[Federal Register Volume 76, Number 84 (Monday, May 2, 2011)]
[Notices]
[Pages 24523-24533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10506]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10-18]
Sun & Lake Pharmacy, Inc.; D/B/A the Medicine Shoppe; Revocation
of Registration
On October 19, 2009, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Sun & Lake Pharmacy, Inc., d/b/a The Medicine Shoppe
(hereinafter, Respondent) of Lakeland,
[[Page 24524]]
Florida. The Show Cause Order proposed the revocation of Respondent's
Certificate of Registration, BS9433828, as a retail pharmacy, and the
denial of any pending applications to renew or modify the registration,
on the ground that its registration is ``inconsistent with the public
interest.'' ALJ Ex. 1, at 1 (citing 21 U.S.C. 823(f) & 824(a)(4)).
More specifically, the Show Cause Order alleged that Respondent had
violated both federal and state laws by distributing controlled
substances to persons throughout the United States ``based on purported
prescriptions issued to hundreds of customers through Internet websites
* * * by physicians who were not licensed to practice medicine in the
states in which the customers resided.'' Id. at 2 (citations omitted).
The Show Cause Order also alleged that the prescriptions violated 21
CFR 1306.04(a) because the ``physicians failed to establish a valid
physician-patient relationship as required by multiple state laws'' and
were therefore issued ``for other than a legitimate medical purpose
and/or outside the usual course of professional practice.'' Id. at 3
(citations omitted).
Finally, the Order alleged that Respondent filled unlawful
prescriptions issued by one Robert Reppy, D.O., because Reppy ``issued
* * * prescriptions for controlled substances to customers throughout
the United States even though he was licensed to practice medicine only
in the State of Florida'' and was therefore engaged in the unauthorized
practice of medicine when he prescribed to persons outside of Florida.
Id. The Order also alleged that Reppy violated Florida law by ``issuing
prescriptions via the Internet without a documented patient evaluation
and discussion between [him] and [the] patient regarding treatment
options.'' Id. (citations omitted).
On November 23, 2009, Respondent, through its counsel, requested a
hearing on the allegations and the matter was placed on the docket of
the DEA Administrative Law Judges (ALJs). ALJ Ex. 2. Following pre-
hearing procedures, on February 24-25, 2010, an ALJ conducted a hearing
in Tampa, Florida. At the hearing, the Government called witnesses to
testify and introduced extensive documentary evidence; Respondent
called no witnesses and introduced a single exhibit. Following the
hearing, both parties submitted briefs containing their proposed
findings of fact, conclusions of law and argument.
On April 8, 2010, the ALJ issued his Recommended Decision (also
ALJ). As to factor one--the recommendation of the state licensing
authority--the ALJ noted that there was no evidence that the State
licensing authority had taken any action against Respondent's pharmacy
license. ALJ at 28. The ALJ noted, however, that while state licensure
is a necessary condition for holding a registration, Respondent's
continued holding of its state license is not dispositive because DEA
has an ``independent responsibility to determine whether a registration
is in the public interest.'' Id. (citations omitted). The ALJ thus
concluded that Respondent's licensure status neither ``weigh[s] for or
against a determination'' that its ``continued registration * * * is
consistent with the public interest.'' Id.
As to factor three--Respondent's record of conviction of offenses
related to the distribution or dispensing of controlled substances--the
ALJ noted that while Respondent remains the subject of a criminal
investigation, it has not been ``convicted of any crime.'' Id. The ALJ
reasoned, however, that ``the probative value'' of this finding ``is
somewhat diminished by the myriad of considerations that are factored
into a decision to initiate, pursue, and dispose of criminal
proceedings by'' the prosecuting authorities. Id. at 28. The ALJ
apparently concluded that this factor neither supported nor refuted the
conclusion that Respondent's continued registration is inconsistent
with the public interest. Id. at 29.
The ALJ considered the remaining factors--its experience in
dispensing controlled substances (factor two), its compliance with
applicable laws relating to controlled substances (factor four), and
other conduct which may threaten public health and safety (factor
five)--together. Id. at 29-48. With regard to these factors, the ALJ
noted that there were two primary issues: (1) Whether Respondent
complied with its ``corresponding responsibility'' under 21 CFR
1306.04(a) to not knowingly fill a prescription which has not been
issued for a legitimate medical purpose, and (2) whether it ``was
authorized to dispense controlled substances to the ultimate user who
received them where they were delivered.'' Id. at 32.
As to the first issue, the ALJ explained that a ``pharmacy
registrant must understand the requirements attendant upon the issuance
of an effective prescription under the regulations.'' Id. at 33. The
ALJ further noted that under the Controlled Substances Act, ``it is
fundamental that a physician practitioner must have established a bona
fide doctor-patient relationship in order to act `in the usual course
of professional practice' and to issue a prescription `for a legitimate
medical purpose,' '' and that at the time of the conduct at issue,
``the CSA generally looked to state law to determine whether a bona
fide doctor patient relationship existed.'' Id. at 33-34 (citations
omitted). The ALJ also explained that under agency precedent, `` `an
entity which voluntarily engages in commerce by shipping controlled
substances to persons located in other States is properly charged with
knowledge of the laws regarding both the practice of medicine and
pharmacy in those States,' '' and this obligation includes ``
`determin[ing] whether the physicians were in compliance with the
States' licensure requirements and specific standards for issuing
treatment recommendations and prescribing controlled substances.' ''
Id. at 38 (quoting Bob's Pharmacy & Diabetic Supplies, 74 FR 19599,
19601 (2009); United Prescriptions Servs., Inc., 72 FR 50397, 50408
(2007)). Moreover, the ALJ also cited Agency precedent that, under the
CSA, ``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 or other
authority required to practice medicine within a State is therefore
unlawful under the CSA.'' Id. (citations omitted).
The ALJ also concluded that Respondent had ignored evidence that
the prescriptions were not issued pursuant to a valid doctor-patient
relationship. The ALJ noted that a DEA Diversion Investigator (DI) had
provided Respondent with various documents including a Guidance
Document on Dispensing and Purchasing Controlled Substances Over the
Internet, 66 FR 21181 (2001), which explained four widely accepted
elements for establishing a bona fide doctor-patient relationship
(including, inter alia, that a medical history be taken and a physical
examination be performed) and the DEA Pharmacist's Manual. ALJ at 34-
35. The ALJ also found that Respondent's owner had expressed to the DI
that it had been solicited to distribute drugs for an internet
prescribing scheme but that he declined to do so because he did not
believe there would be adequate doctor-patient relationships to support
the prescriptions and thus he ``expressed actual understanding'' that
``where doctor and patient are geographically isolated from each other,
it increases the risk that the requisite doctor-patient relationship
does not exist.'' Id. at 35.
Noting that Respondent had filled several prescriptions which were
[[Page 24525]]
shipped to Alabama residents and which were authorized by a Dr. Flynn,
who was located in Pennsylvania, and Dr. De LaGuardia, who was located
Kansas, the ALJ reasoned that ``[t]he fact that the prescriptions were
authorized by practitioners geographically isolated from Alabama made
it unlikely that the issuing physician had the requisite doctor-patient
relationship with the ultimate user''; he then found that Respondent
``took no steps to resolve these red flags prior to dispensing
controlled substances'' and thus violated ``its corresponding
responsibility'' under Federal law. Id. at 40. The ALJ further noted
that Respondent ``had * * * ignored similar obligations to resolve
anomalies attendant upon remote doctor and patient locations prior to
dispensing controlled substances prescribed by [these two doctors] to
customers in states including, inter alia, California, Georgia,
Illinois, Louisiana, Mississippi, North Carolina, and South Carolina.''
Id. at 40-41. (citing numerous State laws).
The ALJ also noted that ``apart from the geographic separation
between Dr. Flynn and his nationwide ultimate-user base, * * *
Respondent * * * possess[ed] * * * documents that reflected that on
single days, this physician issued 837, 347, 344 and 314 prescriptions,
[and this] should have resulted in great concern [on its part] that
this number of individuals was not being examined and treated on a
daily basis by'' Flynn, who was ``one of [its] regular prescribing
physicians.'' Id. at 44-45. Similarly, the ALJ noted that ``on several
days Dr. De La Guardia, another regular prescriber, issued over 100
prescriptions.'' Id. at 45. Because Respondent ignored both the
geographic separation between the patients and prescribers as well as
the high volume of their prescriptions, the ALJ concluded that it
violated Federal and state laws related to controlled substances and
``its obligations as a DEA registrant'' and that this ``militate[s]
strongly in favor of revocation.'' Id. at 46.
The ALJ further noted that ``these prescriptions were issued by
physicians not licensed to practice in the states in which the
customers resided'' and that this issue ``needed to be resolved [by
Respondent] prior to the dispensing of a single controlled substance''
pursuant to these prescriptions. Id. at 41.
Next the ALJ noted that ``[t]he CSA requires that a practitioner *
* * be currently authorized to handle controlled substances in `the
jurisdiction in which he practices' in order to maintain a DEA
registration.'' Id. at 42 (citing 21 U.S.C. 802(21) & 823(f)).
Reasoning that ``state authorization of the pharmacy registrant to
dispense in the state where the controlled substance is ultimately
dispensed stands as a fundamental condition precedent to establishing
that a prescription has been lawfully filled,'' the ALJ, citing
numerous state laws requiring that a pharmacy be licensed in the State
to deliver drugs to one of its residents, concluded that Respondent's
``filling and shipping of * * * controlled substances was done in
direct violation of state laws relating to controlled substances.'' Id.
at 43-44.
Finally, the ALJ noted that Mr. Fosu ``elected not to testify'' and
that Mrs. Fosu, who was also involved in Respondent's operations, had
invoked the Fifth Amendment when called to testify. Id. at 47. Noting
the Agency rule that where the Government makes out a prima facie case,
the Respondent must accept responsibility for its misconduct, the ALJ
concluded that the Fosus had failed ``to accept any responsibility for
any of [Respondent's] prescription filling practices'' and that this
``militates strongly in favor of revocation.'' Id. at 48. The ALJ thus
concluded that Respondent had not rebutted the Government's prima facie
case and recommended that Respondent's registration be revoked and any
pending applications be denied. Id. at 48-49.
Neither party filed exceptions to the ALJ's decision. Thereafter,
the record was forwarded to me for final agency action.
Having considered the entire record in this matter, I adopt the
ALJ's findings of fact and conclusions of law except as specifically
noted herein. I further adopt the ALJ's recommended sanction that
Respondent's registration be revoked and its pending application be
denied. I make the following findings.
Findings
Respondent is a Florida corporation which owns and operates a
retail pharmacy doing business under the name of The Medicine Shoppe.
GX 2. Respondent, which first became registered on September 1, 2005,
holds DEA Certificate of Registration BS9433828, which authorizes it to
dispense controlled substances in schedules II through V as a retail
pharmacy at the registered location of 1231 Lakeland Hills Blvd.,
Lakeland, Florida. Id. Respondent's registration was last renewed on
February 15, 2008 and was not due to expire until February 28, 2011.
Id. According to the registration records of the Agency, of which I
take official notice, see 5 U.S.C. 556(e); on January 12, 2011,
Respondent submitted a renewal application. I therefore find that
Respondent's registration has remained in effect pending the issuance
of this Decision and Final Order.\1\ See 5 U.S.C. 558(c); 21 CFR
1301.36(i).
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\1\ Under the Administative Procedure Act (APA), and agency
``may take official notice of facts at ay stage in a proceeding-even
in the final decision.'' U.S. Dept. of Justice, Attorney General's
Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt &
Sons, Inc., Reprint 1979). In accordance with the APA and DEA's
regulations, Respondent is ``entitled on timely request, to an
opportunity to show to the contrary.'' 5 U.S.C. 556(e); see also 21
CFR 1316.59(e). Respondent can dispute the fact of which I take
oficial notice by filing a properly supported motion for
reconsideration within twenty days of service of this Order, which
shall begin on the date it is mailed.
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Kwame Fosu, who is a registered pharmacist, is the director,
registered agent, and owner of Respondent. ALJ Ex. 6, at 2 (stipulated
facts); GX 7. Patricia Fosu, who is Mr. Fosu's wife, Tr. 184, is also a
registered pharmacist in Florida. Id. at 317.
Sometime in early 2005, DEA Investigators (DIs) with the Tampa
Field Division started receiving a large volume of complaints about
various Florida pharmacies from persons who had ordered drugs through
Web sites. Id. at 29, 31. Using an agency database, the DIs determined
that there were ``a lot of small pharmacies'' in the Tampa Bay area
that were purchasing ``large amounts of hydrocodone,'' (a schedule III
controlled substance as it is usually dispensed to patients), including
some that were purchasing ``over a million dosage units'' and these
quantities were at least twice as great as those being purchased by
large chain drugstores such as Walgreens or CVS.\2\ Id. at 33. The DIs
also noticed that the largest purchasers were usually pharmacies that
had recently obtained DEA registrations. Id. at 35.
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\2\ The DI did not clarify te time period during which these
purchases occurred.
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With this information, the Tampa DIs commenced visiting these
pharmacies to determine what was going on and to educate them about
DEA's position on the lawfulness of prescriptions originating through
the Internet. Id. at 36 & 40. The Tampa Office also decided that every
time they received a new application for a pharmacy registration, they
would ``be proactive'' and visit the pharmacies and explain to them
that prescriptions that were not issued based on ``a doctor-patient
relationship'' were not legal and that, if the doctor was located in a
State other than where the patient resides, ``there is no way there
could be a doctor-patient relationship.'' \3\ Id. at 41-42.
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\3\ The DI also testified that while some of the pharmacists
they encountered claimed that they were just doing mail order they
were not because in ``[m]ail order, the doctor sees the patient, the
patient gets the prescription [and] mails the prescription into
their pharmacy * * * This [internet prescribing] was done completely
different.'' Tr. 42.
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[[Page 24526]]
Pursuant to this policy, on December 5, 2005, two DIs went to
Respondent and met with Mr. Fosu.\4\ The DIs gave Mr. Fosu a package of
documents which included the DEA Pharmacist's Manual, the Agency's 2001
Guidance Document entitled Dispensing and Purchasing Controlled
Substances over the Internet \5\ along with a one page document
summarizing some of the critical points of the Guidance Document, as
well as documents containing Frequently Asked Questions regarding the
dispensing and purchasing of controlled substances over the internet,
and provisions of Florida law setting forth grounds for disciplinary
action against a pharmacist's license (including where a pharmacist
dispenses a drug either knowing or having reason to know that a
prescription is not based upon a valid practitioner-patient
relationship). GX 7. During their discussion of the use of the
internet, the DI told Mr. Fosu that internet prescribing was illegal as
were prescriptions that were digitally signed. Tr. 150-51, 153. Mr.
Fosu told the DI ``that he was aware of the internet situation because
he had been approached by an individual'' about filling prescriptions
for an internet site, but ``he had informed that individual that he
wasn't interested in doing internet because he did no see the doctor-
patient relationship and he didn't want to have any trouble [and]
wasn't going to be doing [the] internet.'' Tr. 49; see also id. at 45.
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\4\ The DI had previously gone to Respondent in October but was
informed that Mr. Fosu was out of the country. Tr, 43. Because the
DI wanted to discuss these issues with Mr. Fosu, she decided that
she would revisit Respondent when he returned. Id.
\5\ This document had previously been pubished in the Federal
Register at 66 FR 21181. GX 8, at 2. The Guidance Document
specifically stated 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 action in the usual course of his professional
practice.' '' 66 FR at 21182 (quoting 21 CFR 1306.04(a)). The
Guidance explained that ``[e]very state separately imposes the same
requirement under its laws'' 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.
Continuing, the Gudance exlained 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.
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The DI further testified that she had given Mr. Fosu her business
card and that she asked him to call her if he was ever approached again
by someone about filling internet prescriptions and to obtain as much
information as he could to identify the person. Id. at 50 & 102. The DI
was never subsequently contacted by Mr. Fosu. Id.
In late January or early February 2007, another DI, who was
assigned to the Pittsburgh, Pennsylvania Resident Office, received a
phone call from a pharmacy owner who reported that he had been called
by a person who represented that he worked for an entity known as
Coralpines and who had solicited him to fill prescriptions that were
issued over the internet. Id. at 332 & 337. The pharmacy owner stated
that the Coralpines' representative had told him that if he agreed to
do so, he would be given a user name and password so that he could
access a Web site and download prescriptions which he was to fill. Id.
at 332-33. When the pharmacy owner ``expressed [his] reservations'' to
Coralpines' representative, it wired ``a significant amount of money''
to him to show its ``good faith.'' Id. at 333.
Thereafter, the pharmacy owner accessed Coralpines' Web site and
downloaded hundred of prescriptions that it wanted his pharmacy to
fill. Id. Upon printing out the prescriptions, which totaled about 200,
the pharmacy owner noted that they were issued by ``mainly three
doctors'' and yet were for persons located throughout the country. Id.
More specifically, the prescribing doctors were Michael Flynn, who was
located in Wallingford, Pennsylvania; Alfredo Valdivieso, who was
located in Puerto Rico; and Enrique De La Guardia, who was located in
Ft. Leavenworth, Kansas. Id. at 337-38. With the exceptions of Dr. De
La Guardia, who was licensed in both Kansas and Nebraska, the other
doctors were licensed only in the States where they were located. Id.
at 338-39.
Apparently because all of the prescriptions were for controlled
substances, the pharmacy owner decided not to do business with
Coralpines and turned over the prescriptions to the DI. Id. at 333.
According to the DI, the prescriptions were primarily for phentermine,
diazepam, and alprazolam, all of which are schedule IV controlled
substances. Id. at 335; see also 21 CFR 1308.14(c) & (e).
According to the DI, the prescription forms were divided into three
sections; one section contained prescription information such as the
customer's name, address, drug, quantity, date, and a physician's
signature; another section contained the label that goes on the
prescription vial, and the third section contained either a UPS or Fed
Ex shipping label with an account number, the pharmacy's name, and the
patient's name. Id. at 334-36.
Each prescription form also included the name of the Web site which
the customer had accessed to order the drugs. Id. at 339-40. There were
approximately 30 Web sites including pillforce.com, pillpush.com and
pillroyal.com; the DI later determined that crownpills.com was also
affiliated with Coralpines. Id. at 340-41 & 349. The DI also determined
that Coralpines was located in Durban, South Africa. Id. at 340.
On February 15, 2007, the DI, using an undercover name, visited
pillpush.com and purchased alprazolam. Id. at 350 & 354. In additional
to providing his name and address, the DI was directed to complete a
ten-question questionnaire. Id. at 351. The DI gave a false height and
weight, and when asked why he wanted the drug, wrote ``anxiety.'' Id.
The DI then provided his credit card information and placed his order.
Id.
A week later, the DI received a package containing a drug vial
which contained 60 tablets of alprazolam.\6\ Id. The vial label
indicated that the prescription had been filled by Respondent and that
the prescribing physician was Dr. Flynn. Id. at 351-52. Prior to the
issuance of the prescription, the DI neither saw nor spoke with Dr.
Flynn. Id. at 352. Nor, prior to his receiving the prescription, did he
speak with anyone at Respondent. Id. at 354.
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\6\ The DI subsequently testified that he received the drugs on
February 23, 2007. Tr. 353. The DI also testified that the drugs
were tested by a DEA laboratory and found to be alprazolam. Id.
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Thereafter, a subpoena was issued to UPS for shipping records for
the account number (which was the same number as had been on the 200
prescriptions that were turned over to DEA by the western Pa. pharmacy
owner) under which the alprazolam had been shipped. Id. at 354-55. UPS
turned over the records which showed that in a one to one-and-a-half-
month time period, Respondent had made 1600 shipments to persons
located throughout the country. Id. at 355.
Using the UPS records, the DI contacted several persons who lived
near Pittsburgh. Id. at 359. The DI (accompanied by another DI)
interviewed B.F. at her residence; B.F. told them that she had ordered
[[Page 24527]]
alprazolam through a Web site (pillroyal.com), which was one of those
known to be an affiliate of Coralpines. Id. at 359-60; GX 16, at 1.
While B.F. related as to how she had filled out a questionnaire and
provided credit card information, she also stated that she did not have
to provide medical records and neither was examined by, nor spoke with
a physician. Tr. 361. Shortly thereafter, B.F. received a bottle of
alprazolam; its label indicated that the prescription had been filled
by Respondent and listed Dr. Flynn as the prescribing physician. Id. at
361-62. B.F. also printed out copies of e-mail correspondence (which
she gave to the DIs) which had confirmed her order and the subsequent
shipment of it. GX 16, at 1-3. The DIs subsequently confirmed that the
e-mail address of the sender was the same as had been used by
representatives of Coralpines in contacting the pharmacy owner who had
declined to fill prescriptions for it. Tr. 362-63.
The DI also interviewed C.S. Id. at 369. C.S. also related that he
had gone to a Web site that the DIs had identified as being affiliated
with Coralpines and ordered 90 tablets of diazepam ``merely through''
completing a questionnaire and providing credit card information. Id.
at 370. C.S. ``did not have to provide any additional records'' and was
neither examined by nor spoke ``with a doctor.'' Id. at 371 & 373. C.S.
subsequently received a prescription which had been issued by Dr. Flynn
and filled by Respondent. Id.; see also GX 18 (copy of March 26, 2007
prescription for 90 tablets of diazepam 10 mg.).\7\
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\7\ The prescription was seized from Respondent in June 2007
during the execution of a search warrant. See GX17.
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On June 12, 2007, a search warrant was executed at Respondent.
During the search, the authorities seized hard copies of the controlled
substance prescriptions Respondent had dispensed; Respondent's
purchasing, dispensing records, and shipping documents; and various
notes that related to the investigation of Coralpines. Tr. 381.
Moreover, computer forensic examiners imaged the hard drives of
Respondent's computers. Id. at 381-82.
During the search, members of the search party (including the
Pittsburgh-based DI) interviewed Patricia Fosu. Id. at 385. Ms. Fosu
stated that her husband had purchased Respondent in 2005 and that she
had initially worked there on a part-time basis; however, her hours had
increased in the months before the warrant was executed (which
corresponds with the period in which Respondent commenced filling
prescriptions for Coralpines). Id. at 385-86.
Ms. Fosu further stated that in November 2006, she and her husband
were approached by one Gerald Wright, who identified himself as a
pharmacist, and who solicited them to fill prescriptions issued by
doctors who worked for Coralpines. Id. at 390. Wright, who practiced at
CRJ Pharmacy, told the Fosus that he was personally filling
prescriptions for Coralpines.\8\ Id. According to Ms. Fosu, while she
and her husband had expressed their concern to Wright that the
Coralpines' physicians were not seeing the patients, Wright stated that
they had nothing ``to worry about because other pharmacies across the
country'' were also filling prescriptions that were issued ``in a
similar manner.'' Id. at 397.
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\8\ In February 2007, I ordered that CRJ Pharmacy's DEA
registration be immediately suspended. See 72 FR 30846 (2007).
Subsequently, CRJ surrendered its state license and went out of
business. Id. at 30847
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During the interview, Ms. Fosu identified Drs. Flynn and De La
Guardia as the prescribers of the prescriptions which Respondent filled
for Coralpines. Id. at 396. While Ms. Fosu related that she had
initially made a few phone calls to Dr. De La Guardia to verify that he
had issued the prescriptions, she was never able to speak with Dr.
Flynn, whose prescribing practices raised her concern because of the
large number of prescriptions he was issuing. Id. Ms. Fosu further
asserted that she and her husband became concerned that most of the
Coralpines prescriptions were for controlled substances. Id. at 397-98.
She further maintained that she and her husband had decided in April
2007 to stop filling prescriptions for Coralpines because they did not
believe that there was ``a legitimate doctor-patient relationship''
between the patients and Drs. Flynn or De La Guardia. Id. at 398.
Ms. Fosu also related that in January 2007, she and her husband had
been visited by Dr. Robert Reppy, a Tampa-area physician, who solicited
Respondent to fill prescriptions that he would be writing for persons
who were located throughout the United States. Id. at 399. Reppy
``assured'' the Fosus that ``his patients would be flying in from all
across the country to be seen by [him] at his'' Tampa office. Id.
The Fosus agreed to fill Reppy's prescriptions and shortly
thereafter started receiving faxed prescriptions which were ``mainly
for hydrocodone,'' which is a schedule III narcotic. Id.; see also 21
CFR 1308.13(e). Ms. Fosu further stated that because she and her
husband ``were concerned about whether [Reppy] was actually seeing
these patients,'' they made an unannounced visit to his office. Tr.
399. Reppy assured the Fosus that ``he was actually seeing these
patients.'' Id. at 400.
During the course of executing the warrant, Respondent received six
prescriptions via fax from Reppy's office. Id. The prescriptions were
for patients who did not reside in Florida. Id. at 403. The DI did not,
however, have any information linking Reppy to Coralpines and did not
know if Reppy was issuing prescriptions through any other internet
sites. Id. at 401.
Later that morning, Mr. Fosu arrived at Respondent and agreed to be
interviewed. Id. at 413-14. Mr. Fosu related that, in the summer of
2006, he had received a phone call from a woman working for Coralpines
who solicited him to fill prescriptions for it. Id. at 414-15. Mr. Fosu
maintained that he was not comfortable with Coralpines' proposal
because he ``didn't believe that the doctors would actually be seeing
the patients'' and believed that there would not be ``a legitimate
doctor-patient relationship.'' Id. at 415. Mr. Fosu claimed that he had
called the DEA Tampa office and was told to contact the Florida Board
of Pharmacy. Id. at 415-16. Mr. Fosu spoke with a representative of the
Board to inquire about the legality of filling prescriptions for
doctors who were not in the same area as their patients. Id. at 416.
The Board's representative told Mr. Fosu not to fill the prescriptions
if they ``were not based on a legitimate doctor-patient relationship.''
Id. at 416-17. Mr. Fosu then questioned the Board representative as to
what constitutes a doctor-patient relationship and was advised to
contact the Florida Board of Medicine for further guidance. Id. at 417.
During the interview, Mr. Fosu corroborated that in November 2006,
he was approached by Wright, who solicited him to fill prescriptions
for doctors affiliated with the Pitcairn Group.\9\ Id. at 417. Wright
told Fosu that he was filling prescriptions for Pitcairn and asked him
if he was
[[Page 24528]]
interested in doing so. Id. at 417-18. Fosu maintained that he
questioned Wright about whether the prescriptions were based on
legitimate doctor-patient relationships and that Wright had told him
not worry because other pharmacies were filling prescriptions for
Pitcairn. Id. at 418.
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\9\ While in this portion of his testimony, the DI referred to
the Pitcairn Group, the evidence suggests that Pitcairn either
changed its name to Coralpines, Tr. 420, was an entity that was
controlled by Coralpines, or was taken over by it. GX 15, at 4 (Jan.
30, 2007 e-mail from Coralpines Support to ``Kwamen and Pat''
stating in part: ``Pitcairn has a credit balance with Sunlake for
8k. We will deduct this of [sic] next weeks report. Thanks,
Coralpines Support.''); id. at 6 (Jan. 10, 2007 e-mail with subject
line of ''Pitcairn migrating to Coralpines,'' and stating: ``My name
is Justin, I will be taking over for Pitcairn as Juan has gone on
leave.'').
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In the interview, Mr. Fosu maintained that during the course of his
relationship with Coralpines, he had become ``increasing[ly]
concerned'' that the prescriptions were only for controlled substances
such as hydrocodone and alprazolam and that when he raised this issue
with Coralpines, he was told that he would start seeing a ``mix of
prescriptions.'' Id. at 420. However, Coralpines continued to send him
alprazolam prescriptions. Id. Mr. Fosu further related that he had
worked for Coralpines from November 2006 through April 2007, that
Coralpines paid him $20 per prescription, and that Coralpines had paid
him a total of between $150,000 to $250,000 for Respondent's
services.\10\ Id. at 421. These payments came from foreign sources and
according to Mr. Fosu, further raised his concern. Id.
---------------------------------------------------------------------------
\10\ Various e-mails suggest that this amount was Respondent's
compensation for filling the prescriptions and that it was also
reimbursed for its drug costs. GX 15, at 3-14 (stating ``your
estimated cost for my totals for week 4 & 5 was about $31,000 that
is only my cost of drugs. My service fee is about 13,180 for 670
script[s] filed''); id. at 17 (stating that in the ``week ending 02/
09/2007 I did 579 prescriptions my service fee is 11,580,000 [and
my] drug cost is obout [sic] $12,000'').
---------------------------------------------------------------------------
Mr. Fosu also admitted that he was concerned about Dr. Reppy's
prescriptions and that this had prompted the visit to Reppy's office,
which had occurred approximately one month before the warrant was
executed. Id. at 422. After the visit, Respondent continued to fill
Reppy's prescriptions. Id. at 423. However, during his interview, Mr.
Fosu announced that from that ``day forward, [he] would no longer fill
these prescriptions because [he] did not believe that Dr. Reppy was
ever seeing these patients from out of state.'' Id.
The day after the interview, Mr. Fosu called the DI and asked him
whether he should fill the hydrocodone refills which Reppy had
authorized on his prescriptions. Id. at 428. The DI instructed Fosu
``to use his best judgment as a pharmacist'' and, if he did ``not
believe that these prescriptions were issued for a legitimate medical
purpose, then [he] shouldn't be refilling the prescriptions.'' Id. The
DI further explained that if Reppy ``was not seeing these patients,''
then ``there was no doctor-patient relationship'' and he should not
refill the prescriptions. Id. Mr. Fosu then told the DI that he would
not refill Reppy's prescriptions. Id. at 428-29.
As found above, during the search, the hard drives of Respondent's
computers were imaged and subsequently analyzed by the National Drug
Intelligence Center. Id. at 423-24. According to the DI, the analysis
showed that between January and the June 2007, Respondent had filled
2,400 prescriptions issued by Reppy, which were primarily for
hydrocodone, and that the prescriptions had been sent to residents of
46 different States. Id. at 425. However, the Government did not submit
any report or summary providing further detail as to Reppy's
prescribing practices. Nor did the Government submit copies of any of
Reppy's prescriptions.
As found above, the search party also seized numerous hard copy
prescriptions that Respondent had filled which were issued by Drs.
Flynn and De La Guardia. Id. at 447. The DI (along with other DEA
employees) prepared a spreadsheet listing each doctor's prescriptions
by date of issuance and drug prescribed; the spreadsheet also provided
a daily total of the prescriptions. Id.; see also GXs 12 & 13.
The Government also submitted representative samples of the
controlled substance prescriptions issued by Drs. Flynn and De La
Guardia which were filled by Respondent. With respect to Dr. Flynn, the
exhibits included copies of 97 controlled substance prescriptions, see
GX 10; with respect to Dr. De La Guardia, the exhibit included copies
of 94 controlled substance prescriptions. See GX 11. Both of these
exhibits included a cover page which listed the number of prescriptions
by State of the patient. GX 10, at 1; GX 11, at 1.
Upon reviewing Dr. Flynn's prescriptions, the DI found that on
numerous days, Flynn had issued an extraordinary number of
prescriptions. More specifically, on February 2, 2007, Flynn had issued
344 prescriptions including 235 for alprazolam, 86 for diazepam, 4 for
lorazepam, and 12 for clonazepam. GX 12, at 1. Moreover, on February
19, 2007, Flynn had issued 837 prescriptions including 581 for
alprazolam, 183 for diazepam, 1 for lorazepam, and 37 for clonazepam.
Id. In addition, on February 23, Flynn issued 314 prescriptions; on
February 28, 338 prescriptions; on March 26, 347 prescriptions, and on
April 3, 267 prescriptions.\11\ Id. at 1-2. In addition, on February 14
and 15, he issued 195 and 247 prescriptions respectively; \12\ there
were also multiple other days on which he issued between 100 and 200
prescriptions. Id. In each instance, the great majority of the
prescriptions were for controlled substances. Between January 31 and
April 5, Dr. Flynn wrote a total of 3,227 alprazolam prescriptions,
1,310 diazepam prescriptions, 415 lorazepam prescriptions, and 195
clonazepam prescriptions.\13\ Id. at 2.
---------------------------------------------------------------------------
\11\ Flynn's February 23rd prescriptions included 84 alprazolam,
30 for diazepam, 176 for lorazepam, and 12 for clonazepam; his
February 28 prescriptions included 222 for alprazolam, 54 for
diazepam, 9 for lorazepam, and 14 for clonazepam; his March 26
prescriptions included 137 for alprazolam and 210 for diazepam, and
his April 3 prescriptions included 136 alprazolam, 76 for diazepam,
34 for lorazepam and 21 for clonazepam. GX12, at 1-2.
\12\ His February 14 prescriptions included 136 for alprazolam
and 58 for diazepam; his February 15 included 181 for alprazolam and
64 diazepam. GX 12, at 1.
\13\ Based on this information, in July 2007, DEA personnel
obtained a warrant to search Dr. Flynn's registered location, which
was also his home. Tr. 461. While Dr. Flynn was not home when the
warrant was executed, he returned the following day and was
interviewed by the DI and others. Id. at 463. During his interview,
Flynn admitted that he worked for Coralpines; he further admitted
that he would go to its website and see ``hundreds of
questionnaires,'' that he issued prescriptions ``without talking to
any of the customers by phone [and] without reviewing any other
medical records.'' Id. at 464. He further admitted that ``in most
cases * * * he didn't even review the questionnaires,'' that ``[h]e
viewed this as an easy way to make money, and that this ``was not a
legitimate medical practice.'' Id. at 464. Flynn also stated that
``he was never contacted by any pharmacy to verify [his]
prescriptions'' and was ``never questioned about'' the legitimacy of
the prescriptions. Id. On July 30, 2007, Dr. Flynn surrendered his
registration and eventually pled guilty to violating 21 U.S.C. 846
Tr. 465; GXs 4 & 23.
As for Dr. De La Guardia, the record shows that he surrendered
his registration on August 1, 2007. GX 5.
---------------------------------------------------------------------------
As for Dr. De La Guardia, the evidence showed that between November
30, 2006 and February 6, 2007, Respondent filled 1,366 alprazolam
prescriptions, 628 diazepam prescriptions, 187 lorazepam prescriptions,
58 clonazepam prescriptions, and 64 phentermine prescriptions which he
had issued. GX 14, at 2. While De La Guardia generally did not issue
prescriptions at the same rate as Flynn, there were numerous days on
which he wrote more than 50 controlled substance prescriptions and
several days on which he wrote more than 100. Id.
In September 2007, Mr. Fosu called the DI, who had since returned
to the Pittsburgh office. Id. at 430. Mr. Fosu reported that he had
been solicited by another entity to fill more internet prescriptions
for hydrocodone, which were issued by a physician in Puerto Rico, and
that he had been sent copies of two prescriptions, one of which was for
a Pennsylvania resident. Id. at 430-
[[Page 24529]]
31. Mr. Fosu stated that he did not feel comfortable with the proposal
and that he wanted to provide this information to the DI. Id. at 431.
Mr. Fosu then told the DI that he had since met again with Dr.
Reppy, who told him that he had ``weeded out the bad people'' and that
Reppy had asked him to continue to fill his prescriptions. Id. Mr. Fosu
maintained that Reppy had assured him that he was actually seeing the
patients and that he was requiring them to provide some form of
identification. Id. at 432. Mr. Fosu then stated that he planned on
filling these prescriptions ``if he had some sort of identification for
the patient to [show] that the patient was who they said they were''
and that ``would match what was on the'' prescription. Id.
However, on cross-examination, the DI admitted that he did not know
whether Reppy's patients were actually coming in to see him. Id. at
541. Moreover, the Government offered no other evidence probative of
whether Reppy's patients were actually seeing him. Id. The DI also
acknowledged that he did not know whether there was anything wrong with
Reppy's prescriptions, none of which were entered into evidence. Id.
Indeed, the DI acknowledged that he did not know whether Respondent had
filled any prescriptions issued by Reppy and that it was ``possible''
that Respondent had not even filled Reppy's prescriptions. Id. at 543.
During their respective interviews, both Mr. and Mrs. Fosu
acknowledged that Respondent had actually dispensed the Coralpines
prescriptions, which had been placed in several boxes found in one of
Respondent's back rooms. Id. 493-95, 497-500, 545. I thus find that
Respondent filled and distributed the prescriptions identified in
Government Exhibits 10 and 11.\14\ I further find that Government
Exhibits 12 & 13 accurately reflect prescriptions that Drs. Flynn and
De La Guardia issued on various dates and which were eventually filled
by Respondent.
---------------------------------------------------------------------------
\14\ The Government also introduced a single prescription for
alprazolam which was written by Dr. Shabir Bhimji of Austin, Texas
for a patient in Boulder, Colorado, and a single prescription
written by Dr. Gerard Romain of Tampa, Florida for a patient in
Boston, Massachusetts. GXs 19 & 21. With respect to Dr. Bhimji, the
DI testified that he had written 100 prescriptions on a signle day
in April 2007. Tr. 458. However, other thant the single alprazolam
prescription, the record does not establish that any of the other
prescriptions were for controlled substances.
As for the prescription issued by Dr. Romain, while the DI
testified ``that there were a number of other prescriptions from
other physicians not previously identified as being affiliated with
Coralpines'' and named Dr. Romain as someone who was ``allegedly
issuing prescriptions for patients all across the United States,''
and that an ``examination of prescriptions [Respondent] filled * * *
showed that there were patients all across the United States
receiving these prescriptions,'' id. at 377-78, the DI subsequently
admitted (on direct examination no less) that he had no information
linking Romain to either Coralpines or any other internet
facilitator. Tr. 407. Moreover, the Government did not produce any
other evidence probative of whether the single Romain prescription
laced a legitimate medical purpose and was issued outside of the
usual course of professional practice.
---------------------------------------------------------------------------
The Government also introduced into evidence various e-mails that
were sent from the Fosus to Coralpines and vice versa. See GX 15. Among
these is a February 13, 2007 e-mail from ``Kwamen and Pat'' to
``Coralpines Support'' with the subject line of ``sun&lake costs.'' Id.
at 20. In this e-mail, Pat Fosu wrote:
The volume is NOT the problem but rather your erratic payments.
Do you know the amount of drugs and boxes upon boxes of UPS bags
that we ordered just to service your company? Do you know the risk
that we have to take to order enough narcotic or control [sic]
medications just to meet your client needs?
I have gone out of my way to order huge inventory of narcotics
plus hire additional labor to take care of your needs only to
experince [sic] your erratic, sluggish, and when-you-like payment
attitude.
Just last week, the DEA confiscated all the narcotics or control
medications in another pharmacy and I stand to lose these meds if
they should come to my pharmacy. But you don't have anything to
lose! And when I go through all these headaches to satisfy your
needs then I have to put up with your PAYMENT PLAN!
Id.
As part of its investigation, a DI sent administrative subpoenas to
the boards of pharmacy of each State (except for Florida) and the
District of Columbia to determine whether Respondent or each of the
Fosus held the requisite pharmacy license. Tr. 204. The DI received a
response from all but four States; these responses were submitted into
the record as Government Exhibit 6. Id. at 205. According to the DI,
neither of the Fosus was licensed in these States. Id. at 205-06.
However, the Government did not submit a copy of the subpoenas it
issued, and the ALJ found that the responses from the States of
Delaware, Kansas, Missouri, New Hampshire, South Carolina, and Wyoming
did not adequately establish ``what inquiry was made and answered or
why the author possesses the requisite competence to provide the
information contained therein'' and were therefore unreliable. ALJ at 9
n.15. I agree with the ALJ's findings. I further agree with the ALJ's
findings that Respondent did not have a state license in the remaining
States.
Respondent did not call any witnesses to testify on its behalf. It
introduced but a single exhibit, which was comprised of photographs
showing both the exterior and interior of its premises. See RX 11.
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 [its]
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 determining the public interest in the case of a
practitioner, the Act directs that the Attorney General consider the
following factors:
(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.
(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).
``[T]hese 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 a registration should be revoked
and/or an application should be denied. Id. Moreover, it is well
settled that 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 (D.C. Cir. 2005).
The Government has the burden of proving that the Respondent has
committed acts which render its registration inconsistent with the
public interest. 21 CFR 1301.44(d) & (e). However, where the Government
has made out a prima facie case, the burden shifts to the applicant to
``present[] sufficient mitigating evidence'' to show why it can be
entrusted with a new 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))), aff'd, Medicine
Shoppe-Jonesborough v.
[[Page 24530]]
DEA, 2008 WL 4899525 (6th Cir. 2008). ``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 Trong Tran, 63 FR 64280,
62483 (1998); Prince George Daniels, 60 FR 62884, 62887 (1995).
Having considered all of the factors, I conclude that the evidence
pertinent to factors two and four makes out a prima facie showing that
Respondent ``has committed such acts as would render [its] registration
* * * inconsistent with the public interest.'' \15\ 21 U.S.C.
824(a)(4). I further hold that Respondent has not rebutted the
Government's prima facie case. Accordingly, Respondent's registration
will be revoked and any pending applications will be denied.
---------------------------------------------------------------------------
\15\ This Agency has repeatedly held that the possession of 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). Nor is the lack of any
criminal convictions related to controlled substances dispositive.
Edmund Chein, 72 FR 6580, 6793 n.22 (2007), aff'd, Chein v. DEA, 533
F.3d 828 (D.C. Cir. 2008). Thus, the fact that Respondent may still
hold its Florida pharmacy license and that neither it, not its
owners, have been convicted of a criminal offense is not
dispositive.
---------------------------------------------------------------------------
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Compliance With Applicable Laws Relating to Controlled
Substances
Under a longstanding DEA regulation, a prescription for a
controlled substance is unlawful unless it has been ``issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice.'' 21 CFR 1306.04(a). The
regulation further provides that while ``[t]he responsibility for the
proper prescribing and dispensing of controlled substances is upon the
prescribing practitioner, * * * a corresponding responsibility rests
with the pharmacist who fills the prescription.'' Id. (emphasis added).
Continuing, the regulation states that ``the person knowingly filling
such a purported prescription, as well as the person issuing it, [is]
subject to the penalties provided for violations of the provisions of
law relating to controlled substances.'' Id.
DEA has consistently interpreted this provision ``as prohibiting a
pharmacist from filling a prescription for a controlled substance when
he either `knows or has reason to know that the prescription was not
written for a legitimate medical purpose.' '' Medicine Shoppe-
Jonesborough, 73 FR at 381 (quoting Medic-Aid Pharmacy, 55 FR 30043,
30044 (1990)); see also Frank's Corner Pharmacy, 60 FR 17574, 17576
(1995); Ralph J. Bertolino, 55 FR 4729, 4730 (1990); United States v.
Seelig, 622 F.2d 207, 213 (6th Cir. 1980). This Agency has further held
that ``[w]hen prescriptions are clearly not issued for legitimate
medical purposes, a pharmacist may not intentionally close his eyes and
thereby avoid [actual] knowledge of the real purpose of the
prescription.'' Bertolino, 55 FR at 4730 (citations omitted).\16\
---------------------------------------------------------------------------
\16\ 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 (1975)).
---------------------------------------------------------------------------
Under the CSA, it is fundamental that ``a practitioner must
establish a bona fide doctor-patient relationship in order to act `in
the usual course of * * * professional practice' and to issue a
prescription for a `legitimate medical purpose.' '' Patrick W. Stodola,
74 FR 20727, 20731 (2009) (citing Moore, 423 U.S. at 141-43). At the
time of the events at issue here, the CSA generally looked to state law
to determine whether a doctor has established a bona fide doctor-
patient relationship with an individual.\17\ Stodola, 74 FR at 20731;
see also Kamir Garces-Mejias, 72 FR 54931, 54935 (2007); United
Prescription Servs., Inc., 72 FR 50397, 50407 (2007). As explained
below, prior to the dispensings at issue here, numerous States had
either enacted legislation or promulgated administrative rules which
generally prohibited (except for in narrow circumstances not relevant
here) a physician from prescribing a controlled substance to a person
without having personally performed a physical examination.
---------------------------------------------------------------------------
\17\ On October 15, 2008, the President signed into law the Ryan
Haight Online Pharmacy Consumer Protection Act of 2008, Pub. L. 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. 289(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.
---------------------------------------------------------------------------
In United Prescription Services, I further explained that ``[a]
physician who engages in the unauthorized practice of medicine is not a
`practitioner acting in the usual course of * * * professional
practice.' '' 72 FR at 50407 (citing 21 CFR 1306.04(a)). This rule
derives from the text of the CSA, which defines the ``[t]he 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). See also 21 U.S.C. 823(f) (``The Attorney General shall
register practitioners * * * to dispense * * * if the applicant is
authorized to dispense * * * controlled substances under the laws of
the State in which he practices.'').
As the Supreme Court held 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.'' United States v. Moore, 423 U.S. 122, 140-
41 (1975) (emphasis added). 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. 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[.]'').
Finally, as I have previously explained, an entity which
voluntarily engages in interstate commerce by shipping controlled
substances to persons located in other States is properly charged with
knowledge of the laws regarding both the practice of medicine and
pharmacy in those States. United Prescription Servs., 72 FR at 50408;
Bob's Pharmacy & Diabetic Supplies, 74 FR 19599, 19601 (2009); see also
Hageseth v. Superior Court, 59 Cal. Rptr.3d 385, 403 (Ct. App. 2007)
(noting that the ``proscription of the unlicensed practice of medicine
is neither an obscure nor an unusual state prohibition of which
ignorance can
[[Page 24531]]
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.'').\18\
---------------------------------------------------------------------------
\18\ In Hageseth, the California Court of Appeals upheld the
State's jurisdiction to criminally prosecute an out-of-state
physician who prescribed a drug to a California resident over the
internet, for the unauthorized practice of medicine.
---------------------------------------------------------------------------
The Fosus had ample reason to know that the prescriptions
Respondent filled for Coralpines were issued outside of the course of
professional practice and lacked a legitimate medical purpose for
multiple reasons. 21 CFR 1306.04(a). First, the Fosus knew that Drs.
Flynn and De La Guardia were prescribing controlled substances without
establishing a valid doctor-patient relationship. Indeed, the evidence
is clear that the Fosus knew from the outset of their agreement with
Pitcairn/Coralpines that Drs. Flynn and De La Guardia were issuing the
prescriptions without having performed a physical examination of the
persons who were seeking the drugs.
During the interviews they gave when the warrant was executed, both
of the Fosus admitted they knew from the time they were approached by
Mr. Wright that the Coralpines' scheme involved physicians issuing
prescriptions for persons they never saw. Tr. 397 (DI's testimony
regarding interview of Patricia Fosu) & 417-18 (DI's testimony
regarding interview of Kwame Fosu). Moreover, certainly within days of
agreeing to fill the prescriptions, the Fosus knew that, given the
respective locations of Drs. Flynn (in Pennsylvania) and De La Guardia
(Kansas) and the persons they were prescribing to, who were located
throughout the country, neither doctor was performing physical
examinations of these persons and establishing legitimate doctor-
patient relationships with Coralpines' customers. Indeed, the Fosus
admitted as much in their respective interviews. Id. at 396-97 & 419.
The volume of the prescriptions provided further reason to know--as
if it was needed--that neither Dr. Flynn nor Dr. De La Guardia was
physically examining these persons. As early as February 2, 2007, Dr.
Flynn issued 344 prescriptions on a single day. Yet this did not lead
the Fosus to stop filling the prescriptions. Indeed, on February 19,
Flynn issued 837 prescriptions, a rate of nearly 35 prescriptions per
hour had he worked around the clock. Notwithstanding their knowledge of
Flynn's assembly line rate of prescribing, the Fosus continued to fill
his prescriptions. While there were numerous other days on which Flynn
wrote hundreds of prescriptions, Respondent continued to fill the
prescriptions for several months thereafter.
While at the time of the events at issue, the CSA did not
explicitly require that a physician perform a physical examination
prior to prescribing a controlled substance through the Internet,\19\
as DEA explained in the 2001 Guidance Document (a copy of which was
provided to the Fosus shortly after they obtained Respondent's
registration and which was published in the Federal Register), most
state medical boards considered that a doctor's performance of a
physical examination (and the taking of a medical history) to be
essential steps in establishing a legitimate doctor-patient
relationship. See 66 FR at 21182-83. Moreover, prior to Respondent's
agreeing to fill the Pitcairn/Coralpines prescriptions, most States had
enacted legislation, promulgated administrative rules, or issued policy
statements making clear that, except for in limited circumstances not
relevant here, a physician must physically examine a patient before
prescribing to him/her. As licensed health care providers and
participants in interstate commerce, the Fosus ``cannot reasonably
claim ignorance'' of state rules and standards of medical practice
applicable to the issuance of treatment recommendations as well as
those prohibiting the unauthorized practice of both medicine and
pharmacy. See United Prescription Servs., 72 FR at 50408 (quoting
Hageseth, 59 Cal. Rptr.3d at 403).
---------------------------------------------------------------------------
\19\ It now does. See Ryan Haight Online Pharmacy Consumer
Protection Act of 2008, Public Law 110-425, 122 Stat. 4820 (2008).
These provisions are codified throughout the CSA.
---------------------------------------------------------------------------
Since January 2001, California has prohibited 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, except as authorized by Section 2242.''
Cal. Bus. & Prof. Code Sec. 2242.1. In 2003, the Medical Board of
California made clear that ``[b]efore prescribing a dangerous drug, a
physical examination must be performed'' by the prescribing physician.
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). Furthermore, the Medical Board of California determined 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 conversation with the patient, without a physical
examination of the patient.'' Id.
Moreover, well before Respondent commenced to dispense the
prescriptions at issue here, the Medical Board of California had issued
numerous Citation Orders to out-of-state physicians for prescribing
over the Internet to California residents. These Orders invariably
cited both the physicians' failure to perform 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 (August 15, 2003); see also Citation Order, Harry
Hoff (June 17, 2003); Citation Order, Carlos Gustavo Levy (Jan. 28,
2003); Citation Order, Carlos Gustavo Levy (November 30, 2001).\20\
Respondent nonetheless dispensed controlled substance prescriptions
issued by Drs. Flynn and De La Guardia to California residents and thus
violated both the CSA and California law.
---------------------------------------------------------------------------
\20\ The Medical Board of California had also issued press
releases announcing its position on the issuance of prescriptions by
physicians who do not hold a California license. See Medical Board
of California, Record Fines Issued by Medical Board to Physicians in
Internet Prescribing Cases (News Release Feb. 10, 2003) http://www.mbc.ca.gov/NR_2003_02-10_Internetdrugs.htm
---------------------------------------------------------------------------
Similar to California, regulations adopted by the States of Ohio
and Indiana require that a physician perform a physical examination of
his/her patient prior to prescribing a controlled substance, except in
limited circumstances not applicable here. 844 Ind. Admin. Code Sec.
5-4-1(a); Ohio Admin. Code Sec. 4731-11-09(A). The record shows that
both Drs. Flynn and De La Guardia issued controlled substance
prescriptions to residents of each State without performing physical
examinations of them and thus violated the regulations of Indiana and
Ohio.\21\ While Respondent clearly had reason to know that the
prescriptions were issued outside of the usual course of professional
practice and lacked a legitimate medical purpose, it nonetheless filled
them. In doing so, Respondent violated the CSA. 21 CFR 1306.04(a).
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\21\ There is no dispute that those persons who received
prescriptions through Coralpines did not see either Dr. Flynn or Dr.
De La Guardia.
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Under Virginia law, a doctor must establish a bona fide
practitioner-patient relationship prior to prescribing a controlled
substance. Va. Code Ann. Sec. 54.1-3303(A). Moreover, Virginia law
expressly requires that a practitioner ``perform or have performed an
[[Page 24532]]
appropriate examination of the patient, either physically or by use of
instrumentation and diagnostic equipment through which images and
medical records may be transmitted electronically'' and that ``except
for [in] medical emergencies, the examination shall have been performed
by the practitioner himself, within the group in which he practices, or
by a consulting practitioner prior to issuing a prescription.'' Id.
Both Drs. Flynn and De La Guardia issued controlled substance
prescriptions to residents of Virginia without performing physical
examination of them and thus failed to establish bona fide doctor-
patient relationships with these persons. Respondent nonetheless
dispensed these prescriptions and thus failed to comply with its
``corresponding responsibility'' under Federal law to dispense only
lawful prescriptions. Id.
These are but a few representative examples of state medical
practice standards that Drs. Flynn and De La Guardia violated and which
rendered their prescriptions unlawful. See also ALJ at 39-41 (citing
various state authorities). Yet the Fosus filled thousands of
controlled substance prescriptions issued by them.\22\
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\22\ For the reasons given by the ALJ, I also reject
Respondent's argument that under Forlaw v. Fitzer, 456 So.2d 432,
435 (Fla. 1984), a physician's failure to conduct a physical
examination is not a basis to conclude that a prescription is
invalid. See ALJ at 36; Resp. Br. 18. I further note that even if
this is an accurate statement of Florida law, Florida's standards
for prescribing a controlled substance do not apply in other States.
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Many of the controlled substance prescriptions issued by Drs. Flynn
and De La Guardia were unlawful for the further reason that both
doctors prescribed to persons who resided in States where they were not
licensed to practice medicine and where they were therefore engaged in
the unauthorized practice of medicine. As noted above, a controlled
substance prescription issued by a practitioner who is engaged in the
unauthorized practice of medicine is not a prescription issued in the
usual course of professional practice. Moore, 423 U.S. at 140-41;
United, 72 FR at 50407.
For example, the evidence shows that both Drs. Flynn (who was
licensed only in Pennsylvania) and De La Guardia (who was licensed only
in Kansas and Nebraska) issued controlled substance prescriptions to
residents of numerous States where they were not licensed to practice
medicine including, inter alia, California, Georgia, Indiana, North
Carolina, Ohio, Texas, and Virginia. See GX 10, at 1; GX 11, at 1.
These prescriptions violated the laws of these States as well as the
CSA. See Cal. Bus. & Prof. Code Sec. Sec. 2052 (criminalizing the
practice of medicine without state license); Ga. Code Ann. Sec. Sec.
43-34-26(a) (requiring license), 43-34-31 (requiring state license for
medical treatment of individual in State by physician in another
State); 43-34.31.1(a) (2007) (defining practice of medicine to include
electronic prescribing by ``[a] person who is physically located in
another state'' and requiring Georgia license); \23\ 225 Ill. Comp.
Stat. Ann. Sec. 60/3 (licensure requirement); id. Sec. 60/3.5
(prohibiting unlicensed practice); id. Sec. 60/49 (listing acts
constituting holding oneself out to the public as a physician); id.
Sec. 60/49.5 (requiring persons engaged in telemedicine to hold
Illinois license); Ind. Code Ann. Sec. Sec. 25-22.5-8-1 (prohibiting
the practice of medicine without a state license) & 25-22.5-1-1.1(a)
(defining practice of medicine); N.C. Gen. Stat. Ann. Sec. 90-18
(prohibiting practice of medicine across state lines unless licensed in
state); Ohio Rev. Code Ann. Sec. Sec. 4731.296 (prohibiting out-of-
state practice of telemedicine without a special permit), 4731.41
(prohibiting practice of medicine without state license); Tex. Occup.
Code Ann. Sec. Sec. 155.001 (requiring license to practice medicine),
151.056(a) (making out-of-state treatment of individual in state the
practice of medicine in state); Va. Code Ann. Sec. Sec. 54.1-2902
(prohibiting practice of medicine without state licensure), 54.1-2903
(making prescribing the practice of medicine), 54.1-2929 (requiring
license for the practice of medicine).\24\ The Fosus nonetheless filled
these prescriptions even though they were clearly illegal under both
the respective State's law and the CSA.
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\23\ This provision was re-designated as Ga. Code Ann. Sec. 43-
34-31 by Ga. L. 2009, p. 859, Sec. 1/HB509.
\24\ In his opinion, the ALJ discussed at length various
provisions of Alabama's law that require a special purpose license
to practice medicine across state lines. ALJ at 39 (citing Ala Code.
Sec. Sec. 34-24-343, 34-24-501, 34-24-502(a); Ala. Admin. Code r.
540-x-16.03). However, as the ALJ noted, a physician is not required
to obtain a special purpose license if he engages in such activity
on an ``irregular or infrequent basis'' as defined by three
different criteria. Id. (quoting Ala. Code Sec. 34-24-505; Ala.
Admin. Code r. 540-x-16.02). The record does not, however, establish
that either Drs. Flynn or De La Guardia prescribed to Alabama
residents at a frequency which required them to obtain an Alabama
special purpose license.
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Finally, as discussed at length in the ALJ's opinion, Respondent
violated the laws of numerous States by engaging in the unauthorized
practice of pharmacy. See ALJ at 43-44 & nn. 61-91 (citing numerous
state laws). See also, e.g., Alaska Stat. Sec. 08.80.158, GX 6 at 5,
GX 10 at 2, GX 11 at 2-3; Ark. Code Ann. Sec. Sec. 17-92-301
(prohibiting practice of pharmacy without a license) & 17-92-302
(prohibiting filling of prescription by other than Arkansas-licensed
pharmacist), GX 6 at 8-9, GX 10 at 5-6, GX 11, at 6-7; Cal. Bus. &
Prof. Code Sec. 4120 (requiring special permit for nonresident
pharmacies), GX 6 at 10-15, GX 10 at 9-11, GX 11 at 11; Conn. Gen.
Stat. Ann. Sec. 20-627 (requiring registration of nonresident
pharmacies), GX 6 at 17-18, GX 10 at 14-15, GX 11, at 14-15; La. Rev.
Stat. Ann. Sec. 37:1221 (requiring special permit for out-of-state
pharmacies to provide pharmacy services to residents of the state), GX
6 at 27, GX 10 at 36-38, GX 11 at 36. Respondent dispensed
prescriptions to residents of all of these States without holding the
pharmacy licenses required to do so.\25\ See GXs 10 & 11.
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\25\ In light of the extensive evidence that Respondent violated
Federal law in filling the Coralpines prescriptions, I deem it
unnecessary to make any findings as to whether it failed to comply
with its corresponding responsibility in filling Dr. Reppy's
prescriptions.
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In its brief, Respondent contends that it filled the Internet
prescriptions for only ``a brief period of time'' and that ``[t]he vast
majority of its business is, and always has been'' retail `walk-up'
service and prescriptions deliveries to local nursing homes.'' Resp.
Br. at 1. Contrary to Respondent's contention, its conduct in filling
thousands of unlawful prescriptions over a period of five to six months
was not a ``brief'' sojourn into illegality.
By itself, Respondent's (and the Fosus') conduct is egregious
enough to conclude that its registration is inconsistent with the
public interest. 21 U.S.C. 823(f). Indeed, the evidence shows that
Respondent (and the Fosus) acted with flagrant and intentional
disregard for both the CSA and state laws as demonstrated by the facts
that: (1) Even though the Fosus had been previously advised by both DEA
personnel (through both a briefing and written materials such as the
2001 Guidance Document) and by a representative of the Florida Board of
Pharmacy that it was unlikely that internet prescriptions are issued in
the course of a legitimate doctor-patient relationship, they knowingly
filled the prescriptions; (2) Mr. Fosu's statement to the DIs during
the December 2005 meeting that he had rejected a proposal to fill
internet prescriptions because ``he did not see the doctor-patient
relationship,'' Tr. 49; as well as the Fosus' statements during their
June 2007 interviews that they had raised similar questions when
approached by Wright; and (3) Mrs. Fosu's Feb. 13, 2007 e-mail in which
she asked Coralpines whether it ``kn[ew] the risk that we have to take
to order enough
[[Page 24533]]
narcotic or control medications just to meet your client needs'' and
noted that ``[j]ust last week, the DEA confiscated all the narcotics or
control medication in another pharmacy and I stand to lose these meds
if they should come to my pharmacy.'' GX 16, at 20. In short, the Fosus
clearly knew that in filling the Coralpines prescriptions, they were
violating the CSA.
Under Agency precedent, where, as here, the Government has
established its prima facie case, the burden shifts to the Respondent
to demonstrate why the continuation of its registration is consistent
with the public interest. See, e.g., Medicine Shoppe, 73 FR at 387. An
essential element of this showing is that the registrant and its
principals accept responsibility for their misconduct by acknowledging
their wrongdoing. Id.; see also Jackson, 72 FR at 23853; Kennedy, 71 FR
at 35709.
Here, however, Mr. Fosu did not testify and Mrs. Fosu invoked her
Fifth Amendment privilege. I therefore hold that the Fosus (and
Respondent) have failed to accept responsibility for their misconduct.
Because Respondent has failed to rebut the Government's prima facie
case, I further conclude that its registration should be revoked and
that any pending application should be denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a), as well as by 28 CFR 0.100(b) and 0.104, I order that DEA
Certificate of Registration, BS9433828, issued to Sun & Lake Pharmacy,
Inc., be, and it hereby is, revoked. I further order that any pending
applications of Sun & Lake Pharmacy, Inc., to renew or modify its
registration, be, and they hereby are, denied. This Order is effective
June 1, 2011.
Dated: April 22, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-10506 Filed 4-29-11; 8:45 am]
BILLING CODE 4410-09-P