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MT Oct. 10, 2017 The Goldwater Institute wants the FDA to release more documents so it can see if the federal agency follows its own rules about experimental drugs. The federal agency that oversees drug safety made a quick decision in 2014 to allow two health-care workers to take a yet-to-be-tested drug after they contracted the Ebola virus while volunteering in Liberia. The two health workers, Dr. Kent Brantly and Nancy Writebol, became the first humans to ever get the experimental drug, called ZMapp, and both recovered from their illness. But it has remained largely a mystery how the U.S. Food and Drug Administration decided those missionaries in Liberia should be allowed access to the drug. In 2015, the Phoenix-based Goldwater Institute sued the FDA to obtain records that could shed light on whether the federal agency followed its own rules when allowing emergency access to the drug. The U.S. District Court in Arizona ordered the FDA to produce some records as well as an index that identifies documents that have been withheld and the reason the federal agency did not produce those records. However, Goldwater contends the FDA has not produced records that respond to its request under the Freedom of Information Act and in court filings. Among the records Goldwater seeks is information about the FDA's drug importation rules, including details that suggest a third patient received an emergency dose of ZMapp. On Tuesday, Goldwater attorneys asked U.S. District Judge Susan Bolton to order the release of more records. "The drug approval process in the United States shouldn't be a government secret," said Jonathan Riches, a Goldwater Institute attorney. "The public has a right to know how drugs are made available to the patient." FDA attorneys argued that the agency considers information about yet-to-be-approved drugs to be confidential and proprietary to the companies seeking FDA approval to market their drugs. The FDA corresponds with every drugmaker on various topics — for example, a drug's purity, toxicity and pharmacology — as part of its deliberative process, said agency attorney Leslie Cohen. "That is why the deliberations are inextricably intertwined with confidential, commercial information," Cohen said.
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