Court Opinion

ID: 4377177
Source: CourtListenerOpinion
Date Created: 2019-03-14 22:00:35.9492+00
Date Added: 2024-06-11T14:49:27.745565
License: Public Domain

UNITED STATES DISTRICT COURT
                            FOR THE DISTRICT OF COLUMBIA

 VANDA PHARMACEUTICALS, INC.

         Plaintiff,

         v.                                                 Civil Action No. 19-301 (JDB)

 FOOD AND DRUG ADMINISTRATION,
 et al.

         Defendants.

                            MEMORANDUM OPINION & ORDER

       Vanda Pharmaceuticals, Inc., (“Vanda”) wants to conduct a 52-week clinical trial of the

drug tradipitant as a treatment for gastroparesis, a serious, chronic digestive disorder. The Food

and Drug Administration (“FDA”) imposed a partial clinical hold that prevents Vanda from

continuing the clinical trial beyond 90 days until Vanda conducts additional chronic toxicity

studies in animals. Vanda filed suit against FDA under the Administrative Procedure Act, alleging

that FDA’s clinical hold was arbitrary and capricious and contrary to law because FDA failed to

address substantial scientific evidence Vanda submitted and because FDA relied on a non-binding

guidance document as if it imposed regulatory requirements. Compl. [ECF No. 1] ¶¶ 1–26.

       A week after the summons issued, FDA moved for a voluntary remand of its decision and

a stay of the case for 75 days to reevaluate its position in light of the procedural issues that Vanda

raised in its complaint. Mem. in Supp. of Defs.’ Mot. for a Voluntary Remand to the Agency &

for a Stay of the Case (“FDA Remand Mot.”) [ECF No. 6-1] at 1. FDA also requested that the

case be remanded without vacatur of the clinical hold to protect patient safety during the period of

reconsideration. Id. at 7. Vanda does not oppose FDA’s request for a voluntary remand or stay,
but Vanda insists that vacatur of the clinical hold is appropriate because the “FDA’s motion

effectively admits that the partial clinical hold . . . has no legal basis.” Pl.’s Partial Opp’n to Defs.’

Mot. (“Vanda Opp’n”) [ECF No. 7] at 1. Vanda also argues that the agency should be given 30

days, not 75 days, to reconsider its position. Id. at 2. *

         Upon consideration of the parties’ filings addressing FDA’s motion for voluntary remand,

as well as relevant case authority and the entire record, the Court grants FDA’s motion for

voluntary remand without vacatur and stays the case up to and including April 28, 2019.

         I.       Voluntary Remand Is Appropriate

         Out of respect for administrative agencies’ “inherent power to reconsider their own

decisions,” courts in this Circuit “commonly grant motions to remand an administrative record to

allow an agency to consider new evidence” or otherwise “cure their own mistakes rather than

wasting the courts’ and the parties’ resources reviewing a record that both sides acknowledge to

be incorrect or incomplete.” Sierra Club v. Van Antwerp, 560 F. Supp. 2d 21, 23 (D.D.C. 2008)

(quoting Prieto v. United States, 655 F. Supp. 1187, 1191 (D.D.C. 1987); Ethyl Corp. v. Browner,

989 F.2d 522, 524 (D.C. Cir. 1993)). Voluntary remand is appropriate so long as “an agency’s

concern is substantial and legitimate” rather than “frivolous or in bad faith.” Id. at 23–24

(comparing Citizens Against Pellissippi Parkway Extension, Inc. v. Mineta, 375 F.3d 412, 417

(6th Cir. 2004), and Lutheran Church–Mo. Synod v. FCC, 141 F.3d 344, 349 (D.C. Cir. 1998)).

         The Court agrees with both parties that a voluntary remand to the agency is appropriate.

FDA has identified “substantial and legitimate concerns” related to the completeness and accuracy

         *
           Additionally, Vanda moves for leave to file a surreply and, in the alternative, requests oral argument. Pl.’s
Mot. for Leave to File Surreply & for Oral Arg. (“Mot. for Leave to File”) [ECF No. 9] at 1. FDA objects. Defs.’
Opp’n to Mot. for Leave to File (“Opp’n to Mot. for Leave to File”) [ECF No. 10] at 1. Because Vanda’s proposed
surreply neither addresses issues newly raised in FDA’s reply nor would assist the Court in its determination of FDA’s
motion, leave to file a surreply is denied. See Banner Health v. Sebelius, 905 F. Supp. 2d 174, 187 (D.D.C. 2012).
The Court also declines Vanda’s request for oral argument. See Fed. R. Civ. P. 27(e).

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of the agency’s explanation for the clinical hold, and there is no reason to believe that FDA’s

request for a voluntary remand is frivolous or in bad faith. A voluntary remand will allow FDA to

cure its mistakes and will avoid wasting the Court’s and the parties’ resources reviewing a record

that FDA acknowledges to be incomplete. Hence, FDA’s request for voluntary remand is granted.

       II.     Vacatur Is Not Appropriate

       The Court declines to vacate the partial clinical hold. As a threshold matter, the Court has

reason to question whether it has authority to vacate an agency action before issue has been joined,

without an administrative record, and in the absence of a request for emergency relief such as a

temporary restraining order. See Carpenters Indus. Council v. Salazar, 734 F. Supp. 2d 126, 135–

36 (D.D.C. 2010) (concluding that the Court lacked authority to vacate an agency decision without

conducting an independent determination on the merits). FDA’s filings do not concede that the

clinical hold order is invalid, only that the agency intends to reevaluate its decision. FDA Remand

Mot. at 5–7. Thus, no grounds for vacating the clinical hold are currently before the Court.

       Even if the Court could vacate the partial clinical hold, it would not do so. Under the

factors set out in Allied-Signal, courts assessing remand with or without vacatur are to consider

“the seriousness of the order’s deficiencies (and thus the extent of doubt whether the agency chose

correctly) and the disruptive consequences of an interim change that may itself be changed.”

Allied-Signal, Inc. v. U.S. Nuclear Regulatory Comm’n, 988 F.2d 146, 150–51 (D.C. Cir. 1993);

see also Heartland Regional Med. Ctr. v. Sebellius, 566 F.3d 193 (D.C. Cir. 2009) (analyzing

Allied-Signal factors). The first prong of this analysis “deals with the likelihood that a rule’s

deficiencies can be redressed on remand, ‘even if the agency reaches the same result.’” Am. Forest

Res. Council v. Ashe, 946 F. Supp. 2d 1, 44 (D.D.C. 2013); see also U.S. Sugar Corp. v. EPA, 830
F.3d 579, 630 (2016) (describing factor as simply likelihood of “cure on remand”). Here, the

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procedural defects that Vanda alleges in its complaint are likely to be corrected on remand, even

if FDA keeps the clinical hold in place. And as noted above, the clinical hold has not been

pronounced deficient, so its deficiency does not weigh in favor of vacatur.

       The second Allied-Signal factor considers the practical impact of vacatur, including

whether remand with vacatur “may have unpredictable and irreversible consequences” and

whether remand without vacatur will “unduly prejudice[]” any party. Id. at 46. Here, Vanda is

not prejudiced because it will receive part of the relief that it seeks—reevaluation of the partial

clinical hold—in a much shorter time than it would following review of the order on the merits.

See Compl. at 55 (asking in part that FDA reevaluate Vanda’s proposed 52-week trial under the

proper regulatory factors). The fact that risks to patient safety from a clinical trial could be

“unpredictable and irreversible” further supports remand without vacatur. See Am. Forest Res.

Council, 946 F. Supp. 2d at 44. Both Allied-Signal factors, then, support remand without vacatur,

and hence, assuming that the Court has authority to vacate the rule at this juncture, it nevertheless

would conclude under Allied-Signal that vacatur is inappropriate.

       As to timing, FDA stated in its initial filing on February 14, 2019, that it seeks remand for

75 days and added in its reply that FDA has “already has begun the process of reevaluating the

scientific submissions and addressing the issues acknowledged in the remand motion.” Reply in

Supp. of FDA Remand Mot. at 10. Vanda argues that a stay should last no more than 30 days,

which is the amount of time that FDA would normally have to consider “an entirely new IND

application.” Vanda Opp’n at 24. A compromise is appropriate here. The Court will stay the case

for 45 days from the date of this order—up to and including April 28, 2019—which happens to

equal approximately 75 days from the date that FDA filed its motion for a voluntary remand.

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                                          CONCLUSION

         Upon consideration of [6] FDA’s motion for a voluntary remand without vacatur and stay

of the case, [9] Vanda’s motion for leave to file a surreply, the parties’ filings in support of and in

opposition to each motion, and the entire record herein, and for the reasons given above, it is

hereby

         ORDERED that [9] Vanda’s motion for leave to file a surreply is DENIED; it is further

         ORDERED that [6] FDA’s motion for a voluntary remand without vacatur is GRANTED;

it is further

         ORDERED that the FDA’s partial clinical hold order is REMANDED to the agency for

further consideration; it is further

         ORDERED that this case is STAYED pending FDA’s reevaluation of its partial clinical

hold order, up to and including April 28, 2019; and it is further

         ORDERED that the parties shall file, jointly if possible, a status report by not later than

April 29, 2019, which shall propose a schedule for further proceedings in this case.

         SO ORDERED.

                                                                             /s/
                                                                      JOHN D. BATES
                                                                United States District Judge
Dated: March 14, 2019

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