Sebelius Takes Two Key Actions On Strategic National Stockpile‏

Health and Human Services Secretary Kathleen Sebelius announced yesterday that the Federal government will purchase an additional 13 million treatment courses to help fight influenza, including the 2009 H1N1 flu virus. The additional treatment courses will be added to the Strategic National Stockpile. The Secretary also announced that HHS began moving 400,000 treatment courses to Mexico to help slow the spread of the H1N1 virus.

"As this flu virus outbreak expands across the country, we have been taking necessary steps to ensure states have the resources they need," said Sebelius. "The 13 million additional treatment courses that we will purchase will allow us to replenish our national stockpile and further
ensure we are prepared to provide the American people with the treatments they may need to stay healthy."

HHS has stockpiled approximately 50 million courses of antiviral drugs in the Strategic National Stockpile, and state stockpiles across the country include an additional 23 million more treatment courses. Earlier this week, HHS released a total of 11 million treatment courses to help
all 50 states. Today HHS began moving 400,000 treatment courses to Mexico to help stop the spread of the virus. The 400,000 courses represent less than 1 percent of the total American stockpile.

As a result of yesterday's action by the Secretary, HHS will spend an estimated $251 million to refill the Strategic National Stockpile and replace the 11 million treatment courses offered to states and to purchase an additional two million treatment courses. These additional two million treatment courses will be used to replace those that have been provided to Mexico or could also be available to respond to other outbreak needs.

"Flu viruses don't stop at the border, and it is imperative we do whatever we can to slow the spread of the virus and help stop this outbreak," said Sebelius.

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HHS Declares Public Health Emergency for Swine Flu

The Department of Health and Human Services yesterday issued a nationwide public health emergency declaration in response to recent human infections with a newly discovered swine influenza A (swine flu) virus.

The formal declaration of a Public Health Emergency (PHE) is a tool that facilitates HHS’ preparation and mobilization for disasters and emergencies. For example, PHEs were recently declared for flooding in North Dakota, the Inauguration, and several 2008 hurricanes.

Yesterday’s declaration, made under section 319 of the Public Health Service Act, will help HHS prepare for prevention and mitigation activities by enabling Food and Drug Administration (FDA) emergency use authorizations of drugs, devices, or medical tests under certain circumstances.

Specifically, the PHE will enable the FDA to review and issue emergency use authorizations (EUAs) for the use of certain laboratory tests to help detect the newly discovered strain of influenza and for the emergency use of certain antivirals.

“HHS is taking these steps today to be proactive in responding to this new influenza virus by offering national tools in support of community-led preparedness and response efforts,” Acting HHS Secretary Charles Johnson said. “The declaration allows us the flexibility, while we learn more about the virus and its impact in the United States, to take additional steps to fully mobilize our prevention, treatment and mitigation capabilities should those actions become necessary.”

In addition to the declaration, HHS leaders are working together across operating divisions to coordinate response to the swine flu outbreak. For example, the FDA, the National Institutes of Health, and the Centers for Disease Control and Prevention are working together to develop a vaccine precursor that could be used to develop a vaccine for this swine flu virus.

To date, there have been 20 confirmed cases of swine Influenza A (swH1N1) in California, Texas, Kansas, New York, and Ohio. No deaths in the U.S. have been reported due to the illness. Additional cases of the virus have been confirmed in Mexico and Canada.

Swine flu is a respiratory disease of pigs caused by type A influenza that regularly causes outbreaks of influenza among pigs. Swine flu viruses do not normally infect humans; however, human infections with swine flu do occur, and cases of human-to-human spread of swine flu viruses have been documented.

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