U.S. Drug Approval Process Shouldn’t Be a Government Secret

February 12, 2020
By Jon Riches

The purpose of the Freedom of Information Act is to make government functions transparent, so that the public can know what our government is up to. And the drug approval process in the United States is one of the most critical functions the federal government performs. That’s why the Goldwater Institute was recently in court fighting for more openness in how the U.S. Food and Drug Administration (FDA) decides who can access investigational treatments that could save lives.

In 2014, when a deadly Ebola outbreak in West Africa infected thousands of patients, including several Americans, the FDA made one investigational drug, ZMapp, available for use in an incredibly expeditious manner that did not appear to be in line with the normal drug approval process. Shortly after reports about the ZMapp approval surfaced, the Goldwater Institute, which has been engaged in public policy research and analysis on the drug approval process for years, submitted a Freedom of Information Act request seeking information about how the FDA’s drug approval process worked in this case. 

The Institute was glad that the FDA made this drug available to the patients infected with Ebola, and we were interested in researching how that process occurred so that other sick and dying patients might also gain access to investigational drugs. 

In its FOIA request, the Institute did not seek commercial information. The Institute did not seek financial information. The Institute did not seek any information about the activities of private parties. In its FOIA request, it sought information only about government functions; specifically, how the approval process worked in this case and whether the FDA’s own rules and processes were followed. 

Yet the FDA claimed that FOIA Exemption 4—a limited exemption meant to protect only commercial and financial information about private parties—justified withholding records about government processes. 

Last Friday, the U.S. Court of Appeals for the Ninth Circuit heard argument from the Goldwater Institute, asking the court of appeals to set aside a lower court’s ruling that allowed the FDA to withhold these records. (Goldwater’s case was selected as one of a handful of arguments to be held at the Arizona State University School of Law when the Ninth Circuit traveled through Arizona.)

The drug approval process in the United States should not be a government secret. The Institute is hopeful that the appellate court will agree, rule in favor of transparency, and release the records at issue.

You can read more about our lawsuit here, and you can watch the full oral argument here.

Jon Riches is the Director of National Litigation at the Goldwater Institute.