$1.9B makeover to fight bioterror, flu

WASHINGTON — Acknowledging that the development of medical countermeasures against bioterrorism threats and pandemic flu is lagging, federal authorities Thursday announced a $1.9 billion makeover of the system for identifying and manufacturing drugs and vaccines for public-health emergencies.

The overhaul includes manufacturing refinements aimed at shaving weeks off the time it takes to produce pandemic flu vaccine and a series of steps aimed at more quickly detecting promising scientific discoveries and getting them to market.

"We aren't generating enough new products," said Health and Human Services (HHS) Secretary Kathleen Sebelius, citing "leaks, chokepoints and dead ends" in the medical-development pipeline.

Money for the changes comes from funds initially allocated for the H1N1 flu pandemic and are directed at what Sebelius described as five key areas of public-health defense:

• $822 million for upgrades to speed production of pandemic flu vaccine.

• $678 million to set up at least one private facility that would work under government contract with small firms to make new products, develop new manufacturing processes and help produce vaccines during periods of peak demand.

• A $200 million fund to invest in small companies developing promising technologies. The fund would be set up as a nonprofit business run by an independent board.

• $170 million for improving regulatory science, the methods used by the Food and Drug Administration (FDA) to measure the safety and effectiveness of new products.

• $33 million for new teams at the National Institutes for Health to identify promising research and help translate it into usable vaccines and drugs.

The changes were detailed in an HHS report commissioned in late 2009 and released Thursday, along with a separate report by the President's Council of Advisors on Science and Technology that focused on improving response to pandemic flu and other outbreaks.

Both reports were spurred by months-long delays in production of the H1N1 vaccine last year. The pandemic flu turned out to be relatively mild, but health authorities said it exposed flaws in response that could cost thousands of lives in future outbreaks if uncorrected.

Although Sebelius did not address it directly, the changes are an implicit admission that Project BioShield, a $5.6 billion fund set up in 2004, had not led to the quick development of a stream of vaccines, drugs and equipment for the bioterrorism medicine chest.

Key congressional lawmakers last month proposed cutting $2 billion from BioShield.

White House spokesman Nick Shapiro said BioShield and HHS's Biomedical Advanced Research and Development Authority, which manages it, remain important players in bioterrorism defense, but "we are now finally creating conditions that will enable their success."