Phoenix—Yesterday the U.S. Food and Drug Administration denied a Freedom of Information Act request seeking information about the FDA's internal approval process that allowed two American doctors infected with Ebola to be successfully treated with a drug that is still in development.
The Phoenix-based Goldwater Institute filed the information request in an effort to understand the internal decision-making process used by the FDA to allow the two doctors to access the drug, ZMapp, which is still under safety review. The Institute was not seeking any information about the drug itself. Despite that, the FDA denied the request on the basis that complying would violate the drug maker's trade secrets.
The Goldwater Institute wants to know if the doctors were required to comply with the FDA's standard "compassionate use" process and procedures that other Americans seeking access to experimental medications must follow. The average compassionate use request takes 300 hours to complete.
"If these doctors were allowed access to experimental medication without following the FDA's normal process, we want to know why and how other sick or dying Americans can also get an exception," said Jon Riches, an attorney at the Goldwater Institute.
The Goldwater Institute is leading a nationwide effort to have states adopt "Right to Try" laws. Right to Try gives terminally ill patients the right to try investigational medicines that have passed the first phase of FDA approval but still may be years away from reaching pharmacy shelves. Right to Try lets patients work directly with their doctors to access promising investigational medicines now.
Right to Try is currently law in Colorado, Louisiana, and Missouri. It has been passed by the Michigan legislature and is awaiting the governor's signature. Arizona voters will vote on the measure in the November election. In Colorado, Louisiana, and Missouri, the law passed with unanimous, bipartisan support. In Michigan, only one lawmaker voted against it.
"When time is of the essence, as it was in these two Ebola cases, we can all agree that the government shouldn't stand in the way of a potentially life-saving treatment. But every sick American should be treated the same by the government; and if the FDA is willing to forego its own process for some, it should do it for everyone. All we want to know is whether or not the FDA followed its own procedures when dealing with these doctors," said Riches.
Riches will appeal the denial of his Freedom of Information Act request.