HHS extends liability shield to antivirals used for H1N1

Robert Roos  News Editor

Jun 26, 2009 (CIDRAP News) – The Department of Health and Human Services (HHS) recently provided a shield against damage claims related to the use of the antiviral drugs oseltamivir (Tamiflu) and zanamivir (Relenza) in the current H1N1 influenza pandemic.

HHS Secretary Kathleen Sebelius signed a notice extending liability protection under the Public Readiness and Emergency Preparedness (PREP) Act. It was published in the Federal Register on Jun 19.

The PREP Act allows the HHS secretary to provide liability protection related to the use of various medical measures against diseases that HHS determines to be health emergencies. Protections are already in place for the two antivirals when used against H5N1 influenza and for vaccines for H5N1 and other potential pandemic flu strains, among other drugs and vaccines.

Liability protection is provided to groups and individuals involved in the development, manufacture, testing, distribution, administration, and use of medical countermeasures, according to HHS.

Gretchen Michael, an HHS spokeswoman in the Office of the Assistant Secretary for Preparedness and Response, described the antiviral-related move as routine. "This just sort of adapted the previous PREP Act documents for H1N1," she said.

Michael said the impulse for PREP Act liability protections has come primarily from the manufacturers of the relevant products. She said the oseltamivir protection measure was not related to the reports, mainly from Japan, of abnormal behavior in some adolescents who were given the drug.

See also:

Federal Register notice about liability protection for oseltamivir and zanamivir
http://edocket.access.gpo.gov/2009/pdf/E9-14412.pdf

HHS PREP Act page with links to liability protection declarations
http://www.hhs.gov/disasters/discussion/planners/prepact/