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Goldwater loses bid to unveil information on experimental drugs

Cork, Ireland

A federal judge rejected efforts by the Goldwater Institute to force the Food and Drug Administration to detail publicly how dying people can get access to unapproved medicines.

In a 12-page ruling, U.S. District Court Judge Susan Bolton said attorney Jonathan Riches has no legal right to force 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. Riches contends the public is entitled to know how the FDA reached that conclusion.

But Riches said Monday the issues go beyond what happened in this one case.

“How the government makes life-saving drugs available, particularly in an emergency situation, we have a right to know that,” he said.

“That shouldn’t be a government secret,” Riches said. “The FDA should be as transparent as possible when it comes to how patients who are sick and dying can get access to drugs that might save their lives.”

And he said he intends to appeal.

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 despite the records not being made public.

Riches sought information on how all that happened.

His lawsuit relied 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.

When the FDA refused to disclose it, he filed suit in 2015 in federal court.

Bolton acknowledged the federal Freedom of Information Act requires government agencies to make certain information about their activities available to the public.

“The FOIA embodies a strong federal policy in favor of full agency disclosure of government documents,” Bolton wrote, citing U.S. Supreme Court precedent. “Any inquiry under the act begins with a strong presumption of disclosure.”

But Bolton said the records being sought are part of what the FDA considers an “investigational drug application.” And she said these files contain information that is designed to be kept confidential to promote “candor” by companies seeking agency approval.

Bolton, in her ruling, found several problems with the claim, starting with the fact that the FOIA itself does not require disclosure of trade secrets or commercial or financial information obtained from anyone else that they consider privileged or confidential.

She also noted the regulations of the FDA itself on investigating an experimental drug’s safety and effectiveness preclude even the disclosure that there is an “investigational drug application” before it is publicly disclosed. And even if there is public disclosure, Bolton said, nothing in the file is available for public disclosure before a license is issued.

The ability to keep certain information confidential, Bolton said, is necessary. She said the documents being sought contain “important developmental, compositional, safety and manufacturing data, the revelation of which before a licensing decision would likely impede future candor on the part of submitting entities.”

Bolton also said that Riches cannot get access to other information like emails related to the application, saying allowing that would make it impossible for the FDA to discuss what’s in the file “without simultaneously forfeiting the confidentiality of the information they contain.”

But Riches said the flaw in all that is that Bolton’s ruling, left unchallenged, would allow the agency itself to decide that everything it has is part of the confidential file. He said that includes internal emails among FDA employees about the timing of a new drug submission.

“Now if the timing of a submission to an agency is not public information, I don’t know what is,” Riches said.

“It’s certainly not privileged, it’s certainly not a trade secret,” he said. “It’s just a government agency deciding how it’s going to function, it’s processes and procedures which, under the plain language of the FOIA is public information.”

The status of the ZMapp application remains unclear.

No one from the company that is pursuing the drug returned messages. And the last published report, from a year ago, said the Ebola treatment was going to be tested at a Texas laboratory.

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