United States District Court, District of Columbia
REV. RYAN “SASHA” GALLAGHER, Plaintiff,
FOOD AND DRUG ADMINISTRATION et al., Defendants.
TIMOTHY J. KELLY UNITED STATES DISTRICT JUDGE
Rev. Ryan “Sasha” Gallagher, proceeding pro
se, sues the Food and Drug Administration (FDA) and Dr.
Stephen D. Hardeman, a senior official at its Center for Drug
Evaluation and Research. Before the Court is Defendants'
motion to dismiss. Because Gallagher's complaint does not
include a short and plain statement showing why he is
entitled to relief, the Court will grant the motion and
dismiss the case without prejudice for failure to comply with
Federal Rule of Civil Procedure 8(a).
prepared by pro se litigants are held to less
stringent standards than those that apply to pleadings
prepared by lawyers. See Haines v. Kerner, 404 U.S.
519, 520 (1972). However, pro se litigants must
follow the Federal Rules of Civil Procedure. Jarrell v.
Tisch, 656 F.Supp. 237, 239 (D.D.C. 1987). Rule 8(a)
requires a complaint to include “a short and plain
statement of the claim showing that the pleader is entitled
to relief.” Fed.R.Civ.P. 8(a). “The purpose of
the rule is to give fair notice of the claim being asserted
so as to permit the adverse party the opportunity to file a
responsive answer, prepare an adequate defense and determine
whether the doctrine of res judicata is
applicable.” Brown v. Califano, 75 F.R.D. 497,
498 (D.D.C. 1977). “Where a complaint is insufficiently
focused, it places an undue burden on the defendant to answer
or move and it invites unnecessary delay and confusion in the
proceedings.” Achagzai v. Broad. Bd. of
Governors, 109 F.Supp.3d 67, 71 (D.D.C. 2015).
liberally construed, Gallagher's complaint and his
subsequent pleadings do not contain a short and plain
statement explaining why he is entitled to
relief. Gallagher's complaint focuses on the
(“4-OH-MiPT”). According to Gallagher, it is
central to his religious beliefs:
Within the Shaivite Temple, we do believe that Dr. Sasha
Shulgin performed Miracles in his life, we do believe
Shaivism, created in the Bronze age, is the Religion of the
Atomic Age. We believe 4-OH-MiPT to be the Lord God Soma. AN
UNSCHEDULED SUBSTANCE. 4-OH-MiPT is a Sacred Food, not a
1 (“Compl.”) at 2. Gallagher alleges that he
wrote to the FDA about “a Religious Exemption for
4-OH-MiPT use within the practices of the Shaivite
Temple.” Id. at 1. Hardeman responded.
Id. at 4. The FDA interpreted Gallagher's letter
as a request for an exemption from the requirement to submit
an Investigational New Drug Application (IND) to conduct a
clinical investigation of 4-OH-MiPT. Id.; see
also 21 C.F.R. § 312.2(b). Hardeman listed the
requirements for an exemption, but informed Gallagher that he
did not appear to qualify for one. Compl. at 4. Hardeman
informed Gallagher that, as a result, he would have to submit
an IND if he wished to conduct a clinical investigation of
4-OH-MiPT. Id. Gallagher further alleges that
Hardeman told him in a later email that the FDA “does
not consider Religiousity [sic] when evaluating the safety of
proposed clinical experimentation on Humans.”
Id. at 2.
complaint, Gallagher alleges that the FDA's “IND
program is in violation of the First Amendment, ” and
cites a case in which the D.C. Circuit held that the Drug
Enforcement Administration (DEA) was not required to provide
a religious-use exemption from federal laws proscribing
marijuana. Id. at 2 (citing Olsen v. Drug
Enf't Admin., 878 F.2d 1458 (D.C. Cir. 1989). He
also asserts that “they are refusing to create
processes similar to the DEA's” and cites a case in
which the Supreme Court held that the Department of Justice
had not shown, under the Religious Freedom Restoration Act
(RFRA), 42 U.S.C. § 2000bb-1 et seq., a
compelling interest in barring a religious sect's
sacramental use of a substance regulated under Schedule I of
the Controlled Substances Act (CSA), 21 U.S.C. § 812(c).
Id. at 3 (citing Gonzales v. O Centro Espirita
Beneficente Uniao do Vegetal, 546 U.S. 418 (2006)).
complaint also includes several unexplained references to
marijuana. For example, Gallagher references “Federal
Marijuana Patients, [sic] and GW Pharma THCv, ” and
says he told Hardeman that “[w]e consider THCv to be
the non-Marijuana form of Lord Shiva.” Id. at
1. And he alleges that “Synthetic THCv is not
Scheduled” and cites a case from outside this Circuit
holding that “the DEA's relevant rules and
regulations may be enforced only insofar as they ban the
presence of marijuana or synthetic THC.” Id.
at 7 (quoting Hemp Indus. Ass'n. v. Drug Enf't
Admin., 357 F.3d 1012, 1013 (9th Cir. 2004)). But he
never explains how marijuana or THC bear on the instant
allegations in the complaint do not constitute “a short
and plain statement of the claim” showing that
Gallagher “is entitled to relief.” Fed.R.Civ.P.
8(a). An IND is the start of the process through which
pharmaceutical drug sponsors seek FDA approval to test
proposed new pharmaceutical drugs for safety and efficacy,
before they are approved for sale and marketing. See
21 U.S.C. § 355(i); 21 C.F.R. § 312.1. But
Gallagher does not allege that he seeks to test,
sell, or market a pharmaceutical drug. See generally
Compl. Nor does he allege that his intended use of
4-OH-MiPT-whatever that may be-would cause that substance to
be subject to the Federal Food, Drug, and Cosmetic Act
(FDCA), 21 U.S.C. § 301, et seq. See 21 U.S.C.
§ 321(g)(1) (defining the term
“drug”). In sum, he does not explain how the
“IND program” or any part of the FDCA even
applies to him, let alone violates his First Amendment rights
or burdens the practice of his religion.
subsequent filings only further muddy the waters, as he
appears to shift the basis for his claim away from the
allegations in the complaint. In his Opposition, he
reiterates that “our Temple, the Shaivite Temple,
believes that 4-OH-MiPT, Miprocin, is a Soma, a Sacred Drink,
a Sacred Substance, used by and given to us by the
Gods.” ECF No. 15 at 1. He requests, with more
specificity than in the complaint, that he “be allowed
to Manufacture and Transport this NON-SCHEDULED
SUBSTANCE” and that he “be able to use it in
Ritual and Ceremony.” Id. And he suggests that
he is barred from doing so under the Controlled Substance
Analogue Enforcement Act (“Analogue Act”),
see 21 U.S.C. § 813, because “the FDA and
DEA are treating 4-OH-MiPT, Miprocin, when ingested by
Humans, as if it is a Schedule I substance.”
Id. But once again, Gallagher does not allege that
he seeks to test, sell, or market a pharmaceutical drug such
that he would need an IND, the focus of his complaint and the
letter he received from Defendants. Moreover, he does not
plead facts that suggest that the government is, in fact,
treating 4-OH-MiPT as a Schedule I substance. And even
assuming it is, this allegation hardly clarifies his
claim-because he also asserts that the FDA informed
him that the Analogue Act “has no bearing on the
applicability of” an IND exemption. See Compl.
at 2. As Defendants point out, “[t]he laws regulating
scheduled substances are separate and distinct from the new
drug provisions of the FDCA.” ECF No. 12 at 4.
in a subsequent “Motion to Deny Defendant, ”
Gallagher argues-for the first time-that “this is an
Administrative Procedure Act (APA) case, regarding the
FDA.” ECF No. 20 at 1. But he does not identify any
allegedly unlawful final agency action that caused him harm.
See 5 U.S.C. § 704.
explained above, nowhere in Gallagher's complaint or
subsequent pleadings does he provide a short and plain
statement of why he is entitled to relief. Therefore, he has
failed to comply with Rule 8(a). Accordingly, the Court will
grant Defendants' motion and dismiss the case without
prejudice. A separate order will issue.