Litigation Against FDA Over Vasopressin is Resolved

Endo has agreed to voluntary dismiss its lawsuit against the FDA, the company announced Monday, in light of a favorable outcome for the company through a second lawsuit. The first lawsuit had argued that vasopressin should be excluded from the agency’s compounding list.¹

The first lawsuit was initiated by Endo in October 2017, when the company challenged the FDA’s interim policy authorizing the bulk compounding of drugs. That policy included “enforcement discretion” of vasopressin, the active ingredient in Vasostrict, which is manufactured by Par Sterile Products, a subsidiary of Endo.¹

Vasopressin is a form of an antidiuretic hormone that affects osmotic balance, blood pressure regulation, and proper kidney function.² The drug can cost nearly $2,000 for 10 mL and created more than $450 million in revenue in 2018.³

Endo's lawsuit argued that the policy violated Section 503(B) of the Drug Quality and Security Act (DQSA) and other provisions of the Federal Food, Drug, and Cosmetic Act, which only allows bulk compounding if the FDA determines that there is a genuine “clinical need” for compounding from that specific substance.¹

In response to this lawsuit, the FDA took steps to implement the requirements of the DQSA and Endo stayed its litigation to allow the agency time to complete the implementation process. The FDA also issued an administrative decision that bulk compounders of vasopressin competing with Vasostrict could not satisfy the “clinical need” requirement.¹

In response to that decision, Athenex Inc. filed its own lawsuit, the second against the FDA, arguing that they should be permitted to compound vasopressin in bulk. Endo successfully defended the FDA’s decision alongside the administration and the Department of Justice.¹

The US District Court for the District of Columbia concluded on August 1, 2019, that the exclusion of vasopressin from the clinical need list was not arbitrary, and also denied Athenex’s subsequent motion for a stay of its ruling pending appeal.¹

Following this decision, Endo announced its voluntary dismissal of its initial lawsuit against the FDA.¹

REFERENCES

• Endo Announces Successful Culmination of Litigation Regarding FDA Compounding Policy [news release]. Dublin, Ireland; September 30, 2019: Endo International website. https://investor.endo.com/news-releases/news-release-details/endo-announces-successful-culmination-litigation-regarding-fda. Accessed 2 Oct. 2019.
• Cuzzo B, Lappin SL. Vasopressin (Antidiuretic Hormone, ADH) In: StatPearls [Internet]. Treasure Island, FL: StatPearls website. https://www.ncbi.nlm.nih.gov/books/NBK526069/. Updated February 2, 2019. Accessed October 2, 2019.
• Regulatory Affairs Professionals Society. FDA Wins Court Case to Not Put Vasopressin on Compounding List. RAPS webiste. https://www.raps.org/news-and-articles/news-articles/2019/8/fda-wins-court-case-to-not-put-vasopressin-on-comp. Published August 20, 2019. Accessed 2 Oct. 2019.