United States District Court, District of Columbia
E. BOASBERG, UNITED STATES DISTRICT JUDGE.
- three individuals and the Center for Responsible Science -
believe that everyone who participates in a clinical-drug
trial should be aware of differences in the data between
preclinical animal testing and clinical human-subject
experimentation. To that end, in May 2014, they submitted a
Citizen Petition to the Commissioner of the Food and Drug
Administration requesting that three specific warnings be
added to the standard informed-consent materials. When the
FDA denied the Petition, Plaintiffs brought this one-count
Administrative Procedure Act suit against the current
Commissioner, Scott Gottlieb. Defendant now moves to dismiss,
contending that none of the Plaintiffs has standing, thus
robbing the Court of subject-matter jurisdiction. For the
reasons discussed below, the Court agrees and will grant the
Motion, but permit Plaintiffs an opportunity to amend.
understand the long and arduous road a new drug takes to
finally come to market. After the drug is developed,
researchers often test its safety on laboratory animals in
preclinical trials. See Compl., ¶¶ 91-92.
If it can clear the preclinical stage, the drug sponsor
submits an investigational new-drug application to the FDA,
the agency responsible for regulating research on human
subjects. Id., ¶¶ 88, 93. If approved,
clinical research - i.e., testing conducted on
humans rather than animals - begins. As part of its duty to
protect human subjects, the FDA requires the drug sponsor to
obtain “legally effective informed consent” for
each participant. See 21 C.F.R. § 50.20. Under
current Agency regulations, informed-consent documents must
contain eight elements, one of which describes “any
reasonably foreseeable risks or discomforts to the
subject.” Id. § 50.25(a)(2).
on this last point that Plaintiffs believe the FDA is
abdicating its duty. Two of the Plaintiffs, Hal Garcia-Smith
and John Tessmer, have previously participated in clinical
trials and believe that informed consent should include
warnings about the differences between animal and human
testing. See Compl., ¶¶ 11, 15-16, 20, 24.
The third individual Plaintiff, Michael Vokhgelt, lost a son
as a result of his participation in a clinical trial.
Id., ¶¶ 25-28. Because Vokhgelt has other
children who he fears may need experimental cancer
treatments, he also would like the FDA to mandate that drug
sponsors alert people of the risks of using data from
preclinical animal testing before they decide to do a
clinical trial. Id., ¶ 36. CRS is a non-profit,
non-member organization that seeks to “promote advances
in regulatory science” by “advocat[ing] for
better results for patients” and “bringing policy
up to date with existing science.” Id.,
¶¶ 1-4. As part of its mission and activities, CRS
“monitors serious adverse events . . . in clinical
trials.” Id., ¶ 4.
30, 2014, the organization and two of the individual
Plaintiffs petitioned the FDA to amend its informed-consent
regulation to include information about preclinical animal
testing. Id., ¶¶ 65, 68. Specifically, the
Petition requested that the FDA add three informed-consent
elements to the eight extant ones:
(9) The drug you will be given has been tested in animals and
by other laboratory methods to determine whether it is likely
to be safe and effective in humans. The decision to allow
testing of this drug on humans relies heavily on the
presumption that animal tests predict human response. Due to
differences between animals and humans, animal tests may not
predict whether a drug is safe and/or effective for use in
(10) Some participants in clinical trials in which other
investigative drugs were tested have died or have been
seriously injured by the drug that was tested.
(11) The drug you will be given may later prove to be either
unsafe for humans or ineffective in treating the condition
for which it is being tested. You should not assume the drug
will treat a medical condition you may have, because a
determination of efficacy in an animal study does not
necessarily predict efficacy in humans.
Exh A at 7. On April 12, 2017, the FDA denied the Petition,
stating that the additional elements pertain to drug trials
only, while the informed-consent regulations apply to all
clinical trials. The Petition's warnings, therefore,
“raise[d] broader concerns that make them inappropriate
for inclusion in FDA's existing informed consent
regulations.” Compl., Exh. D at 3.
months later, Plaintiffs brought this suit for declaratory
and injunctive relief, alleging that the FDA's denial was
“arbitrary, capricious, an abuse of discretion, and
otherwise not in accordance with law, in violation of 5
U.S.C. § 706(2)(a).” Compl., ¶ 215.
Defendant, contending that all Plaintiffs lack standing, now
moves to dismiss for want of jurisdiction.
evaluating Defendant's Motion to Dismiss, the Court must
“treat the complaint's factual allegations as true
. . . and must grant plaintiff ‘the benefit of all
inferences that can be derived from the facts
alleged.'” Sparrow v. United Air Lines,
Inc., 216 F.3d 1111, 1113 (D.C. Cir. 2000) (quoting
Schuler v. United States, 617 F.2d 605, 608 (D.C.
Cir. 1979)) (internal citation omitted); see also Jerome
Stevens Pharms., Inc. v. FDA, 402 F.3d 1249, 1253 (D.C.
Cir. 2005). The Court need not accept as true, however,
“a legal conclusion couched as a factual allegation,
” nor an inference unsupported by the facts set forth
in the Complaint. Trudeau v. Fed. Trade Comm'n,
456 F.3d 178, 193 (D.C. Cir. 2006) (quoting Papasan v.
Allain, 478 U.S. 265, 286 (1986) (internal quotation
survive a motion to dismiss under Rule 12(b)(1), Plaintiffs
bear the burden of proving that the Court has subject-matter
jurisdiction to hear their claims. See Lujan v. Defenders
of Wildlife, 504 U.S. 555, 561 (1992); U.S. Ecology,
Inc. v. U.S. Dep't of Interior, 231 F.3d 20, 24
(D.C. Cir. 2000). A court has an “affirmative
obligation to ensure that it is acting within the scope of
its jurisdictional authority.” Grand Lodge of the
Fraternal Order of Police v. Ashcroft, 185 F.Supp.2d 9,
13 (D.D.C. 2001). For this reason, “‘the
[p]laintiff's factual allegations in the complaint . . .
will bear closer scrutiny in resolving a 12(b)(1) motion'
than in resolving a 12(b)(6) motion for failure to state a
claim.” Id. at 13-14 (quoting 5A Charles A.
Wright & Arthur R. Miller, Fed. Practice &
Procedure § 1350 (2d ed. 1987)) (alteration in
original). Additionally, unlike with a motion to dismiss
under Rule 12(b)(6), the Court ...