The U.S. government proposed major changes Thursday to the way it works with companies to fight disease threats such as flu, including reform at the Food and Drug Administration and setting up centers to make vaccines quickly.
The report from the Health and Human Services Department said the U.S. ability to respond to new outbreaks is far too slow and it lays out a plan for helping researchers and biotechnology companies develop promising new drugs and vaccines.
“The closer we looked … the more leaks, choke points and dead ends we saw,” Health and Human Services Secretary Kathleen Sebelius said at a news briefing.
“At a moment when the greatest danger we face may be a virus we have never seen before … we don’t have the flexibility to adapt,” she added. “We saw that we needed better coordination not just within our department but across government.”
She said much of the $2 billion needed to make the first changes would come from money allocated to fight H1N1.
The report suggests providing clearer guidance to industry on regulatory approval of new drugs and vaccines — something industry has asked for — and says new teams should be set up at FDA to help this.
“The report does address some key areas that can help make the process more efficient in the event of future public health emergencies,” said Karen Lancaster, a spokeswoman for vaccine maker MedImmune, owned by AstraZeneca.
Sebelius said the plan calls for $170 million to kick start reforms at FDA, including adding “a stronger, expert scientific workforce and infrastructure.”
“We are also going to reach out to product developers earlier in the process so they know what to expect,” she said.
HHS and the Department of Defense should set up Centers for Innovation in Advanced Development and Manufacturing, it said.
“These centers will provide assistance to industry and government by advancing state-of-the-art, disposable, modular manufacturing process technologies,” the report said.
The report also calls for better monitoring to give a much quicker heads-up when new diseases emerge. H1N1 had been circulating for weeks or months before it was detected.
The report says new teams also will look for promising ideas for fighting disease or other threats and make sure they get developed.
“Some of these great ideas are going to come from very small companies that don’t really have the capital and wherewithal to get a product from microscope to market,” Sebelius said.
