination before he did his 
telephone consultations with them. Id. at 206-07, 220. According to 
Respondent, prior to his contacting the customers, the other employees 
obtained the required medical records, imaging studies, and sometimes, 
documentation of an actual in-person consultation with what he called a 
``mid-level provider.'' Id. at 199-200. This was so Respondent would 
not have ``to waste [his] time with being a police agent or * * * a 
lawyer.'' Id. at 208.
    He also maintained that customers ``wouldn't get me on the phone 
until they had gone through some of these hurdles.'' Id. at 208. Here 
again, Respondent's testimony is contradicted by the purchases made by 
the DEA and DOH Investigators, both of whom obtained hydrocodone 
without sending in their medical records.
    Later in his testimony, Respondent claimed that he could make a 
``judgment'' that persons were either drug abusers or drug seekers 
based on their ``voice,'' ``diction,'' and ``answers to some of the 
questions that I might have posed to them.'' Id. at 230. However, he 
then admitted that this ``is, by no means, any criteria to determine 
who is being evasive and who is being under-handed or who is 
legitimately seeking a substance. It is very, very less than perfect.'' 
Id. at 231.
    Respondent further maintained that ``[t]here was not one letter, 
not one comment from any medical quality boards or anyone, regarding 
safety, regarding guidance in any way'' as to ``the practice of 
telemedicine.'' Id. at 209. However, as explained below, at the time 
Respondent issued the prescriptions, substantial guidance was available 
as to the legality of this practice. Respondent further claimed that he 
was ``very glad that since that faithful [sic] day in September 2004'' 
(apparently the date on which the search warrant was executed) he had 
``not returned to internet medicine because [he] do[es] think it does 
have some holes in it.'' Id.
    Respondent also asserted that he visited the Ken Drugs corporate 
headquarters to meet the clerks and the personnel handling the 
telephone consultation transfers because he ``need[ed] to talk to them 
and find out that everything [was] happening legitimately and 
appropriately.'' Id. at 202. The record, however, contains no evidence 
that Respondent sought to independently determine whether the practices 
he was engaging in were legal. Moreover, the ALJ found Respondent's 
``asserted reliance on Ken Drugs' administrative personnel disingenuous 
at best.'' ALJ at 44.
    Respondent further maintained that he kept medical records ``of 
every conversation or most of the conversations'' in one of his 
notebooks. Tr. 210. However, when asked whether he wrote the 
prescriptions contained in Government Exhibit 18, Respondent stated 
that he did not bring his records with him to the hearing. Id. at 225-
26.

[[Page 78750]]

    Respondent further asserted that he discussed the patients' 
diagnoses with the patients and that he ``absolutely'' discussed 
alternative treatments such as physical therapy, magnetic therapy, 
acupuncture and eating ``certain anti-inflammatory foods.'' Id. at 210, 
214-15. He also maintained that he discussed the risks and benefits of 
treatment with controlled substances, i.e., the risk of ``habituation 
and the risk of acetaminophen damage,'' the latter concern compelling 
him to inquire always about blood tests, liver damage and kidney 
function. Id. at 216-17.
    While the evidence pertaining to the undercover purchases indicates 
that Respondent did discuss the risks to liver function caused by 
taking too much acetaminophen, there is no evidence that he discussed 
the risk of addiction caused by taking narcotics with either 
Investigator. Nor did Respondent even discuss, let alone recommend, to 
the DEA and DOH Investigators that they try alternative treatments.
    For Florida residents, Respondent claimed that he provided outside 
referrals and that it was ``fairly infrequent'' that customers did not 
have ``background'' MRIs, blood work, or x-rays. Id. at 213-14. 
However, he claimed that he could not do this for his out-of-state 
patients. Id. at 213.
    According to Respondent, the audio recording of his telephone 
consultation with the DEA DI was ``[n]ot necessarily'' representative 
of his typical consultation, as it was the ``minority of the time'' 
that he participated in a consultation without the medical records in 
front of him; he also claimed that he would later review the medical 
record if it was not available at the time of the consultation. Id. at 
224-25. He also maintained that he was ``[s]ometimes'' available to 
customers to review the ``course and efficacy of the treatment.'' Id. 
at 218.
    As for the prescriptions identified in Government Exhibit 18, 
Respondent maintained that he had actually signed only one of them. Tr. 
226 (discussing GX 18, at 6). As for the others, Respondent stated that 
they looked like they had been stamped. Id. at 228. However, he 
admitted that the stamp was a facsimile of his signature and that he 
``may have'' provided the Kennedy clinic with a stamp containing his 
signature. Id. He then stated that while ``it was [his] practice to 
sign'' the prescriptions ``when he could,'' he had granted ``the 
pharmacist'' at Ken Drugs ``some permission to use the stamp, if [he] 
was not able to do that'' himself. Id. at 229. With respect to those 
prescriptions which were stamped, Respondent could not even address 
whether he did ``indeed, * * * have a consultation with these * * * 
individuals.'' Id. at 228.
    Respondent also testified on his own behalf. Respondent primarily 
testified about his professional background and that in 2006, he had 
attended a course offered by the American Academy of Pain Management 
which included classes about DEA, controlled substances, and the use or 
misuse of opioids.\12\ Id. at 281-84. Respondent also further asserted 
that he has identified drug seeking patients in his ``current 
practice'' and that he handles them by discharging them. Id. He further 
testified that from 2005 on, he sees 100 percent of his patients in ``a 
face to face setting,'' and that he will diagnose a person he does not 
know over the telephone only in an emergency. Id. at 290.
---------------------------------------------------------------------------

    \12\ His testimony as to what subjects were covered was vague.
---------------------------------------------------------------------------

Discussion

    Section 304(a) of the Controlled Substances Act (CSA) provides that 
a registration to ``dispense a controlled substance * * * may be 
suspended or revoked by the Attorney General upon a finding that the 
registrant * * * has committed such acts as would render his 
registration under section 823 of this title inconsistent with the 
public interest as determined under such section.'' 21 U.S.C. 
824(a)(4). In the case of a practitioner, Congress directed that the 
following factors be considered in making the public interest 
determination:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The [registrant's] experience in dispensing * * * controlled 
substances.
    (3) The [registrant's] conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (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.

21 U.S.C. 823(f).

    ``[T]hese factors are considered in the disjunctive.'' Robert A. 
Leslie, 68 FR 15227, 15230 (2003). I may rely on any one or a 
combination of factors and give each factor the weight I deem 
appropriate in determining whether to revoke or renew an existing 
registration. Id. Moreover, I am ``not required to make findings as to 
all of the factors.'' Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 
2005); see also Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009).
    In this matter, I acknowledge that the State of Florida has taken 
no action against Respondent's medical license (factor one) and that 
Respondent has not been convicted of an offense related to controlled 
substances (factor three). However, under settled Agency precedent, 
``neither of these factors is dispositive.'' Joseph Gaudio, 74 FR 
10083, 10090 n.25 (2009) (citing Edmund Chein, 72 FR 6580, 6590 n.22 
(2007) and Mortimer B. Levin, 55 FR 8209, 8210 (1990)).
    Rather, the gravamen of the Government's case is that Respondent 
violated the CSA and numerous state laws by: (1) Prescribing controlled 
substances to persons whom he never met and physically examined, and 
(2) by engaging in the unauthorized practice of medicine because he 
lacked the state licenses required to prescribe to the residents of 
various States. Gov. Br. at 5-9 (discussing factors two and four). The 
Government further argues that Respondent's conduct in prescribing over 
the Internet creates an extraordinary threat to public health and 
safety. Id. at 9-10. While Respondent offered some testimony as to 
changes he has made in his medical practice, as explained below, I 
agree with the ALJ's finding that his testimony was evasive and that he 
repeatedly failed to accept responsibility for his misconduct.

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

    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 relating to controlled 
substances.'' Id.
    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.'' Gonzalez v. Oregon, 
546 U.S. 243, 274

[[Page 78751]]

(2006) (citing United States v. Moore, 423 U.S. 122, 135 (1975)).
    Under the CSA, it is ``fundamental'' that a practitioner must 
establish a bonafide doctor-patient relationship to act ``in the usual 
course of * * * professional practice'' and to issue a prescription for 
a ``legitimate medical purpose.'' Gaudio, 74 FR at 10090 (citing Moore, 
423 U.S. at 141-43). Moreover, at the time of the events at issue here, 
whether a doctor and patient have established a bona fide doctor-
patient relationship under the CSA was generally a question of state 
law. Id.; see also Kamir Garces-Mejias, 72 FR 54931, 54935 (2007); 
United Prescription Services, Inc., 72 FR 50397, 50407 (2007); 
Dispensing and Purchasing Controlled Substances Over the Internet (DEA 
Guidance Document), 66 FR 21181, 21182-83 (2001).
    Moreover, ``[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' '' under the CSA. Gaudio, 
74 FR at 10090 (quoting United Prescription Services, 72 FR at 50407). 
As the Supreme Court explained shortly after the CSA's enactment, ``in 
the case of a physician,'' the CSA ``contemplates that he is authorized 
by the State to practice medicine and to dispense drugs in connection 
with his professional practice.'' Moore, 423 U.S. at 140-41. This rule 
derives from the plain text of the statute which defines the term 
``practitioner'' to mean ``a physician * * * licensed, registered, or 
otherwise permitted, by the United States or the jurisdiction in which 
he practices * * * to * * * dispense a controlled substance,'' 21 
U.S.C. 802(21), and the term ``dispense'' to mean ``to deliver a 
controlled substance to an ultimate user * * * by, or pursuant to the 
lawful order of a practitioner.'' 21 U.S.C. 802(10). Thus, a 
controlled-substance prescription issued by a physician who lacks the 
license or other authority necessary to practice medicine within a 
State is unlawful under the CSA. See 21 CFR 1306.04(a); Cf. 21 CFR 
1306.03(a)(1) (``A prescription for a controlled substance may be 
issued only by an individual practitioner who is * * * [a]uthorized to 
prescribe controlled substances by the jurisdiction in which he is 
licensed to practice his profession.'').
    The record establishes that Respondent repeatedly violated the CSA 
when he prescribed controlled substances for the customers of the 
Kennedee Group. He did so for two reasons: (1) He failed to establish a 
bona fide doctor-patient relationship as required by the laws of the 
States where the patients resided, and (2) because he was licensed only 
in Florida (and possibly New York at the time), he engaged in the 
unauthorized practice of medicine in those States (other than Florida 
and possibly New York) where the customers lived. Nor can Respondent 
credibly claim that ``[t]here was not one letter, not one comment from 
any medical quality boards or anyone, regarding safety, regarding 
guidance in any way'' as to the practice of telemedicine.'' Id. at 209.
    As found above, Respondent issued three prescriptions for schedule 
III controlled substances containing hydrocodone to residents of 
California. However, in 2000, California enacted a provision which 
prohibits the prescribing or dispensing of a dangerous drug ``on the 
Internet for delivery to any person in this state, without an 
appropriate prior examination and medical indication therefore.'' Cal. 
Bus. & Prof. Code Sec.  2242.1. Moreover, in 2003 (and prior to the 
three prescriptions identified in GX 18), the Medical Board of 
California (MBC) revoked a physician's medical license when he engaged 
in practices similar to those of Respondent. See In re Steven Opsahl, 
M.D., Decision and Order, at 3 (Med. Bd. Cal. 2003) (available by query 
at http://publicdocs.medbd.ca.gov/pdl/mbc.aspx).
    In Opsahl, the MBC explained that ``[b]efore prescribing a 
dangerous drug, a physical examination must be performed.'' Id. The MBC 
held that a physician ``cannot do a good faith prior examination based 
on a history, a review of medical records, responses to a 
questionnaire, and a telephone consultation with the patient, without a 
physical examination of the patient.'' Id. The MBC also held that a 
``medical indication'' is determined only after the taking of a 
history, the conducting of a physical examination, and an assessment of 
``the patient's condition.'' Id. The MBC further explained that ``[a] 
physician cannot determine whether there is a medical indication for 
prescription of a dangerous drug without performing a physical 
examination.'' Id.
    In approximately the same time-frame, MBC also issued numerous 
Citation Orders to out-of-state physicians for prescribing over the 
Internet to California residents. These Orders cited both the 
physicians' failure to conduct ``a good faith prior examination'' and 
their lack of ``a valid California Physician and Surgeon's License to 
practice medicine in California.'' Citation Order, Martin P. Feldman 
(Aug. 15, 2003); see also Citation Order, Harry Hoff (June 17, 2003); 
Citation Order, Carlos Gustav Levy (Jan. 28, 2003); Citation Order, 
Carlos Gustav Levy (Nov. 30, 2001).
    As the evidence shows, Respondent has never held a California 
Physician and Surgeon's license. Moreover, given Respondent's admission 
that the scheme ``[o]bviously, did not lend itself to do any physical 
examinations,'' Tr. 212-13, I conclude that Respondent did not conduct 
a physical examination of any of the three California residents he 
prescribed to (and who were identified in GX 18). Accordingly, I 
conclude that in prescribing to these three persons, Respondent 
violated California law by engaging in the unauthorized practice of 
medicine and by prescribing ``without an appropriate prior examination 
and medical indication therefore.'' Cal. Bus. & Prof. Code Sec.  
2242.1. I further hold that these prescriptions lacked a ``legitimate 
medical purpose'' and were issued ``outside of the usual course of 
[his] professional practice'' and therefore violated the CSA as well. 
21 CFR 1306.04(a); 21 U.S.C. 841(a)(1).
    Respondent issued a prescription for hydrocodone to an Ohio 
resident. As does every State, Ohio prohibits the practice of medicine 
without a state license. Ohio Rev. Code Ann. Sec.  4731.41 (1998). 
Moreover, Ohio has enacted a statute which defines ``telemedicine'' as 
``the practice of medicine in this state through the use of any 
communication, including oral, written, or electronic communication, by 
a physician outside th[e] state'' and requires that a physician obtain 
a ``telemedicine certificate'' to lawfully prescribe within the State, 
id. Sec.  4731.296 (effective 4-10-01), and a ``special activity 
certificate.'' Id. Sec.  4731.294 (effective 4-10-01). Moreover, in 
2002, Ohio adopted a regulation which, except for in circumstances not 
at issue here, prohibits the dispensing of controlled substances ``to a 
person who the physician has never personally examined and diagnosed.'' 
Ohio Admin. Code Sec.  4731-11-09(A).
    Respondent did not possess either an Ohio medical license or Ohio 
``telemedicine certificate'' and thus, he was not authorized to 
prescribe to an Ohio resident. Moreover, because Respondent did not 
perform a physical examination of the Ohio resident as required by the 
State's rule, he did not establish a legitimate doctor-patient 
relationship with this person. In prescribing hydrocodone to this 
person, not only did Respondent violate Ohio law and regulation, he 
also acted outside of the usual course of professional practice and 
lacked a legitimate medical purpose and

[[Page 78752]]

therefore violated the CSA as well. 21 CFR 1306.04(a); 21 U.S.C. 
841(a)(1).
    Respondent issued six prescriptions for controlled substances 
(which included hydrocodone, as well as alprazolam and diazepam), to 
residents of Tennessee. Tennessee law prohibits the practice of 
medicine within the State without a license issued by the State. Tenn. 
Code Ann. Sec.  63-6-201(a) (2002); see also id. Sec.  63-6-204 (2002) 
(defining ``a person [who is] regarded as practicing medicine'' as one 
``who treats, or professes to diagnose, treat, operate[] on or 
prescribes for any physical ailment or any physical injury to or 
deformity of another''). Like Ohio, Tennessee also provides for 
``restricted licenses and special licenses based upon licensure to 
another state for the limited purpose of authorizing the practice of 
telemedicine.'' Id. Sec.  63-6-209(b) (1996).
    Prior to the prescribings at issue here, Tennessee had also 
promulgated a regulation which provided clear notice that, prior to 
issuing a prescription for a controlled substance ``by electronic means 
or over the Internet or over telephone lines,'' a physician must 
``[p]erform[] an appropriate history and medical examination,'' 
``[m]a[k]e a diagnosis based upon the examinations and all diagnostic 
and laboratory tests consistent with good medical care,'' 
``[f]ormulate[] a therapeutic plan,'' and ``[i]nsure[] availability of 
the physician or coverage for the patient for appropriate follow-up 
care.'' Tenn. Comp. R. & Regs. 0880-2-14.(7)(a) (2002). Here again, 
Respondent did not possess a Tennessee license and violated state law 
when he issued the six prescriptions to Tennessee residents. He also 
violated Tennessee's regulation because he did not perform a medical 
examination of the persons he prescribed to. Because Respondent did not 
establish a legitimate doctor-patient relationship and lacked the 
necessary State license, in issuing these prescriptions, he acted 
outside of the usual course of professional practice and lacked a 
legitimate medical purpose and therefore violated the CSA as well.\13\
---------------------------------------------------------------------------

    \13\ In addition to these statute and rules, which had been 
promulgated prior to his conduct, in April 2001, DEA published a 
guidance document entitled Dispensing and Purchasing Controlled 
Substances over the Internet, 66 FR 21181. The Agency's 2001 
Guidance expressly stated 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.'' 66 FR at 
21182. Continuing, the Guidance observed that ``[f]or purposes of 
state law, many state authorities, with the endorsement of medical 
societies, consider the existence of the following four elements as 
an indication that a legitimate doctor/patient relationship has been 
established:
    A patient has a medical complaint;
    A medical history has been taken;
    A physical examination has been performed; and
    Some logical connection exists between the medical complaint; 
the medical history, the physical examination, and the drug 
prescribed.
    Id. at 21182-83. The Guidance further stated 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.'' Id. at 21183.
    Of further relevance, the Guidance explained that ``[o]nly 
practitioners acting in the usual course of their professional 
practice may prescribe controlled substances. These practitioners 
must be registered with DEA and licensed to prescribe controlled 
substances by the State(s) in which they operate.'' Id. at 21181 
(emphasis added).
---------------------------------------------------------------------------

    Respondent also violated both Florida's telemedicine regulation 
(which was promulgated in September 2003) and the CSA when he 
prescribed hydrocodone to the DEA and DOH Investigators. The Florida 
rule defines ``the term `telemedicine' '' to include the ``prescribing 
[of] legend drugs'' made to patients via the internet, telephone, or 
facsimile. Fla. Admin. Code Ann. r. 64B8-9.014(5). The rule provides 
that prescribing medications solely on the basis of an electronic 
questionnaire ``constitutes the failure to practice medicine with that 
level of care, skill, and treatment which is recognized by reasonably 
prudent physicians as being acceptable under similar conditions and 
circumstances, as well as prescribing legend drugs other than in the 
course of a physician's professional practice.'' Fla. Admin. Code Ann. 
r. 64B8-9.014 (emphasis added). The rule further provides that 
physician shall not issue a prescription, through electronic or other 
means, unless following are done:

    (a) A documented patient evaluation, including history and 
physical examination to establish the diagnosis for which any legend 
drug is prescribed.
    (b) Discussion between the physician * * * and the patient 
regarding treatment options and the risks and benefits of treatment.
    (c) Maintenance of contemporaneous medical records meeting the 
requirements of [Fla. Admin. Code] Rule 64B8-9.003.

Id. r. 64B8-9.014(2).
    In her recommended decision, the ALJ noted that ``the Florida 
regulation governing telemedicine standards does not specify who must 
conduct the physical examination.'' ALJ at 38. Rather than research 
whether the Florida Medical Board had resolved this apparent ambiguity, 
the ALJ found ``it reasonable to infer that the examination must be 
conducted by the prescribing physician or a health care provider under 
his direction (such as a nurse or physician assistant).'' Id.
    The ALJ did not, however, cite any authority such as an 
administrative or judicial opinion of the Florida Board of Medicine, 
the Florida Attorney General, or the Florida courts definitively 
construing the regulation as imposing this requirement. Moreover, as 
the Supreme Court has made clear, while DEA has authority under the 
public interest standard to determine whether a physician has complied 
with state law, it does not have the power to ``authoritatively 
interpret'' ambiguous provisions of State law. Gonzales v. Oregon, 546 
U.S. 243, 264 (2006) (noting ``the obvious constitutional problems'' 
were the Attorney General to ``do[] so''). Thus, while it may be 
reasonable to construe the regulation as the ALJ did, absent either an 
administrative or judicial decision interpreting the regulation in this 
manner, I am compelled to reject the ALJ's conclusion that Florida's 
telemedicine rule ``require[s] that the prescribing physician or a 
provider under his supervision personally conduct a physical 
examination.'' ALJ at 38-39.
    In any event, whatever the rule requires as far as who can perform 
the physical exam, it does not matter because the rule clearly requires 
that a physician cannot prescribe a drug unless there is ``[a] 
documented patient evaluation'' and neither the DEA nor DOH 
investigator provided any medical records to Ken Drugs.\14\ Thus, it is 
clear that Respondent violated the Florida rule when he prescribed 
hydrocodone to the DEA and DOH investigators. Moreover, it is clear 
that Respondent acted outside of the usual course of professional 
practice and lacked a legitimate medical purpose and thus violated the 
CSA.\15\ 21 CFR 1306.04(a); 21 U.S.C. 841(a)(1).
---------------------------------------------------------------------------

    \14\ The ALJ also found that ``the record establishes that 
Respondent failed to review medical records for most, if not all, of 
his patients.'' ALJ at 38. While there is evidence that Respondent 
failed to review the medical records of the DEA and DOH 
Investigators, and there is evidence that other doctors admitted 
that in many instances they did not review medical records before 
prescribing, it is not necessary to decide whether the ALJ's finding 
is supported by substantial evidence. Given that: (1) the 
Investigators obtained prescriptions without providing medical 
records, and (2) even putting aside the ALJ's finding that 
Respondent's testimony that he had the medical records in front him 
``[a]t least 75 to 85 percent of the time,'' Tr. 206, was not 
credible, ALJ at 39; it is still clear that Respondent frequently 
prescribed without reviewing a person's medical record. Beyond this, 
given the clear requirements of California, Ohio, and Tennessee that 
the prescribing physician must perform the physical examination, 
whether he reviewed medical records of these persons is immaterial.
    \15\ In his brief, Respondent argues that ``there is no 
requirement that the prescribing physician personally conduct a 
physical examination of a patient for a valid doctor-patient 
relationship to exist.'' Resp. Br. at 10 (citing Forlaw, M.D. v. 
Fitzer, 246 So.2d 432, 435 (Fla. 1984)). However, as explained 
above, in California, Ohio and Tennessee there is such a 
requirement. Moreover, with respect to the undercover purchases, the 
argument provides no comfort to Respondent because he prescribed 
without obtaining a ``documented patient evaluation, including [a] 
physical examination'' and the Florida rule expressly provides that 
such prescribing is not ``in the course of a physician's 
professional practice.'' Fla. Admin. Code Ann. R. 64B8-9.014.(1) & 
(2).
    Respondent also testified that Ken Drugs had ``other locations 
that were designed for seeing patients'' and that the patients 
``would be directed to an office where they could get a physical 
examination, where they could go through getting their vital signs 
and so forth.'' Tr. 203. Respondent did not, however, produce any 
evidence showing that any of the patients identified in Government 
Exhibit 18 were physically examined at these ``other locations.'' 
Nor did he offer any evidence showing that the so-called regional 
staffers were qualified to perform physical exams and diagnose 
patients. Finally, Respondent does not cite to any law or regulation 
of the States of California, Ohio or Tennessee authorizing this 
practice.

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

[[Page 78753]]

    In his testimony, Respondent appeared to deny having personally 
issued all but one of the prescriptions contained in Government Exhibit 
18. Tr. 228-29. However, as found above, in an interview, Respondent 
admitted that he was electronically transmitting prescriptions to Ken 
Drugs, and in his testimony, Respondent admitted that he had provided a 
stamp with his signature to at least one of the Ken Drugs pharmacies. 
Thus, it is clear from his testimony that Respondent's intent in doing 
so was to authorize Ken Drugs to dispense prescriptions under his 
registration number. Id. at 229 (``It was my practice to sign them when 
I could and when everything was variable and proper and there would be 
some permission to use the stamp, if I was not able to do that 
myself.''). I thus reject Respondent's contention that he did not 
authorize the nine stamped prescriptions.\16\
---------------------------------------------------------------------------

    \16\ Even if he did not authorize the prescriptions, the 
evidence supports a finding that Respondent authorized the 
pharmacist to issue prescriptions under the authority of his 
registration. Under DEA case law, a registrant who authorizes others 
to use his registration is responsible for any misuse of his 
registration by these individuals. See Paul H. Volkman, 73 FR 30630, 
30644 n.42 (2008); Rose Mary Jacinta Lewis, 72 FR 4035, 4040 (2007); 
Robert G. Hallermeier, 62 FR 26818, 26820 (1997); Summer Grove 
Pharmacy, 54 FR 28522, 28523 (1989).
---------------------------------------------------------------------------

    Moreover, Respondent did not claim that these were oral 
prescriptions. Thus, Respondent also violated DEA regulations because 
he did not manually sign the prescriptions. See 21 CFR 1306.05(a) 
(``Where an oral order is not permitted, prescriptions shall be written 
with ink or indelible pencil or typewriter and shall be manually signed 
by the practitioner.'') \17\
---------------------------------------------------------------------------

    \17\ An oral prescription must be ``reduced to writing by the 
pharmacist'' and ``contain[ ] all information required by 21 CFR 
1306.05, except for the signature of the practitioner.'' 21 CFR 
1306.21(a).
---------------------------------------------------------------------------

    As the foregoing demonstrates, Respondent's experience in 
dispensing controlled substances and his record of compliance with laws 
related to controlled substances is characterized by his repeated 
prescribing in violation of state laws prohibiting the unauthorized 
practice of medicine as well as those requiring that a physician 
personally perform a physical examination of a patient he prescribes 
to. These prescriptions also violated Federal law because in issuing 
them, Respondent lacked ``a legitimate medical purpose'' and acted 
outside of ``the usual course of [his] professional practice.'' 21 CFR 
1306.04(a). I thus hold that the Government has satisfied its prima 
facie burden of showing that Respondent has committed acts which 
``render his registration * * * inconsistent with the public 
interest.'' 21 U.S.C. 824(a)(4).

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, [he] 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); 
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).
    It is acknowledged that Respondent ceased his internet prescribing 
activities shortly after the execution of the search warrant. It is 
also acknowledged that Respondent took a course of the American Academy 
of Pain Management, which included subjects pertaining to the 
prescribing of controlled substances.
    The ALJ found, however, that Respondent has not accepted 
responsibility for his misconduct. ALJ at 43-45. As support for this 
finding, the ALJ cited: (1) Respondent's statement to the investigators 
that he believed the Ken Drugs' scheme was lawful because the Kennedee 
Group was well known, had a large business, and that Shobola had 
researched its legality, (2) his testimony that he relied on Ken Drugs' 
employees to screen for drug abusers, which she characterized as 
``disingenuous at best,'' and (3) his ``evasive and unresponsive'' 
testimony in ``describing his interactions with Ken Drugs patients.'' 
ALJ at 43-44.
    The ALJ's finding is well supported by the record. With respect to 
Respondent's contention that he believed that what he was doing was 
lawful, I have previously held that ``a licensed physician * * * is * * 
* properly charged with the obligation to determine what the law 
require[s] with respect to his prescribing activities.'' Patrick W. 
Stodola, M.D., 74 FR 20727, 20735 (2009). In short, Respondent's 
various contentions as to why he believed Shobola's internet 
prescribing scheme was lawful are absurd on their faces.
    Indeed, further evidence of Respondent's failure to accept 
responsibility is his testimony that ``[t]here was not one letter, not 
one comment from any medical quality boards or anyone, regarding 
safety, regarding guidance in any way'' as to ``the practice of 
telemedicine.'' Tr. 209.\18\ As noted above, this is utter nonsense, as 
prior to his prescribing, each of the three States whose residents he 
prescribed to (California, Ohio, and Tennessee) had enacted statutes 
and/or promulgated regulations which clearly prohibited his prescribing 
without obtaining a state license and without physically examining his 
patients.
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    \18\ Notably, at an earlier point in his testimony, Respondent 
stated: ``We were all constantly reviewing legalities and making 
certain that we were responding to the best practice possible.'' Tr. 
202. See also Tr. 222 (``there were very, very few guidelines'').
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    As the California Court of Appeal has noted, ``the proscription of 
the unlicensed practice of medicine is neither an obscure nor an 
unusual state prohibition of which ignorance can reasonably be claimed, 
and certainly not by persons * * * who are licensed health care 
providers. Nor can such persons reasonably claim ignorance of the fact 
that authorization of a prescription pharmaceutical constitutes the 
practice of medicine.'' Hageseth v. Superior Court, 59 Cal. Rptr. 3d 
385, 403 (Ct. App. 2007). The same is true of the state law standards 
for establishing a valid doctor-patient relationship.
    Respondent's testimony regarding how Ken Drugs screened for drug 
abusers likewise manifests a degree of irresponsibility that is 
incompatible

[[Page 78754]]

with what DEA expects of a registrant. While Respondent testified that 
other employees were responsible for screening the patients, he 
acknowledged that if the patients ``were liars * * * they could break 
through'' and that ``a lot of fraud can happen.'' He then justified his 
prescribing notwithstanding the obvious diversion risk, claiming that 
he is not a lawyer or police agent and that as ``a physician * * * I 
take people at their word'' and ``as a family physician, I have 
patients that come to me face-to-face and can be dishonest with me.'' 
Id. at 206-09.
    Later, Respondent claimed that he could identify drug abusers and 
drug seekers by their voice or diction, but then acknowledged that this 
was ``by no means, any criteria to determine who is being evasive'' and 
that it was ``very, very less than perfect.'' Id. at 230-31. Putting 
aside the obvious risk of diversion by prescribing to people one never 
meets, if Respondent, as a trained physician, could not identify drug 
abusers and drug seeking patients, it should have been apparent that 
Ken Drugs' employees could not either. Yet he proceeded to prescribe 
controlled substances to numerous persons even though he had no idea as 
to whether they were legitimate patients or drug seekers and 
abusers.\19\
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    \19\ The National Center on Addiction and Substance Abuse (CASA) 
has reported that ``[t]he number of people who admit abusing 
controlled prescription drugs increased from 7.8 million in 1992 to 
15.1 million in 2003.'' National Center on Addiction and Substance 
Abuse, Under the Counter: The Diversion and Abuse of Controlled 
Prescription Drugs in the U.S. 3 (2005) (cited in Stodola, 74 FR at 
10089 n.24). Moreover, ``[a]pproximately six percent of the U.S. 
population (15.1 million people) admitted abusing controlled 
prescription drugs in 2003, 23 percent more than the combined number 
abusing cocaine (5.9 million), hallucinogens (4.0 million), 
inhalants (2.1 million) and heroin (328,000).'' Id. Relatedly, 
``[b]etween 1992 and 2003, there has been a * * * 140.5 percent 
increase in the self-reported abuse of prescription opioids''; in 
the same period, the ``abuse of controlled prescription drugs has 
been growing at a rate twice that of marijuana abuse, five times 
greater than cocaine abuse and 60 times greater than heroin abuse.'' 
Id.
     CASA has further reported that teenagers ``represent an 
especially vulnerable group,'' because ``[t]eens may view 
prescription drugs as relatively safe either when abused alone or in 
combination with alcohol or other drugs.'' Id. According to CASA, 
``[i]n 2003, 2.3 million teens ages 12 to 17 (9.3 percent) reported 
abusing a controlled prescription drug in the past year; 83 percent 
of them reported abusing opioids.'' Id. Moreover, ``[b]etween 1992 
and 2002, the number of [first time] teenage prescription opioid 
abusers increased by 542 percent.'' Id.
     Finally, CASA noted that ``[i]nternet sites not adhering to 
state licensing requirements, medical board standards or Federal law 
have enabled consumers to obtain controlled prescription drugs 
without a valid prescription or physician supervision and without 
regard to age.'' Id. at 63. CASA also noted that ``illegal 
[i]nternet pharmacies have introduced a new avenue through which 
unscrupulous buyers and users can purchase controlled substances for 
unlawful purposes.'' Id. Moreover, ``[t]he age of the customers 
appears not to be an issue for Internet pharmacies,'' and that there 
are ``no mechanisms in place to block children from purchasing 
controlled drugs over the Internet.'' Id. at 66.
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    The ALJ was also unimpressed by Respondent's testimony regarding 
his interactions with Ken Drugs' patients. For example, Respondent 
testified that Ken Drugs' customers would not be able to get him ``on 
the phone until they had gone through some of these hurdles'' such as 
sending in their medical records. Id. at 206. He also claimed that 
there were times when the customers got through to him without having 
provided their medical records, and that he ``would have to say, `No, 
we can't help you.' '' Id. at 214. Yet he prescribed to both the DEA 
and DOH Investigators who had not sent in any records. He also 
testified that he discussed ``the risk of habituation'' with the 
persons he prescribed to. Id. at 217. Once again, he did not do so when 
he prescribed to either the DEA or DOH Investigators.
    As the ALJ found, much of Respondent's testimony was self-serving 
and disingenuous. Moreover, Respondent repeatedly attempted to minimize 
his misconduct, which is egregious. In short, Respondent has failed to 
acknowledge any wrongdoing on his part. Accordingly, I agree with the 
ALJ's finding that Respondent has failed to accept responsibility for 
his misconduct and that this ``warrants the finding * * * that his 
continued registration poses a threat to the public health and 
safety.'' ALJ at 46.\20\ Having concluded that Respondent has failed to 
rebut the Government's prima facie case, his registration will be 
revoked and any pending application will be denied.
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    \20\ See also Stodola, 74 FR at 20730-31 (practitioner's 
continued registration deemed inconsistent with the public interest 
where, inter alia, ``he has not accepted responsibility for his 
misconduct but blames others''); Leslie, 68 FR at 15231 (revoking 
registration where, inter alia, ``Respondent refuse[d] to take 
responsibility for his past misconduct'' and ``remain[ed] steadfast 
in his insistence upon denying any previous wrongdoing''); Prince 
George Daniels, 60 FR 62881, 62887 (1995) (registrant's ``lack of 
candor * * * as to the full extent of his involvement in the cocaine 
incident creates concern about his future conduct''); John Stanford 
Noell, 59 FR 47359, 47361 (1994) (denying Respondent's application 
for registration where, as to factor five, ``Respondent has 
exhibited no remorse for his illegal activities'').
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Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) & 
824(a)(4), as well as by 28 CFR 0.100(b) & 0.104, I order that DEA 
Certificate of Registration, BL6686541, issued to Ronald Lynch, M.D., 
be, and it hereby is, revoked. I further order that any application for 
renewal or modification of such registration be, and it hereby is, 
denied. This Order is effective January 18, 2011.

    Dated: December 3, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-31650 Filed 12-15-10; 8:45 am]
BILLING CODE 4410-09-P