The overhaul includes refinements to manufacturing aimed at shaving weeks off the time it takes to produce pandemic flu vaccine, and a series of steps aimed at more quickly spotting promising scientific discoveries and getting them to market.
We aren’t generating enough new products,” said Health and Human Services 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.
Among other things, the effort would provide $822 million for upgrades to speed up production of pandemic flu vaccine. Another large block, $678 million, would be used to set up at least one private facility that would work under government contract with small companies to manufacture new products, develop new manufacturing processes and help produce vaccines during periods of peak demand.
The reforms were detailed in a Health and Human Services Department report commissioned in late 2009 and released Thursday along with a separate report by the President’s Council of Advisors on Science and Technology.
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 the delay exposed flaws in response that could cost thousands of lives in future outbreaks if uncorrected.
The changes, particularly the additional money for drug development and improvement of the FDA’s regulatory process, are important steps in the right direction, said Dr. Brad Spellberg of the Infectious Diseases Society of America.
“This is a sign that the federal government is starting to get it,” said Spellberg, author of “Rising Plague,” which describes that emergence of antibiotic-resistant “superbugs.”
Although Sebelius did not address it directly, the changes are an implicit acknowledgement that Project BioShield, a $5.6-billion fund set up in 2004, has 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 that BioShield and Health and Human Service’s Biomedical Advanced Research and Development Authority, which manages it, remained important players in bioterrorism defense, but that “we are now finally creating conditions that will enable their success.”
Los Angeles Times