Lawsuit asks FDA to disclose how dying people can access unapproved meds

The experimental drug ZMapp offers the ‘best option’ for people infected with the Ebola virus, say researchers who published their findings.

By Howard Fischer | Capitol Media Services via Arizona Daily Star

The Goldwater Institute goes to court today, trying to force the FDA to reveal details on how dying people can get access to unapproved medicines.

Attorney Jonathan Riches wants U.S. District Court Judge Susan Bolton to order the Food and Drug Administration to disclose exactly how it reached the decision to allow two people infected with the Ebola virus to be administered ZMapp even though the drug had not yet been approved for human testing.

He contends the public is entitled to know, and that the case is about more than approving one drug in one instance.

“If the FDA can do that in this case, can it do it in other cases where other sick and dying Americans might need access to investigational drugs?” Riches asked. How that happened, he said, “shouldn’t be a government secret.”

Riches said the government has disclosed the process it used to grant approval. What it won’t provide, he said, are the steps it took in reaching various decisions along the way. Such details could provide a road map for others seeking to use unapproved drugs, he said.


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October 2017