HHS Shields ZMapp from Legal Liability
HHS has promised to protect the maker of the experimental Ebola virus drug ZMapp from legal liability, meaning the company can’t be sued for claims of injury or loss related to use of the monoclonal antibody cocktail.
ZMapp is now a covered countermeasure under the 2005 Public Readiness and Emergency Preparedness Act, which allows the government to declare a public health emergency and grant emergency use authorization for investigational drugs with FDA-approved clinical trials.
The law also authorizes HHS to shield the manufacturers of EUA drugs from liability claims since they haven’t been approved as safe and effective by the FDA.
Mapp Biopharmaceuticals joins three other makers of Ebola products shielded by HHS. NewLink Genetics, GlaxoSmithKline and Janssen gained legal protection for Ebola vaccines in December.
ZMapp is being evaluated in a large trial in the U.S. and Liberia comparing the drug with supportive care methods such as rehydration and medications to stabilize blood pressure, oxygen levels and electrolytes.
Read HHS’ announcement at www.fdanews.com/04-24-15-ZMappnotice.pdf. — Lena Freund