FDA loses fight to prevent transparency in drug-approval process’

By WND Staff

A federal appeals court has cleared the way for researchers to access the Food and Drug Administration’s emergency drug-approval process.

The ruling from the 9th U.S. Circuit Court of Appeals comes as the nation seeks treatments for the Chinese coronavirus.

The ruling concerns ZMapp, a drug given emergency FDA approval to treat Ebola during the 2014-16 outbreak.

The Goldwater Institute took the FDA to court,  seeking transparency in the drug-approval process.

The agency, upheld by a lower court, refused to accept that there were grounds for the public to have information about the process.

But the appeals court ruled the lower court should have looked at the federal Freedom of Information Act to determine whether the information should have been released, not the FDA’s regulations.

The FDA approved ZMapp, then an experimental drug, within just days of hearing about the Ebola outbreak in Africa. That was even though the regular process for approving drugs is years long.

The Goldwater Institute asked the FDA about its process for such emergencies and was denied the information.

The 9th Circuit ruled the FDA had cited only its own rules, not the FOIA requirements, in refusing to release its information.

The court found, “When examined under the requirements of Exemption 4 [of the FOIA], the FDA’s blanket refusal to produce any records … does not warrant summary judgment in its favor.

“The agency’s argument boils down to the assertion that the documents must contain such [private] information. … But this is insufficient under FOIA.

“On the present record, the agency has failed to meet its burden of establishing that the documents it withheld are exempt from disclosure,” the court ruled.

The case was sent back to the lower court so it “can determine whether, under established FOIA criteria, the documents at issue are exempt from disclosure.”

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