[Federal Register Volume 81, Number 148 (Tuesday, August 2, 2016)]
[Notices]
[Pages 50723-50726]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18278]


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 DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Alaaeldin A. Babiker, M.D.; Decision and Order

    On January 21, 2015, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Alaaeldin A. Babiker, M.D. (hereinafter, Registrant), of 
Yuma, Arizona. The Show Cause Order proposed the revocation of 
Registrant's DEA Certificate of Registration BB7566461, pursuant to 
which he is authorized to dispense controlled substances in schedules 
II through V as a practitioner, as well as the denial of any 
applications, on two grounds. GX 1, at 1.
    First, the Show Cause Order alleged that on October 4, 2014, the 
Arizona Medical Board issued Registrant an ``Order for Decree of 
Censure, Probation, and Practice Restriction and Consent to the Same'' 
which ``restricted [him] from prescribing any controlled substances.'' 
Id. The Show Cause Order thus alleged that because Registrant does not 
have authority to dispense controlled substances in Arizona, the State 
in which he is registered with DEA, his registration is subject to 
revocation. Id. (citing 21 U.S.C. 802(21), 823(f), 824(a)(3)).
    Second, based on various findings of fact and legal conclusions 
contained in the Board's Order, the Show Cause Order alleged that 
Registrant had committed acts which render his registration 
``inconsistent with the public interest'' in that he ``did not comply 
with applicable state law related to controlled substances.'' Id. at 2 
(citing 21 U.S.C. 823(f)(4)). More specifically, the Show Cause Order 
alleged that: (1) ``[F]rom 2008 through 2012, [Registrant] issued 
controlled substance prescriptions to [his] wife''; and that (2) on 
December 8, 2012, he was ``diagnosed with opioid dependence, Xanax 
abuse and Adderall abuse.'' Id. Ariz. Rev. Stat. Sec.  32-1401(27)(h) & 
(g)).
    The Show Cause Order then made multiple allegations regarding 
Registrant's prescribing of narcotics to patient B.S. These included 
that: (1) During the period he prescribed oxycodone to B.S., he ``added 
morphine to the patient's medications'' and also increased B.S.'s 
oxycodone prescriptions without explaining why he did so in B.S.'s 
chart; (2) he ``did not treat [B.S.'s] chronic pain with additional 
evaluations or other therapeutic interventions''; and (3) that he 
``deviated from the standard of care by failing to address'' lab 
results which suggested that B.S. was using marijuana as well as by 
failing to adequately document B.S.'s marijuana usage. Id. (citing 
Ariz. Rev. Stat. Sec.  32-1401(27)(e) & (q)).
    Finally, the Show Cause Order notified Registrant of his right to 
request a hearing on the allegations or to submit a written statement 
of position while waiving his right to a hearing, the procedure for 
electing either option, and the consequence of failing to elect either 
option. GX 1, at 2-3 (citing 21 CFR 1301.43; id. Sec.  1301.46).
    On January 29, 2015, a Special Agent went to an address in Yuma, 
Arizona which was identified as Registrant's address by a lawyer who 
had represented him before the Arizona Medical Board. According to the 
Special Agent, he arrived at the residence at 4:30 p.m. at which time 
he ``encountered no persons at the residence'' and there were ``[n]o 
vehicles or indications of any persons at the residence during the 
time'' he was present. GX 7, at 1. The Special Agent reported that he 
left a copy of the Show Cause Order ``in the door jamb of the front 
door in plain sight.'' Id. However, at this juncture, the Government 
undertook no other steps to effect service.
    Several months later, the Government submitted a Request for Final 
Agency Action contending that 30 days had passed since Registrant was 
served with the Show Cause Order and that neither he, nor anyone 
representing him, had requested a hearing or sent any correspondence to 
DEA. Request for Final Agency Action, at 7-8. On review by my Office, 
service was deemed to be inadequate and the Government was directed to 
re-serve Registrant with the Show Cause Order.
    On October 2, 2015, a Diversion Investigator mailed the Show Cause 
Order to Registrant at his residence address (as identified by his 
lawyer) by first class mail. GX 9, at 2 (Supplemental Declaration of 
DI). Thereafter, ``[o]n or about January 20, 2016,'' the DI mailed the 
Show Cause Order to Registrant by Certified Mail, Return Receipt 
Requested addressed to him at the same address as well as at two other 
reported addresses. Id. However, each of these mailings was returned 
unclaimed. Id. Subsequently, on April 6, 2016, the DI re-mailed the 
Show Cause Order to Registrant by regular First Class Mail to each of 
the three addresses. Id. According to the affidavit of a Legal 
Assistant with the Office of Chief Counsel, as of July 13, 2016, the 
Office of Administrative Law Judges had not received either a hearing

[[Page 50724]]

request or a written statement of position from him.
    Based on the above, I find that the Government has satisfied its 
obligation under the Due Process Clause ``to provide `notice reasonably 
calculated, under all the circumstances, to apprise interested parties 
of the pendency of the action and afford them an opportunity to present 
their objections.' '' Jones v. Flowers, 547 U.S. 220, 226 (2006) 
(quoting Mullane v. Central Hanover Bank & Trust Co., 339 U.S. 306, 314 
(1950)). As more than 30 days have now passed since Registrant was 
served with the Show Cause Order and neither Registrant nor anyone 
representing him has either requested a hearing or submitted a written 
statement of position, I find that Registrant has waived his right to a 
hearing or to submit a written statement. I therefore issue this 
Decision and Order based on relevant evidence contained in the 
Investigative File. I make the following findings.

Findings of Fact

    Registrant is the holder of DEA Certificate of Registration 
BB7566461, pursuant to which he is authorized to dispense controlled 
substances in schedules II through V, as a practitioner, at the 
registered address of 2140 W. 24th St., Suite A, Yuma, Arizona. GX 2. 
Registrant's registration does not expire until July 31, 2016. Id.
    Registrant also previously held a medical license issued by the 
Arizona Medical Board. GX 3, at 1. While as of the date on which the 
Show Cause Order was issued, Registrant still had a license, albeit one 
which was restricted to prohibit him from prescribing controlled 
substances, on March 17, 2016, Registrant entered into an Order For 
Surrender Of License And Consent To The Same with the Board, which the 
latter approved on April 7, 2016. GX 9, at 9,11.
    Therein, the Board found that pursuant to its October 3, 2014 Order 
for Decree of Censure, Probation, and Practice Restriction and Consent 
to the Same, Registrant was required to participate in the Board's 
Physician Health Program (PHP).\1\ Id. at 5. Pursuant to the Order, 
Registrant was required to ``submit to random biological fluid, hair, 
or nail testing to ensure compliance with the PHP'' and call in to a 
hotline ``on a daily basis to determine if he [wa]s required to submit 
to a drug test.'' Id. Registrant did not, however, call in ``[f]rom 
February 3 through February 8, 2015,'' and ``completely ceased checking 
in with the hotline on February 12, 2015.'' Id. Based on his 
noncompliance with the PHP and the Board's Order, on February 26, 2015, 
Registrant entered into an Interim Consent Agreement for Practice 
Restriction with the Board which barred him from practicing medicine in 
the State. Id. at 5-6.
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    \1\ The October 2014 Order found that in December 2013, 
Registrant underwent a clinical evaluation and was diagnosed ``with 
opioid dependence, alcohol abuse, Xanax abuse, and Adderall abuse.'' 
GX 3, at 2-3. After Registrant completed inpatient and outpatient 
treatment, the Board determined that he could resume practicing, 
subject to probationary terms and restrictions, if he was ``enrolled 
in the PHP for a five year term.'' Id. at 3.
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    In the October 3, 2014 Order, the Board also made various findings 
regarding Registrant's prescribing of controlled substances to both his 
wife and patient B.S. GX 3, at 1-2, 4-5. As to the former, the Board 
found that Registrant ``had prescribed controlled substances to his 
wife on multiple occasions beginning in 2008'' and that in an August 
2013 ``interview with Board staff, [he] said that he had only 
prescribed controlled substances to [her] a few times starting in 
2012.'' Id. at 1. The Board also found that Registrant only ``began to 
maintain medical records for his wife in 20011'' and ``did not maintain 
complete records for'' her. Id. at 2.
    As to his patient B.S., the Board found that Registrant first 
treated B.S. in April 2012, when the latter ``requested prescriptions 
so he could continue with the same dosing of Alprazolam 1mg (TID), 
oxycodone 30mg 6/day, and oxycodone 15mg 6/day'' and that Registrant 
kept B.S. on this regimen until September 2012, when he added morphine 
sulfate 30mg 2/day. Id. at 4. The Board found, however, that Registrant 
did not document an explanation in B.S.'s chart for adding the 
morphine. Id.
    The Board further found that in May 2013, Registrant prescribed 
``an additional 60 pills of oxycodone 30mg and an additional 60 pills 
of OxyContin 80mg for the month.'' Id. at 4-5. While the Board found 
that ``this was the only month in which the increase occurred, there 
[was] no explanation in the patient's chart to explain the change.'' 
Id.
    The Board also found that Registrant conducted drug testing on B.S. 
several times during the course of treatment. While the Board found 
that B.S. properly tested positive for the medications he was 
prescribed, ``he also tested positive for THC, suggesting marijuana 
usage.'' Id. The Board further found that while the positive test for 
marijuana ``was circled on one of the lab reports,'' it was ``not 
otherwise documented in the chart.'' Id. (emphasis added).
    The Board then found that Registrant deviated from the standard of 
care in multiple ways. First, he deviated by failing to address B.S.'s 
positive test for marijuana. Id. Second, he deviated ``by managing 
B.S.'s chronic pain with pain medications without additional 
evaluations or other therapeutic interventions.'' Id. Third, he 
deviated ``by dramatically increasing B.S.'s pain medication in May 
2013,'' and that ``[a]s a result of the dramatic increase, B.S. could 
have suffered an accidental overdose.'' Id. Finally, the Board found 
that Registrant ``failed to maintain adequate, legible medical 
records.'' Id. at 6.
    Based on these findings, the Board found that Registrant had 
engaged in multiple forms of unprofessional conduct. These included by: 
(1) ``failing or refusing to maintain adequate records on a patient''; 
(2) ``habitual intemperance in the use of alcohol or habitual substance 
abuse''; (3) ``using controlled substances except if prescribed by 
another physician for use during a prescribed course of treatment''; 
(4) ``prescribing or dispensing controlled substances to members of the 
physician's immediate family''; (5) engaging in ``[a]ny conduct or 
practice that is or might be harmful or dangerous to the health of the 
patient or the public''; and (6) ``making a false or misleading 
statement to the board.'' Id. at 6 (citing Ariz. Rev. Stat. Sec.  32-
1401(27) (e), (f), (g), (h), (q), and (jj)).\2\
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    \2\ In agreeing to the Order, Registrant waived ``any rights to 
a hearing or judicial review in state or federal court on the 
matters alleged.'' GX 3, at 13. He also agreed that ``[t]his Order 
is a public record that will be publicly disseminated as a formal 
disciplinary action of the Board.'' Id. at 14. Thus, as between 
Registrant and the Board, the Order was entitled to preclusive 
effect even though the issues were not litigated. See Chaney 
Building Co., v. City of Tuscon, 716 P.2d 28, 30 (Ariz. 1986) (en 
banc) (even where a judgment is entered by stipulation or consent, 
it ``may be conclusive, with respect to one or more issues, if the 
parties have entered an agreement manifesting such 
intention'')(citing Restatement (Second) of Judgments Sec.  27 
comment e)). The Order nonetheless states that:
    [a]ll admissions made by [Registrant] are solely for final 
disposition of this matter and any subsequent related administrative 
proceedings or civil litigation involving the Board and 
[Registrant]. Therefore, said admissions by [Registrant] are not 
intended or made for any other use, such as in the context of 
another state or federal government regulatory agency proceeding, 
civil or criminal court proceeding, in the State of Arizona or any 
other state or federal court.
    GX 3, at 13.
    Notwithstanding this language, I give preclusive effect to the 
findings of the October 2014 Board Order. Notably, most of the 
findings discussed above do not appear to be based on admissions 
made by Registrant but on other evidence. See David A. Ruben, 78 FR 
38363, 38366-66 n.7 (2013), pet. for review denied, Ruben v. DEA, 
617 Fed. Appx. 837, 838-39 (Mem.) (9th Cir. 2015). To the extent any 
of these findings relied on Registrant's admissions, neither the 
Arizona Medical Board nor Registrant can dictate to an Agency of the 
United States what weight it can attach to the Order's findings. Cf. 
id. at 38365-67.

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[[Page 50725]]

Discussion

Loss of State Authority

    Pursuant to 21 U.S.C. 824(a)(3), ``[a] registration . . . to . . . 
dispense a controlled substance . . . may be suspended or revoked by 
the Attorney General upon a finding that the registrant . . . has had 
his State license or registration suspended, revoked, or denied by 
competent State authority and is no longer authorized by State law to 
engage in the . . . dispensing of controlled substances.'' This Agency 
has further held that notwithstanding that this provision grants the 
Agency authority to suspend or revoke a registration, other provisions 
of the Controlled Substances Act ``make plain that a practitioner can 
neither obtain nor maintain a DEA registration unless the practitioner 
currently has authority under state law to handle controlled 
substances.'' James L. Hooper, 76 FR 71371, 71372 (2011), pet. for rev. 
denied, Hooper v. Holder, 481 F. App'x 826 (4th Cir. 2012). See also 
Frederick Marsh Blanton, M.D., 43 FR 27616, 27617 (1978) (``State 
authorization to dispense or otherwise handle controlled substances is 
a prerequisite to the issuance and maintenance of a Federal controlled 
substances registration.'').
    These provisions include section 102(21), which defines the term 
``practitioner'' to ``mean[ ] a physician . . . licensed, registered, 
or otherwise permitted, by . . . the jurisdiction in which he practices 
. . . to distribute, dispense, [or] administer . . . a controlled 
substance in the course of professional practice,'' 21 U.S.C. 802(21), 
as well as section 303(f), which directs that ``[t]he Attorney General 
shall register practitioners . . . to dispense . . . controlled 
substances . . . if the applicant is authorized to dispense . . . 
controlled substances under the laws of the State in which he 
practices.'' Id. Sec.  823(f). As the Supreme Court has explained, 
``[i]n the case of a physician, this scheme contemplates that he is 
authorized by the State to practice medicine and to dispense drugs in 
connection with his professional practice.'' United States v. Moore, 
423 U.S. 122, 140-41 (1975).
    Here, the evidence shows that Registrant has been without state 
authority since the Board's October 3, 2014 Order restricted his 
prescribing authority and the Board has since ordered Registrant to 
surrender his medical license. I therefore find that Registrant is 
without authority to dispense controlled substances in Arizona, the 
State in which he is registered. Because Registrant no longer meets the 
CSA's prerequisite for maintaining a practitioner's registration, I 
will order that his registration be revoked and that any pending 
application be denied.

Public Interest Grounds

    Under the CSA, ``[a] registration pursuant to section 823 of this 
title to manufacture, distribute, or dispense a controlled substance . 
. . may be suspended or revoked by the Attorney General upon a finding 
that the registrant . . . has committed such acts as would render his 
registration under section 823 of this title inconsistent with the 
public interest as determined under such section.'' 21 U.S.C. 
824(a)(4). The Act further provides that in determining ``the public 
interest'' with respect to a practitioner, the following factors are to 
be considered:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The [registrant's] experience in dispensing, or conducting 
research with respect to controlled substances.
    (3) The [registrant'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.

21 U.S.C. 823(f).
    ``[T]hese factors are . . . considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that I 
``may rely on any one or a combination of factors, and may give each 
factor the weight [I] deem appropriate in determining whether a 
registration should be revoked.'' Id.; see also MacKay v. DEA, 664 F.3d 
808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 
2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while 
I am required to consider each of the factors, I ``need not make 
explicit findings as to each one.'' MacKay, 664 F.3d at 816 (quoting 
Volkman, 567 F.3d at 222 (quoting Hoxie, 419 F.3d at 482)).\3\
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    \3\ While I have considered all of the factors, the Government 
does not argue that any of the other factors are relevant in making 
the public interest determination in this matter. Be that as it may, 
``this is not a contest in which score is kept; the Agency is not 
required to mechanically count up the factors and determine how many 
favor the Government and how many favor the registrant. Rather, it 
is an inquiry which focuses on protecting the public interest; what 
matters is the seriousness of the registrant's misconduct.'' Jayam 
Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly, as the Tenth 
Circuit has recognized, findings under a single factor can support 
the revocation of a registration. See MacKay, 664 F.3d at 821.
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    The Government has the burden of proving, by a preponderance of the 
evidence, that the requirements for revocation or suspension pursuant 
to 21 U.S.C. 824(a) are met. 21 CFR 1301.44(e). This is so even in a 
non-contested case.
    In this matter, the Government argues that the Board's findings of 
fact and conclusions of law are entitled to preclusive effect and 
establish that Registrant ``violated applicable controlled substance 
state laws under'' factor four of the public interest standard. Request 
for Final Agency Action, at 6 (citing 21 U.S.C. 823(f)(4)). I agree 
that Registrant failed to comply with state laws related to controlled 
substances as evidenced by the findings that he prescribed controlled 
substances to his wife, notwithstanding that under Arizona law, 
``[p]rescribing or dispensing controlled substances to members of the 
physician's immediate family'' is ``unprofessional conduct.'' Ariz. 
Rev. Stat. Sec.  32-1401(27)(h). Based on the plain language of this 
provision, I conclude that even though it is found in the State's 
medical practice act, it is a law ``relating to controlled 
substances.'' 21 U.S.C. 823(f)(4).
    The Board also found that Registrant has been diagnosed as 
dependent on opioids, and that he has abused both Xanax (alprazolam), a 
schedule IV benzodiazepine, and Adderall, (amphetamine and 
dextroamphetamine), a schedule II stimulant. See 21 CFR 1308. 14(c)(2); 
id. 1308.12 (d)(1). Based on these findings, the Board concluded that 
Registrant has committed ``unprofessional conduct'' by engaging in 
``habitual substance abuse'' and ``using controlled substances except 
if prescribed by another physician for use during a prescribed course 
of treatment.'' Ariz. Rev. Stat. Sec.  32-1301(27)(f) & (g). Here too, 
while these provisions are located in the State's medical practice act, 
the plain language of these provisions supports the conclusion that 
they are laws ``relating to controlled substances.'' 21 U.S.C. 823(f) 
(4).\4\
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    \4\ While not cited by the Government, DEA has long held that a 
practitioner's self-abuse of a controlled substance is actionable 
under factor five as ``[s]uch other conduct which may threaten 
public health and safety.'' See Tony T. Bui, 75 FR 49979, 49989 
(2010) (citing cases).
    The Board also made several findings that Registrant deviated 
from the standard of care when he prescribed narcotic controlled 
substances to B.S. and which are highly suggestive of a finding that 
he acted outside of the usual course of professional practice and 
lacked a legitimate medical purpose in prescribing to B.S. 21 CFR 
1306.04(a). These include that he failed to address B.S.'s positive 
test for marijuana, that he did not perform additional evaluations 
or use therapeutic interventions other than prescribing controlled 
substances, that he dramatically increased B.S.'s pain medications 
and did not document an explanation for doing so, and that he failed 
to maintain adequate and legible medical records.
    The Board did not, however, find that Registrant engaged in 
``[p]rescribing, dispensing, or administering any controlled 
substance . . . for other than accepted therapeutic purposes,'' 
Ariz. Rev. Stat. Sec.  32-1401(27)(j), a standard similar to that of 
21 CFR 1306.04(a). See GX 3, at 6; see also Kenneth Harold Bull, 78 
FR 62666, 62674 (2013) (holding that physician's violation of a 
State's ``injudicious prescribing'' standard did not establish a 
violation of 21 CFR 1306.4(a) when the State also had a standard 
prohibiting ``prescribing . . . or dispensing of narcotic, stimulant 
or hypnotic drugs for other than accepted therapeutic purposes'' but 
did not find a violation). Instead, the Board found that he 
committed unprofessional conduct by engaging in ``[a]ny conduct or 
practice that is or might be harmful or dangerous to the health of 
the patient or the public.'' GX 3, at 6 (citing Ariz. Rev. Stat. 
Sec.  32-1401(27)(q)).
    In its Request for Final Agency Action, the Government did not 
allege that the Board's findings with respect to B.S. supported a 
finding that Registrant violated 21 CFR 1306.04(a). Nor did it argue 
that the Board's findings establish reckless or negligent conduct in 
the handling of controlled substances, which is a basis to revoke a 
registration under Paul J. Caragine, 63 FR 51592, 51601 (1998).
    Moreover, the Government offers no argument as to why the 
Board's standard of ``[a]ny conduct or practice that is or might be 
harmful or dangerous to the health of the patient or the public'' is 
a law related to controlled substances under factor four. I 
therefore do not consider whether this provision falls within factor 
four. Nor do I consider the Board's findings with respect to B.S.

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[[Page 50726]]

    The Board's conclusions of law that Registrant committed 
unprofessional conduct by prescribing controlled substances to his 
wife, as well as by engaging in habitual substance abuse and using 
controlled substances which were not prescribed to him by another 
physician in the course of treatment, support the conclusion that he 
has committed such acts as to render his registration ``inconsistent 
with the public interest.'' 21 U.S.C. 824(a)(4). These findings provide 
an additional and independent basis to revoke Registrant's 
registration.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 824(a) and 
823(f), as well as 28 CFR 0.100(b), I order that DEA Certificate of 
Registration BB7566461 issued to Alaaeldin Babiker, M.D., be, and it 
hereby is, revoked. I further other that any application of Alaaeldin 
Babiker, M.D., to renew or modify this registration, or for any other 
registration, be, and it hereby is denied. This Order is effective 
immediately.\5\
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    \5\ For the same reasons which led the Board to order Registrant 
to immediately surrender his state license, I conclude that this 
Order should be effective immediately. GX 9, at 9; see also 21 CFR 
1316.67.

    Dated: July 22, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-18278 Filed 8-1-16; 8:45 am]
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