FDAnews Drug Daily Bulletin


May 5, 2006

HHS wants domestic drug manufacturers to ramp up production capability enough so that the U.S. can vaccinate its entire population within six months of a pandemic flu outbreak, according to a recent government report.

The White House unveiled the "Implementation Plan for the National Strategy for Pandemic Influenza," which outlines in more detail the U.S. pandemic flu strategy issued last November.

HHS said in the report it wants to achieve its manufacturing capability goal in five years. To ensure that U.S. manufacturers can handle a surge in demand, HHS will appraise existing plants within six months to see if they need to be retrofitted for pandemic vaccine production, the report said.

The short-term goal is to establish and maintain a stockpile of 75 million doses of antivirals and 20 million doses of vaccine, according to the report. More than 4 million doses of antivirals are currently in the Strategic National Stockpile (SNS) and another 31 million doses are in state stockpiles.

The plan establishes a number of timelines, ranging from awarding contracts for renovating and building facilities that produce FDA-licensed cell-based vaccines or biologics over the next three years to giving contracts and grants toward the development of cell-based vaccines within six months. Contracts will also be granted to developers of novel influenza vaccines and to antiviral drug manufacturers and distributors in the next year.

The report can be found here (http://www.whitehouse.gov/homeland/nspi_implementation.pdf).