HHS extends liability shield to antivirals used for H1N1
submited by kickingbird at Jun, 27, 2009 22:3 PM from CIDRAP
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.
Federal Register notice about liability protection for oseltamivir and zanamivir
HHS PREP Act page with links to liability protection declarations
- WOAH: Influenza A viruses of high pathogenicity (Infection with H5N1) (non-poultry including wild birds) (2017-), China 14 days ago
- China: Confirmed human case of avian influenza A(H9N2) reported in Sichuan province Jun, 29, 2022
- China: A human case of avian influenza A(H5N6) reported in Jiangxi province Jun, 27, 2022
- China: Confirmed human cases of avian influenza A(H9N2) reported in Hunan and Guizhou province Jun, 9, 2022
- China: Confirmed human case of avian influenza A(H3N8) reported in Hunan province Jun, 1, 2022