HHS offers legal shield to anthrax manufacturers, distributors

Published 21 October 2008

The U.S. Department of Health and Human Services offers legal shield to manufacturers and distributors of anthrax vaccines and treatments under a “public health emergency” to be in effect until the end of 2015

The U.S. Health and Human Services Department (HHS) on 1 October moved to protect government, industry, and business officials from lawsuits filed by those who have received the anthrax vaccine. Elaine Grossman writes in Govexec that HHS secretary Michael Leavitt created legal immunity for public and private officials who oversee the production or distribution of the anthrax vaccine by declaring a “public health emergency” due to the risk of a bioterrorism attack. He said the emergency began on 1 October and would run through 31 December 2015. U.S. law provides protection from lawsuits to individuals responsible for selected countermeasures, including antibiotics, during a declared emergency.

Under the Public Readiness and Emergency Preparedness Act, which President George Bush signed into law in December 2005, a health and human services secretary’s emergency declaration can limit financial risk for government program planners and the manufacturers or distributors of pharmaceutical countermeasures. One exception to this immunity would be willful misconduct on the part of covered individuals.

Among the activities now afforded liability protection are those “related to developing, manufacturing, distributing, prescribing, dispensing, administering and using anthrax countermeasures in preparation for, and in response to, a potential anthrax attack,” the HHS news release states. “This includes entities, such as large ‘big-box’ retail stores, retail pharmacies, and other private sector businesses, that help to deliver and distribute medicines.” HHS added that “Providing liability protection to all involved in such efforts will help ensure their full participation and bolster response efforts…. Preparedness is a shared responsibility that must involve all sectors of society, including the private sector, community groups, families and individuals,” Leavitt stated in the release. “We are using the authorities available to us to do all we can to support preparedness at all levels.”

Rockville, Maryland-based Emergent BioSolutions, the U.S. only manufacturer of an FDA-approved anthrax vaccine, earlier this month announced that HHS had ordered 14.5 million doses of its BioThrax vaccine, worth as much as $404 million. The company is already under a $448 million contract to produce 18.8 million doses of the vaccine. The vaccine regimen calls for six shots over an eighteen month period, plus annual boosters.