Public Citizen v. FDA (cesium chloride)

Cesium chloride is a bulk drug substance used to compound certain drugs promoted for treatment of cancer. In 2016, FDA reviewers determined that cesium chloride presents “serious safety concerns,” “is not safe for human use,” and had not been shown to be effective for “the prevention or treatment of any form of cancer.” In addition, an FDA advisory committee recommended that FDA keep cesium chloride off a list of bulk drugs substances that can be used in pharmacy compounding.

After the FDA failed to act, Public Citizen, in December 2017, submitted a citizen petition to the FDA requesting that it take action to prevent the continued use of cesium chloride to produce compounded drugs promoted for treatment of cancer. The FDA did not substantively respond to the petition, and in July 2018, Public Citizen filed suit to compel the FDA to respond. The complaint explained that FDA’s failure to address the petition was unreasonable in light of the nature and extent of the public health interests at stake.

Shortly after the case was filed, the FDA partially granted Public Citizen’s December 2017 petition and recategorized cesium chloride so that pharmacists and physicians cannot continue using it in compounding without FDA approval or compliance with FDA requirements. In light of the FDA’s action, Public Citizen dismissed the lawsuit.