United States District Court, District of Columbia
E. BOASBERG UNITED STATES DISTRICT JUDGE
a new pharmaceutical drug can come to market, testing must
prove it to be both safe and effective. Plaintiff Center for
Responsible Science believes that the Food and Drug
Administration's informed-consent regulation governing
these initial human tests does not sufficiently warn
participants of the dangers they face. CRS thus proposed that
the FDA amend its regulation to add three additional
disclosures, but the Agency demurred. Plaintiff then turned
to the courts. It filed a one-count Complaint under the
Administrative Procedure Act against Scott Gottlieb, the
FDA's current commissioner, asking the Court to require
what CRS could not convince the Agency to adopt. The
threshold question - and the one that ultimately trips
Plaintiff up - is whether it can invoke this Court's
jurisdiction. Once before, this Court found that CRS had
failed to sufficiently demonstrate Article III standing, but
sent it back to the drawing board instead of dismissing the
case. CRS now returns with added detail. Its Amended
Complaint, however, still falls short of establishing the
organizational injury necessary for this suit to continue. As
round two thus yields the same result, the Court will grant
Defendant's Motion to Dismiss.
brief rehearsal of the facts is necessary to tee up the sole
jurisdictional issue at play. For a deeper dive into the
governing regulatory scheme and requested disclosures that
color this case, the Court directs interested readers to its
first Opinion on this issue. See Ctr. for Responsible
Sci. v. Gottlieb, 311 F.Supp.3d 5, 6-8 (D.D.C. 2018).
regulations require that certain information “shall be
provided to each subject” of a clinical trial within
the Agency's jurisdiction. See 21 C.F.R. §
50.25. Simply put, CRS believes that these disclosures are
not enough. It contends that participants should be warned
that testing drugs on laboratory animals - which generally
precedes clinical trials involving humans - can be a poor
predictor of safety and efficacy in human subjects.
See ECF No. 17 (Pl. Opp.) at 3-6.
took action. Armed with its criticism, Plaintiff submitted a
Citizen Petition to the FDA in May of 2014 requesting that
the Agency amend its disclosure requirements for human
subjects in clinical trials to provide three additional
warnings. See ECF No. 14 (Am. Compl.), ¶ 37.
Paraphrased, these warnings would disclose that prior animal
tests may not be predictive of safety in humans and that, in
the past, participants died during clinical trials as a
result of ingesting the tested drugs. Id, ¶ 40.
The warning would also caution participants that the drug may
not be effective in treating their condition even if that
efficacy was shown in animal-based tests. Id
denied the Petition. It reasoned that the requested
modification was overbroad, since the disclosures were
relevant only to drug trials, but the regulations cover all
clinical trials. The FDA also decided that these additions
would preclude needed flexibility in informed-consent
disclosures. Id, ¶¶ 152, 154.
with this response, CRS filed suit under the Administrative
Procedure Act. It alleged that the Agency's rej ection of
its Petition was arbitrary and capricious as well as beyond
the FDA's statutory authority. In the first round of this
litigation, the Court dismissed Plaintiffs Complaint without
reaching the merits of its contention, finding that CRS had
not cleared the first hurdle of any suit in federal court:
demonstrating Article III standing. Open to the possibility
that Plaintiffs deficiency could lie in the inartfulness of
its pleading rather than a lack of interest in the case, the
Court granted CRS a second bite at the apple and permitted
leave to amend. See Ctr. for Responsible Sci., 311 F.Supp.3d
returns with a beefed-up Complaint. It provides the Court
with additional detail concerning both its mission and the
actions it has taken relevant to the challenged conduct.
Established in 2012, Plaintiff is a “non-profit
watchdog group” whose mission serves to “promote
advances in regulatory science.” Am. Compl., ¶ 1.
Although its interests are broad ranging, CRS realizes this
mission in part by promoting “safer, more effective
outcomes during human trials.” Id, ¶ 191.
To perform this function, it monitors clinical trials for
deaths and other serious adverse events and provides
education to various stakeholders interested in human test
methods. Id, ¶¶ 4, 192. CRS's staff
consists of one full-time, salaried employee and one
part-time volunteer. Id, ¶ 202.
also provides more detail on the actions that it alleges its
employee took in response to the FDA's denial of the
Citizen Petition. These actions fall, roughly, into three
buckets. First, this employee - Tamara Drake - has been
compiling data of adverse events in clinical trials.
Id, ¶ 198. Plaintiff does not hide, however,
that Drake has long performed this task, dating back to
before the denial of the Citizen Petition. See Pl.
Opp. at 25-26.
Drake began compiling a list of all clinical trials that were
either in the process of recruiting human participants or
planned to begin recruiting shortly. See Am. Compl.,
¶ 198. Unlike the aggregation of adverse events, she did
not begin this task until after the FDA's denial of
CRS's Citizen Petition. Id.; Pl. Opp. at 26.
Starting in May 2018, approximately one year after the denial
of the Citizen Petition, but only two weeks after this Court
first dismissed CRS's Complaint for lack of standing,
Drake also began contacting the principal investigators of
these trials. See Am. Compl., ¶ 198; Pl. Opp.
at 27. She urged each investigator to voluntarily adopt the
disclosures that the FDA had decided not to require.
See Am. Compl., ¶ 198. Only a small percentage
of investigators have responded to CRS's outreach
efforts. See Pl. Opp. at 27.
and finally, CRS points to public education. Through press
releases and other mechanisms (which it has not specified),
CRS has notified the public and other stakeholders of the
FDA's denial of the Citizen Petition and the
“limitations of animal testing.” Am. Compl.,
again, Defendant has filed a Motion to Dismiss under Rule
12(b)(1) because, the Agency says, CRS's Amended
Complaint still does not establish that it has Article III
standing. So once more into the breach of organizational
standing ventures the Court. This time, like King Henry
V's final assault on Harfleur, proves the last. Despite
its renewed efforts, CRS's ...