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Regulatory Focus™ > News Articles > 2019 > 8 > FDA Wins Court Case to Not Put Vasopressin on Compounding List

FDA Wins Court Case to Not Put Vasopressin on Compounding List

Posted 20 August 2019 | By Zachary Brennan 

FDA Wins Court Case to Not Put Vasopressin on Compounding List

The US Food and Drug Administration (FDA) has won a case in the US District Court for the District of Columbia that hinged on whether an outsourcing facility could continue to compound a bulk substance without a clinical need for that compounded drug.

At issue is a drug made by Endo International, known as Vasostrict (vasopressin), which can cost almost $2,000 for 10 milliliters and brought in more than $450 million in 2018 revenues, but which can also be compounded for a fraction of that cost by Athenex Inc. and other outsourcing facilities.

So when FDA rejected the pleas of Athenex to continue to allow the compounded version of vasopressin, and declined to find a “clinical need” for bulk-compounded vasopressin, Athenex filed suit.

Now, in an opinion filed 1 August, the District Court re-affirmed FDA’s exclusion of vasopressin from the “clinical need” list.

The opinion says: “Plaintiffs contend that their vasopressin drug product meets a ‘clinical need’ even under FDA’s interpretation for two reasons. First, Plaintiffs argue that Vasostrict is medically unsuitable for certain patients because it contains the allergen chlorobutanol, thereby giving rise to a ‘clinical need.’

“But in denying listing, FDA identified a chlorobutanol-free version of Vasostrict,” the opinion says, explaining how Athenex does “not appear to dispute this agency finding, as they do not contest it in their reply brief.”

And although Athenex also claimed that its compounded product is available in a ready-to-use, intravenous form, which offers safety benefits for patients relative to Endo’s Vasostrict, FDA rejected this “ready-to-use” claim and the court noted how the “ready-to-use” claim, though advantageous, “does not mean that Vasostrict—because it is not ready-to-use—is medically unsuitable.”

FDA leaders said they were “pleased with the court’s decision, which is a victory for public health in the first such case since the Drug Quality and Security Act (DQSA) was enacted.” there are still compounders that are not in compliance.

Paul Campanelli, Endo president and CEO, also praised the court’s decision in a recent earnings call, noting price increases and “business mix” helped Vasostrict to pull in $116 million in the second quarter, almost 10% more in this most recent quarter compared to the same period last year.

Meanwhile, Jeffrey Yordon, chief operating officer of  Athenex , said, “While we are disappointed by the court’s decision, it does not come unexpected. We believe our vasopressin product helps to meet an important clinical need, so while we will comply with the court’s and FDA’s decision, we may explore additional actions, including an appeal.”



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