FDA sued over secretive process for doling out Ebola drugs

Originally written by Robert King for Washington Examiner

Now advocates want the agency to do the same for other terminally ill victims and will take the FDA to court over the issue.

The libertarian think tank Goldwater Institute sued the agency Tuesday to force the release of records on the decision to dole out the Ebola therapy ZMapp. The drug, now being tested on humans in Liberia, was given to two Americans, three African doctors and a Spanish missionary last year.

The institute wants to know whether the recipients went through standard agency procedures for “compassionate use,” a process that gives terminal patients an opportunity to receive experimental medications if no comparable treatment is available. Normally a patient’s physician must apply.

Goldwater attorney Jon Riches said the think tank suspected the agency didn’t go through the proper channels when it doled out the ZMapp, hence the public records request. If the agency didn’t, then Goldwater wants to know why.

“Americans have a right to know how their government approves drugs. That shouldn’t be a government secret,” Riches told the Washington Examiner Wednesday.

The records request was denied earlier this year to preserve trade secrets surrounding the drug. Riches said the institute doesn’t want any information on the drug itself, just the approval process.

Goldwater has been calling for expanded compassionate use regulations for some time.

It has taken its fight mainly to the states, pushing for passage of “right to try” laws that enable terminally ill patients to access drugs that have passed basic safety testing. The laws shield manufacturers from prosecution if they provide the products and protect doctors from losing their license.

So far 19 states have adopted “right to try” laws and another three are awaiting governors’ signatures, the institute said.

Experts question whether the laws actually help since they don’t require a manufacturer to make an experimental drug available to a patient. The drugs, also, can be expensive.

“Drug and device companies are under no obligation to give patients anything — no matter how sick they are,” wrote bioethicist Arthur Caplan in a 2014 editorial for NBC News. “Where is the money to help people pay for drugs?”

Caplan added that some laws don’t have protections to ensure the treatment isn’t a “crummy drug peddled by a crooked doc looking to make a fast buck off the desperate.”

The FDA said it does not comment on pending lawsuits.

The agency has taken measures to address compassionate use. For instance, it recently proposed reducing the paperwork required for physicians to apply for compassionate use.