Goldwater Institute lawsuit: Unlock the secrets of FDA drug approvals

The federal agency that oversees drug safety made a quick decision in 2014 to allow two health-care workers to take a yet-to-be-tested drug after they contracted the Ebola virus while volunteering in Liberia.

The two health workers, Dr. Kent Brantly and Nancy Writebol, became the first humans to ever get the experimental drug, called ZMapp, and both recovered from their illness.

But it has remained largely a mystery how the U.S. Food and Drug Administration decided those missionaries in Liberia should be allowed access to the drug.

Goldwater sues to get records

In 2015, the Phoenix-based Goldwater Institute sued the FDA to obtain records that could shed light on whether the federal agency followed its own rules when allowing emergency access to the drug.

The U.S. District Court in Arizona ordered the FDA to produce some records as well as an index that identifies documents that have been withheld and the reason the federal agency did not produce those records. 

However, Goldwater contends the FDA has not produced records that respond to its request under the Freedom of Information Act and in court filings. Among the records Goldwater seeks is information about the FDA's drug importation rules, including details  that suggest a third patient received an emergency dose of ZMapp. 

FDA cites confidentiality 

On Tuesday, Goldwater attorneys asked U.S. District Judge Susan Bolton to order the release of more records.

"The drug approval process in the United States shouldn't be a government secret," said Jonathan Riches, a Goldwater Institute attorney. "The public has a right to know how drugs are made available to the patient."

FDA attorneys argued that the agency considers information about yet-to-be-approved drugs to be confidential and proprietary to the companies seeking FDA approval to market their drugs. 

The FDA corresponds with every drugmaker on various topics — for example, a drug's purity, toxicity and pharmacology — as part of its deliberative process, said  agency attorney Leslie Cohen.  

"That is why the deliberations are inextricably intertwined with confidential, commercial information," Cohen said.

In 2014, Goldwater filed a Freedom of Information Act request for records about the FDA's approval process, deliberations and final approval records that allowed an experimental drug to be used on Brantly and Writebol.

The FDA denied Goldwater's initial records request in 2014, citing an exemption under a provision that protected trade secrets and confidential commercial information. 

In its federal lawsuit, Goldwater argues that it did not seek commercial trade secrets or private patient information.

It wants to "determine whether the government followed its own requirements when it made a life-saving drug available to patients infected with the Ebola virus," according to a Goldwater motion for summary judgment.

The court already ordered that the FDA produce an index that identifies records that have been withheld and the reason the federal agency did not produce those records. 

When the federal agency produced the index of records, Goldwater contended that exemptions claimed by the FDA did not apply and some records classified as non-responsive may have been responsive to Goldwater's request.

Did FDA follow its own rules?

According to Goldwater, the FDA must determine that potential benefits justify the potential risks of a drug, and that such risks are not unreasonable given the disease. 

Furthermore, the FDA must determine that a patient has a life-threatening disease, that drug access won't interfere with a clinical study or development of the drug, and that the patient can't otherwise obtain the drug. 

Goldwater contends that it has not received enough records to determine whether the FDA met its own criteria in the Ebola case.

Goldwater is familiar with the FDA's emergency drug-approval process. The watchdog group has championed “right-to-try” bills and voter initiatives in Arizona and several other states. These legislative efforts aim to give people with a terminal illness emergency access to experimental drugs.

Although voters passed Arizona's right-to-try measure in 2014, backers have been unable to publicly identify a single patient who has received an experimental drug under this initiative.