PHOENIX — A new lawsuit could help Arizonans who are dying get access to experimental drugs that could save their lives.
The Goldwater Institute is asking U.S. District Court Judge Susan Bolton to force the Food and Drug Administration to release records of the procedures it used to decide that two individuals infected with the Ebola virus could be administered ZMapp, an experimental drug.
The FDA has refused, saying the information is proprietary.
But attorney Jonathan Riches said there is no basis for the denial, noting the Goldwater Institute does not want information about the drug but about how the FDA decided it could be made available.
The issue, he said, is more than an academic exercise.
“We know a mechanism was used here,” Riches said of the federal agency granting an exception to its normal procedures about when a drug can be made available. “And if a government mechanism was used to approve these drugs, how can other sick and dying Americans also use that same mechanism? That shouldn’t be a government secret.”
That issue of access could be particularly important in Arizona.
Last year, voters approved a “right-to-try” law that says doctors can prescribe drugs that have not been approved by the FDA to their terminally ill patients. But there are limits, including those which specify the drug has to have completed at least what is called Phase 1, meaning the manufacturer has tested it on a small group of people to evaluate safety, determine a safe dosage and identify side effects.
The FDA itself also has a “compassionate use” exception from its requirement for final approval before a drug can be used. It is that part of the issue on which the lawsuit relies.
Last August, the Goldwater Institute filed a request under the federal Freedom of Information Act wanting to know what processes and deliberations the FDA used before allowing ZMapp to be administered to aid workers Dr. Kent Brantly and Nancy Writebol, as well as anyone else suspected to have been infected with the Ebola virus.
FDA officials said the records sought contain proprietary information about the drug.
In a letter to Riches, Catherine Teti, an FOIA officer for the agency, said the file with that information contains trade secrets. And that, she said, means the manufacturer is entitled to be sure the FDA does not release the information to others.
Riches said there’s no basis for that denial.
“We did ask about — and only about — the FDA’s own approval process in this particular case,” he said. And Riches said he presumes the agency has uniform processes for approval of exceptions like this.
“We know that this was approved under these circumstances,” he said.
“Why is it that it was done in this way in this case?” Riches added. “And why isn’t it that other sick and dying Americans can’t also utilize a similar approval process if one exists?”
