Goldwater Institute seeks FDA details on accessing untested drugs

The Goldwater Institute goes to court today in a bid to force the U.S. Food and Drug Administration to cough up 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 agency to disclose exactly how it reached the decision to allow two people infected with the Ebola virus to be administered ZMapp even though it had not even gotten to the stage where it was approved for human testing. He contends the public is entitled to know how the FDA reached that conclusion.

But Riches said this is about more than approving this one drug in this 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?” he told Capitol Media Services. 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 that it took in reaching various decisions along the way – steps he argues are the public’s right to know.

But Peter Lantka, an assistant U.S. attorney, is telling Bolton that what Goldwater wants is protected under various exceptions to the federal Freedom of Information Act. He said the agency is not required to release information that could include trade secrets of the manufacturer or personal information about patients.

Riches said he doesn’t want any of that. Anyway, the names of the two people who got emergency access to ZMapp already have been made public.

That means the fight will likely center around whether giving Riches what he wants would improperly – and illegally – disclose the internal discussions of federal officials. And that, Lantka said, would undermine the process “because if agencies were forced to operate in a fishbowl, candid exchange of ideas within an agency would cease and the quality of decisions would suffer.”

The legal fight traces its roots to 2014, when Dr. Kent Brantly and Nancy Writebol, aid workers who had been treating patients in west Africa, were infected with the virus for which there is no known cure. The FDA agreed to allow them to be administered ZMapp, a drug which had not cleared even preliminary review to allow it to be tested on humans. They eventually recovered and wrote about it, which is why their names are known.

Riches sought information on how all that happened. When the FDA refused to disclose it, he filed suit in 2015 in federal court.

“It appeared at the time as though the process to approve that drug was done on a very, very expedited fashion,” he said. Riches said details on how all that happened could provide a road map for others seeking to use unapproved drugs.

Lantka said there are procedures for a drug company or a treating physician to seek permission to administer a product for treatment ahead of normal testing. But he said there are strict guidelines.

First, the doctor must determine the probable risk to the patient is not greater than the probable risk from the disease. There also needs to be finding that a patient has a serious or immediately life-threatening condition, that there is no comparable or satisfactory alternative, and that the potential benefit to the patient justifies the potential risks of the treatment.

But he told the judge that the internal deliberations of the FDA on how they reached that conclusion in the ZMapp case are not subject to disclosure under the federal FOIA. He also said that information submitted by the drug company is also considered confidential.

Riches, in his own legal filings, said what he wants does not fit within any exemption to federal public records laws.

“The agency has failed to demonstrate how releasing information regarding how it made investigational drugs available under existing law and whether the agency complied with federal regulations in doing so would impact agency decision-making,” he told Bolton.

The lawsuit dovetails with state “right to try” legislation approved in 2014, which says that doctors can prescribe drugs to terminally ill patients which have not yet been approved by the FDA.

But that law has limits, including a requirement that the drug has completed at least what is called Phase 1. That means the manufacturer has tested it on a small group of people to evaluate safety, determine a safe dosage and identify side effects.

ZMapp has not been through that first step.

This lawsuit relies on the fact that FDA itself has a “compassionate use” exception from its requirement for final approval before a drug can be used. That is the one which requires a balance between harm and benefit for severely ill patients, the one that was used to give ZMapp to the two patients with the Ebola virus.

In a news release last month, company MappBio said the drug has “yielded promising safety and efficacy data from animal models,” as well as from clinical trial it was allowed to conduct during the Ebola outbreak between 2013 and 2016 in west Africa. The company said ZMapp is being made available to patients in the United States, Guinea, Liberia and Sierra Leone through that compassionate use exception.