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Goldwater Institute sues FDA over Ebola drug protocol

June 12, 2015

Originally written by Angela Gonzales for Phoenix Business Journal

The FDA denied the Phoenix-based think tank’s Freedom of Information Act request for information about the FDA’s internal approval process that allowed Americans infected withEbola to be successfully treated with a drug under development.

Jon Riches, an attorney with the Goldwater Institute, said the FDA told his group it could not give away trade secrets.

Last year, Arizona voters approved the “Right To Try” law, which gives terminally ill patients the right to try investigational medicines that have passed the first phase of FDA approval, but could be years away from commercialization. Similar laws have been adopted in 19 states and are waiting on governors’ signatures in three more states.

We didn’t ask for any proprietary commercial information,” he said. “All we asked for was the government process used to approve these drugs. The FDA drug approval process should be open to the scrutiny of the public.”

He would like to know why these Ebola patients were allowed access to experimental medication without following the FDA’s normal process so that other sick or dying Americans could have access to other drugs not quite approved by the FDA that could potentially save their lives.

It takes about 10 years and $1 billion to get a drug through the FDA process, Riches said.

“We think Arizonans and Americans have a right to know how their government is approving new drugs,” he said. “That shouldn’t be a government secret.”

 

 

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