About 6 weeks after Vanda filed its complaint, the company’s lawsuit has joined its clinical trial: on hold. Last week, the District Court of D.C. granted FDA’s motion for a voluntary remand of the case challenging FDA’s requirement to perform 9-month large animal studies prior to commencing studies in humans staying the case for 45 days from the Court’s Order while FDA reevaluates its position. While Vanda supported a voluntary remand, it strongly advocated that the Court stay the case while vacating the clinical hold on its 52-week human study.
FDA requested a voluntary remand to “address certain procedural issues Vanda noted in its Complaint, including the allegations about the agency’s response to scientific arguments submitted by Vanda and the treatment of a guidance document as a binding rule.” Notwithstanding all the usual pre-litigation negotiations about the issue that were discussed in Vanda’s Complaint, only now will FDA “provide a full written explanation of the agency’s analysis and ultimate position.” FDA does not, however, seem willing to reexamine its fidelity to guidance – stating that it intends to address on remand “the legal import of the guidance document and fully setting out the scientific basis for its actions here.” From this statement, it is unclear whether FDA is actually planning to re-review the scientific merits of Vanda’s arguments or merely provide more explanation upon remand. Importantly, FDA also requested that the Court remand without vacatur of the original agency decision if the court agrees to FDA’s remand request, meaning that the the Partial Clinical Hold should remain in place until FDA provides its new analysis.
Because Vanda agreed to the voluntary remand, the only issues remaining for the Court decide with respect to this motion are the questions of remand without vacatur and length of a stay. Vanda argued that the Clinical Hold has no valid legal basis because FDA was required to analyze these issues before issuing the Clinical Hold. Vanda hypothesized that FDA is “merely stalling in an attempt to make superficial changes to a legally deficient hold—in effect ‘putting lipstick on a pig’” and shouldn’t be given additional time to make procedural corrections while further delaying Vanda’s clinical trial program. Because “unsupported agency action normally warrants vacatur” and because remand without vacatur is fundamentally inconsistent with the APA, Vanda argued that only remand with vacatur is appropriate. Vanda also argued against the 75 day stay that FDA requested, arguing that a 30 day stay – the amount of time that FDA would normally have to consider an entirely new IND – is more appropriate.
The Court agreed to the voluntary remand to give FDA the opportunity to “cure its mistakes,” but declined to vacate the Clinical Hold. The Court actually questioned whether it has authority to vacate an agency action in the absence of a request for emergency relief. This is especially true because FDA’s filing did not concede that the Clinical Hold order is invalid. But the Court emphasized that even if it could, it would not vacate the Clinical Hold because it has not been determined deficient and the procedural defects are likely to be corrected on remand. Questions of patient safety risks further supported the Court’s decision. In an act of compromise, the Court decided to stay the case for 45 days (75 days from FDA’s motion) – until April 28, 2019 – rather than the 75 days (from the Court’s decision) FDA requested.
Given that Vanda has been fighting its battle with FDA on this issue since May 2018, it’s interesting that it took litigation to compel FDA to address Vanda’s procedural and scientific complaints with any sort of gravity. The government notes that Vanda did not “invoke the appeal procedures,” but Vanda explained in its Complaint that its attempt to do so through the Formal Dispute Resolution process was met with additional procedural roadblocks. FDA’s remand request is especially considering in that FDA essentially admits that it did not fully comply with the procedural requirements for imposing a Clinical Hold. Many small companies are before FDA every day and may encounter similar issues but don’t have the resources to fight FDA in court. The Agency fully admits that it did not comply with its own requirements, and it is now asking for the opportunity to do so only after Vanda filed a lawsuit. Even if FDA is just going to “put lipstick on a pig” here and redraft its Clinical Hold Letter to include a reasoned explanation, all interested parties should agree that it shouldn’t take litigation to pry such an explanation from FDA.