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Michael J. Millette, M.D.; Revocation of Registration
FR Doc 05-9249 [Federal Register: May 10, 2005 (Volume 70, Number 89)]
[Notices] [Page 24622-24625] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10my05-108]
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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