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Center for Responsible Science v. Gottlieb

United States District Court, District of Columbia

October 22, 2018




         Before 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.

         I. Background

         Only a 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).

         FDA 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.

         So CRS 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

         Defendant 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.

         Unhappy 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 at 10.

         CRS now 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.

         CRS 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.

         Second, 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.

         Third, 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., ¶ 204.

         Once 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 ...

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