Judge Nixes Goldwater Institute Access Info Request
An Arizona federal judge has rejected a Goldwater Institute effort to force FDA to publicly describe how dying people can get access to unapproved medicines. The Arizona Daily Star reports that judge Susan Bolton said attorney Jonathan Riches has no legal right to force the agency to disclose how it reached the decision to allow two people infected with the Ebola virus to be administered ZMapp when it still had not been approved for human testing.
“How the government makes life-saving drugs available, particularly in an emergency situation, we have a right to know that,” Riches told the newspaper. “That shouldn’t be a government secret. 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.” He said he would appeal the ruling.
Riches’ suit relied on the fact that FDA has a “compassionate use” exception from its requirement for final approval before a drug can be used. The exception requires a balance between harm and benefit for severely ill patients. When FDA refused to disclose its reasoning in the Ebola case, Riches filed suit in 2015.
Bolton said the records sought by Riches through a Freedom of Information Act request were part of an investigational new drug application and thus contain information that is designed to be kept confidential to promote “candor” by companies filing INDs. She said the law 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 that FDA regulations preclude even the disclosure that an IND has been filed. And if there is public disclosure, nothing in the file is available for public disclosure before a license is issued.
Riches countered that if Bolton’s ruling stands, FDA could decide that everything it has is part of a confidential file, including internal e-mails 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,” he declared. “It’s certainly not privileged, it’s certainly not a trade secret. 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 Freedom of Information Act, is public information.”