[Federal Register Volume 76, Number 69 (Monday, April 11, 2011)]
[Notices]
[Pages 20020-20025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8546]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Glenn D. Krieger, M.D.; Denial of Application

    On August 31, 2009, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Glenn D. Krieger, M.D. (``Applicant''), of West 
Bloomfield, Michigan. The Show Cause Order proposed the denial of 
Applicant's application for a DEA Certificate of Registration on the 
ground that his ``registration would be inconsistent with the public 
interest as defined by 21 U.S.C. Sec. Sec.  823(f) and 824(a)(4).'' 
Show Cause Order, at 1.
    More specifically, the Show Cause Order alleged that Applicant 
filed an

[[Page 20021]]

application for a DEA registration on October 9, 2008. Id. The Order 
further alleged that on ``June 28, 2007, July 19, 2007, and August 1, 
2007,'' Applicant was subjected to random urine drug tests and tested 
positive for fentanyl, a Schedule II controlled substance,\1\ although 
the drug had never been prescribed to him. Id. Relatedly, the Order 
alleged that on November 7, 2008, Applicant told DEA Investigators that 
he ``obtained the fentanyl from patients who returned unused fentanyl 
to [him], because [he] was collecting pain medication to give as a 
donation to the Oakpointe Church's missionary project in Zambia, 
Africa.'' Id. The Order further alleged that DEA Investigators were 
subsequently ``informed by Oakpointe Church executives that the church 
did not conduct any Zambian missionary projects in 2007, that the 
Zambian missionary projects of previous years did not collect donated 
controlled substances, and that [Applicant] did not participate in any 
of the Zambian missionary projects.'' Id. at 1-2. The Order then 
alleged that Applicant's ``false statements to DEA investigators 
constituted both conduct which may threaten the public health and 
safety pursuant to 21 U.S.C. Sec.  823(f)(5) and criminal acts pursuant 
to 18 U.S.C. 1001. Id. at 2.
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    \1\ See 21 CFR 1308.12(c)(9).
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    Next, the Show Cause Order alleged that Applicant had previously 
held a DEA Certificate of Registration, BK4918528, which he 
``surrendered for cause on March 7, 2008.'' Id. The Order then alleged 
that ``[b]etween March 7, 2008 and November 1, 2008,'' Applicant 
``issued approximately 435 prescriptions for controlled substances 
despite not having a valid DEA Certificate of Registration, in 
violation of 21 U.S.C. Sec.  841(a).'' Id. Finally, the Order alleged 
that Applicant's ``violation[s] of Federal laws and regulations are 
inconsistent with the public interest.'' Id. (citing 21 U.S.C. 823(f) 
and 824(a)(4)).
    The Show Cause Order also explained that Respondent had the right 
to request a hearing on the allegations or to submit a written 
statement in lieu of a hearing, the procedures for doing either, and 
the consequences for failing do so. Id. (citing 21 CFR 1301.43(c), (d), 
& (e)). On or about September 2, 2009, the Government attempted to 
serve Applicant with the Order by certified mail addressed to him at 
the address he provided in his application for a new registration. 
However, on or about September 11, 2009, the Post Office returned the 
Order as ``not deliverable as addressed.''
    On or about September 25, 2009, DEA made a second attempt to serve 
Applicant with the Order by certified mail addressed to him at the 
address given on his application. Again, however, the Post Office 
returned the mailing as ``not deliverable as addressed.''
    On or about September 16, 2009, DEA mailed a copy of the Show Cause 
Order to Applicant's counsel.\2\ As evidenced by a signed return 
receipt card, Applicant's counsel received the letter on September 18, 
2009.
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    \2\ Applicant's counsel had represented him during an interview 
with DEA Investigators on November 7, 2008.
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    On February 2, 2010, the Office of Administrative Law Judges 
received a letter from Applicant (dated Jan. 28, 2010). Therein, 
Applicant stated that ``[a]round mid-October 2009, I received a letter 
from my attorney * * * that was supposed to contain a complete copy of 
the letter he received only a few days earlier. Due to several 
different miscommunications and difficulty with traveling due to 
expenses, I did not appear for the scheduled show cause on December 1, 
2009. In spite of my absence, I am very interested in scheduling a show 
cause.''
    Upon receipt of this letter, the ALJ ordered that the Government 
provide evidence of the date of service of the Show Cause Order upon 
Applicant by February 19, 2010 and to file any motion to terminate 
based on his failure to timely request a hearing by the same date. 
Order Granting the Government's Motion to Terminate Proceedings, at 1. 
The Order further directed Applicant to file a responsive pleading by 
February 26, 2010. Id.
    Thereafter, the Government timely filed a Motion to Terminate. 
Therein, it asserted that it ``effected service of the OSC on 
Respondent's counsel via certified mail on or around September 18, 
2009,'' that the Show Cause Order clearly set forth the procedures for 
requesting a hearing and the consequences for failing to do so, and 
that he did not request a hearing within 30 days of receiving the Order 
as required by DEA regulations. Id. at 2. Applicant did not file a 
response to the Government's motion.
    The ALJ granted the Government's motion noting that Applicant did 
not contest the Government's representation that the Show Cause Order 
had been served on his legal counsel/agent on or about September 18, 
2009, and that, in his letter requesting a hearing, Applicant had 
acknowledged that in mid-October 2009, he had received a document from 
his attorney ``related to this proceeding and `did not appear for the 
scheduled show cause hearing on December 1, 2009,''' which information 
was contained on the front page of the Show Cause Order. Id. at 2-3. 
Because Applicant did not request a hearing until ``several months 
after effective service of the'' Order, and did not offer good cause 
for his failure to do so, the ALJ concluded that he had waived his 
right to a hearing and terminated the proceeding. Id. at 3 (citing 21 
CFR 1301.43). I adopt this finding.\3\
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    \3\ Respondent did not challenge whether the Government's 
mailing of the Show Cause Order to the lawyer who previously 
represented him constituted sufficient service. See 21 U.S.C. 824(c) 
(``Before taking action pursuant * * * to a denial of registration 
under section 823 of this title, the Attorney General shall serve 
upon the applicant * * * an order to show cause. * * * .''); see 
also United States v. Ziegler Boat and Parts Co., 111 F.3d 878, 881 
(Fed. Cir. 1997) (``The mere relationship between a defendant and 
his attorney does not, in itself, convey authority to accept 
service. * * * Even where an attorney exercises broad powers to 
represent a client in litigation, these powers of representation 
alone do not create a specific authority to receive service.'') 
(citing numerous authorities). However, a challenge to the 
sufficiency of service is deemed waived if it is not raised in a 
party's first responsive pleading. See Hemisphere X Biopharma, Inc., 
v. Johannesburg Consol. Investments, 553 F.3d 1351, 1360 (11th Cir. 
2008). Accordingly, I hold that Respondent has waived any challenge 
to the sufficiency of service.
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    Thereafter, the investigative record was forwarded to me for final 
agency action. Based on relevant evidence contained in the record, I 
conclude that granting Respondent's application would be ``inconsistent 
with the public interest.'' 21 U.S.C. 823(f). Accordingly, his 
application will be denied. I make the following findings of fact.

Findings

    On October 9, 2008, Applicant filed an application for a DEA 
Certificate of Registration through DEA's Web site. The application is 
the subject of this proceeding.
    Applicant previously held DEA Certificate of Registration 
BK4918528. On March 7, 2008, Respondent voluntarily surrendered this 
registration and executed a DEA Form 104, Voluntary Surrender of 
Controlled Substances Privileges (which his counsel signed as a 
witness). The form clearly stated that it provided ``authority for the 
Administrator * * * to terminate and revoke my registration without an 
order to show cause, a hearing, or any other proceedings.'' In 
addition, the form stated: ``I understand that I will not be permitted 
to * * * prescribe, or engage in any other controlled substance 
activities whatsoever, until such time as I am again properly 
registered.''
    According to a report obtained by an Agency Investigator from the 
Michigan

[[Page 20022]]

Automated Prescription System (MAPS), within less than three weeks of 
the surrender, Applicant issued prescriptions to two patients for 60 
and 90 tablets of OxyContin 80 mg. The report further showed that by 
the end of July, Applicant had resumed prescribing controlled 
substances full-bore.
    The investigative record establishes that Applicant voluntarily 
surrendered his registration in connection with an Administrative 
Complaint (``Complaint'') filed by the Michigan State Bureau of Health 
Professionals (BHP) on December 20, 2007. The Complaint alleged two 
counts. Administrative Complaint, In re Glenn D. Krieger, M.D., No. 43-
07-106420.
    First, the Complaint alleged that Applicant had self-reported that 
he was abusing fentanyl, a schedule II controlled substance, to the 
Michigan Health Professional Recovery Program (HPRP) and had undergone 
a substance abuse evaluation and been diagnosed as abusing opioids. Id. 
at 5-6. The Complaint alleged that he had tested positive for fentanyl 
during urine drug screens conducted on June 28, July 19, and August 1, 
2007, and that thereafter, HPRP advised him that ``he was not safe to 
practice'' medicine and recommended that he admit himself into an 
inpatient rehabilitation program. Id. at 6. The Complaint further 
alleged that he had failed to enter an inpatient drug rehabilitation 
program or enter into a monitoring agreement with HPRP. The BHP charged 
that his conduct ``constitute[d] a mental or physical inability 
reasonably related to and adversely affecting Respondent's ability to 
practice in a safe and competent manner,'' ``constitute[d] a conduct 
that impairs or may impair his ability to safely and skillfully 
practice medicine,'' and ``constitute[d] substance abuse,'' all in 
violation of state law. Id. at 6-7.
    Second, the Complaint alleged that, in treating S.S. for chronic 
back pain, TMJ,\4\ fibromyalgia and depression, Applicant's ``chart for 
S.S. [was] devoid of physical exams or clinical findings to support his 
long term prescribing of high doses of opioids, benzodiazepines, and 
stimulants'' and that he had ``failed to recognize that his prescribing 
of escalating doses of opioids was detrimental to S.S.'s overall 
functioning and quality of life.'' Id. at 10. The BHP charged that his 
conduct ``constitute[d] negligence,'' ``incompetence,'' and the 
``prescribing, giving away or administering [of] drugs for other than 
lawful diagnostic or therapeutic purposes,'' all in violation of 
Michigan law. Id.
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    \4\ Temporo-mandibular joint dysfunction.
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    The investigative file contains copies of the results from the 
urine drop assessments of June 28, July 19, and August 1, 2007. These 
documents establish that Applicant tested positive for fentanyl on each 
occasion.
    On December 28, 2007, the BHP's Board of Medicine's Disciplinary 
Subcommittee (DS) summarily suspended Applicant's state medical license 
effective on service of the order. Order of Summary Suspension, at 1. 
On May 30, 2008, Applicant entered into a Consent Order with the State. 
Consent Order, at 6. The Consent Order provided that the DS found 
``that the allegations of fact contained in the complaint are true'' 
and that Applicant had violated sections 16221(a),\5\ (b)(i),\6\ 
(b)(ii),\7\ (b)(iii),\8\ and (c)(iv)\9\ of the Michigan Public Health 
Code. Id. at 2. The DS thus ordered that Applicant's license be 
``LIMITED for a minimum period of two years'' such that he ``shall not 
obtain, possess, dispense, administer, or have access to any drug 
designated as a controlled substance under the Public Health Code or 
its counterpart in federal law unless the controlled substance is 
prescribed or dispensed by a licensed physician for [Applicant] as a 
patient.'' Id. The Consent Order also placed him ``on PROBATION for a 
period of two years.'' Id.
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    \5\ Section 16221(a) ``provides the [DS] with the authority to 
take disciplinary action against [Applicant] for a violation of 
general duty, consisting of negligence or failure to exercise due 
care . . . or any conduct, practice, or condition which impairs or 
may impair, the ability to safely and skillfully practice 
medicine.'' Administrative Complaint, at 2.
    \6\ Section 16221(b)(i) provides the DS with authority to take 
disciplinary action against a licensee for ``incompetence,'' defined 
as ``[a] departure from, or failure to conform to, minimal standards 
of acceptable and prevailing practice for a health profession 
whether or not actual injury to an individual occurs.'' 
Administrative Complaint, at 2.
    \7\ Section 16221(b)(ii) provides the DS with authority to take 
disciplinary action against a licensee for ``substance abuse,'' 
defined as ``the taking of alcohol or other drugs at dosages that 
place an individual's social, economic, psychological, and physical 
welfare in potential hazard or to the extent that an individual 
loses the power of self-control as a result of the use of alcohol or 
drugs, or while habitually under the influence of alcohol or drugs, 
endangers public health, morals, safety, or welfare, or a 
combination thereof.'' Administrative Complaint, at 2.
    \8\ Section 16221(b)(iii) provides the DS with authority to take 
disciplinary action against a licensee ``for a mental or physical 
inability reasonably related to and adversely affecting the 
licensee's ability to practice in a safe and competent manner.'' 
Administrative Complaint, at 2.
    \9\ Section 16221(c)(iv) provides the DS with authority to take 
disciplinary action against a licensee for ``obtaining, possessing, 
or attempting to obtain or possess a controlled substance[] * * * 
without lawful authority; or selling, prescribing, giving away, or 
administering drugs for other than lawful diagnostic or therapeutic 
purposes.'' Administrative Complaint, at 3.
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    As one of the probationary conditions, the State ordered that 
Applicant ``shall comply with the terms of the monitoring agreement'' 
which he had entered into with the HPRP on May 15, 2008. Id. at 3. The 
Monitoring Agreement provided, inter alia, that he ``will not obtain, 
possess, dispense, or administer controlled substances,'' that he 
``will practice total abstention from alcohol, controlled substances, 
and other mood-altering substances,'' and that he ``will submit to drug 
screens as requested by HPRP.'' Monitoring Agreement, at 1-2. In the 
Consent Order, the parties stipulated that Applicant ``does not contest 
the allegations of fact and law contained in the complaint'' but that 
``by pleading no contest * * * does not admit the truth of the 
allegations [and] agrees that the Disciplinary Subcommittee may treat 
the allegations as true for the resolution of the complaint.'' Consent 
Order, at 4-5.\10\
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    \10\ On June 4, 2008, a State ALJ dissolved the summary 
suspension of his medical license. Order Dissolving Suspension, at 
1.
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    On September 26, 2008, a Diversion Investigator (DI) with the DEA 
Detroit Division Office received information that Applicant was issuing 
prescriptions using the DEA registration number which he had previously 
surrendered. That day he contacted Applicant's attorney and left a 
phone message advising him that Applicant could not issue controlled 
substance prescriptions without a valid DEA registration.
    On October 3, 2008, a pharmacist phoned the DI and told him that 
Applicant had issued a prescription for Vicotussin, a controlled 
substance. The pharmacist further stated that he had determined that 
Applicant did not have a valid registration, and therefore, did not 
fill the prescription. The DI again left a phone message with 
Applicant's attorney advising that Applicant could not issue controlled 
substance prescriptions without a valid registration. The DI also 
attempted to contact Applicant directly; the DI left a phone message 
advising him that he was not legally authorized to write controlled 
substance prescriptions unless and until he obtained a new 
registration.
    The same day, Applicant's attorney contacted the DI and informed 
him that Applicant's Michigan medical license had been reinstated; the 
attorney further stated that he had advised Applicant that all of his 
licensure had been restored upon the reinstatement of his medical 
license such that Applicant had issued controlled substance

[[Page 20023]]

prescriptions based on the attorney's erroneous advice. The DI informed 
the attorney that Applicant would have to apply for a new registration 
in order to prescribe controlled substances.
    On October 5, 2008, the DI received a letter from Applicant's 
attorney, dated October 1, 2008. The letter requested the reinstatement 
of Applicant's controlled substances privileges, based on the 
reinstatement of his medical license.
    The following day, on October 6, 2008, the DI received a telephone 
call from a second pharmacist regarding a controlled substance 
prescription (for 120 tablets of Oxycontin 80 mg.) issued by Applicant 
on September 10, 2008. The pharmacist had also checked Applicant's 
registration, found that he lacked a valid registration, and did not 
fill the prescription.
    On October 9, 2008, Applicant filed an application for a new 
registration. Six days later, the DI received a telephone call from a 
third pharmacist. The pharmacist reported that the day before, a person 
had presented to him controlled substance prescriptions (for OxyContin, 
Roxicodone, Norco and Xanax) issued by Applicant on October 3, 2008. 
However, the pharmacy had experienced a delay in ordering the 
prescribed medications.\11\
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    \11\ The record contains copies of various controlled substance 
prescriptions issued by Applicant on which he used the DEA 
registration number he had previously surrendered.
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    On October 15, the pharmacist called the customer to advise her of 
the delay. Within fifteen minutes, he received a phone call from 
Applicant about the delay. Finding this suspicious, the pharmacist 
contacted the DI, who advised him that Applicant did not have a valid 
registration.
    On November 7, 2008, the DI and his Group Supervisor interviewed 
Applicant in the presence of his attorney. During the interview, 
Applicant's attorney stated that he had ``fumbled the ball'' by 
advising Applicant that he could resume his customary practice, 
including prescribing controlled substances, upon the reinstatement of 
his medical license.\12\ During the interview, Applicant stated that he 
had stopped issuing controlled substance prescriptions on October 3, 
2008, when the DI had notified him that he could not do so without 
first obtaining a new registration. He further acknowledged that he had 
previously executed a Voluntary Surrender Form.
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    \12\ The attorney also stated that he was unaware that Applicant 
was required to apply for a new registration, despite his having 
witnessed the Voluntary Surrender Form previously executed by 
Applicant which had clearly stated that ``I will not be permitted to 
* * * dispense, administer, prescribe, or engage in any other 
controlled substance activities * * * until such time as I am again 
properly registered.'' DEA Form 104.
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    The DI also questioned Applicant about his abuse of fentanyl. 
Noting that he had obtained a report from the Michigan Automated 
Prescription System (MAPS) \13\ showing the prescriptions Applicant had 
received as a patient and that no fentanyl prescriptions were listed, 
the DI asked Applicant how he had obtained the fentanyl. Applicant 
stated that he obtained the fentanyl by collecting unused pain 
medication from his patients, which he was collecting to give as a 
donation to his church's missionary project in Zambia. He further 
denied that he had issued fentanyl prescriptions to patients in order 
to have them fill the prescriptions and return the drugs to him for his 
personal use.
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    \13\ MAPS is part of a mandatory system in Michigan through 
which pharmacies and dispensing physicians report their controlled 
substance dispensings twice a month.
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    The DI subsequently interviewed several individuals associated with 
the church's missionary project. The church's senior pastor stated that 
while he knew Applicant through the church, he was not a member of it, 
and that while the church did conduct missionary projects in Zambia, 
Applicant had not participated in any of them. Subsequently, the DI 
interviewed a physician, who had run the project in 2003 and 2008, and 
a physician assistant, who had run the project in 2004 and 2005. Both 
individuals stated that there had been no missionary projects in 2006 
and 2007, when Respondent tested positive for fentanyl. Moreover, the 
physician had never met Applicant and the physician assistant had not 
spoken to him since 2005. Finally, according to the church's Executive 
Pastor, the 2008 project did not use controlled substances and any 
drugs that were used had been bought and not donated.
    On November 19, 2008, the DI ran another MAPS inquiry, this time 
for controlled substance prescriptions written by Applicant between 
March 1 and November 1, 2008. The report shows that between March 7, 
the date on which he surrendered his registration, and November 1, 
Applicant issued approximately 438 controlled substance prescriptions. 
The report also shows that he issued three controlled substance 
prescriptions prior to June 4, the date on which his Michigan medical 
license was reinstated,\14\ and that he issued eight controlled 
substance prescriptions after October 3, 2008,\15\ the date he received 
the DI's phone message to stop writing prescriptions and the date he 
claimed that he had ceased doing so.
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    \14\ Two of the prescriptions, dated March 19 and April 11, 
2008, were issued to patient A.F. and were for first 60 tablets and 
then 90 tablets of OxyContin 80 mg. The third prescription, issued 
March 26, 2008, was for patient D.P. and was for 90 tablets of 
OxyContin 80 mg.
    \15\ On October 4, 2008, Applicant issued two prescriptions to 
patient L.V.: One for hydrocodone/APAP 10 mg./325 mg. (90 tablets) 
and one for OxyContin 40 mg. (180 tablets). On October 8, 2008, 
Applicant wrote five prescriptions for patient K.B.: For clonazepam 
1 mg. (30 tablets), for Endocet 325 mg./10 mg. (90 tablets), for 
Methadone Hcl 10 mg. (90 tablets), for Methylin 20 mg. (90 tablets), 
and for OxyContin 80 mg. (75 tablets). On October 9, 2008, he issued 
a prescription to patient D.P. for alprazolam 1 mg. (75 tablets).
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Discussion

    Section 303(f) of the Controlled Substances Act (CSA) provides that 
the Attorney General ``shall register practitioners * * * to dispense * 
* * controlled substances in schedule II, III, IV, or V, if the 
applicant is authorized to dispense * * * controlled substances under 
the laws of the State in which he practices.'' 21 U.S.C. 823(f). 
However, the statute also provides that the Attorney General ``may deny 
an application for such registration if he determines that the issuance 
of such a registration is inconsistent with the public interest.'' Id. 
In determining the public interest, Congress directed that the 
following factors be considered:
    (1) The recommendation of the appropriate State licensing board or 
professional disciplinary authority.
    (2) The applicant's experience in dispensing * * * 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 and 
safety. Id.
    ``[T]hese factors are * * * considered in the disjunctive.'' Robert 
A. Leslie, 68 FR 15227, 15230 (2003). I may rely on any one or a 
combination of factors and may give each factor the weight I deem 
appropriate in determining whether to revoke an existing registration 
or to deny an application. Id. Moreover, I am ``not required to make 
findings as to all of the factors.'' Hoxie v. DEA, 419 F.3d 477, 482 
(6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165, 173-74 (D.C. 
Cir. 2005).
    In this matter, I have considered all of the factors. While 
Applicant's state medical license has been re-instated (factor one) and 
there is no evidence

[[Page 20024]]

that he has been convicted of an offense related to the distribution or 
dispensing of controlled substances,\16\ I conclude that the evidence 
relevant to Respondent's experience in dispensing controlled substances 
(factor two) and his compliance with applicable laws related to 
controlled substances (factor four), conclusively establishes that 
granting his application would be ``inconsistent with the public 
interest.'' 21 U.S.C. 823(f).
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    \16\ Putting aside that the State of Michigan has made no 
recommendation as to whether Respondent's application should be 
granted, this Agency has repeatedly held that the possession of a 
valid state license is not dispositive of the public interest 
inquiry. See Patrick W. Stodola, 74 FR 20727, 20730 n.16 (2009); 
Robert A. Leslie, 68 FR at 15230. As DEA has long recognized, ``the 
Controlled Substances Act requires that the Administrator * * * make 
an independent determination as to whether the granting of 
controlled substances privileges would be in the public interest.'' 
Mortimer Levin, 57 FR 8680, 8681 (1992).
     Nor is the lack of any criminal convictions related to the 
distribution or dispensing of controlled substances dispositive. 
Edmund Chein, 72 FR 6580, 6593 n.22 (2007), aff'd, Chein v. DEA, 533 
F.3d 828 (D.C. Cir. 2008). Thus, the facts that Respondent holds a 
Michigan medical license (assuming that he is actually authorized to 
dispense controlled substances under the Consent Order) and has not 
been convicted of a relevant criminal offense are not dispositive.
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Factors Two and Four--Respondent's Experience in Dispensing Controlled 
Substance and Compliance With Applicable Laws Related to Controlled 
Substances

    Under Federal law, it is unlawful ``for any person [to] knowingly 
or intentionally * * * dispense a controlled substance'' ``except as 
authorized by'' the CSA. 21 U.S.C. 841(a)(1). It is ``unlawful for any 
person knowingly or intentionally * * * to use in the course of the * * 
* dispensing of a controlled substance * * * a registration number 
which is * * * revoked.'' Id. Sec.  843(a)(3). Moreover, ``[e]very 
person who dispenses, or propose to dispense, any controlled substance, 
shall obtain from the Attorney General a registration issued in 
accordance with the rules and regulations promulgated by him.'' Id. 
Sec.  822(a)(2); see also 21 CFR 1301.11(a) (same). Also relevant here 
is 21 CFR 1301.13(a), which provides that ``[n]o person required to be 
registered shall engage in any activity for which registration is 
required until the application for registration is granted and a 
Certificate of Registration is issued by the Administrator to such 
person.''
    As found above, Applicant issued more than 400 controlled substance 
prescriptions even after he had surrendered his registration and had no 
authority to lawfully do so. Moreover, upon surrendering his 
registration, Respondent acknowledged his understanding that his 
registration was being revoked and that he could not engage in any 
controlled substance activities including the dispensing of drugs 
``until such time as I am again properly registered.'' Yet within three 
weeks of surrendering his registration, Applicant issued two 
prescriptions for OxyContin 80 mg. Moreover, in late July, he escalated 
his prescribing activities.
    During the November 7, 2008 interview, Applicant's lawyer stated 
that he had erroneously advised Applicant that upon the restoration of 
his state medical license, he could resume prescribing controlled 
substances. However, both the Voluntary Surrender Form and Federal law 
clearly stated that he could not issue controlled substances 
prescriptions until he obtained a new DEA registration. Moreover, the 
evidence shows that Applicant issued controlled substance prescriptions 
two months before his medical license was reinstated \17\ and that he 
issued controlled substances prescriptions even after he was told to 
stop doing so by the DI. Thus, it is clear that Applicant knowingly and 
intentionally issued prescriptions in violation of Federal law. See 21 
U.S.C. 822(a)(2), 841(a)(1), 843(a)(3). These violations were extensive 
and provide reason alone to deny his application.
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    \17\ Given the terms of the Consent Order, which prohibited him 
from dispensing controlled substances, it also appears that his 
issuance of the prescriptions violated that order. However, the 
Government did not allege this in the Show Cause Order and thus I do 
not consider this conduct.
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    In addition, on at least three occasions during the summer of 2007, 
Respondent tested positive for fentanyl, a schedule II controlled 
substance. See 21 CFR 13087.12(c). According to a MAPS report obtained 
by the DI which listed the prescriptions Applicant had obtained between 
September 20, 2004 and November 20, 2007, Respondent was never 
prescribed fentanyl by any physician. Moreover, as found above, 
Respondent told the DI that he obtained unused fentanyl from his 
patients to donate to his church's missionary project.
    At a minimum, the evidence establishes a violation of 21 U.S.C. 
844(a), which makes it ``unlawful for any person knowingly or 
intentionally to possess a controlled substance unless such substance 
was obtained directly, or pursuant to a valid prescription or order, 
from a practitioner acting in the usual course of his professional 
practice, or except as otherwise authorized by'' the CSA or the 
Controlled Substances Import and Export Act. Moreover, while Applicant 
still held a practitioner's registration during the period in which he 
tested positive for fentanyl, such a registration authorizes its holder 
only to dispense, i.e., ``to deliver a controlled substance to an 
ultimate user.'' 21 U.S.C. 802(10). A practitioner's obtaining of a 
controlled substance from a patient is not dispensing and thus is not 
an authorized activity under a practitioner's registration. See 21 CFR 
1301.13(e). Thus, even if Applicant had not engaged in the self-abuse 
of fentanyl, he was not lawfully authorized to obtain possession of the 
drug in this manner.\18\ This conduct further supports the conclusion 
that granting Respondent's application would be ``inconsistent with the 
public interest.'' 21 U.S.C. 823(f).
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    \18\ The record does not conclusively establish whether he told 
this story to the persons from whom he obtained the fentanyl. Were 
this shown to be the case, Respondent would have violated 21 U.S.C. 
843(a)(3), which renders it ``unlawful for any person knowingly or 
intentionally * * * to acquire or obtain possession of a controlled 
substance by misrepresentation, fraud, * * * deception, or 
subterfuge[.]''
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Factor Five--Such Other Conduct As May Threaten Public Health and 
Safety

    The Government further alleged that Applicant made a false 
statement to an Agency Investigator when he stated that he had obtained 
the fentanyl he self-abused because he collected the drugs ``to give as 
a donation to the Oakpointe Church's missionary project in Zambia.'' 
Show Cause Order at 1 (para.2) (citing 18 U.S.C. 1001). The evidence 
clearly shows that Applicant's statement to the DI was false in that he 
did not participate in the missionary project, let alone collect drugs 
for it.
    That his statement was false does not, however, establish a 
violation by 18 U.S.C. 1001, because this provision requires that the 
statement be material to the matter being investigated by the 
Government. See 18 U.S.C. 1001(a) (``whoever, in any matter within the 
jurisdiction of the executive * * * branch of the Government of the 
United States, knowingly and willfully * * * (2) makes any materially 
false, fictitious, or fraudulent statement or representation * * * 
shall be fined under this title, imprisoned not more than five years * 
* * or both''). The Supreme Court has held that for a statement to be 
``material'' for purposes of section 1001, it ``must have a `natural 
tendency to influence, or [be] capable of

[[Page 20025]]

influencing, the decisionmaking body to which it is addressed.' '' 
United States v. Gaudin, 515 U.S. 506, 509 (1995) (quoting Kungys v. 
United States, 485 U.S. 759, 770 (1988)). The Court has further 
explained:

    Deciding whether a statement is ``material'' requires the 
determination of at least two subsidiary questions: (a) ``What 
statement was made?'' and (b) ``what decision was the agency trying 
to make?'' The ultimate question: (c) ``Whether the statement was 
material to the decision,'' requires applying the legal standard of 
materiality (quoted above) to these historical facts.

Gaudin, 515 U.S. at 512. The ``evidence must be clear, unequivocal, and 
convincing.'' Kungys, 485 U.S. at 772.
    While the DI's affidavit establishes the falsity of Applicant's 
statements, the Government does not explain what decision the statement 
had ``the natural tendency'' to influence or ``was capable of 
influencing.'' Gaudin, 515 U.S. at 509 (quoting Kungys, 485 U.S. at 
770). Among the possibilities are whether to grant or deny his 
application for registration, to pursue criminal charges against him, 
or to conduct further investigation to determine whether he had 
committed additional crimes or whether individuals (other than 
na[iuml]ve patients \19\) were involved in supplying him with fentanyl. 
However, because the DI's affidavit does not offer any explanation as 
to why the false statement was ``capable of influencing'' any of the 
possible agency decisions, let alone identify which decision(s) the 
false statement was capable of influencing, I decline to address 
whether the statement was material.
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    \19\ During the interview, Applicant also denied that he had 
ever issued prescriptions to patients to have them obtain drugs for 
himself. There is, however, no evidence that this statement was 
false.
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    In any event, given the extensive evidence under factors two and 
four establishing that Respondent knowingly wrote hundreds of 
controlled substance prescriptions even though he had surrendered his 
registration, that he wrote prescriptions within weeks of having 
surrendered his registration, that he wrote prescriptions even after 
being told to stop and that he could not do so until he obtained a new 
registration, as well as the evidence that he abused fentanyl, it is 
clear that issuing him a new registration would ``be inconsistent with 
the public interest.'' 21 U.S.C. 823(f). Accordingly, Respondent's 
application will be denied.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well 
as by 28 CFR 0.100(b) & 0.104, I order that the application of Glenn D. 
Krieger for a DEA Certificate of Registration as a practitioner be, and 
it hereby is, denied. This Order is effective immediately.

    Dated: April 1, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-8546 Filed 4-8-11; 8:45 am]
BILLING CODE 4410-09-P