A libertarian advocacy group that backs right-to-try laws pressed the FDA in federal court to release information about the agency’s “incredibly expeditious” decision to authorize the treatment of two Ebola patients with an unapproved drug.
The group, the Goldwater Institute, promotes right-to-try legislation via its website righttotry.org and it supports access by terminally ill patients to experimental drugs that may be short of full FDA approval. In the Ebola case, the institute says it is seeking to “bring transparency” to the process by which the FDA authorizes the use of those drugs.
The institute presented an oral argument in the U.S. District Court in Arizona on why the FDA should provide the decision records, which the institute asked for in a Freedom of Information Act request in 2014. The FDA denied the request, and the institute sued to force production of the information.
The Ebola case centers on the treatment of two American aid workers who returned from West Africa after contracting Ebola and were administered the monoclonal antibody cocktail ZMapp in 2014. Both recovered.
Zmapp is an investigational drug from Mapp Biopharmaceuticals that has not been approved by the FDA. It is currently offered to Ebola patients through expanded-access protocols at sites in the U.S. and West Africa, the company says.