Virtus Pharmaceuticals vs. FDA: Lawsuit Seeks to Prevent a Monopoly for Potassium Chloride Products

TAMPA, Fla.--(BUSINESS WIRE)--Virtus Pharmaceuticals, LLC (Virtus), a specialty pharmaceutical company with a broad portfolio of products covering women’s health, cardiovascular, pain management, and gastrointestinal diseases, today announced a lawsuit against the Food and Drug Administration (FDA) and Department of Health and Human Services (HHS). The lawsuit was filed in the U.S. District Court in the Middle District of Florida.

“Guidance for FDA Staff and Industry— Marketed Unapproved Drugs—Compliance Policy Guide, Sect. 440.100 Marketed New Drugs Without Approved NDAs or ANDAs”

The lawsuit seeks to prevent FDA from removing existing potassium chloride (KCI) products from the marketplace which would result in the creation of a monopolies for certain pharmaceutical companies on grandfathered drugs. These monopolies will only serve to harm consumers by significantly reducing competition and increased prices for drugs that were historically readily available from multiple sources.

“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,” said Tina Guilder, CEO of Virtus Pharmaceuticals, LLC. “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.”

Virtus’ lawsuit requests that FDA follow the requirements of the Administrative Procedure Act (APA) and the Federal Food, Drug, and Cosmetic Act (FDCA) before removing existing KCl products from the marketplace.

For example, FDA’s regulations state that FDA will not take action against a KCl drug product unless that product fails to meet certain requirements under the Code of Federal Regulations Title 21 (21 CFR § 201.306). Under this regulation, the FDA may not initiate regulatory proceedings against any KCl product that supplies 20 milligrams or more of potassium per milliliter, labeled or intended for human use if specific conditions are met.

FDA has also previously explained that 21 CFR § 201.306 was intended to bind the agency when it regulates KCl products, and has informed other governmental agencies in the past that products like Virtus’s KCl do not require formal FDA approval in order to be legally marketed.

Finally, HHS in conjunction with FDA, has previously engaged in notice-and-comment rulemaking and concluded that KCl solution drug products are lawfully sold grandfathered drug products that have been sold legally on the market since before 1938.

“Virtus believes that it is clear that HHS, in conjunction with FDA, has already determined through regulations carrying the force of law, and has maintained for decades, that these drug products are lawfully sold pre-1938 drug products,” added Don Mizerk, Partner at Husch Blackwell LLP.

Specifically, Virtus brought the lawsuit to:

(1) Obtain a declaratory judgment that FDA may not take enforcement action against Virtus’ KCl product without a formal and specific determination that the product is either unsafe or ineffective;

(2) Require that FDA engage in appropriate procedures under the Administrative Procedures Act prior to taking any such action against Virtus’ KCl; and

(3) Set aside FDA’s unlawful rule, “Guidance for FDA Staff and Industry— Marketed Unapproved Drugs—Compliance Policy Guide, Sect. 440.100 Marketed New Drugs Without Approved NDAs or ANDAs” (September 19, 2011) (“the 2011 Guidance”), at least as it applies to KCl products.

KCl is a drug that is used to treat patients suffering from potassium deficiency. Potassium is a vital mineral for the human body and participates in a number of essential physiological processes including the maintenance of intracellular tonicity; the transmission of nerve impulses; the contraction of cardiac, skeletal, and smooth muscle; and the maintenance of normal renal function.

Additionally, some patients require external supplemental potassium in order to prevent hypokalemia (the medical name for a potassium deficiency). Hypokalemia can be life-threatening and increases the risk of death in patients with cardiovascular disease.

KCl has been a safe and effective treatment for certain conditions for over 100 years.

About Virtus Pharmaceuticals, LLC

Virtus Pharmaceuticals’ mission is to be the leading specialty niche pharmaceutical company providing the highest quality products through experienced leadership, innovative approaches and outstanding customer service. For more information, please visit the Company’s Web site at www.virtusrx.com