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Exposing the FDA’s Drug Approval Process

Goldwater v. HHS

Case Status

Date Filed

August 3, 2017

Last Step

Victory in Ninth Circuit and records released after remand to district court.

Next Step

Case Overview

The Goldwater Institute is taking the U.S. Food and Drug Administration (“FDA”) to court to bring transparency to the drug approval process.

The FDA previously denied a Freedom of Information Act (“FOIA”) request by the Goldwater Institute seeking information about the FDA’s drug approval process that allowed two American doctors infected with Ebola to be successfully treated with a drug that is still in development.

Although the Goldwater Institute sought only information about the government’s internal operations in order to increase public awareness about the drug approval process in the United States, the FDA claimed that releasing the records would invade trade secrets of drug manufacturers. The FDA’s arbitrary withholding of public information violates federal law and undermines the public’s right to know the decisions a government agency is making on life and death matters.

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