Vanda-lay Litigation Industries, Inc.: Taking Stock of Vanda Pharmaceuticals, Inc.’s Big Bets on Petitioning and Litigation Against FDA and the Federal Government

By Kurt R. Karst —

If you monitor Regulations.gov dockets and litigation dockets on PACER like we do, then you know that one company name—more than any other over the past several years—pops up: Vanda Pharmaceuticals, Inc. But unlike the fictitious Vandelay Industries of Seinfeld that George Costanza claims to have been interviewed for as a latex salesman, Vanda Pharmaceuticals, Inc.—and the issues the company raises—are very, very real.

Not only that, but they are often novel issues! Consider, for example, a Complaint filed just recently in the U.S. District Court for the District of Columbia (“DDC”) against FDA alleging that the Agency’s structure of NDA review is unconstitutional (by our count the 31st Vanda litigation against FDA or another government entity in the last five years, including appeals).

Or consider Vanda’s challenge that FDA’s approval of a generic version of one of the company’s drugs violated the Appointments Clause of the Constitution (U.S. Const. art. II, § 2, cl. 2) because the FDA employees who approved the application were not “Officers of the United States.” In that case, the DDC recently said:

[T]he Court has lingering concerns about whether [Dr. Iilun C. Murphy, Director of the Office of Generic Drugs’] ratification cured any Appointments Clause deficiency because it is unclear whether any statute properly authorized her appointment. Given this uncertainty, as well as the maze of procedural barriers that may prevent the Court from even considering the matter, the Court will allow the FDA one more chance to put the matter to bed for good (should it so choose) before the Court renders a final decision on it.

Or consider Vanda’s lawsuit filed in the U.S. Court of Federal Claims alleging that FDA improperly disclosed Vanda’s trade secrets by offering certain recommendations to various generic competitors, and thus that FDA breached its duty of confidentiality. Specifically, Vanda alleges that FDA communications to certain generic competitors regarding dissolution rates, impurities, and micronization revealed Vanda’s confidential manufacturing information and caused economic injury to the company. To that end, Vanda asserts a Fifth Amendment takings claim based upon a government official’s alleged disclosure—intentional or inadvertent—of claimed trade secrets and confidential commercial information. In January 2024, the U.S. Court of Federal Claims allowed Vanda’s Fifth Amendment takings claim to move forward in litigation.

The ramifications of the Federal Claims case and some of the other lawsuits brought by Vanda could be significant to regulated industry and to the food and drug bar.

Given all of the Vanda lawsuits flying around, some of which are based on FDA Citizen Petition decisions or other FDA decisions, we thought it would be helpful to pull them all together in a couple of tables. To that end, below is a list of the cases Vanda has filed over the past five years or so against FDA or another government agency or entity, as well as a list of FDA Citizen Petitions and appeals.

Table 1. Litigation filed by Vanda Pharmaceuticals against FDA (and the Federal Government) Since 2019

Table 2. Citizen Petitions and Appeals Filed by Vanda Pharmaceuticals Against FDA Since 2019