[Federal Register Volume 70, Number 95 (Wednesday, May 18, 2005)]
[Notices]
[Pages 28575-28579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9838]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Salvatore DeFrank, D.P.M. Revocation of Registration

    On October 28, 2004, the Deputy Administrator of the Drug 
Enforcement Administration (DEA) issued an Order to Show Cause and 
Immediate Suspension of Registration to Salvatore DeFrank, D.P.M. (Dr. 
DeFrank) of Dallas, Texas. Dr. DeFrank was notified of an opportunity 
to show cause as to why DEA should not revoke his DEA Certificate of 
Registration, BD8259346, as a practitioner, and deny any pending 
applications for renewal or modification of such registration pursuant 
to 21 U.S.C. 823(f) and 824(a)(4) for reason that his continued 
registration would be inconsistent with the public interest. Dr. 
DeFrank was further notified that his DEA registration was immediately 
suspended as an imminent danger to the public health and safety 
pursuant to 21 U.S.C. 824(d).
    The Order to Show Cause and Immediate Suspension of Registration 
alleged in sum, that Dr. DeFrank was illegally prescribing controlled 
substances over the Internet without personal contacts, examinations or 
bona fide physician/patient relationships with the customers ordering 
the medications. These prescriptions were not issued ``in the usual 
course of professional treatment'' and violated 21 CFR 1306.04 and 21 
U.S.C. 841(a).
    According to the investigative file, the order to Show Cause and 
Immediate Suspension of Registration was personally accepted on Dr. 
DeFrank's behalf by his attorney in Carrolltown, Texas, on November 4, 
2004. More than thirty days have passed since service of the Order to 
show Cause and Immediate Suspension of Registration and DEA has not 
received a request for hearing or any other reply from Dr. DeFrank or 
anyone purporting to represent him in this matter.
    Therefore, the Deputy Administrator of DEA, finding that (1) thirty 
days having passed since the delivery of the Order to Show Cause and 
Immediate Suspension of Registration to Dr. DeFrank's attorney, and (2) 
no request for hearing having been received, concludes that Dr. DeFrank 
is deemed to have waived his hearing right. See David W. Linder, 67 FR 
12579 (2002). After considering material from the investigative file in 
this matter, the Deputy Administrator now enters her final order 
without a hearing pursuant to 21 CFR 1301.43(d) and (e) and 1301.46.
    While some consumers use Internet pharmacies for convenience, 
privacy and cost savings, others, including minor children, use the 
anonymity of the Internet to procure controlled substances illegally. 
The role of a legitimate online pharmacist is to dispense prescription 
medications and to counsel patients about the proper use of these 
medications, not to write or originate prescriptions. Internet 
profiteers are online suppliers of prescription drugs, be they owners, 
operators, pharmacists, or doctors, who illegally and unethically 
market controlled substances via the Internet for quick profit. 
Operation PHARMNET, which this Order to show Cause and Immediate 
Suspension of Registration is a part of, is a nationwide action by the 
DEA to disrupt and dismantle this illegal and dangerous cyberspace 
threat to the public health and safety.

[[Page 28576]]

    The Controlled Substances Act (CSA) establishes a ``closed system'' 
of distribution regulating the movement of controlled medications from 
their importation or manufacture, through delivery to the ultimate user 
patient, pursuant to a lawful order of a practitioner. The regulations 
implementing the CSA explicitly describe the parameters of a lawful 
prescription as follows: ``A prescription for a controlled substance to 
be effective must be issued for a legitimate medical purpose by an 
individual practitioner acting in the usual course of his professional 
practice.'' 21 CFR 1306.04(a).
    Prescriptions issued not in the ``usual course of professional 
treatment'' are not ``prescriptions'' for purposes of the CSA and 
individuals issuing and filling such purported prescriptions are 
subject to the penalties for violating the CSA's controlled substances 
provisions.
    In United States v. Moore, 423 U.S. 122 (1975), the Supreme Court 
held that, ``Implicit in the registration of a physician is the 
understanding that he is authorized only to act `as a physician.' '' 
Id., at 141. In Moore the court implicitly approved a jury instruction 
that acting ``as a physician'' is acting ``in the usual course of a 
professional practice and in accordance with a standard of medical 
practice generally recognized and accepted in the United States.'' Id., 
at 138-139; see, United States v. Norris, 780 F.2d 1207, 1209 (5th Cir. 
1986).
    Responsible professional organizations have issued guidance in this 
area. The American Medical Association's guidance for physicians on the 
appropriate use of the Internet in prescribing medication (H-120.949 
Guidance for Physicians on Internet Prescribing) states:

    ``Physicians who prescribe medications via the Internet shall 
establish, or have established, a valid patient-physician 
relationship, including, but not limited to, the following 
components. The physician shall:
    I. Obtain a reliable medical history and perform a physical 
examination of the patient, adequate to establish the diagnosis for 
which the drug is being prescribed and to identify underlying 
conditions and/or contraindications to the treatment recommended/
provided;
    ii. Have sufficient dialogue with the patient regarding 
treatment options and the risks and benefits of treatment(s);
    iii. As appropriate, follow up with the patient to assess the 
therapeutic outcome;
    iv. Maintain a contemporaneous medical record that is readily 
available to the patient and, subject to the patient's consent, to 
his or hear other health care professionals; and
    v. Include the electronic prescription information as part of 
the patient medical record.''

    In April 2000, the Federation of State Medical Boards adopted Model 
Guidelines for the Appropriate Use of the Internet in Medical Practice, 
which state, in pertinent part, that:

    ``Treatment and consultation recommendations made in an online 
setting, including issuing a prescription via electronic means, will 
be held to the same standards of appropriate practice as those in 
traditional (face-to-face) settings. Treatment, including issuing a 
prescription, based solely on an online questionnaire or 
consultation does not constitute an acceptable standard of care.''

    The CSA regulations establish certain responsibilities not only on 
individual practitioners who issue prescriptions for controlled 
substances, but also on pharmacists who fill them. A pharmacist's 
``corresponding responsibility'' regarding the proper dispensing of 
controlled substances is explicitly described in 21 CFR 1306.04(a). It 
provides:

    ``A prescription for a controlled substance to be effective must 
be issued for a legitimate medical purpose by an individual 
practitioner acting in the usual course of his professional 
practice. The responsibility for the proper prescribing and 
dispensing of controlled substances is upon the prescribing 
practitioner, but a corresponding responsibility rests with the 
pharmacist who fills the prescription.''

    In an April 21, 2001, policy statement, entitled, Dispensing and 
Purchasing Controlled Substances Over the Internet, 66 FR 21 181 
(2001), DEA delineated certain circumstances in which prescribing over 
the Internet is unlawful. The policy provides, inter alia, that a 
controlled substance should not be issued or dispensed unless there was 
a bona fide doctor/patient relationship. Such a relationship requires 
that the patient have a medical complaint, a medical history taken, a 
physical examination performed and some logical connection between the 
medical complaint, the medical history, the physical examination and 
the drug prescribed. The policy statement specifically explains that 
the completion of ``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 21 182-21183.
    Rogue Internet pharmacies bypass a legitimate doctor-patient 
relationship, usually by use of a cursory and incomplete online 
questionnaire or perfunctory telephone ``consult'' with a doctor, who 
usually has a contractual arrangement with the online pharmacy and is 
often paid on the basis of prescriptions issued. The Food and Drug 
administration (FDA) considers the questionnaire, in lieu of face-to-
face interaction, to be a practice that undermines safeguards of direct 
medical supervision and amounts to substandard medical care. See U.S. 
Food and Drug Administration, Buying Medicines and Medical Products 
Online, General FAQs (http://fda.gov/oc/buyonline/default.htm).
    The National Association of Boards of Pharmacy considers Internet 
pharmacies to be suspect if:

    ``they dispense prescription medications without requiring the 
consumer to mail in a prescription, and if they dispense 
prescription medications and do not contact the patient's prescriber 
to obtain a valid verbal prescription. Further, online pharmacies 
are suspect if they dispense prescription medications solely based 
upon the consumer completing an online questionnaire without the 
consumer having a pre-existing relationship with a prescriber and 
the benefit of an in-person physical examination. State boards of 
pharmacy, boards of medicine, the FDA, as well as the AMA, condemn 
this practice and consider it to be unprofessional.''

See National Association of Boards of Pharmacy, VIIPS Program, Most 
Frequently Asked questions (http://www.nabp.net/vipps/consumer/faq.asp).

    Rogue Internet pharmacies often use persons with limited or no 
knowledge of medications and standard pharmacy practices to fill 
prescriptions, do not advertise the availability of pharmacists for 
medication consultation, and focus on select medications, usually 
lifestyle, obesity and pain mediations. Rogue Internet pharmacies 
generally do not protect the integrity of original faxed prescriptions 
by requiring that they be received directly from the prescriber (not 
the patient) and do not verify the authenticity of suspect 
prescriptions.
    When the established safeguards of an authentic doctor-patient 
relationship are lacking, controlled substance prescription drugs can 
not only be misused, but also present potentially serious health risks 
to patients. Rogue Internet pharmacies facilitate the easy 
circumvention of legitimate medical practice. The FDA has stated:

    ``We know that adverse events are under-reported and we know 
from history that tolerating the sale of unproven, fraudulent, or 
adulterated drugs results in harm to the public health. It is 
reasonable to expect that the illegal sales of drugs over the 
Internet and the number of resulting injuries will increase as sales 
on the Internet grow. Without clear and effective law enforcement, 
violators will have no reason to stop their illegal practices.

[[Page 28577]]

Unless we begin to act now, unlawful conduct and the resulting harm 
to consumers most likely will increase.''

See U.S. Food and Drug Administration, Buying Medicines and Medical 
Products Online, General FAQs (http://fda.gov/oc/buyonline/default.htm).

    The Deputy Administrator finds that Dr. DeFrank is currently 
registered with DEA as a practitioner under DEA Registration, BD8259346 
with a registered address in Dallas, Texas. He is licensed as a 
podiatrist in the State of Texas.
    Prior to October 2003, Dr. ``J.D.'' had been issuing large amounts 
of controlled substances from his clinic, the Mid-Florida Medical 
Clinic (MFMC), located in Haines City, Florida. These prescriptions, 
issued pursuant to an unlawful Internet scheme as described above, were 
dispensed directly from MFMC and from National Scripts, Inc. (NSI), a 
pharmacy located in Earth City, Missouri, which was filling thousands 
of Internet prescriptions authorized by various physicians, in addition 
to Dr. J.D.
    On October 16, 2003, as a result of a DEA investigation into these 
activities, Dr. J.D. was served with an Order to Show Cause and 
Immediate Suspension of his DEA practitioner's registration. Shortly 
thereafter, Dr. DeFrank met with Dr. J.D. and others associated with 
MFMC and NSI, to discuss who would take over Dr. J.D.'s role, now that 
he could no longer issue prescriptions because of the suspension order. 
Dr. DeFrank agreed to take over Dr. J.D.'s prescribing 
responsibilities.
    On October 21, 2003, after a diversion investigator from DEA's 
Orlando District Office discovered Dr. DeFrank was issuing controlled 
substance prescriptions from MFMC's Florida location, he contacted Dr. 
DeFrank to advise him he was not authorized to issue Internet 
prescriptions in Florida, as he was not licensed to practice in that 
state. Dr. DeFrank responded that his prescribing was lawful, because 
it was done over the Internet. The investigator then advised Dr. 
DeFrank that they knew that Dr. DeFrank's Florida-licensed physician 
assistants were authorizing Internet controlled substance prescriptions 
in Dr. DeFrank's name, which was a violation of Florida law. The 
investigator further advised Dr. DeFrank that issuing prescriptions for 
controlled substances without a face-to-face examination was illegal 
and that this practice was the basis for the immediate suspension of 
Dr. J.D.'s registration, which was ultimately surrendered in lieu of 
further proceedings.
    On November 20, 2003, an investigator from DEA's Dallas Field 
Division contacted Dr. DeFrank's Texas attorney to advise him that DEA 
prohibited issuance of controlled substance prescriptions without a 
face-to-face examination and that such prescribing practices also 
violated Texas law.
    On December 4, 2003, DEA served a Federal search warrant on the NSI 
pharmacy in Earth City, Missouri. Over 3,000 controlled substance 
dispensing records were recovered showing Dr. DeFrank had prescribed 
controlled substances over the Internet, mostly hydrocodone, a Schedule 
III controlled substance. These records showed Dr. DeFrank continued 
Internet prescribing even after he and his attorney were specifically 
warned of its illegal nature and put on notice that DEA was 
investigating this activity.
    On February 24, 2004, Dr. DeFrank's Texas attorney was again 
contracted by DEA investigators. They advised counsel that his client 
was continuing to unlawfully prescribe controlled substances through 
the Internet and unsuccessfully sought surrender of Dr. DeFrank's 
registration.
    On April 9, 2004, a DEA undercover investigator went online to 
order a controlled substance prescription through the Web site http://www.mypainmeds.com. He falsely filled out an Internet questionnaire 
indicating he was overweight and suffering from back pain and insomnia. 
After providing an undercover phone number where he could be contacted, 
at a designated time the investigator was called by an unknown male and 
asked a few questions. While refusing to order one controlled 
medication because of its high asking price, the investigator agreed to 
purchase 60 dosage units of 10 mg. hydrocodone, at a price which 
included a $38.00 doctor's ``consultation'' fee. The hydrocodone was 
then shipped via Federal Express to an undercover address in Florida 
and Dr. DeFrank was listed on the vial's label as the prescribing 
physician.
    While Dr. DeFrank was issuing controlled substance prescriptions 
over the Internet, he was licensed in the State of Texas as a 
podiatrist. Because Texas law permits a podiatrist to issue controlled 
substances only for the treatment of foot ailments, Dr. DeFrank's 
Internet prescribing for complaints that were unrelated to foot 
ailments was prohibited by state law.
    Further, as of December 1999, Texas has imposed the following 
requirements, (1) A physician must verify the identity of the person 
requesting medication. (2) The physician must establish a diagnosis 
with accepted medical practices such as patient history, mental status 
exam, physical exam and appropriate diagnostic and laboratory testing. 
(3) The physician must discuss with the patient the diagnosis and 
evidence of the medical complaint and the risks and benefits of 
treatment options. (4) The physician must insure the availability of 
appropriate follow-up care. The Internet prescriptions issued by Dr. 
DeFrank did not comply with these state requirements.
    On September 15, 2004, Dr. DeFrank was interviewed by two 
detectives from the Sheriff's Department of Ventura County, California. 
Dr. DeFrank admitted he was then-currently managing a web site call 
center which employed one physician and a physician's assistant to 
issue controlled substance prescriptions over the Internet. The 
California investigation also discovered that between July 16 and 28, 
2004, Dr. DeFrank personally issued 32 controlled substance 
prescriptions for Internet customers.
    Pursuant to 21 U.S.C. 823(f) and 824(a)(4), the Deputy 
Administrator may revoke a DEA Certificate of Registration and deny any 
pending application for renewal of such registration, if she determines 
that the continued registration would be inconsistent with the public 
interest. Section 823(f) requires that the following factors be 
considered in determining the public interest:
    (1) The recommendation of the appropriate state licensing board or 
professional disciplinary authority.
    (2) The applicant's experience in dispensing or conducting research 
with respect to 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 or 
safety.
    These factors are to be considered in the disjunctive; the Deputy 
Administrator may rely on any one or a combination of factors and may 
give each factor the weight she deems appropriate in determining 
whether a registration should be revoked or an application for 
registration denied. See Henry J. Schwartz, Jr., M.D., 54 FR 16422 
(1989).
    In this case, the Deputy Administrator finds factors two, four and 
five relevant to a determination of whether Dr. DeFrank's continued 
registration

[[Page 28578]]

remains consistent with the public interest.
    With regard to factor one, the recommendation of the appropriate 
state licensing board or professional disciplinary authority, there is 
no evidence in the investigative file that Dr. DeFrank has been the 
subject of a state disciplinary proceeding, nor is there evidence 
demonstrating that his state podiatry license or state controlled 
substance authority are currently restricted in any form. Nevertheless, 
state licensure is a necessary, but not sufficient condition for 
registration, and therefore, this factor is not dispositive. See e.g., 
Wesley G. Harline, M.D., 65 FR 5665-5672 (2000); James C. LaJevic, 
D.M.D., 64 FR 55962 (1999).
    With regard to factors two and four, the Deputy Administrator finds 
the primary conduct at issue in this proceeding (i.e., the unlawful 
prescribing and dispensing of controlled substance prescriptions for 
use by Internet customers) relates to Dr. DeFrank's experience in 
prescribing controlled substances, as well as his compliance with 
applicable state, federal, or local laws relating to controlled 
substances.
    A DEA registration authorizes a physician to prescribe or dispense 
controlled substances only within the usual course of his or her 
professional practice. For a prescription to have been issued within 
the course of a practitioner's professional practice, it must have been 
written for a legitimate medical purpose within the context of a valid 
physician-patient relationship. See Mark Wade, M.D., 69 FR 7018 (2004). 
Legally, there is absolutely no difference between the sale of an 
illicit drug on the street and the illicit dispensing of a licit drug 
by means of a physician's prescription. See Floyd A. Santner, M.D., 55 
FR 37581 (1990).
    The Deputy Administrator concludes from a review of the record that 
Dr. DeFrank did not establish valid physician-patient relationships 
with the Internet customers to whom he prescribed controlled 
substances. DEA has previously found that prescriptions issued through 
Internet websites under these circumstances are not considered as 
having been issued in the usual course of medical practice, in 
violation of 21 CFR 1306.04 and has revoked DEA registrations of 
several physicians for participating in Internet prescribing schemes 
similar to or identical to that of Dr. DeFrank. See, Marvin L. Gibbs, 
Jr., M.D., 69 FR 11658 (2004); Mark Wade, M.D., supra, 69 FR 7018; 
Ernesto A. Cantu, M.D., 69 FR 7014-7015 (2004); Rick Joe Nelson, M.D., 
66 FR 30752 (2001).
    Similarly, DEA has issued orders to show abuse and subsequently 
revoked DEA registrations of pharmacies which have failed to fulfill 
their corresponding responsibilities in Internet prescribing operations 
similar to, or identical to that of Dr. DeFrank. See, EZRX, L.L.C. 
(EZRX), 69 FR 63178 (2004); Prescriptiononline.com, 69 FR 5583 (2004).
    In the instant case, Dr. DeFrank and other practitioner associated 
with this Internet scheme, authorized prescriptions for controlled 
substances without the benefit of face-to-face physician-patient 
contact, physical exam or medical tests. Beyond occasional phone calls 
to customers or their family members, there is no information in the 
investigation file demonstrating that Dr. DeFrank and other issuing 
physicians even took time to corroborate responses to the questionnaire 
submitted by the customers. Here, it is clear that the issuance of 
controlled substance prescriptions to persons whom Dr. DeFrank had not 
established a valid physician-patient relationship is a radical 
departure from the normal course of professional practice and he 
knowingly participated in this scheme.
    With regard to factor three, Dr. DeFrank's conviction record under 
federal or state laws relating to the dispensing of controlled 
substances, the record does not reflect that he has yet been convicted 
of a crime related to controlled substances.
    Regarding factor five, such other conduct which may threaten the 
public health or safety, the Deputy Administrator finds this factor 
particularly relevant. Dr. DeFrank continued prescribing to Internet 
customers, not only after issuance of policy statements designed to 
assist licensed practitioner and pharmacies in the proper prescribing 
and dispensing of dangerous controlled drugs, but after multiple 
warnings were personally delivered to Dr. DeFrank and his attorney and 
he was put on notice of the reason for his MFMC predecessor's immediate 
suspension. That he continued this activity after being made aware of 
its illegal nature and that it was the focus of an investigation, 
speaks volumes regarding Dr. DeFrank's willingness to abandon his 
responsibilities as a practitioner and registrant.
    The Deputy Administrator has previously expressed her deep concern 
about the increased risk of diversion which accompanies Internet 
controlled substance transactions. Given the nascent practice of cyber-
distribution of controlled drugs to faceless individuals, where 
interaction between individuals is limited to information on a computer 
screen or credit card, it is virtually impossible to insure that these 
highly addictive, and sometimes dangerous products will reach the 
intended recipient, and if so, whether the person purchasing these 
products has an actual need for them. The ramifications of obtaining 
dangerous and highly addictive drugs with the ease of logging on to a 
computer and the use of a credit card are disturbing and immense, 
particularly when one considers the growing problem of the abuse of 
prescription drugs in the United States. See, EZRX, supra, 69 FR at 
63181; Mark Wade, M.D., supra, 69 FR 7018.
    The Deputy Administrator has also previously found that in a 2001 
report, the National Clearinghouse for Alcohol and Drug Information 
estimated that 4 million Americans ages 12 and older had acknowledged 
misusing prescription drugs. That accounts for 2% to 4% of the 
population--a rate of abuse that has quadrupled since 1980. 
Prescription drug abuse--typically of painkillers, sedatives and mood-
altering drugs-- accounts for one-third of all illicit drug use in the 
United States. See, EZRX, supra, 69 FR at 63181-63182; Mark Wade, M.D., 
supra, 69 FR 7018.
    The Deputy Administrator finds that with respect to Internet 
transactions involving controlled substances, the horrific untold 
stories of drug abuse, addiction and treatment are the unintended, but 
foreseeable consequence of providing highly addictive drugs to the 
public without oversight. The closed system of distribution, brought 
about by the enactment of the Controlled Substances Act, is completely 
compromised when individuals can easily acquire controlled substances 
without regard to age or health status. Such lack of oversight 
describes Dr. DeFrank's practice of issuing prescriptions for 
controlled substances to indistinct Internet customers which were then 
filled by pharmacies participating in the scheme. Such conduct 
contributes to the abuse of controlled substances by Dr. DeFrank's 
customers and is relevant under factor five, further supporting 
revocation of his DEA Certificate of Registration.
    Blindly motivated by financial gain, Dr. DeFrank demonstrated a 
cavalier disregard for controlled substance laws and regulations and a 
disturbing indifference to the health and safety of individuals 
purchasing dangerous drugs through the Internet. Such lack of character 
and flaunting of the responsibilities inherent with a DEA registration 
show, in no uncertain terms,

[[Page 28579]]

that Dr. DeFrank's continued registration would be inconsistent with 
the public interest.
    Accordingly, the Deputy Administrator of the Drug Enforcement 
Administration, pursuant to the authority vested in her by 21 U.S.C. 
823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that DEA 
Certificate of Registration DB8259346, issued to Salvatore DeFrank, 
D.P.M., be, and it hereby is revoked. The Deputy Administrator further 
orders that any pending applications for renewal or modification of 
such registration be, and they hereby are, denied. This order is 
effective June 17, 2005.

    Dated: May 9, 2005.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 05-9838 Filed 5-17-05; 8:45 am]
BILLING CODE 4410-09-M