Notice2025-19705
Lawrence Michael Willis, D.D.S.; Decision and Order
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Published
October 30, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 90 Issue 208 (Thursday, October 30, 2025)</title>
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[Federal Register Volume 90, Number 208 (Thursday, October 30, 2025)]
[Notices]
[Pages 48898-48900]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19705]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Lawrence Michael Willis, D.D.S.; Decision and Order
On November 20, 2024, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Lawrence Michael
Willis, D.D.S., of Commerce City, Colorado (Registrant). OSC, at 1, 6;
Request for Final Agency Action (RFAA), Exhibit (RFAAX) 1, at 1, 6. The
OSC proposed the revocation of Registrant's DEA Certificate of
Registration No. AW1335822, alleging that Registrant has committed acts
that are inconsistent with the public interest. OSC, at 1 (citing 21
U.S.C. 823(g)(1); 824(a)(4)).\1\ More specifically, the OSC alleged
that Registrant repeatedly violated Colorado law by failing to register
for and query the Colorado Prescription Drug Monitoring Program, in
violation of Colo. Rev. Stat. Sec. Sec. 12-30-109(1)(b), 12-280-
403(2)(a), 12-280-404(4)(a), 12-280-404(4)(a.5). OSC, at 2-4.
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\1\ Based on the Government's submissions in its RFAA dated
February 4, 2025, the Agency finds that service of the OSC on
Registrant was adequate. Specifically, the Declaration from a DEA
Diversion Investigator (DI) indicates that on December 3, 2024, the
DI, along with a second Diversion Investigator, traveled to
Registrant's registered address and personally served the OSC on
Registrant. RFAAX 2, at 1.
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On February 4, 2025, the Government submitted an RFAA requesting
that the Agency issue a default final order revoking Registrant's
registration. RFAA, at 4-5. After carefully reviewing the entire record
and conducting the analysis as set forth in more detail below, the
Agency grants the Government's request for final agency action and
revokes Registrant's registration.
I. Default Determination
Under 21 CFR 1301.43, a registrant entitled to a hearing who fails
to file a timely hearing request ``within 30 days after the date of
receipt of the [OSC] . . . shall be deemed to have waived their right
to a hearing and to be in default'' unless ``good cause'' is
established for the failure. 21 CFR 1301.43(a) & (c)(1). In the absence
of a demonstration of good cause, a registrant who fails to timely file
an answer also is ``deemed to have waived their right to a hearing and
to be in default.'' 21 CFR 1301.43(c)(2). Unless excused, a default is
deemed to constitute ``an admission of the factual allegations of the
[OSC].'' 21 CFR 1301.43(e).
Here, the OSC notified Registrant of his right to file a written
request for hearing, and that if he failed to file such a request, he
would be deemed to have waived his right to a hearing and be in
default. RFAAX 1, at 4-5 (citing 21 CFR 1301.43). According to the
Government's unrebutted RFAA, Registrant failed to request a hearing
and the Agency so finds. RFAA, at 2. Thus, the Agency finds that
Registrant is in default and therefore is deemed to have admitted to
the factual allegations in the OSC. 21 CFR 1301.43(e).
II. Applicable Law
As the Supreme Court stated in Gonzales v. Raich, 545 U.S. 1
(2005), ``the main objectives of the [Controlled Substances Act (CSA)]
were to conquer drug abuse and control the legitimate and illegitimate
traffic in controlled substances.'' 545 U.S. at 12. Gonzales explained
that:
Congress was particularly concerned with the need to prevent the
diversion of drugs from legitimate to illicit channels. To effectuate
these goals, Congress devised a closed regulatory system making it
unlawful to manufacture, distribute, dispense, or possess any
controlled substance except in a manner authorized by the CSA . . . .
The CSA and its implementing regulations set forth strict requirements
regarding registration, labeling and packaging, production quotas, drug
security, and recordkeeping.
Id. at 12-14.
The OSC's allegations concern the CSA's ``statutory and regulatory
provisions . . . mandating . . . compliance with . . . prescription
requirements'' and, therefore, go to the heart of the CSA's ``closed
regulatory system'' specifically designed ``to conquer drug abuse and
to control the legitimate and illegitimate traffic in controlled
substances,'' and ``to prevent the diversion of drugs from legitimate
to illicit channels.'' Id. at 12-14, 27.
A. Allegation That Registrant Failed To Register for and Query the
Colorado Prescription Drug Monitoring Program
Colorado regulations require that every practitioner licensed in
the state register for and maintain an account with the Colorado
Prescription Drug Monitoring Program (PDMP) and query the Colorado PDMP
prior to prescribing any opioid or benzodiazepine. Colo. Rev. Stat.
Sec. Sec. 12-30-109(1)(b), 12-280-403(2)(a), 12-280-404(4)(a), 12-280-
404(4)(a.5).
III. Findings of Fact
The Agency finds that, in light of Registrant's default, the
factual allegations in the OSC are deemed admitted.\2\ 21 CFR
1301.43(e). Accordingly, Registrant is deemed to have admitted to each
of the following facts and the Agency finds unrebutted evidence
thereof.
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\2\ According to the Controlled Substances Act (CSA),
``[f]indings of fact by the [DEA Administrator], if supported by
substantial evidence, shall be conclusive.'' 21 U.S.C. 877. Here,
where Applicant is found to be in default, all the factual
allegations in the OSC are deemed to be admitted. These uncontested
and deemed admitted facts constitute evidence that exceeds the
``substantial evidence'' standard of 21 U.S.C. 877; it is unrebutted
evidence.
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Registrant admits that as a licensed practitioner in Colorado, he
was required to registered with the Colorado PDMP. RFAAX 1, at 2.
Despite this requirement, he failed to timely register for the Colorado
PDMP, and on December 16, 2022, the Colorado Dental Board issued a
disciplinary order against him for his failure to register for the
Colorado PDMP. Id. at 3. Registrant admits that from at least July 2018
through at least June 2023, he failed to register for the Colorado
PDMP. Id. at 3-4.
Registrant further admits that as a licensed practitioner in
Colorado, he was required to query the Colorado PDMP prior to issuing
prescriptions for opioids and benzodiazepines. Id. at 3. Registrant
admits that from at least July 2018 through at least June 2023, he
failed to query the Colorado PDMP prior to issuing numerous opioid and
benzodiazepine prescriptions to his patients. Id. at 3-4.
Specifically, Registrant admits that between July 2018 and June
2023, he issued the following prescriptions without querying the PDMP:
\3\ approximately three prescriptions for hydrocodone-acetaminophen
7.5-325 mg (a Schedule II opiate) and 67 prescriptions for hydrocodone-
acetaminophen 10-325 mg to M.G; approximately 27 prescriptions for
[[Page 48899]]
hydrocodone-acetaminophen 10-325 mg to R.H.; approximately one
prescription for diazepam 5 mg (a Schedule IV benzodiazepine), three
prescriptions for hydrocodone-acetaminophen 7.5-325 mg, and 40
prescriptions for hydrocodone-acetaminophen 10-325 mg to A.M.;
approximately 26 prescriptions for hydrocodone-acetaminophen 10-325 mg
to J.M.; and approximately 28 prescriptions for hydrocodone-
acetaminophen 10-325 mg to L.W. Id. at 3-4.
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\3\ These prescriptions were all issued by Registrant's
receptionist and patient, M.G., using Registrant's prescription pad.
Id. at 3-4. Registrant admits that he permitted M.G. to sign and
authorize prescriptions on his behalf. Id. at 3. Although the
Government alleges that Registrant's delegation of his prescribing
authority is evidence that Registrant ``failed to take appropriate
measures to safeguard against potential misuse, abuse, and/or
diversion of controlled substances,'' the Government does not cite
any specific violations of state or federal law or explain the nexus
to public interest factors B and D (see infra IV.A). Id. at 3-4.
Although the Agency notes that this conduct is clearly unlawful,
see, e.g., Neeraj B. Shah, M.D., 89 FR 84195, 84197 n.11 (2024)
(``[W]here a registrant's actions allow an unregistered person to
prescribe controlled substances, as Respondent did here, the
registrant can be found in violation of 21 CFR 1306.04(a)''), the
Agency need not adjudicate these allegations because there is other
substantial evidence on the record demonstrating that Registrant's
registration is inconsistent with the public interest.
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In consideration of the above, the Agency finds unrebutted record
evidence that Registrant failed to register for the Colorado PDMP and
that Registrant issued at least 195 prescriptions for opioids and
benzodiazepines without first querying the Colorado PDMP.
IV. Public Interest Determination
A. Legal Background on Public Interest Determinations
When the CSA's requirements are not met, the Attorney General ``may
deny, suspend, or revoke [a] registration if . . . the [registrant's]
registration would be `inconsistent with the public interest.' ''
Gonzales v. Oregon, 546 U.S. 243, 251 (2006) (quoting 21 U.S.C.
824(a)(4)). In the case of a ``practitioner,'' Congress directed the
Attorney General to consider five factors in making the public interest
determination. Id.; 21 U.S.C. 823(g)(1)(A-E).\4\
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\4\ The five factors are:
(A) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(B) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(C) The [registrant's] conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(D) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(E) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(g)(1)(A-E).
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The five factors are considered in the disjunctive. Gonzales v.
Oregon, 546 U.S. at 292-93 (Scalia, J., dissenting) (``It is well
established that these factors are to be considered in the
disjunctive,'' quoting In re Arora, 60 FR 4447, 4448 (1995)); Robert A.
Leslie, M.D., 68 FR 15227, 15230 (2003). Each factor is weighed on a
case-by-case basis. David H. Gillis, M.D., 58 FR 37507, 37508 (1993).
Any one factor, or combination of factors, may be decisive, David H.
Gillis, M.D., 58 FR at 37508, and the Agency ``may give each factor the
weight . . . deem[ed] appropriate in determining whether a registration
should be revoked or an application for registration denied.'' Morall
v. Drug Enf't Admin., 412 F.3d. 165, 185 n.2 (D.C. Cir. 2005)
(Henderson, J., concurring) (quoting Robert A. Smith, M.D., 70 FR
33207, 33208 (2007)); see also Penick Corp. v. Drug Enf't Admin., 491
F.3d 483, 490 (D.C. Cir. 2007).
Moreover, while the Agency is required to consider each of the
factors, it ``need not make explicit findings as to each one.'' MacKay
v. Drug Enf't Admin., 664 F.3d 808, 816 (10th Cir. 2011) (quoting
Volkman v. U.S. Drug Enf't Admin., 567 F.3d 215, 222 (6th Cir. 2009));
Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d
823, 830 (11th Cir. 2018); Hoxie v. Drug Enf't Admin., 419 F.3d 477,
482 (6th Cir. 2005). ``In short, . . . 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, M.D.,
74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has
recognized, Agency decisions have explained that findings under a
single factor can support the revocation of a registration. MacKay, 664
F.3d at 821.
The Government has the burden of proof in this proceeding. 21 CFR
1301.44(e).
B. Registrant's Registration Is Inconsistent With the Public Interest
While the Agency has considered all the public interest factors of
21 U.S.C. 823(g)(1),\5\ the Government's evidence in support of its
prima facie case is confined to Factor D.\6\ OSC, at 2-4. Evidence is
considered under Factor D when it reflects compliance or non-compliance
with laws related to controlled substances. Kareem Hubbard, M.D., 87 FR
21156, 21162 (2022).
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\5\ As to Factor A, there is no record evidence of disciplinary
action against Registrant's state medical license. 21 U.S.C.
823(g)(1)(A). State authority to practice medicine is ``a necessary,
but not a sufficient condition for registration.'' Robert A. Leslie,
M.D., 68 FR at 15230. Therefore, ``[t]he fact that the record
contains no evidence of a recommendation by a state licensing board
does not weigh for or against a determination as to whether
continuation of the Respondent's DEA certification is consistent
with the public interest.'' Roni Dreszer, M.D., 76 FR 19434, 19444
(2011). As to Factor C, there is no evidence in the record that
Registrant has been convicted of any federal or state law offense
``relating to the manufacture, distribution, or dispensing of
controlled substances.'' 21 U.S.C. 823(g)(1)(C). However, as Agency
cases have noted, ``the absence of such a conviction is of
considerably less consequence in the public interest inquiry'' and
is therefore not dispositive. Dewey C. MacKay, M.D., 75 FR at 49973.
As to Factor E, the Government's evidence fits squarely within the
parameters of Factors B and D and does not raise ``other conduct
which may threaten the public health and safety.'' 21 U.S.C.
823(g)(1)(E). Accordingly, Factor E does not weigh for or against
Registrant.
\6\ The OSC also alleges that Factor B weighs against
Registrant's continued registration, but it does not specify what
factual or legal allegations are relevant to the Agency's Factor B
analysis. See supra n.3.
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Here, as found above, Registrant is deemed to have admitted and the
Agency finds that Registrant failed to register for the Colorado PDMP
and that Registrant issued at least 195 prescriptions for opioids and
benzodiazepines without first querying the Colorado PDMP. Accordingly,
the Agency finds substantial record evidence that Registrant violated
Colo. Rev. Stat. Sec. Sec. 12-30-109(1)(b), 12-280-403(2)(a), 12-280-
404(4)(a), and 12-280-404(4)(a.5). The Agency further finds that after
considering the factors of 21 U.S.C. 823(g)(1), Registrant's continued
registration is ``inconsistent with the public interest.'' 21 U.S.C.
824(a)(4). Accordingly, the Government satisfied its prima facie burden
of showing that Registrant's continued registration would be
``inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). The
Agency also finds that Registrant has presented no mitigating evidence
to rebut the Government's prima facie case. Thus, the only remaining
issue is whether, in spite of Registrant's misconduct, he can be
trusted with a registration.
V. Sanction
Where, as here, the Government has met the burden of showing that
Registrant's registration is inconsistent with the public interest, the
burden shifts to Registrant to show why he can be entrusted with a
registration. Morall, 412 F.3d. at 174; Jones Total Health Care
Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018);
Garrett Howard Smith, M.D., 83 FR 18882, 18904 (2018). The issue of
trust is necessarily a fact-dependent determination based on the
circumstances presented by the individual registrant. Jeffrey Stein,
M.D., 84 FR 46968, 46972 (2019); see also Jones Total Health Care
Pharmacy, 881 F.3d at 833. Moreover, as past performance is the best
predictor of future performance, the Agency requires that a registrant
who has committed acts inconsistent with the public interest accept
responsibility for those acts and demonstrate that he will not engage
in future misconduct. See Jones Total Health Care Pharmacy, 881 F.3d at
833; ALRA Labs, Inc. v. Drug Enf't Admin.,
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54 F.3d 450, 452 (7th Cir. 1995). The Agency requires a registrant's
unequivocal acceptance of responsibility. Janet S. Pettyjohn, D.O., 89
FR 82639, 82641 (2024); Mohammed Asgar, M.D., 83 FR 29569, 29573
(2018); see also Jones Total Health Care Pharmacy, 881 F.3d at 830-31.
In addition, a registrant's candor during the investigation and hearing
is an important factor in determining acceptance of responsibility and
the appropriate sanction. See Jones Total Health Care Pharmacy, 881
F.3d at 830-31; Hoxie, 419 F.3d at 483-84. Further, the Agency
considers the egregiousness and extent of the misconduct as significant
factors in determining the appropriate sanction. See Jones Total Health
Care Pharmacy, 881 F.3d at 834 & n.4. The Agency also considers the
need to deter similar acts by a Registrant and by the community of
registrants. Jeffrey Stein, M.D., 84 FR at 46972-73.
Here, Registrant did not request a hearing or answer the
allegations in the OSC, and was therefore deemed to be in default. See
supra I. To date, Registrant has not filed a motion with the Office of
the Administrator to excuse the default. 21 CFR 1301.43(c)(1).
Registrant has thus failed to answer the allegations contained in the
OSC and has not otherwise availed himself of the opportunity to refute
the Government's case.\7\ As such, Registrant has not accepted
responsibility for the proven violations, has made no representations
regarding his future compliance with the CSA, and has not demonstrated
that he can be trusted with registration. Accordingly, the Agency will
order the revocation of Registrant's registration.
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\7\ Notably, and as described supra III, Registrant failed to
register for the Colorado PDMP even after he was disciplined by the
Colorado Dental Board for his failure to register. RFAAX 1, at 3-4.
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Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a) and 21 U.S.C. 823(g)(1), I hereby revoke DEA Certificate
of Registration No. AW1335822 issued to Lawrence Michael Willis, D.D.S.
Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by
21 U.S.C. 823(g)(1), I hereby deny any pending applications of Lawrence
Michael Willis, D.D.S., to renew or modify this registration, as well
as any other pending application of Lawrence Michael Willis, D.D.S.,
for additional registration in Colorado. This Order is effective
December 1, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
October 9, 2025, by Administrator Terrance Cole. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-19705 Filed 10-29-25; 8:45 am]
BILLING CODE 4410-09-P
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