Court Opinion

ID: 187206
Source: CourtListenerOpinion
Date Created: 2011-02-05 03:15:25+00
Date Added: 2024-06-11T17:26:33.818300
License: Public Domain

United States Court of Appeals
              FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued January 15, 2008                   Decided July 22, 2008

                          No. 07-1051

                     EDMUND CHEIN, M.D.,
                         PETITIONER

                                v.

        DRUG ENFORCEMENT ADMINISTRATION ET AL.,
                    RESPONDENTS

           On Petition for Review of an Order of the
           United States Drug Enforcement Agency

   Jonathan W. Emord argued the cause for the petitioner.
Charles M. Sevilla was on brief.
    Teresa A. Wallbaum, Attorney, United States Department of
Justice, argued the cause for the respondent.
  Before: SENTELLE, Chief Judge, and HENDERSON and
RANDOLPH, Circuit Judges.
    Opinion for the court filed by Circuit Judge HENDERSON.
   KAREN LECRAFT HENDERSON, Circuit Judge: Edmund
Chein (Chein) seeks review of the revocation of his
practitioner’s registration and the denial of his application for a
                               2

registration to export Schedule III non-narcotic and Schedule IV
controlled substances—both actions taken by the United States
Drug Enforcement Administration (DEA). The DEA Deputy
Administrator (DA) found that it was not in the public interest
to renew Chein’s practitioner’s registration or to grant him an
export registration because he provided several undercover
agents with anabolic steroids to enhance athletic performance;
committed a number of record keeping violations; ordered
controlled substances using an unauthorized DEA registration
number; illegally imported controlled substances from an
unregistered Mexican pharmacy and illegally shipped controlled
substances to hundreds of overseas patients without a DEA
export registration. Moreover, the DA found that Chein
continued to dispense controlled substances even after his DEA
registration had been suspended and continued to export
controlled substances even after being informed by DEA that it
was illegal to do so. For the reasons set forth below, we deny
his petition.
                               I.
    Chein is the owner of the Palm Springs Life Extension
Institute (PSLEI) in Palm Springs, California. He is a physician,
having graduated in 1980 from the American University of the
Caribbean School of Medicine. He also holds a law degree.
Edmund Chein, M.D.; Revocation of Practitioner’s Registration,
Denial of Application for Exporter’s Registration, 72 Fed. Reg.
6580, 6582 (Feb. 12, 2007). Chein is licensed to practice
medicine in California and in Utah and was, before the
proceeding under review, registered with DEA to dispense
controlled substances (Schedules II through V). See Gov’t Ex.
(GX) 2. Chein purports to be “one of the world’s leading
authorities in the field of anti-aging medicine.” Chein Br. 8. He
believes that “every adult experiences hormone level reductions
over time and those reductions coincide with outward and
                                    3

inward signs of aging.” Id. Chein claims that “through gradual
increases in hormones to those approximating youthful levels,
along with exercise and diet modification, individuals can slow
the process of aging and delay the onset of, or prevent, age-
related conditions.” Id. This is accomplished through the
“administration of very low doses of hormones over an extended
period of time, accompanied by continued monitoring of
baseline hormone levels until they slowly rise to approximate
levels of a healthy young adult.” Id. at 9. Chein calls the
practice “total hormone replacement therapy.” (THRT). Id. at
8. According to Chein, THRT differs from traditional
gastroenterology in that “[a physician] administers hormones
when they are less than those common in people of comparable
age; [in] THRT, by contrast, [a physician] administers
hormone[s] when levels drop below those of a typical healthy
young adult.” Id. at 8–9. He asserts that “[n]o patient has ever
complained” about his practice. Id. at 9.
   Chein has had a tense history, however, with the California
Medical Board (CMB), DEA and law enforcement in general.1
The CMB has taken action against Chein’s medical license three
times. In 1995, the CMB revoked Chein’s license, stayed the
revocation and put him on probation for “failing to obtain a . . .
business license and for falsely advertising himself as a

    1
     In 1996, Chein was convicted in California state court of three
counts of criminal perjury for exaggerating his qualifications as an
expert witness in two civil lawsuits, see In re Edmund Chein, M.D.,
No. 02-9, 02-43, Recommended Findings of Fact, Conclusions of
Law, and Decision of the Administrative Law Judge (July 28, 2005)
(ALJ Dec.) ¶ 48; GX 33; Tr. 221. Chein sought habeas corpus relief
in district court, id., and the Ninth Circuit reversed the district court’s
denial of Chein’s petition. Chein v. Shumsky, 373 F.3d 978, 993 (9th
Cir. 2004) (en banc).
                                4

physician and lawyer when he had never obtained a license to
practice law.” Chein v. Med. Bd. of Cal., No. 00CS00319, at 4
(Cal. Super. Ct. Nov. 9, 2000); GX 125. In 2000 the CMB again
revoked Chein’s medical license, charging that he had
“prescribed human growth hormone for a patient without
medical indication and . . . had made false and misleading
statements in certain publications and advertisements about
hormone replacement therapy.” Id. at 1. Chein challenged the
revocation in state court and was successful in part. Id. at 17.
The CMB and Chein ultimately entered into a settlement
agreement revoking Chein’s license, staying the revocation and
suspending Chein from the practice of medicine for 10½ months
“with credit for 10½ months already served.” GX 113, at 4; GX
125, at 2.
    In 2002, the CMB initiated a third disciplinary action against
Chein alleging, inter alia, that he had “prescrib[ed] . . . [human
growth hormone] without a good faith examination and medical
indication,” “fail[ed] to maintain adequate and accurate
records,” “obtained controlled substances by deceit,
misrepresentation and subterfuge” and “dispensed controlled
substances without proper privileges.” In re Edmund Chein,
M.D., No. 19-2000-107723, Accusation ¶¶ 18, 21–23, 31 (filed
Aug. 15, 2002). The CMB and Chein eventually settled this
dispute as well, noting that the settlement “[was] intended to
resolve,” in addition to the CMB’s disciplinary action, “any
disciplinary action taken by another state or the federal
government based on the conduct alleged in the [August 15,
2002 Accusation].” In re Edmund Chein, M.D., No. 19-2000-
107723, Stipulated Settlement & Disciplinary Order 2-3 (filed
Sept. 22, 2005). Under the settlement, the CMB revoked
Chein’s medical license, stayed the revocation and placed Chein
                                  5

on probation for five years.2
   Chein has also had a long history with DEA. In 1994 and
1995, investigators from DEA, the Food and Drug
Administration (FDA) and the United States Customs Service
(Customs) conducted a series of undercover visits to PSLEI.
During the visits Chein dispensed and prescribed Human
Growth Hormone (HGH) and anabolic steroids3 to the
investigators ostensibly to improve athletic performance.4 On

    2
      The settlement occurred after the DEA Administrative Law Judge
(ALJ) issued her recommendation in this case, see ALJ Dec. ¶ 55, but
the DA noted it in her decision. See Chein, 72 Fed. Reg. at 6583 n.4
(citing 5 U.S.C. § 556(e)).
    3
      An anabolic steroid is a Schedule III controlled substance. See
21 U.S.C. § 812(c) (Schedule III). While HGH is not included as a
scheduled controlled substance, see id.; see also 72 Fed. Reg. at 6582
n.3, federal law prohibits knowingly distributing, or possessing with
intent to distribute, HGH for any use in humans except as authorized
by the Secretary of the United States Department of Health and
Human Services and pursuant to a physician’s order. 21 U.S.C.
§ 333(e).
    4
     The first visit occurred on September 9, 1994. Brannon Affidavit
¶ 18. An undercover FDA Special Agent (SA) visited Chein posing
as a rugby player who wanted to “build up” to avoid injury. Id.
¶ 19(d). Chein informed the SA that he could use HGH to “build
muscle, endurance, speed, strength and muscle mass,” and that “[i]n
the next decade, competitive sport athletes will be doing human
growth hormone and natural testosterone.” Id. ¶ 19(d)(ii), (vi). Chein
drew blood from the SA to test HGH and testosterone levels; during
the same office visit, and without knowing the blood test results,
Chein dispensed HGH to the SA. Id. ¶ 19(e)-(h). He also provided a
prescription for insulin syringes. Id. ¶ 19(f). Chein subsequently
dispensed several additional shipments of HGH to the undercover SA
                                   6

via Airborne Express. Id. ¶¶ 21–23.
     On October 17, 1994, another FDA undercover SA visited Chein.
The SA informed Chein that he “had experienced difficulties in
putting on muscle mass while weight-lifting.” Id. ¶ 25(d). He also
told Chein that he had taken steroids previously “but wanted a safer
alternative.” Id. Chein informed the SA that “[t]he latest development
in ‘body-building science or medicine’ involved both human growth
hormone and natural testosterone administered through the skin by
means of a patch or gel, both having a synergistic effect in building up
lean muscle.” Id. ¶ 25(d)(iii). Chein drew blood to test the SA’s
testosterone and HGH levels; again, during the same office visit, and
without knowing the blood test results, Chein prescribed insulin
syringes, testosterone gel and HGH for the SA. Id. ¶ 25(e)-(g).
     On March 17, 1995, an undercover Customs SA visited Chein
posing as a competitive weightlifter. Id. ¶ 36. The SA explained that
“he was interested in human growth hormone for gaining strength for
competitive powerlifting and gaining strength, had been taking
Anadrol (an anabolic steroid), but wanted [HGH] because he was
losing to guys who are ‘on the juice.’” Id. ¶ 37(c). Chein told the SA
that “[a]fter 1990, the whole body-building industry had switched to
natural testosterone, and the ‘new power lifting people use
testosterone and HGH.’” Id. ¶ 37(d)(i). Chein claimed that the
hormone treatments could “increase his capacity” by 75-100 lbs
“within a month.” Id. ¶ 37(d)(viii). Moreover, he informed the SA
that “[t]he human growth hormone and testosterone would not show
up in drug testing at competitions if [he] followed Chein’s
instructions.” Id. ¶ 37(d)(iv). Again, Chein ordered a blood test, and,
again, before the result was available, Chein gave the SA a vial of
HGH and a prescription for testosterone gel, explaining “I would
rather see you abuse this than abuse Anadrol.” Id. ¶ 37(d)(vii).
     On July 20, 1995, a DEA SA visited Chein posing as a power
lifter training for the Olympics. Id. ¶ 38(c). Chein ordered a blood
test for testosterone and HGH levels. Id. ¶ 38(d)(h). He explained
                                    7

May 23, 1996, FDA obtained a search warrant for PSLEI. See
Search Warrant 1, No. 96-1101 (May 23, 2006). FDA and DEA
investigators who conducted the search seized various anabolic
steroids. Tr. 132. Although DEA regulations require a
registrant to maintain purchase records, an inventory and a
dispensing log at his registered address; see, e.g., 21 C.F.R.
§§ 1304.03-.04, no such records were found during the search.
Tr. 134.5

that the treatment was to be “[o]ff the record” because he “had a strict
agreement with the U.S. Attorney’s office not to give [HGH] to people
who didn’t need it or to simply help them ‘build up strength’ and that
they would . . . ‘handcuff [him]’” if he did. Id. ¶ 38(e)-(f). He then
joked with the SA, “[i]f you are [a federal agent], I’m dead.” Id.
¶ 38(e). Chein planned to put the SA on a regimen of four different
hormones—testosterone, HGH, insulin and dehydroepiandrosterone
(DHEA)—“all of which would help with weight lifting.” Id.
¶ 38(c)(v). He further explained that the testosterone “would not show
up in a drug test related to power lifting if [the SA] stopped taking [it]
two days before” the test. Id. ¶ 38(c)(iv). Chein provided the SA with
a one-month supply of HGH and prescriptions for the other hormones.
He told the SA that, if the blood test result “came back low,” he would
ship additional HGH. Id.¶ 38(c)(ii).
     For his part, Chein argues that he did not improperly prescribe
and/or dispense controlled substances to the undercover officers. He
claims that “[a]thletes, particularly those who engage in endurance
exercise training, commonly suffer from low testosterone levels” and
that he provided HGH and testosterone to the investigators “[b]ased
on each patient’s respective descriptions of their physical regimens
and complaints.” Chein Br. 11-12.
    5
     The record does not indicate that DEA took any disciplinary
action against Chein following the undercover visits or the 1996
search. Cf. Tr. 113 (noting that investigations “never resulted in any
kind of activity” by DEA).
                                   8

    On July 20, 2000, Chein applied to renew his DEA
practitioner’s registration. See GX 1. Because Chein’s
California medical license was revoked at the time, his
application received close scrutiny. On January 31, 2001, DEA
Diversion Investigator (DI) Doris DeSantis, accompanied by DI
Linda Martin, visited PSLEI to interview Chein, inspect his
clinic and review his records. Tr. 263. Chein was not there at
the time and the two met instead with Darryl Garber—another
physician practicing at PSLEI. Garber informed DI DeSantis
that he could not provide the biennial inventory and dispensing
logs because they were stored electronically and none of the
employees on duty knew how to access PSLEI’s computer
system. Id. at 268–69. Another PSLEI employee informed DI
DeSantis that the purchase invoices were stored off-site with
PSLEI’s accountant. Id. at 273. Garber was eventually able to
provide only two invoices, both for the purchase of phentermine
(a Schedule III controlled substance). Id. at 275-76. DI
DeSantis informed Garber that DEA regulations require records
to be readily available for inspection and copying and that
invoices be stored on-site. Id. at 274; see also infra note 6.
    Five days later, DI DeSantis and DI Martin returned to
PSLEI to review the records that were not available during their
earlier visit. Id. at 277. Again, Chein was not present. Id. at
279. Garber asked the investigators to wait while he retrieved
the records. After two or three hours he returned with a one-
page computer generated inventory report, id. at 281; GX 8,
dispensing logs for phentermine and various forms of
testosterone, id. at 284; GX 9-16, and four purchase invoices for
phentermine, id. 331–33; GX 17.6 The documents revealed

    6
     DEA regulations provide that financial and shipping records
(such as invoices and packing slips) may be kept off-site (e.g., with an
accountant) only if the registrant has notified the DEA in writing of his
                                   9

several irregularities. DEA regulations require a registrant to
maintain most records for two years “for inspection and
copying” by DEA employees, 21 C.F.R. § 1304.04(a); however,
the dispensing logs Garber produced covered only the seven-
month period from July 1, 2000 to February 5, 2001. See Tr.
286-87; GX 9-16. In addition, the dispensing logs indicated that
during the seven-month period, PSLEI physicians had dispensed
controlled substances 317 times to patients in foreign countries,
including France, Germany, Great Britain, Spain, Switzerland,
China (Hong Kong), Indonesia, Japan, South Korea and Canada;
see GX 10-12, 15, 16. Neither Chein nor Garber had an export
registration required to dispense overseas. See GX 2; see also
21 U.S.C. §§ 957 & 958. Moreover, some shipments went to
countries where the products were illegal. See, e.g., GX 38(c)
(Garber acknowledged that “[i]n Japan and Korea it is against

intent to do so. 21 C.F.R. § 1304.04(a). Moreover, DEA regulations
require that “[i]nventories and records of controlled substances listed
in Schedule III, IV, and V shall be maintained either separately from
all other records of the registrant or in such form that the information
required is readily retrievable from the ordinary business records of
the registrant.” Id. § 1304.04(f)(2) (emphasis added). A “readily
retrievable” record is “kept by [an] automatic data processing system[]
or other electronic or mechanized recordkeeping system[] in such a
manner that [it] can be separated out from all other records in a
reasonable time.” Id. § 1300.01(b)(38) (emphasis added). Chein
challenged DI DeSantis’s view of “readily retrievable” as
“instantaneous” and the DA acknowledged that DI DeSantis applied
the incorrect standard and, accordingly, did not use the 2-3 hour delay
in her decision. See 72 Fed. Reg. 6593 (“Respondent is correct that
this regulation does not require that records be ‘instantaneously
produced.’ . . . Accordingly, there is no basis to conclude that the
inventory and dispensing records were not readily retrievable . . . .”)
(citation omitted).
                                 10

the law to prescribe Anabolic Steroids and Phentermine for the
purpose of Anti-Aging Medicine.” (citations omitted)); see also
21 U.S.C. § 953(e) (registered exporter required to file export
declaration with DEA indicating “importation is not contrary to
the laws or regulations of the country of destination” for each
shipment). The dispensing logs Garber produced indicated that
PSLEI physicians regularly dispensed various forms of
testosterone, see GX 9-16, but Garber did not provide any
purchase invoices therefor. Tr. 334. Finally, the four
phentermine purchase invoices indicated that PSLEI employees
had been ordering the controlled substance with an unauthorized
DEA registration number. Each of the invoices contained the
DEA registration number of Connie Chein, Chein’s physician
sister. See GX 17. Although Connie Chein owned PSLEI for
approximately 10½ months during 2000 when her brother’s
California medical license was revoked,7 she denied that she
gave her brother permission to use her DEA registration or that
she was aware that anyone at PSLEI had used her registration to

    7
     Connie Chein bought PSLEI from her brother because under
California law only a licensed physician can own a medical facility.
See Tr. 1087 (testimony of Connie Chein). Chein sold PSLEI to his
sister around February 16, 2000—two days before the CMB revoked
his medical license. See ALJ Op. ¶ 24. After the court vacated the
revocation, Connie Chein sold PSLEI back to Chein in December
2000. Tr. 1087. Although Connie Chein owned PSLEI during most
of 2000, there is substantial record evidence indicating that Chein
remained in control of PSLEI. See, e.g., GX 28, at 14 (Connie Chein
visited clinic only once); GX 96, at 32 (correspondence manifesting
Chein’s approval required prior to shipment of prescription); GX 105,
at 36 (Chein ordered shipment of phentermine to patient in Japan); GX
107, at 23 (Chein ordered duplicate shipment of prescription); GX
136, at 14 (Chein described special handling requirements for
shipments to Japan).
                                  11

order controlled substances. See GX 28.
    On March 9, 2001, DI DeSantis telephoned Garber at PSLEI
to inquire about the shipments of controlled substances listed in
the dispensing logs outside the United States. See Tr. 506–07.
Garber confirmed that PSLEI was shipping controlled
substances overseas. Id. at 507; see also GX-25. At that time
DI DeSantis instructed Garber to immediately cease the
shipments because no one at PSLEI had a DEA export
registration. Id. at 508.8 Later that day, PSLEI staff faxed DI
DeSantis copies of purchase invoices for testosterone which had
not been produced during her February 5, 2001 visit. Tr. 516-
18. Again, the records appeared to be incomplete. The earliest
invoice was dated November 20, 2000, see GX 20(k); however,
the dispensing records indicated that testosterone had been
dispensed for several months before November 2000. See GX.
15, at 23-26.9
    On August 23, 2001, DI DeSantis and DI Violeta Willmont
finally met with Chein. Tr. 546-48. Chein acknowledged not
having a DEA export registration; however, he claimed that
because he was shipping controlled substances directly to
overseas physicians, he did not need an export registration. Id.
at 554.10 He told DI DeSantis that he had continued to export

    8
      In April 2001, Chein applied for a registration to export Schedule
III non-narcotic and Schedule IV controlled substances but neither that
application nor a second one was ever processed. GX 48; see also GX
39.
    9
     At least one of the purchase invoices used Connie Chein’s DEA
registration number. See GX 20(j).
    10
     Chein’s dispensing log indicates that, contrary to his claims, he
shipped controlled substances directly to patients overseas. See, e.g.,
                               12

controlled substances despite her earlier instruction to Garber.
Id. at 557. Chein told DI DeSantis that he did not plan to stop
exporting until “he received something in writing” from DEA.
Id. at 558. He did not tell her that he had applied for an export
registration. Id. at 658. During the meeting Chein provided her
with additional purchase invoices for controlled substances.
One of the invoices, dated June 26, 2001, was for the purchase
of 120 units of Depo-testosterone and 40 units of Decadurabolin
(both Schedule III controlled substances) from a pharmacy in
Tijuana, Mexico. See GX 22; Tr. 573. Chein was not then (or
since) registered with DEA as an importer. GX 2; Tr. 167. On
August 31, 2001, DI DeSantis instructed Chein by fax that,
because he was not registered to import or export controlled
substances, he “must immediately cease all acitivity (sic) in
these areas as previously instructed.” Id.
    On November 7, 2001, DEA issued an order to show cause
requiring Chein to show why his practitioner’s registration and
his pending application for renewal should not be denied on the
ground that his continued registration was inconsistent with the
public interest under 21 U.S.C. §§ 823(f) and 824(a). GX 26.
DEA also issued a notice of immediate suspension informing
Chein that his registration was immediately suspended as an
imminent danger to the public health and safety under 21 U.S.C.
§ 824(d). Id. DI DeSantis delivered both documents to PSLEI
on November 12, 2001, Tr. 590, and, while there, inspected
additional purchase invoices. One invoice dated March 26,
2001 indicated that two kilograms of testosterone had been
purchased using Connie Chein’s DEA registration. GX 45(a).
Three invoices indicated that Garber had been receiving

GX 87 (dispensing log for testosterone gel showing shipments to
patients in Japan).
                              13

shipments of testosterone at his home and not at his registered
address (i.e., PSLEI) in violation of 21 U.S.C. § 822(e) and 21
C.F.R. § 1201.12. See GX 45(b), (c), (d) & (g).
    Subsequently DI DeSantis conducted three “trash runs”
(searching garbage left for collection) at PSLEI. Tr. 686. She
found paperwork showing Chein continued to export controlled
substances even after she had ordered him to cease further
exporting. See, e.g., GX 70 (Oct. 24, 2001 invoice for shipment
of phentermine and testosterone to patient in Japan); GX 73
(Oct. 29, 2001 instruction, signed by Chein, ordering shipment
of testosterone to second patient in Japan). Following these
discoveries, DEA obtained an administrative inspection warrant
for PSLEI. GX 82. DEA agents executed the warrant on March
13, 2002, seizing PSLEI’s dispensing logs, patient records for
approximately 100 overseas patients and samples of controlled
substances. Tr. 721, 764, 811. The records showed that Chein
regularly exported controlled substances for almost three months
after DI DeSantis first instructed him to stop in August 2001,
see, e.g., GX 84-88, and that several of the exports took place
even after Chein received DEA’s notice of immediate
suspension. GX 84, at 3-4 (noting eight exports by Chein on
November 13, 2001 and five on November 14, 2001).
    A DEA Administrative Law Judge (ALJ) held a hearing on
January 28-February 6, September 9-10 and December 9-11,
2003. On July 28, 2005, the ALJ issued her recommended
decision. In re Edmund Chein, M.D., No. 02-9, 02-43,
Recommended Findings of Fact, Conclusions of Law, and
Decision of the Administrative Law Judge (July 28, 2005) (ALJ
Dec.). The 82-page decision concluded that Chein’s continued
registration was against the public interest and also
recommended that his application for an export registration be
denied. ALJ Op. 82. (Three years earlier, on May 24, 2002,
DEA had issued a second order to show cause directing Chein
                                    14

to show cause why his application for an export registration
should not be denied.) See ALJ Op. 1. On February 12, 2007,
the DA issued the final agency order revoking Chein’s
practitioner’s registration and denying his pending export
registration application. 72 Fed. Reg. at 6595. Chein then filed
a timely petition for review pursuant to 21 U.S.C. § 877.
                                    II.
    Chein raises a host of objections to the DA’s analysis as well
as to the procedure employed during the ALJ hearing.11 We

    11
         Chein raises the following objections:
    1. The DA revoked his registration when she had not revoked
other physicians’ registrations in analogous circumstances, relying on
Morall v. DEA, 412 F.3d 165, 167 (D.C. Cir. 2005). Chein Br. 26-29.
     2. DEA improperly deviated from its “consistent practice of
cooperating with physician registrants” for export registration by
failing to communicate with him while his applications were pending
and by not providing sufficient guidance during the application
process. Id. at 29-33.
    3. DEA improperly withheld documents from Chein and the ALJ
by improperly invoking a law enforcement privilege. Id. at 34-35.
    4. The DA erroneously concluded that Chein had imported
controlled substances from a Mexican pharmacy despite evidence that
the delivery was routed through a San Diego warehouse. Id. at 33-38.
   5. The DA erred in holding Chein liable for violations of the
Controlled Substances Act committed by other DEA registrants
working at PSLEI. Id. at 39-41.
    6. The DA incorrectly found that Chein violated the
record-keeping requirements of 21 U.S.C. § 827(b)(2)(B). Id. at
41-45.
                                  15

have considered all of Chein’s objections on the briefs and at
oral argument and conclude that only the first merits discussion.
In Morall v. DEA, 412 F.3d 165 (D.C. Cir. 2005), we vacated
DEA’s revocation of a physician’s registration because DEA
had “consistently declined” “to revoke the registration of any
other physician in a comparable context, or even under
significantly more troubling circumstances” and because DEA
offered “no explanation” for the departure from its precedent.
Id. at 181.12 We first explained that under the Administrative

     7. The DA improperly applied the “public interest” tests
prescribed in 21 U.S.C. § 823(a) and (f) by giving insufficient weight
to factors favorable to Chein. Id. at 45-52.
    8. DEA violated due process by submitting evidence it had
agreed not to submit and by offering the testimony of a substitute
witness at the ALJ hearing. Id. at 52-56.
    9. The DA erred in finding that Chein’s shipments of controlled
substances to overseas patients constituted a “diversion” of the
substances “within the meaning of the CSA.” Id. at 56-59.
    12
      The DA’s decision to revoke Morall’s DEA registration was
based “solely on . . . her alleged lying to investigators” and “her
record-keeping failures.” Morall, 412 F.3d at 180. Regarding the
DA’s finding that Morall had lied to investigators, we found that the
decision could “not withstand review because the [DA] entirely
ignored relevant evidence” of Morall’s truthfulness, including
testimony “that the ALJ credited” without providing “any reason for
rejecting the ALJ’s decision to credit Dr. Morall’s account.” Id. at 178
(citing, inter alia, El Rio Santa Cruz Neighborhood Health Ctr., Inc.,
v. United States Dep’t of Health & Human Servs., 396 F.3d 1265,
1278 (D.C. Cir. 2005)) (emphases omitted). Moreover, the record-
keeping failures the DA believed warranted revocation “occurred
during a relatively brief time period” when Morall was struggling with
several personal reversals. Id. at 168, 183. Morall had also recently
                                    16

Procedure Act, 5 U.S.C. § 706(2)(A), the DA’s choice of
sanction is entitled to substantial deference and will be set aside
only if her decision is “ ‘arbitrary, capricious, an abuse of
discretion, or otherwise not in accordance with law.’ ” Id. at
177 (quoting Tourus Records, Inc. v. DEA, 259 F.3d 731, 736
(D.C. Cir. 2001) (quoting 5 U.S.C. § 706(2)(A))). Ordinarily,
the “mere unevenness in the application of [a] sanction [will] not
render its application in a particular case ‘unwarranted in law.’”
Id. at 183 (quoting Butz v. Glover Livestock Comm’n Co., 411
U.S. 182, 188 (1973)) (first alteration in Morall). If the
revocation represents a “flagrant departure from DEA policy and
practice,” however, and if the departure is “not only
unexplained, but entirely unrecognized in the [DA’s] decision,
the agency’s sanction [cannot] withstand abuse of discretion
review.” Id. at 183.
    Addressing Morall’s first factor, we believe Chein has failed
to demonstrate that DEA has a consistent policy of allowing a
practitioner to retain his registration under similar
circumstances. The numerous cases in which Chein claims
DEA has allowed more egregious violators to retain their
registrations are easily distinguishable from his.13 In each of the

split from her former business partner, been evicted from her clinic for
non-payment of rent and had not been able to hire support staff. Id.
When confronted with her record-keeping violations, Morall
acknowledged her errors and “readily agreed to take classes to
improve her record keeping.” Id. at 183. We noted that “[n]owhere
in its decision, in its brief to the court, or during the oral argument, did
DEA identify a single case in which a physician’s registration was
revoked under analogous circumstances.” Id. at 181.
    13
     See, e.g., Theodore Neujahr, D.V.M.; Continuation of
Registration, 65 Fed. Reg. 5680 (Feb. 4, 2000) (no revocation of
                                  17

veterinarian who kept controlled substances in unlocked drawer at
unregistered location; “used his privileges as a DEA registrant to
obtain controlled substances to support his chemical dependency”; and
“materially falsified his . . . renewal applications”); Karen A. Kruger,
M.D.; Grant of Restricted Registration, 69 Fed. Reg. 7016 (Feb. 12,
2004) (no revocation of physician who “unlawfully issued
prescriptions [for] approximately 5,500 dosage units of . . . controlled
substance[s]” and used falsified prescriptions to support her drug
addiction); Jeffrey Martin Ford, D.D.S.; Grant of Restricted
Registration, 68 Fed. Reg. 10,750 (Mar. 6, 2003) (no revocation of
dentist who abused marijuana, LSD, mescaline and cocaine and had
been convicted of drug offenses several years earlier); Wesley G.
Harline, M.D.; Continuation of Registration With Restrictions, 65 Fed.
Reg. 5665 (Feb. 4, 2000) (no revocation of physician who prescribed
medication in violation of state law and “wr[ote] incomplete
prescriptions”); Paul W. Saxton, Continuation of Registration, 64 Fed.
Reg. 25,073 (May 10, 1999) (no revocation of physician who
“prescribed large quantities of controlled substances to individuals
who he knew or should have known abused the drugs”; illegally
prescribed anabolic steroids to family members and could not
“account for large quantities of drugs”); Donald P. Tecca, M.D.;
Continuation of Registration With Restrictions, 62 Fed. Reg. 12,842
(Mar. 18, 1997) (no revocation of physician who eight times
prescribed anabolic steroids “for no legitimate medical reason” and
prescribed controlled substances to undercover agent with alleged
drug problem); Mary Thomson, M.D.; Continuation of Registration
With Restrictions, 65 Fed. Reg. 75,969 (Dec. 5, 2000) (no revocation
of physician who abused opiates and obtained controlled substances
by misrepresentation); Barry H. Brooks, M.D.; Continuation of
Registration, 66 Fed. Reg. 18,305 (Apr. 6, 2001) (no revocation of
physician whose state medical license was suspended and who was
convicted of illegally prescribing Dilaudid for treatment of heroin
addiction); Vincent J. Scolaro, D.O.; Grant of Restricted Registration,
67 Fed. Reg. 42,060 (Jun. 20, 2002) (no revocation of physician who
abused controlled substances, lacked required records and had
                                   18

cases, the DA, using the public interest standard, imposed a
sanction less than revocation primarily because the practitioner
had corrected the prohibited practices, accepted responsibility
for his or her conduct, cooperated fully with DEA and, where
applicable, sought treatment for drug or alcohol addiction
underlying the violation.14 Not so here. Chein cannot credibly

criminal conviction).
    14
       See, e.g., Neujahr, 65 Fed. Reg. at 5682 (“The [DA] finds it
noteworthy that Respondent first sought treatment for his chemical
dependency on his own and not at the direction of [DEA].”); Kreuger,
69 Fed. Reg. at 7017-18 (“The [DA] finds significant the
Respondent’s ready willingness to cooperate with law enforcement
authorities . . . [and] to seek treatment for her drug abuse.”); Ford, 68
Fed. Reg. at 10,753 (“Respondent beg[a]n attending drug
rehabilitation following his . . . arrest, and has not abused controlled
substances [during the intervening twelve years].”); Harline, 65 Fed.
Reg. at 5672 (“Respondent has taken remedial steps to ensure that he
practices in compliance with the law.”); Saxton, 64 Fed. Reg. at
25,073 (“[Respondent] ceased such prescribing immediately upon
learning that it was illegal and has not prescribed anabolic steroids for
muscle enhancement since.” (emphasis added)); Tecca, 62 Fed. Reg.
at 12,846 (respondent acknowledged improper prescribing and
testified he had since “become more conservative in his prescribing
practices.”); Thomson, 65 Fed. Reg. at 75,972 (“Respondent
effectively has addressed the personal and professional problems that
contributed to her drug abuse [and] take[n] affirmative responsibility
for her misconduct . . . .”); Brooks, 66 Fed. Reg. at 18,309
(“Respondent has readily admitted fault, has taken responsibility for
his past misconduct, and has fully cooperated with and assisted in the
investigations concerning his illicit activities.”); Scolaro, 67 Fed. Reg.
at 42,066 (“Respondent has succeeded outstandingly in a well
established, aggressive rehabilitation program . . . .”); see also Morall,
412 F.3d at 183 (“Morall has always acknowledged that her record
                                  19

claim that he has cooperated with DEA given his continued
exporting of controlled substances after he was repeatedly
informed that it was illegal to do so, as well as his continued
dispensing of controlled substances even after his DEA
registration was suspended.         Nor has Chein accepted
responsibility for his misconduct as evidenced by, inter alia, his
continued insistence that his dispensing of anabolic steroids to
the undercover agents was proper and his providing misleading
information to DEA investigators. See supra notes 4, 10.
Moreover, we note that Chein engaged in a persistent course of
misconduct which, at the time of the notice of immediate
suspension, spanned at least seven years. See Morall, 412 F.3d
at 183 (noting “Morall’s record-keeping failures occurred during
a relatively brief time period”).15 Because Chein has failed to
demonstrate that his revocation represents a “flagrant departure
from DEA policy and practice” in analogous cases, Morall, 412
F.3d at 183, we need not reach the question whether DEA

keeping suffered . . . and she readily agreed to take classes to improve
her record keeping.”).
    15
      In fact, in several instances, DEA has revoked the registrations
of physicians involved in comparable behavior. For example, in John
W. Copeland, M.D.; Revocation of Registration, 59 Fed. Reg. 46,063,
46,064 (Sept. 6, 1994), the DA revoked the registration of a physician
who had prescribed controlled substances (e.g., Ritalin, Valium,
Restoril) to drug addicts and anabolic steroids for bodybuilding. In
Rose Mary Jacinta Lewis, M.D.; Affirmance of Immediate
Suspension, 72 Fed. Reg. 4035, 4038, 4041 (Jan. 29 2007), the DA
revoked the registration of a physician who provided her DEA
registration number to an associate so that he could use the number to
order HIV medication to be sent to Nigeria. The physician understood
the drugs were to be shipped overseas although neither she, nor her
associate, had an export registration. Id.
                                  20

adequately explained the departure. Id. Accordingly we deny
the petition for review.16
                                                         So ordered.

    16
      We note, however, the length of time DEA took to issue a final
order in this case. It issued the first order to show cause on November
7, 2001; the DA’s final order did not issue until January 19,
2007—over five years later. See Wedgewood Vill. Pharmacy v. DEA,
509 F.3d 541, 546, 547 (D.C. Cir. 2007) (noting with disapproval one-
year delay between ALJ hearing and ALJ opinion and one-year delay
between ALJ opinion and DA’s final decision).