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Tuesday, August 20, 2019

Organizations allege FDA failed to respond to petition concerning drug


By Bree Gonzales | Aug 2, 2018

WASHINGTON (Legal Newsline) – Two nonprofit, public-interest research, litigation and advocacy organizations allege a federal agency has unlawfully failed to respond to its petition concerning a bulk drug substance.

Public Citizen Inc. and Public Citizen's Health Research Group filed a complaint on July 23 in the U.S. District Court for the District of Columbia against the Food and Drug Administration seeking declaratory and injunctive relief.

According to the complaint, the plaintiffs allege that on Dec. 6, 2017, they petitioned the FDA to add cesium chloride to the 503A Category 2 list of bulk drug substances. They allege that the defendant has failed to response to their petition despite FDA reviewers determining more than two years ago that cesium chloride presents safety concerns.

The plaintiffs seek a declaration that the defendant's failure to respond to the petition is unlawful and seeks an order for the FDA to act on it.

The plaintiffs seek for the court to declare the FDA’s failure to act on the petition is unlawful, order the FDA to issue a decision within 30 days of the court’s order, award costs and attorneys' fees and grant all other appropriate relief. They are represented by Rebecca Smullin and Allison M. Zieve of Public Citizen Litigation Group in Washington, D.C.

U.S. District Court for the District of Columbia case number 1:18-cv-01712-TSC

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Organizations in this Story

Public Citizen Litigation Group U.S. District Court for the District of Columbia

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