Virtus Sues FDA Over Market Restrictions on Potassium Chloride

Virtus Pharmaceuticals has filed a suit against the FDA to prevent the agency from removing potassium chloride from the marketplace.

Virtus says removing potassium chloride from the market will result in a monopoly for certain pharmaceutical companies with grandfathered drugs, and thus will significantly reduce competition, increasing prices for drugs that were readily available. Virtus specializes in women’s health, pain management and cardiovascular and gastrointestinal diseases.

The suit requests that FDA follow the requirements of the Administrative Procedure Act as well as the Federal Food, Drug and Cosmetic Act before removing the chemical. Based on those statutes, a product containing the chemical would not be barred from the market unless it failed to meet certain standards.