Aims v. Usdea ( 2022 )

FOR PUBLICATION
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
ADVANCED INTEGRATIVE MEDICAL No. 21-70544
SCIENCE INSTITUTE, PLLC; SUNIL
AGGARWAL, Doctor, MD, PhD,
FAAPMR; ERINN BALDESCHWILER; OPINION
MICHAL BLOOM,
Petitioners,
v.
MERRICK B. GARLAND, Attorney
General; D. CHRISTOPHER EVANS, in
his official capacity as acting
Administrator of the U.S. Drug
Enforcement Administration; U.S.
DRUG ENFORCEMENT
ADMINISTRATION,
Respondents.
On Petition for Review of an Order of the Drug
Enforcement Agency
Argued and Submitted September 2, 2021
Pasadena, California
Filed January 31, 2022
2 AIMS V. GARLAND
Before: Sandra S. Ikuta, Mark J. Bennett, and
Ryan D. Nelson, Circuit Judges.
Opinion by Judge Ikuta
SUMMARY*
Drug Enforcement Agency
The panel dismissed, for lack of jurisdiction, a petition for
review of the Drug Enforcement Administration (“DEA”)’s
letter sent in response to an attorney’s letter seeking advice
and guidance on how a physician could administer psilocybin
to a terminally ill patient without incurring liability under the
Controlled Substances Act (“CSA”).
Specifically, the attorney’s letter asked the DEA how the
CSA would accommodate the Right to Try Act (amending the
Food, Drug, and Cosmetic Act) to give patients the possibility
of gaining access to new investigational drugs under certain
circumstances. The DEA responded with a letter identifying
the available exemptions in the CSA and indicating that the
Right to Try Act did not create any additional exemptions.
The panel held that the DEA’s response letter was not a
final decision of the Attorney General under 21 U.S.C. § 877,
and therefore the panel lacked jurisdiction to review it.
Joining the D.C. Circuit, the panel applied the standard in
Bennett v. Spear, 520 U.S. 154, 177-78 (1997), which held
*
This summary constitutes no part of the opinion of the court. It has
been prepared by court staff for the convenience of the reader.
AIMS V. GARLAND 3
that two conditions must be satisfied for agency action to be
final, in interpreting “final decision” in § 877. The first
condition is that the agency action must mark the
consummation of the agency’s decisionmaking process; and
the second condition is that the agency action must be one
where rights or obligations have been determined, or from
which legal consequences flow.
Considering the DEA’s response letter, the panel
concluded it was an informational letter of the sort that did
not constitute final agency action under Bennett. First, the
letter was the sort of advice letter that agencies prepare
multiple times a year in dealing with the regulated
community. There was no indication that the letter
represented the consummation of a decisionmaking process.
Second, the DEA letter did not lead to legal consequences for
the prescribing physician. Rather, the letter provided
straightforward guidance about the interaction of the Right to
Try Act and the CSA. The panel concluded that the DEA
letter did not meet either of Bennett’s conditions.
Accordingly, an advice letter recognizing that Congress has
not yet made an exception to the CSA to allow for the legal
use of psilocybin for therapeutic purposes is not a final
agency decision.
COUNSEL
Matthew C. Zorn (argued), Yetter Coleman LLP, Houston,
Texas; Kathryn L. Tucker, Emerge Law Group, Portland,
Oregon; James F. Williams and Thomas J. Tobin, Perkins
Coie LLP, Seattle, Washington; Andrew J. Kline, Perkins
Coie LLP, Denver, Colorado; Holly Martinez, Perkins Coie
4 AIMS V. GARLAND
LLP, Portland, Oregon; Shane Pennington, Vicente Sederberg
LLP, New York, New York; for Petitioner.
Thomas Pulham (argued), and Mark B. Stern, Appellate
Staff; Brian M. Boynton, Acting Assistant Attorney General;
United States Department of Justice, Civil Division,
Washington, D.C.; for Respondents.
Peter B. Gonick (argued) and Brendan Selby, Assistant
Attorneys General; Robert W. Ferguson, Attorney General;
Office of the Attorney General, Olympia, Washington; Mark
Brnovich, Attorney General, Phoenix, Arizona; Kathleen
Jennings, Attorney General, Wilmington, Delaware; Kwame
Raoul, Attorney General, Chicago, Illinois; Dana Nessel,
Attorney General, Lansing, Michigan; Keith Ellison,
Attorney General, St. Paul, Minnesota; David Yost, Attorney
General, Columbus, Ohio; Ellen F. Rosenblum, Attorney
General, Salem, Oregon; Karl A. Racine, Attorney General,
Washington, D.C.; for Amici Curiae States of Washington,
Arizona, Delaware, Illinois, Michigan, Minnesota, Ohio, and
Oregon, and District of Columbia.
Christina Sandefur and Timothy Sandefur, Scharf-Norton
Center for Constitutional Litigation at the Goldwater
Institute, Phoenix, Arizona; Ilya Shapiro and Trevor Burrus,
Cato Institute, Washington, D.C.; for Amici Curiae
Goldwater Institute and Cato Institute.
David M. Poell, Bradley C. Graveline, and Elizabeth M.
Rowe, Sheppard Mullin Richter & Hampton LLP, Chicago,
Illinois; Nicholas W. van Aelstyn, Sheppard Mullin Richter
& Hampton LLP, San Francisco, California; for Amici Curiae
Kathy L. Cerminara, Sylvia Law, Thaddeus Pope, and Rob
Schwartz.
AIMS V. GARLAND 5
Eleanor Hamburger, Sirianni Youtz Spoonemore Hamburger
PLLC, Seattle, Washington; Hank Balson, Budge & Heipt
PLLC, Seattle, Washington; for Amici Curiae End of Life
Washington, EvergreenHealth, The Washington State
Psychological Association, A Sacred Passing, and
Participating End of Life Care Clinicians and Researchers.
John Wolfe, Orrick Herrington & Sutcliffe LLP, Seattle,
Washington; Nicholas Peterson, Orrick Herrington &
Sutcliffe LLP, Washington, D.C.; Nancy Talner, American
Civil Liberties Union of Washington, Seattle, Washington;
for Amicus Curiae American Civil Liberties Union of
Washington.
OPINION
IKUTA, Circuit Judge:
This appeal seeks to challenge a letter sent by the Drug
Enforcement Administration (DEA) in response to an
attorney’s letter seeking advice and guidance on how a
physician could administer psilocybin (a hallucinogenic
substance) to a terminally ill patient without incurring
liability under the Controlled Substances Act (CSA),
21 U.S.C. §§ 801–904. Specifically, the letter asked the DEA
how the CSA would accommodate the Right to Try Act (RTT
Act), 21 U.S.C. § 360bbb-0a, a 2018 enactment which
amended the Food, Drug, and Cosmetic Act (FDCA) to give
patients the possibility of gaining access to new
investigational drugs under certain circumstances. The DEA
responded in a letter identifying the available exemptions in
the CSA and indicating that the RTT Act did not create any
additional exemptions. In this context, we conclude that the
6 AIMS V. GARLAND
DEA’s response letter was not “a final decision of the
Attorney General,” under 21 U.S.C. § 877, and therefore we
lack jurisdiction to review it.1
I
A
The purpose of the FDCA is to protect consumers from
various risks associated with drugs and biological products.
21 U.S.C. § 393(b)(2); see also FDA v. Brown & Williamson
Tobacco Corp., 529 U.S. 120, 133 (2000). The FDA enforces
the provisions of the FDCA through administrative
proceedings, enforcement actions, and civil penalties.
21 U.S.C. §§ 331–337a. In general, before a new drug can be
introduced into the market, the FDA must approve its new
drug application or biologics license application, which must
include data from clinical trials. 21 U.S.C. § 355. To get this
process started, the sponsor of a clinical trial must submit an
investigational new drug (IND) application to the FDA for
permission to test the drugs on human subjects. See
21 C.F.R. § 312.2. Sponsors must provide specified
information and comply with a long list of requirements to
obtain approval of an IND application. See 21 C.F.R.
§ 312.23. If the application is approved, then the sponsor
must embark on three phases of clinical trials. An individual
may be able to access an investigational new drug through a
clinical trial. 21 C.F.R. § 312.300. But in many cases an
individual may be unable to do so if (for example) there is no
ongoing clinical trial with that drug, any such trial is full, or
1
We GRANT the motions filed by Kathy L. Cerminara, Sylvia Law,
Thaddeus Pope, and Rob Schwartz for leave to file an oversized amicus
curiae brief (Dkt. 27, 30).
AIMS V. GARLAND 7
the patient does not meet the testing criteria.2 Alternatively,
a patient may attempt to access an investigational new drug
through the FDA’s expanded access program, but
manufacturers are often reluctant to provide experimental
drugs that may generate adverse event data.3
Because of restrictions on clinical investigations and
difficulties associated with the expanded access program,
Congress passed the RTT Act in 2018 to give certain patients
access to investigational new drugs under certain
circumstances, outside of a clinical trial setting. Pub. L. No.
115-176, 132 Stat. 1372 (2018). The RTT Act’s primary
function is to relieve qualifying individuals from regulatory
requirements that would otherwise be imposed on eligible
investigational drugs under the FCPA. The Act specifies that
it was not intended to “establish a new entitlement” or a
“positive right” in any individual. Id. § 3(1).
Under the RTT Act, the patient or physician must apply
directly to the sponsor of the IND, and the FDA is not
involved in approving or disapproving the patient’s access.
21 U.S.C. § 360bbb-0a(d). The RTT Act applies to
“[e]ligible investigational drugs provided to eligible patients
in compliance with this section” and exempts them from
specified statutory and regulatory provisions otherwise
2
See Agata Bodie, Expanded Access and Right to Try: Access to
Investigational Drugs, Congr. Res. Serv., R45414, at 3, available at
https://crsreports.congress.gov/product/pdf/R/R45414 (updated Mar. 16,
2021).
3
Id. at 4–6.
8 AIMS V. GARLAND
applicable to investigational drugs. Id. § 360bbb-0a(b).4 An
“eligible investigational drug” is an investigational drug that
meets several criteria. Id. § 360bbb-0a(a)(2). An “eligible
patient” is someone who has been diagnosed with a “life-
threatening disease or condition,” has “exhausted approved
treatment options and is unable to participate in a clinical trial
involving the eligible investigational drug” (as certified by a
physician), and has provided written informed consent
4
21 U.S.C. § 360bbb-0a(b) provides, in full:
Eligible investigational drugs provided to eligible
patients in compliance with this section are exempt
from sections 352(f) [directions for use and warning on
label], 353(b)(4) [misbranding], 355(a) [necessity of
effective approval of application], and 355(i)
[exemptions of drugs for research; discretionary and
mandatory conditions; direct reports to Secretary] of
this title, section 351(a) of the Public Health Service
Act [42 U.S.C. 262(a), covering biologics license], and
parts 50 [protection of human subjects], 56
[institutional review boards], and 312 of title 21
[investigational new drug application], Code of Federal
Regulations (or any successor regulations), provided
that the sponsor of such eligible investigational drug or
any person who manufactures, distributes, prescribes,
dispenses, introduces or delivers for introduction into
interstate commerce, or provides to an eligible patient
an eligible investigational drug pursuant to this section
is in compliance with the applicable requirements set
forth in sections 312.6 [labeling of an investigational
new drug], 312.7 [promotion of investigational new
drug], and 312.8(d)(1) of title 21, Code of Federal
Regulations [permitting a sponsor to recover only the
direct costs of making its investigational drug available
when charging for an investigational drug] (or any
successor regulations) that apply to investigational
drugs.
AIMS V. GARLAND 9
regarding the drug. Id. § 360bbb-0a(a)(1). Under the RTT
Act, the sponsor of the drug is responsible for ensuring that
the applicable criteria are met. See id. § 360bbb-0a(b).
The purpose of the CSA, 21 U.S.C. §§ 801–904, is to
prevent the misuse of substances that threaten public health
and welfare. See 21 U.S.C. § 801(1). To this end, the CSA
makes it a crime to manufacture, distribute, or possess a
controlled substance without authorization. 21 U.S.C.
§§ 841(a)(1), 844(a). A “controlled substance” is defined as
“a drug or other substance, or immediate precursor” included
in a schedule established by the CSA. 21 U.S.C. § 802(6)
(citing schedules defined by part B of the CSA, 21 U.S.C.
§ 811–814). The CSA categorizes controlled substances into
five schedules based on safety, accepted medical use, and
potential for abuse. Id. § 812(b). Schedule I drugs have “a
high potential for abuse,” “no currently accepted medical use
in treatment in the United States,” and “a lack of accepted
safety for use . . . under medical supervision.” Id.
§ 812(b)(1). Psilocybin is a hallucinogenic substance
obtained from certain mushrooms, and is a Schedule I drug
under the CSA. Id. § 812, Schedule I(c)(15).
Controlled substances may be used lawfully under limited
circumstances. A person registered with the Attorney
General may dispense controlled substances “to the extent
authorized by their registration and in conformity with the
other provisions of” the CSA. Id. § 822(b).5 Because
5
The Attorney General is authorized to interpret and apply the CSA.
Id. § 871(b). The Attorney General has delegated his authority to the
Administrator of the DEA, except for functions that do not relate to
investigations or matters involving drugs or where otherwise reserved.
28 C.F.R. § 0.100.
10 AIMS V. GARLAND
substances in Schedule I are deemed to have no accepted
medical use under the CSA, they can be produced, dispensed
or possessed only in the context of research, and this research
requires a special registration. Id. § 823(f); see also
21 C.F.R. §§ 1301.18, 1301.32. If an individual is registered
as an approved researcher in controlled substances, the
researcher is exempt from prosecution under federal, state, or
local laws when acting within the scope of his registration
“for offenses relating to possession, distribution or dispensing
of those controlled substances within the scope of his
exemption.” 21 C.F.R. § 1316.24(a). The DEA is
responsible for enforcing the registration requirements of the
CSA. 28 C.F.R. § 0.100(a).
Any person or organization that produces or distributes
prescription drugs that are also controlled substances must
comply with the requirements of both the FDCA and the
CSA.6
B
Dr. Sunil Aggarwal is co-director of the Advanced
Integrative Medical Science Institute (AIMS) in Seattle,
Washington. In January 2021, Kathryn Tucker, counsel to
AIMS and Dr. Aggarwal, wrote a letter to the DEA
Regulatory Section, stating that Dr. Aggarwal was registered
by the DEA to prescribe controlled substances, and sought
“additional registration” pursuant to the RTT Act “to obtain
psilocybin, a Schedule I drug, for therapeutic use with
6
Joanna R. Lampe, The Controlled Substances Act (CSA): A Legal
Overview for the 116th Congress, Congr. Res. Serv., R45948, at 4,
available at https://crsreports.congress.gov/product/pdf/R/R45948 (last
updated Feb. 5, 2021).
AIMS V. GARLAND 11
terminally ill cancer patients suffering anxiety and/or
depression.” According to Tucker, “[t]his letter provides
background information about the RTT, and we seek your
guidance on how DEA will accommodate RTT so that
Dr. Aggarwal and the AIMS Institute can obtain psilocybin
for therapeutic use with terminally ill patients.” The letter
asserted that psilocybin qualified as an eligible investigational
drug under the RTT Act, 21 U.S.C. § 360bbb-0a, and was the
subject of an active IND application obtained by a company
called Organix. The letter then stated:
I look forward to your guidance as to how
DEA will accommodate RTT so that
Dr. Aggarwal and the AIMS Institute can
obtain psilocybin for therapeutic use with
terminally ill patients. The existing DEA
forms do not appear to accommodate the
RTT, which may be due to the fact that it was
relatively recently enacted; hence it is
confusing to use the existing forms for this
purpose. Should Dr. Aggarwal seek
registration as a “researcher,” though his
intention is therapeutic use as a palliative care
clinician, treating terminally ill patients, not a
“researcher” in the traditional sense? If not a
researcher registration, how ought we
proceed?
In the interest of the terminally ill patients
with refractory anxiety and/or depression, we
hope DEA can promptly advise on how to
proceed.
12 AIMS V. GARLAND
Before DEA responded, Tucker sent a follow-up email to
DEA. This email stated:
I recognize that DEA has not yet addressed
how it will accommodate the Right to Try
(RTT) law. As DEA works to determine this,
it occurred to me that perhaps another way for
it to do so would be to issue an exemption
from prosecution from the CSA to
Dr. Aggarwal for treating his patients with
psilocybin under Right to Try . . . This
approach would be something akin to what is
provided for in 21 C.F.R. § 1316.24,
Exemption from prosecution for researchers,
although the use would be therapeutic rather
than ‘research’ in the traditional sense . . .
Please provide DEA’s guidance on whether it
would be preferable to proceed with a Petition
for Exemption. I remind you that the patients
are in advanced stage of cancer and time is of
the essence to accommodate their rights under
RTT.
A week later, Thomas Prevoznik, Deputy Assistant
Administrator, Diversion Control Division of the DEA
responded in a letter addressed to Tucker.7 The letter first
7
The Diversion Control Division’s mission “is to prevent, detect, and
investigate the diversion of controlled pharmaceuticals and listed
chemicals from legitimate sources while ensuring an adequate and
uninterrupted supply for legitimate medical, commercial, and scientific
needs.” DEA, Diversion Control Division, available at
https://www.dea.gov/operational-division/diversion.
AIMS V. GARLAND 13
acknowledged that Dr. Aggarwal “seeks additional
authorization or additional registration (from DEA)” pursuant
to the RTT Act, and “ask[s] DEA for guidance on how DEA
will accommodate the RTT.”
In response, Prevoznik stated that “the RTT does not
waive the requirements of any provision of the Controlled
Substances Act (CSA) or its implementing regulations.”
Prevoznik set out the full text of the RTT exemption section,
21 U.S.C. 360bbb-0a(b), which does not mention the CSA.8
Prevoznik then stated that “absent an explicit statutory
exemption to the Controlled Substances Act (CSA), DEA has
no authority to waive any of the CSA’s requirements pursuant
to the RTT.”
Turning to the CSA, Prevoznik provided guidance on the
applicable exemptions. First, he stated that “[a] potential
avenue for Dr. Aggarwal to pursue is to apply for a schedule
I researcher registration with DEA to conduct research with
psilocybin, a schedule I controlled substance,” and noted that
“[t]he procedures for such application are outlined in
21 U.S.C. 823(f), 21 CFR 1301.18, and 21 CFR 1301.32.” In
response to Tucker’s inquiry “as to the possibility of DEA
issuing an exemption from prosecution to Dr. Aggarwal” that
was “akin to the exemption provided for in 21 CFR 1316.24,”
Prevoznik stated that the § 1316.24 exemption “applies to
individuals already registered with DEA to engage in research
in controlled substances,” and would not be applicable to
Dr. Aggarwal, who did not have registration for researching
in psilocybin. The letter concluded that should
“Dr. Aggarwal obtain a schedule I researcher registration
from DEA, he may then petition the DEA Administrator for
8
See n.3, supra.
14 AIMS V. GARLAND
a grant of exemption from prosecution following the
procedure set forth in 21 CFR 1316.24(b).”
Dissatisfied with this response, AIMS, Dr. Aggarwal, and
two patients (we refer to AIMS and Dr. Aggarwal
individually when appropriate, and collectively as AIMS)
who were seeking to obtain psilocybin from Organix under
the RTT Act, brought an action in our court pursuant to
21 U.S.C. § 877, a provision allowing judicial review of final
decisions of the Attorney General.
II
As a threshold matter, we must determine whether
21 U.S.C. § 877 gives us jurisdiction to review the DEA
letter. We have jurisdiction to determine our own
jurisdiction, In re Gugliuzza, 852 F.3d 884, 889 (9th Cir.
2017), and review questions regarding our jurisdiction de
novo, Sandoval-Luna v. Mukasey, 526 F.3d 1243, 1245 (9th
Cir. 2008) (per curiam) (citations omitted). “It is to be
presumed that a cause lies outside [of federal courts’] limited
jurisdiction, and the burden of establishing the contrary rests
upon the party asserting jurisdiction.” Kokkonen v. Guardian
Life Ins. Co. of Am., 511 U.S. 375, 377 (1994) (citations
omitted).
A
Section 877 states that “[a]ll final determinations,
findings, and conclusions of the Attorney General under
[21 U.S.C. §§ 801–904] shall be final and conclusive
decisions of the matters involved, except that any person
aggrieved by a final decision of the Attorney General may
AIMS V. GARLAND 15
obtain review of the decision” in the appropriate court of
appeals.9
The term “final” is not defined in the statute. However,
“statutes addressing the same subject matter” generally
should be interpreted consistently with each other. Wachovia
Bank v. Schmidt, 546 U.S. 303, 305 (2006); see also United
States v. Stewart, 311 U.S. 60, 64 (1940) (“[A]ll acts in pari
materia are to be taken together, as if they were one law.”).
This interpretive principle is often applied when the language
in an earlier act is the same as, or similar to, the language in
the later act. See, e.g., Oscar Mayer & Co. v. Evans, 441 U.S.
750, 756 (1979) (interpreting language in the Age
Discrimination in Employment Act by considering
interpretation of similar language in Title VII of the Civil
Rights Act). Applying this principle, we look to the Supreme
Court’s definition of “final” in the context of determining
when decisions or actions of administrative agencies are
“final” for purposes of judicial review. In construing the
Administrative Procedure Act (APA), which provides courts
9
21 U.S.C. § 877 states, in full:
All final determinations, finding, and conclusions of the
Attorney General under this subchapter [21 U.S.C.
§§ 801–904, Control and Enforcement] shall be final
and conclusive decisions of the matters involved,
except that any person aggrieved by a final decision of
the Attorney General may obtain review of the decision
in the United States Court of Appeals for the District of
Columbia or for the circuit in which his principal place
of business is located upon petition filed with the court
and delivered to the Attorney General within thirty days
after notice of the decision. Findings of fact by the
Attorney General, if supported by substantial evidence,
shall be conclusive.
16 AIMS V. GARLAND
with jurisdiction to review “final agency actions,” 5 U.S.C.
§ 704, the Court held that “[a]s a general matter, two
conditions must be satisfied for agency action to be ‘final.’”
Bennett v. Spear, 520 U.S. 154, 177–78 (1997). The first
condition is that “the action must mark the ‘consummation’
of the agency’s decisionmaking process,” and “must not be of
a merely tentative or interlocutory nature.” Id. at 177–78
(citation omitted). The second condition that must be
satisfied for agency action to be “final” is that “the action
must be one by which ‘rights or obligations have been
determined,’ or from which ‘legal consequences will flow.’”
Id. at 178 (citation omitted).
The Court has applied this interpretation of “final” outside
of the APA context. For instance, in Whitman v. American
Trucking Ass’ns, the Court had to interpret the word “final”
in § 307(b)(1) of the Clean Air Act, 42 U.S.C. § 7607(b)(1),
which gives a court jurisdiction over “any . . . nationally
applicable regulations promulgated, or final action taken” by
the Environmental Protection Agency (EPA). 531 U.S. 457,
478 (2001). Although § 307(b)(1) used different language
than § 704 (“final action” rather than “final agency actions”),
the Court stated that the phrase “‘final action’ . . . bears the
same meaning in § 307(b)(1) that it does under the
Administrative Procedure Act (APA), 5 U.S.C. § 704.” Id.(citation omitted). The Court explained that “[t]he bite in the
phrase ‘final action” . . . is not the word ‘action,’ which is
meant to cover comprehensively every manner in which an
agency may exercise power,” but “[i]t is rather in the word
“final,” which requires that the action under review “mark the
consummation of the agency’s decisionmaking process.” Id.(quoting Bennett, 520 U.S. at 177–178). Accordingly, the
agency’s action is “‘final’ and thus reviewable” when the
AIMS V. GARLAND 17
agency “has rendered its last word on the matter in question.”
Id. (citation omitted).10
We have likewise applied Bennett’s interpretation of
“final” to uses of the word “final” in other statutes providing
jurisdiction over agency action. Thus in U.S. West
Commc’ns, Inc. v. Hamilton, we concluded that the term
“final order” under the Hobbs Act was “analytically
equivalent” to the term “final agency action” under the APA.
224 F.3d 1049, 1054–55 (9th Cir. 2000). Therefore, we held
that “Bennett governs our understanding of ‘final order’ for
the purposes of the Hobbs Act.” Id. Applying Bennett’s
interpretation, we determined that an order was final, because
it was “neither tentative nor interlocutory” and it
“determine[d] rights and [gave] rise to legal consequences.”
Id. at 1055.
Although we have not expressly applied Bennett in
interpreting “final decision” in § 877, we have applied similar
reasoning in that context. See Hemp Indus. Ass’n v. DEA,
333 F.3d 1082, 1085 (9th Cir. 2003). In Hemp, the DEA
published a rule that banned the sale of certain products
containing hemp products in the Federal Register. Id. at
1084–85. Implicitly applying Bennett’s second condition, we
concluded that the rule was “final” for purposes of our
jurisdiction under § 877 because it imposed “obligations and
sanctions in the event of violation.” Id. at 1085; see also
Oregon v. Ashcroft, 368 F.3d 1118, 1120 (9th Cir. 2004)
10
Whitman also determined that because the “special judicial review
provision” of the Clean Air Act provides for preenforcement review, the
rule had sufficient “concrete effects” for enforcement. Id. at 480–81
(citation omitted).
18 AIMS V. GARLAND
(holding that the court had jurisdiction under § 877 to review
a rule that “orders sanctions for violations of its provisions”).
As these cases indicate, Bennett’s conclusion that an
agency action is final if it is not interim or tentative but has
concrete effects and legal consequences is equally applicable
in construing other statutes authorizing review of agency
action. We conclude that this interpretation is applicable to
our analysis of § 877, because the word “final” in this context
is “analytically equivalent” to the meaning of the same word
in the APA. Hamilton, 224 F.3d at 1054–55. We therefore
join the D.C. Circuit, which reached the same conclusion.
See John Doe, Inc. v. DEA, 484 F.3d 561, 566 n.4 (D.C. Cir.
2007). In John Doe, the D.C. Circuit held that it had
jurisdiction under § 877 to review the DEA’s denial of an
application for a permit. Id. at 567. John Doe explained that
Bennett “firmly support[s] a finding of finality” because the
DEA “affirmatively denied Doe’s permit application,” thus
marking the culmination of its decisionmaking process, and
also established “legal consequences by prohibiting
importation.” Id. at 566–67 (citation omitted). Our
conclusion is also consistent with the Sixth Circuit’s analysis.
See Miami-Luken, Inc. v. DEA, 900 F.3d 738, 743 (6th Cir.
2018). Although the Sixth Circuit primarily relied on the
Supreme Court’s interpretation of 28 U.S.C. § 1291(providing jurisdiction over “final decisions” of district
courts) in interpreting § 877’s finality requirement, the Sixth
Circuit stated that its analysis was “bolstered by the Supreme
Court’s analysis” of the APA in Bennett. Id. at 742 n.4.11
11
We agree with Miami-Luken that interpretations of the word “final”
in 28 U.S.C. § 1291 can also shed light on the use of the word “final” in
§ 877.
AIMS V. GARLAND 19
B
When applying Bennett’s two conditions to a
communication made by an agency, courts differentiate
between an informational document that merely provides the
agency’s interpretation of a statute, see City of San Diego v.
Whitman, 242 F.3d 1097 (9th Cir. 2001), and a decision that
determines how a statute or regulation applies to facts for
enforcement purposes, see U.S. Army Corps. of Eng’rs v.
Hawkes Co., 578 U.S. 1129 (2016).
1
An agency’s informational document, in which “an
agency merely expresses its view of what the law requires of
a party,” is not a final agency action. Indep. Equip. Dealers
Ass’n v. EPA, 372 F.3d 420, 427–28 (D.C. Cir. 2004). In City
of San Diego, for instance, we determined that a letter written
by the EPA, stating it planned to apply the Ocean Pollution
Reduction Act to the City’s future application for renewal of
its wastewater discharge permit, was not final agency action.
242 F.3d at 1098. First, the letter did not mark the
consummation of the agency’s decisionmaking process, the
first Bennett condition. Id. at 1101. Rather, we held that the
agency’s decisionmaking process on the City’s application
would “not even begin until the City files its application,” and
the agency’s process would not be completed until the City
had exhausted the appeal process. Id. at 1101. Second, the
letter did not lead to legal consequences for the City, the
second condition of Bennett, because the letter “simply
responds to the City’s request for ‘assistance’ on the issue” of
whether the EPA would apply a specified statute to its
application, and “only ‘encourage[s]’ the City to submit its
20 AIMS V. GARLAND
application in accordance with the EPA’s interpretation” of
the statute. Id.Similarly, we held that an agency’s informational manual
on compliance with the National Environmental Policy Act
(NEPA) was not a final agency action. Whitewater Draw
Nat. Res. Conservation Dist. v. Mayorkas, 5 F.4th 997 (9th
Cir. 2021), cert. denied sub nom. Whitewater Draw v.
Mayorkas, No. 21-574, 2021 WL 5869442 (U.S. Dec. 13,
2021) (9th Cir. July 19, 2021). First, the manual was not the
culmination of the agency’s decisionmaking process because
it merely “facilitates the beginning of the NEPA review
process for proposed” agency action. Id. at 1008. Second, it
did not lead to legal consequences, because the informational
manual “is not itself a decision that any particular [agency]
action requires or does not require” an environmental impact
statement, and the guidance provided by the manual “would
be subsumed in any final rule issued by [the agency] on a
particular matter.” Id. (citation omitted).
In considering Bennett’s second condition, we have
emphasized that an agency action is not final where the
agency merely “expresses its view of what the law requires.”
Fairbanks N. Star Borough v. U.S. Army Corps of Eng’rs,
543 F.3d 586, 594 (9th Cir. 2008) (citation omitted). This is
because in a later enforcement action, the regulated party
“would face liability only for noncompliance with the
underlying statutory commands, not for disagreement with
the agency’s determination.” Id. (citation omitted). “Absent
some identifiable effect on the regulated community, an
agency works no legal effect merely by expressing its view of
the law.” Valero Energy Corp. v. EPA, 927 F.3d 532, 536
(D.C. Cir. 2019) (citation omitted).
AIMS V. GARLAND 21
2
By contrast, a decision document that marks the
conclusion of an agency’s decisionmaking process and has
legal consequences for the regulated party is a final agency
action. In Hawkes, 578 U.S. 590, the Supreme Court
considered a determination issued by the Army Corps of
Engineers giving its definitive view on whether a particular
piece of property contained wetlands (called an approved
jurisdictional determination, or JD). The Court held first that
“an approved JD clearly mark[s] the consummation of the
Corps’ decisionmaking process” (the first Bennett condition)
because “it is issued after extensive factfinding by the Corps
regarding the physical and hydrological characteristics of the
property . . . and is typically not revisited if the permitting
process moves forward.” Id. at 597–98 (cleaned up). The
Court also held that a JD meets the second Bennett
consideration, because it gives rise to “direct and appreciable
legal consequences.” Id. at 598 (citing Bennett, 520 U.S. at
178). An approved JD stating that a party’s property does not
contain jurisdictional waters “both narrows the field of
potential plaintiffs and limits the potential liability a
landowner faces for discharging pollutants without a permit.”
Id. at 599. And a positive JD (a determination that there are
wetlands on the property) also has legal consequences,
because it represents “the denial of the safe harbor that
negative JDs afford.” Id. (citation omitted).
According to Hawkes, this conclusion “tracks the
pragmatic approach” adopted in Frozen Food Express v.
United States, 351 U.S. 40 (1956), which was decided before
the Court formalized its approach in Bennett. 578 U.S. at
599. In Frozen Foods, after a decisionmaking process that
included a public hearing, the Interstate Commerce
22 AIMS V. GARLAND
Commission (Commission) issued a report and order to
establish which commodities were exempt from regulation.
Id. at 41–42. The Court determined the order was effectively
a declaratory rule with legal consequences, and therefore
constituted final agency action. Id. at 45. The Court
explained that the Commission’s ruling that a commodity was
not exempt had “an immediate and practical impact” on the
regulated community, in that it “warns every carrier, who
does not have authority from the Commission to transport
those commodities, that it does so at the risk of incurring
criminal penalties.” Id. at 44.
We have likewise distinguished between “an agency letter
to a single entity that was purely informational in nature and
compelled no one to do anything,” which is not final agency
action, and an agency’s “application and enforcement” of an
order warning the regulated community not to take prohibited
actions “on pain of fines and imprisonment,” which qualifies
as a final agency action. San Francisco Herring Ass’n v.
Dep’t of the Interior, 946 F.3d 564, 577 (9th Cir. 2019)
(cleaned up). In San Francisco Herring Ass’n, the National
Park Service issued a series of enforcement orders stating it
had jurisdiction over the Golden Gate National Recreation
Area (GGNRA), and announcing its intention “to enforce the
prohibition on commercial fishing” in those waters. Id. at
578. “Subsequently, and critically, the Park Service then put
its declared position into action when its uniformed officers
and California wardens (allegedly acting at the federal
government’s direction) took to the waters to order herring
fishermen to stop fishing in the GGNRA.” Id. We concluded
that the Park Service’s enforcement orders were final agency
action. We explained that “[t]he Park Service had arrived at
a definitive position, fulfilling the first Bennett requirement
of being the consummation of agency decisionmaking
AIMS V. GARLAND 23
regarding that issue.” Id. (citation omitted). The orders also
had legal consequences, satisfying Bennett’s second
requirement, because “there is no dispute that based on the
Park Service’s position, persons who engaged in commercial
fishing in the GGNRA could be punished through fines and
imprisonment,” and such “exposure to the risk of significant
criminal and civil penalties.” Id. at 580 (citing Hawkes,
578 U.S. at 600); see also Hemp Indus. Ass’n, 333 F.3d
at 1085 (holding that an interpretive rule issued by the
Attorney General pursuant to the CSA is a “final
determination” for jurisdictional purposes because the rule
“impos[es] obligations and sanctions in the event of violation
[of its provisions]”).
In short, in considering whether an agency’s
informational document is a final agency action, we take a
“pragmatic approach.” Hawkes, 578 U.S. at 599 (citation
omitted). If the informational document is more analogous to
the “the type of workaday advice letter that agencies prepare
countless times per year in dealing with the regulated
community,” Indep. Equip. Dealers Ass’n, 372 F.3d at 427,
and is little more than a restatement of statute and regulations
in a response to a “request for assistance,” City of San Diego,
242 F.3d at 1100, it is not the consummation of a
decisionmaking process or an order from which “legal
consequences will flow,” Bennett, 520 U.S. at 178. By
contrast, if the informational document “is issued after
extensive factfinding,” see Hawkes, 578 U.S. at 597, or after
a public hearing, see Frozen Foods, 351 U.S. at 41, or after “a
series of formal written notices,” San Francisco Herring
Ass’n, 946 F.3d at 567, and thus indicates the agency’s
determination that a regulated party disobeys the order at its
peril of incurring criminal penalties or sanctions, id., it
satisfies the Bennett conditions and is a final agency action.
24 AIMS V. GARLAND
III
Considering Prevoznik’s letter in light of this standard,
we conclude it is an informational letter of the sort that does
not constitute final agency action under Bennett.
First, the letter is “the type of workaday advice letter that
agencies prepare countless times per year in dealing with the
regulated community,” Indep. Equip. Dealers Ass’n, 372 F.3d
at 427. The letter was a response to a request for assistance
and advice as to whether a physician who was relieved of
certain FCPA registration requirements for the use of
psilocybin under the RTT Act could also be relieved from the
requirements of the CSA. There is no indication that the
response to Tucker’s request for advice was preceded by
agency factfinding or a public hearing, or that the DEA
otherwise engaged in a decisionmaking process resulting in
the response letter.
Despite the lack of indicia that the letter represented the
consummation of a decisionmaking process, AIMS argues
that we should deem it to establish the DEA’s settled views
that the DEA lacked authority to accommodate therapeutic
use of Schedule I substances under state and federal RTT
Acts. To support this claim, AIMS argues it is critical that
the letter was signed by the Deputy Assistant Administrator
of Diversion Control, who has authority over the
promulgation and implementation of many DEA regulations,
see 28 C.F.R. Pt. 0, Subpt. R., App. § 7; 21 C.F.R.
§§ 1301.18, 1301.32. We disagree. Whatever his authority
as Deputy Assistant Administrator to promulgate regulations
or grant waivers, there is no indication that Prevoznik
exercised that authority in signing the letter. Tucker asked
only for advice and guidance; she did not request or propose
AIMS V. GARLAND 25
that the DEA promulgate regulations to harmonize the CSA
with the DEA or apply for relief from CSA provisions.
Therefore, in informing Tucker that the RTT Act itself gave
the DEA no authority to waive CSA’s requirements,
Prevoznik did not grant or deny any request or make any final
decision. In sending the response letter, the DEA’s
decisionmaking process had not yet begun. Cf. Indep. Equip.
Dealers Ass’n, 372 F.3d at 428. Accordingly, Prevoznik’s
letter does not meet Bennett’s first condition.
Second, the letter does not lead to legal consequences for
Dr. Aggarwal. Rather, the letter provided straightforward
guidance about the interaction of the RTT Act and the CSA.
It stated that “absent an explicit statutory exemption to the
Controlled Substances Act (CSA) DEA has no authority to
waive any of the CSA’s requirements pursuant to the RTT”
and then set out the entire text of RTT’s exemption provision,
21 U.S.C. § 360bbb-0a(b), which did not give the DEA
authority to waive CSA requirements. Second, the letter
stated that the CSA provides an exemption from criminal
liability only for researchers who register to conduct research
with Schedule 1 controlled substances. This is likewise a
straightforward statement of Prevoznik’s “view of what the
law requires,” Fairbanks, 543 F.3d at 594. These statements
do not impose legal consequences on Dr. Aggarwal. Should
Dr. Aggarwal obtain psilocybin for his patient, he “would
face liability only for noncompliance” with the CSA, and “not
for disagreement with the agency’s determination,” id.12
12
Thus, AIMS’s reliance on the D.C. Circuit’s decision in John Doe,
484 F.3d at 566, to support its claim that we have jurisdiction under § 877
is misplaced. Prevoznik’s letter did not grant or deny any request, nor
impose any legal consequence on Dr. Aggarwal. In John Doe, by
26 AIMS V. GARLAND
AIMS argues that Prevoznik’s letter had legal
consequences for Dr. Aggarwal and AIMS because it
foreclosed their only avenue to access psilocybin under RTT
Act laws. Further, AIMS argues that Prevoznik’s letter put
them on notice that if they attempt to obtain psilocybin under
the RTT Act they are at risk of civil and criminal liability
under the CSA. But this risk was not created by Prevoznik’s
letter, which did no more than point to the plain language of
existing law. In short, AIMS’s issue is not with the DEA’s
letter, but with the CSA’s criminalization of psilocybin use,
subject to narrow exemptions. An advice letter recognizing
that Congress has not yet made an exception to the CSA to
allow for the legal use of psilocybin for therapeutic purposes
is not a final agency decision.13 Accordingly, the letter does
not meet Bennett’s second condition.14
DISMISSED.
contrast, the DEA “affirmatively denied Doe’s permit application,” and
thus established “legal consequences by prohibiting importation.” Id.
13
Supporters of decriminalization of psilocybin for therapeutic use
have recognized that a legislative approach is necessary. In November
2020, Oregon passed Ballot Measure 109, which legalized psilocybin for
therapeutic use, and several cities have made enforcement of psilocybin
use low priority. Mason M. Marks, Controlled Substance Regulation for
the Covid-19 Mental Health Crisis, 72 Admin. L. Rev. 649, 654, 708–10
(2020).
14
Because we determine that the Prevoznik letter was not final agency
action, we need not address the question whether the letter was a decision
“of the Attorney General,” as required by § 877.