[Federal Register Volume 70, Number 45 (Wednesday, March 9, 2005)]
[Notices]
[Pages 11695-11698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-4563]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Mario Avello, M.D.; Revocation of Registration

    On May 17, 2004, the Deputy Administrator of the Drug Enforcement 
Administration (DEA) issued an Order to Show Cause and Immediate 
Suspension of Registration to Mario Avello, M.D. (Dr. Avello) of Coral 
Gables, Florida. Dr. Avello was notified of an opportunity to show 
cause as to why DEA should not revoke his DEA Certificate of 
Registration, AA0105747, 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. Avello 
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 alleged in sum, 
that Dr. Avello was engaged in illegally prescribing controlled 
substances as part of a scheme in which controlled substances were 
dispensed by pharmacies, based on Internet prescriptions issued by Dr. 
Avello and associated physicians, based solely on their review on 
Internet questionnaires and without personal contact, examination or 
bona fide physician/patient relationships. Such prescriptions were not 
issued ``in the usual course of professional treatment'' and violated 
21 CFR 1306.04 and 21 U.S.C. 841(a). This action was part of a 
nationwide enforcement operation by DEA titled Operation Pharmnet, 
which targeted online suppliers of prescription drugs, including 
owners, operators, pharmacists and doctors, who have illegally and 
unethically been marketing controlled substances via the Internet.
    According to the investigative file, the Order to Show Cause and 
Immediate Suspension of Registration was personally served upon Dr. 
Avello by DEA Diversion Investigators on May 20, 2004. More than thirty 
days have passed since the Order to Show Cause and Immediate Suspension 
of Registration was served and DEA has not received a request for 
hearing or any other reply from Dr. Avello 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. Avello, and (2) no request 
for hearing having been received, concludes that Dr. Avello 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.
    The Deputy Administrator finds Dr. Avello is currently registered 
with DEA as a practitioner under DEA Registration, AA0105747 for 
Schedule II through V Controlled Substances. That registration expires 
on June 30, 2006. His registered address is 363 Aragon

[[Page 11696]]

Avenue, Apartment 413, Coral Gables, Florida 33134. However, 
information obtained from the Florida Power & Light Company indicates 
that someone other than Dr. Avello has been paying the utility bills 
for that apartment since September 2003, and that Dr. Avello has been 
paying the utility bills for another apartment in the same building, 
Apartment No. 711, since March 2003.
    In September 2003, DEA investigators executed a federal search 
warrant on a pharmacy in Iowa and seized multiple prescriptions that 
had been issued by Dr. Avello pursuant to his relationship with 
Pharmacon International, L.L.C. (Pharmacon), an Internet drug company 
which was doing business on http://WWW.Buymeds.com and other affiliated 
Web sites.
    Customers would access a Pharmacon Web site and complete on-line 
questionnaires asking some medical history questions and soliciting 
information as to what drug they were seeking and the method of 
payment. The questionnaire would be electronically forwarded to Dr. 
Avello and, based on the answers to the questionnaire, he would issue 
prescriptions for the desired controlled substances. The primary drug 
prescribed pursuant to this scheme was hydrocodone, a Schedule III 
controlled substance.
    Dr. Avello did not see the customers and had no prior doctor-
patient relationships with them. He did not conduct physical 
examinations, nor did he create or maintain patient records. The only 
information usually reviewed prior to issuing prescriptions was the 
customer's questionnaire and Dr. Avello did not consult with the 
primary care physicians.
    The Iowa Board of Pharmacy contacted over 400 listed customers of 
Buymeds.com to verify purported prescriptions. Approximately half of 
these people advised they never had any contact with the prescribing 
physician or filling pharmacy. They stated their only contact with 
Buymeds.com had been through the Internet Web site, where they filled 
out the brief questionnaire, indicated the form of payment and 
requested their drugs of choice. None of the individual customers had 
any personal contact with the prescribing physicians and many 
prescriptions had been issued to minors.
    Approximately 40 individuals were contacted by the Iowa Board who 
had received controlled substances from Buymeds.com that had been 
prescribed by Dr. Avello. Every customer stated that before receiving 
their controlled substances they had no personal contact with Dr. 
Avello, except by e-mail.
    Dr. Avello, who entered into a ``Professional Services Agreement'' 
with Pharmacon on May 5, 2003, received payment for each questionnaire 
reviewed and he admitted reviewing approximately 100 to 200 requests 
for prescriptions per day. Dr. Avello's son, Alexis M. Avello, was an 
officer of Pharmacon and a signator on the company's contract with Dr. 
Avello.
    The Controlled Substances Act (CSA) establishes a ``closed system'' 
of distribution that regulates the movement of controlled substance 
prescription medications from importation or manufacture through their 
delivery to the ultimate user patient via the dispensing, administering 
or prescribing, pursuant to the 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 her 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 acceptance 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 required 
that the patient has a medical complaint, a medical history be taken, a 
physical examination performed, and some logical connection exists 
between the medical complaint, the medical history, the physical 
examination, and the drug prescribed. The policy

[[Page 11697]]

statement specifically explained 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 21,182-83.
    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 medications. 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. 
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).
    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. Avello's continued 
registration 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. Avello has been the 
subject of a state disciplinary proceeding, nor is there evidence 
demonstrating that his state medical 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 5,665-01 (2000); James C. LaJevic, 
D.M.D., 64 FR 55,962 (1999).
    With regard to factors two and four, the Deputy Administrator finds 
that 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. Avello'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. Avello 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 pharmacy 
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. Avello and Pharmacon. See, 
Marvin L. Gibbs, Jr., M.D., 69 FR 11,658 (2004); Mark Wade, M.D., 
supra, 69 FR 7,018; Ernesto A. Cantu, M.D., 69 FR 7,014-02 (2004); Rick 
Joe Nelson, M.D., 66 FR 30,752 (2001).
    Similarly, DEA has issued orders to show cause 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. Avello and Pharmacon. See, 
EZRX, L.L.C. (EZRX), 69 FR 63,178

[[Page 11698]]

(2004); Prescriptionline.com, 69 FR 5,583 (2004).
    In the instant case, Dr. Avello and other physicians associated 
with the 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 some customers or their family members, there is no information in 
the investigative file demonstrating that Dr. Avello and other issuing 
physicians associated with Pharmacon even took time to corroborate 
response to questionnaires submitted by the customers. Here, it is 
clear the issuance of controlled substance prescriptions to persons 
whom Dr. Avello 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. Avello's conviction record under 
Federal or State laws relating to the dispensing of controlled 
substances, the record does not reflect that he has 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 
relevant to Dr. Avello's continued prescribing to Internet customers 
after issuance of policy statements designed to assist licensed 
practitioners and pharmacists in the proper prescribing and dispensing 
of dangerous controlled drugs.
    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 63181-82, Mark Wade, M.D., 
supra, 679 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. Avello's practice of issuing prescriptions for controlled 
substances to indistinct Internet customers which are then filled by 
pharmacies participating in the scheme. Such conduct contributes to the 
abuse of controlled substances by Dr. Avello and Pharmacon's customers 
and is relevant under factor five, further supporting revocation of his 
DEA Certificate of Registration.
    Motivated purely by profit and in pursuit of financial gain, Dr. 
Avello has demonstrated a cavalier disregard for controlled substance 
laws and regulations and a disturbing indifference to the health and 
safety of individuals who purchased dangerous drugs through the 
Internet. Such demonstrated lack of character and adherence to the 
responsibilities inherent in a DEA registration show in no uncertain 
terms that Dr. Avello's continued registration with DEA 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 AA0105747, issued to Mario Avello, M.D., 
be, and is hereby is, revoked. The Deputy Administrator further orders 
that any pending applications for renewal of such registration be, and 
they hereby are denied. This order is effective April 8, 2005.

    Dated: January 14, 2005.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 05-4563 Filed 3-8-05; 8:45 am]
BILLING CODE 4410-09-M