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Why it took so long for the FDA to approve Ebola vaccine




Aid workers and doctors transfer Miguel Pajares, a Spanish priest who was infected with the Ebola virus while working in Liberia.
Aid workers and doctors transfer Miguel Pajares, a Spanish priest who was infected with the Ebola virus while working in Liberia.
AP Photo/Spanish Defense Ministry, File

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When two American medical workers contracted Ebola in Liberia in July, they were rushed doses of an experimental drug called ZMapp.

The two were flown back to the U.S. where they were treated successfully at Emory University Hospital in Atlanta. Both went on to make a full recovery, but many others have not been so fortunate. The development of this promising drug began years ago, but it was delayed by government bureaucracy.  

"This is a government sponsored medication, or therapy, but the problem and where it's gotten hung up is, about four years, the idea got to the point where it needs to be turned into an approved drug," says Brendan Greelay, who investigated the FDA process for this drug for Bloomberg Businessweek.

It didn't work.

"The U.S. government has to be a pharmaceutical company. There are certain treatments that don't really have a market," Greelay says. "If you're looking at Viagra or Lipitor, there's a market. People will buy that. Nobody is going to buy a therapy for Ebola. Nobody needs it until, all of a sudden, everybody needs it."

ZMapp was picked up by the Defense Threat Reduction Agency (DTRA), an agency part of the Pentagon. 

"DTRA had a problem, which is they have a very slow contracting department... within the Pentagon, which is slow to begin with," Greelay said. "The idea got hung up in the contracting department, and it took two years to dot all the i's and cross all the t's to actually get the check cut."

Greelay admitted that it's not usual for the FDA to take a long time approving new drugs to get on the market.

The Pentagon and Health and Human Services wanted the FDA to give ZMapp a designation for emergency use, Greelay said, which means "you don't need to get full commercial approval."

"It just means you tested for safety in humans — not that it works, just that it doesn't have terrible side affects we need to know about," Greelay says. "That compresses the process. It should... There's no guarantee that if we hadn't lost this time in the contracting process that we would have a stockpile of ZMapp right now."

Read the full story: How the U.S. Screwed Up in the Fight Against Ebola