The Goldwater Institute sued the U.S. Food and Drug Administration for denying a Freedom of Information Act request seeking information about the FDA’s internal approval process that allowed Americans infected with Ebola to be successfully treated with a drug that is still in development.
In August 2014 the Goldwater Institute filed the information request in an effort to understand the internal administrative process used by the FDA to allow Dr. Kent Brantly and Nancy Writebol, and others infected with the Ebola virus, to access the drug ZMapp, which is still under safety review.
According to a press release, the institute was not seeking any information about the drug itself. Despite that, the FDA denied the request on the basis that complying would violate the drug maker’s trade secrets. The Goldwater Institute appealed the FDA’s denial to the Department of Health and Human Services, which oversees the FDA. HHS denied the agency appeal in February 2015.
Now the Goldwater Institute has filed a lawsuit with the U.S. District Court in Arizona claiming that the FDA and HHS are violating the Freedom of Information Act by refusing to make the records public, according to the release.
“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,” stated Jon Riches, an attorney at the Goldwater Institute, in the release. “Opening government processes, such as the FDA’s drug approval process during times of crisis and emergency, to the scrutiny of the general public for study and examination is one of the principal purposes of the FOIA.”
The public records the Goldwater Institute requested from the FDA will be used to aid in research and analysis and will contribute to the public’s understanding of the drug approval process in the United States.
The Goldwater Institute also wants to know if Mr. Brantly and Ms. Writebol, and other Ebola patients, were required to comply with the FDA’s standard “compassionate use” process and procedures that other Americans seeking access to experimental medications must follow, according to the release.
“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,” stated Mr. Riches. “When time is of the essence, as it was in these Ebola cases, we can all agree that the government shouldn’t stand in the way of a potentially life-saving treatment. 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.”
The Goldwater Institute is leading a nationwide effort to encourage states to adopt “Right To Try” laws. Right To Try gives terminally ill patients the right to try investigational medicines that have passed the first phase of FDA approval but still may be years away from reaching pharmacy shelves. Right To Try lets patients work directly with their doctors and drug manufacturers to access promising investigational medicines before it’s too late.
Right To Try laws have been adopted in 19 states and are waiting on governor’s signatures in three more, according to the release. Learn more about Right To Try at RightToTry.org.
“All Americans have a right to know how their government makes decisions that can affect their health, especially in life or death matters,” stated Mr. Riches.
Read more about Goldwater Institute v. Food and Drug Administration here.