Regulatory Focus™ > News Articles > Group Sues FDA, Seeking Access to Ebola Information

Group Sues FDA, Seeking Access to Ebola Information

Posted 10 June 2015 | By Alexander Gaffney, RAC

Group Sues FDA, Seeking Access to Ebola Information

A battle over regulatory documents has led a libertarian-leaning think tank, The Goldwater Institute, to sue the US Food and Drug Administration (FDA) in the hopes of compelling the agency to hand over information related to how several US citizens received drugs to treat the Ebola virus.

Background

In August 2014, the American public became fixated on an outbreak of Ebola in West Africa after two US missionaries, Dr. Kent Brantley and Nancy Writebol, became infected with the disease. In the effort to save their lives, they were flown back to the US and treated with Zmapp, a monoclonal antibody derived from mice.

But as Focus has explained in the past, the story behind how Brantley and Writebol actually obtained access to Zmapp has been something of a mystery.

For example, it is unclear whether the missionaries obtain access to the drug through FDA's "compassionate use" program, which is used to give small numbers of patients access to experimental drugs outside a clinical trial. Neither the company nor FDA has confirmed whether this is the case.

Due to commercial confidentiality laws, FDA isn't allowed to confirm if a company has or has not filed an investigational new drug (IND) application, which is used to start a clinical trial.

Goldwater's Interest

The issue is of great interest to The Goldwater Institute, the group behind a push to enact "Right to Try" laws at the state level. The basic premise of the laws is that FDA's compassionate use process is inadequate, and that desperately ill patients should be afforded extraordinary deference in their pursuit of last-chance, potentially life-saving drugs.

So if FDA's compassionate use process was circumvented, or even accelerated, such information would hypothetically be useful to Goldwater to advance its arguments in favor of circumventing FDA's compassionate use process.

In October 2014, Goldwater filed a Freedom of Information Act (FOIA) request to FDA seeking to find out if the agency had used the compassionate use process to grant Writebol and Brantley access to the drugs, as well as to "understand the internal decision-making process used by the FDA" during that time.

"The Goldwater Institute wants to know if the doctors were required to comply with the FDA’s standard 'compassionate use' process and procedures that other Americans seeking access to experimental medications must follow," the group wrote in a press statement.

But FDA denied the group's requests, citing protections it has against releasing commercially confidential information.

Lawsuit

Now The Goldwater Institute has filed a lawsuit against FDA seeking access to the information requested under its previous FOIA request.

“If these Ebola patients were allowed access to experimental medication without following the FDA’s normal process, we want to know why and how other sick or dying Americans can also get access to potentially life-saving care,” said Jon Riches, an attorney at Goldwater, in a statement. “We are grateful that FDA allowed Ebola patients to be treated with ZMAPP. We simply want to understand how the FDA made its decision to let this treatment be used.”

“Americans have a right to know how their government approves new drugs for use and under what circumstances exceptions to that process are allowed. That should not be a government secret,” Riches added.


Categories: Regulatory News

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