Virtus sues FDA for clearing potassium chloride market of competition

Virtus Pharmaceuticals has filed a lawsuit against the US Food and Drug Administration (FDA) and Department of Health and Human Services (HHS), seeking to prevent a monopoly, and potential price hikes, in the marketplace for potassium chloride products.

In the lawsuit, which has been filed in the US District Court in the Middle District of Florida, the company wants to prevent the regulator from eliminating existing potassium chloride (KCI) products from the marketplace.

Virtus said that the move would create monopolies for several pharmaceutical firms on grandfathered drugs.

The monopolies, according to the company, will reduce competition and increase prices for drugs that were historically readily available from various sources.

The lawsuit requests that FDA follow the requirements of the Administrative Procedure Act and the Federal Food, Drug, and Cosmetic Act prior to removing existing KCl products from the marketplace.

KCl is a drug that is used to treat patients suffering from potassium deficiency. It has been a safe treatment for several conditions for more than 100 years.

Virtus Pharmaceuticals CEO Tina Guilder said: “We have tried every option to engage with the FDA to understand their legal and regulatory basis for clearing the potassium chloride market of competition, but unfortunately our questions remain unanswered.

“We believe that the FDA’s creation of an effective monopoly in the potassium chloride market could lead to severe consequences for patients who depend on this drug and to substantial price hikes, and we are taking legal action to restore a fair and competitive marketplace for potassium chloride products.”