Court Rules Against FDA in FOIA Case as Reforms Await Obama
As president Obama prepares to sign a bill into law that would reform how the government responds to Freedom of Information Act (FOIA) requests, FDA, for now, has lost a bid to withhold FOIA-requested internal records related to investigational drugs (ZMapp) used to treat Ebola victims. An Arizona federal judge has ordered the agency to produce a detailed log of all the records it would not provide to Goldwater Institute because they contained commercial, confidential or personal identifying information. The court will use the log to examine which ones may be released to the organization.
The Goldwater Institute filed suit in 2015 because FDA’s “arbitrary withholding of public information violates federal law and undermines the public’s right to know the decisions a government agency is making on life and death matters.” Despite the public’s substantial interest in the drug approval process in light of the Ebola outbreak, the group said, FDA had declined to address questions regarding its role in the approval or administration of ZMapp and other experimental medications to patients infected with the disease. The institute said it had extensively studied and offered policy recommendations on the U.S. drug approval process and wanted the records on ZMapp approval to further its research and analysis and to increase the public’s understanding of the process.
FDA, the suit said, has a legal obligation to evaluate alternatives to full disclosure. “Based on the size of the responsive records alone, it does not appear as though FDA has evaluated alternatives to full disclosure such as partial disclosure or selective redaction,” Goldwater said. “As a result, FDA has failed to comply with its obligations to disclose public information under the Freedom of Information Act.” The group said that a positive court decision would not only allow access to records that may aid its research into drug approval, but would also uphold significant principles of transparency and open government.
The temporary victory for Goldwater comes as president Obama has signaled he will soon sign a bill that will reform the FOIA law altogether. On his first day in office, Obama pledged that his administration would be the most transparent in history and issued a memorandum directing agencies to administer the FOIA with a clear presumption: “in the face of doubt, openness prevails.” This did not happen — last year, the Associated Press released a report showing the administration set a record again for censoring government files or outright denying access to them in 2014.
Under the FOIA Improvement Act, the government would adopt a “presumption of openness” when processing requests for government records. This means agencies will be required by law to “err on the side of disclosure unless there is foreseeable harm or a legal requirement to withhold specific information,” according to the Union of Concerned Scientists. Additionally, the Office of Government Information Services (OGIS) would be strengthened. This little-known agency will have greater effectiveness and independence, and allow for it to be a strong advocate for transparency and disclosure.