[Federal Register Volume 70, Number 89 (Tuesday, May 10, 2005)]
[Notices]
[Pages 24622-24625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9249]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 04-56]


Michael J. Millette, 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 Michael J. Millette, M.D. (Dr. Millette) 
of Crystal Lake, Illinois and Elizabethtown, Kentucky. Dr. Millette was 
notified of an opportunity to show cause as to why DEA should not 
revoke his DEA Certificates of Registration, BM2349012 and BM8086236, 
as a practitioner, and deny any pending applications for renewal or 
modification of such registrations 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. Millette was further 
notified that his DEA registrations were 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. Millette 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. 
Millette and associated physicians, based solely on their review of 
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.

[[Page 24623]]

    According to the investigative file, the Order to Show Cause and 
Immediate Suspension of Registration was personally served upon Dr. 
Millette by DEA Diversion Investigators on May 19, 2004. Through 
counsel, Dr. Millette filed a timely request for a hearing and the 
matter was docketed before Administrative Law Judge Mary Ellen Bittner. 
On June 22, 2004, Judge Bittner issued an Order for Prehearing 
Statements directing Dr. Millette to file a prehearing statement no 
later than August 4, 2004.
    On August 18, 2004, as a result of Dr. Millette's failure to file a 
prehearing statement, Judge Bittner issued an Order Terminating 
Proceeding. In that Order, Judge Bittner concluded that by his 
inactivity, Dr. Millette had waived his right to a hearing and she 
ordered the proceeding terminated so it could be presented to the 
Deputy Administrator for issuance of a final order. On February 17, 
2005, the investigative file was forwarded by the DEA Office of Chief 
Counsel to the Deputy Administrator for final agency action.
    Accordingly, the Deputy Administrator finds that Dr. Millette is 
deemed to have waived his right to a hearing and after considering 
material from the investigative file in this matter, 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.
    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 filing 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 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 
pharmacists 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 21,182-83.
    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 prescription 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

[[Page 24624]]

FAQ's (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 not 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).
    The Deputy Administrator finds Dr. Millette is currently registered 
with DEA as a practitioner under DEA Registrations BM2349012 and 
BM8086236 for Schedule II through V Controlled Substances. Their 
respective registered addresses are in Crystal Lake, Illinois and 
Elizabethtown, Kentucky and they expire on January 31, 2005 and January 
31, 2006.
    While Dr. Millette had a medical office, his main occupation was 
issuing controlled substance prescriptions to patients (hereinafter 
``customers'') through the Internet company E.V.A. Global, Inc., and 
others doing business under a number of names. Customers accessing Web 
sites owned by these companies would complete cursory questionnaires 
and indicate what drugs were wanted and a method of payment. The 
questionnaires would be electronically forwarded to Dr. Millette and, 
based solely on the answers, he would issue prescriptions for 
controlled substance. These prescriptions would then be dispensed by 
participating pharmacies and sent to customers by such means as FedEx 
and the U.S. Postal Service.
    On six different occasions between March 2003 and April 2004, DEA 
investigators acting in an undercover capacity went online to order 
controlled substances from five Internet company Web sites: 
Clickhererx.com, Activeliferx.com, Dietdrugs.com, IntegraRX.com and RX-MAX.com In each instance, investigators filled out online 
questionnaires and ordered drugs such as Bontril and Phentermine which 
are, respectively, Schedule III and IV controlled substances. These 
controlled substances were then shipped to the addresses provided and 
were received by investigators. Each of the labels on the bottles 
identified Dr. Millette as the prescribing physician. Other than 
initially filling out e-mail questionnaires, the investigators had no 
communications with Dr. Millette or the pharmacies before the 
prescriptions were issued or dispensed.
    On March 9, 2004 Dr. Millette was interviewed by DEA Diversion 
Investigators. He admitted prescribing controlled substances over the 
Internet for several companies since October or November 2002 and 
estimated that on an average day, he issued a ``couple hundred'' 
prescriptions without any personal contact with the customers. Dr. 
Millette admitted being compensated based on the number of 
questionnaires he reviewed and records seized from E.V.A. Global, Inc. 
covering an eight month period during 2004, indicated Dr. Millette was 
paid over $175,000.00 for assisting in this scheme.
    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 16,422 
(1989).
    In this case, the Deputy Administrator finds factors two, four and 
five relevant to the determination of whether Dr. Millette's continued 
registration remains consistent with the public interest.
    With regards 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. Millette has yet been 
the subject of a state disciplinary proceeding, nor is there evidence 
demonstrating that his state medical licenses or state controlled 
substance authorities 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., Mario Avello, M.D., 70 FR 11,695 (2005); 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 
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. Millette's experience in 
prescribing controlled substances, as well as his compliance with 
applicable state, federal, or local laws relating to controlled 
substances.

[[Page 24625]]

    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 Mario Avello, M.D., supra, 70 FR 
11,695; Mark Wade, M.D., 69 FR 7,018 (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 37,581 
(1990).
    The Deputy Administrator concludes from a review of the record that 
Dr. Millette 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 Web sites 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. Millette. See, Mario Avello, 
M.D., supra, 70 FR 11,695; 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. Millette. See, EZRX, L.L.C. 
(EZRX), 69 FR 63,178 (2004); Prescriptiononline.com, 69 FR 5,583 
(2004).
    In the instant case, Dr. Millette and other practitioners 
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 a couple of 
rare direct e-mail contacts with customers, there is no information in 
the investigative file demonstrating that Dr. Millette and other 
issuing physicians even took time to corroborate responses to the 
questionnaires submitted by the customers. Here, it is clear the 
issuance of controlled substance prescriptions to persons whom Dr. 
Millette 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. Millette'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.
    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, Mario Avello, M.D., 
supra, 70 FR 11,695; EZRX, supra, 60 FR at 63,181; Mark Wade, M.D., 
supra, 69 FR 7,018.
    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, Mario Avello, M.D., supra, 70 FR 11,695; EZRX, 
supra, 69 FR at 63,181-82; Mark Wade, M.D., supra, 69 FR 7,018.
    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. Millette'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. Millette's 
customers and is relevant under factor five, further supporting 
revocation of his DEA Certificates of Registration.
    Dr. Millette also 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. Apparently motivated purely by financial gain, Dr. 
Millette has 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, that Dr. 
Millette'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 
Certificates of Registration BM2349012 and BM8086236, issued to Michael 
J. Millette, M.D., be, and hereby are, revoked. The Deputy 
Administrator further orders that any pending applications for renewal 
or modification of such registrations be, and they hereby are, denied. 
This order is effective June 9, 2005.

    Dated: May 2, 2005.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 05-9249 Filed 5-9-05; 8:45 am]
BILLING CODE 4410-09-M