[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]
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