UPDATE 3-US tries to fix slow response to outbreaks

* Calls for helping biotech companies develop new drugs

* Aims to speed production during pandemics
(Updates throughout with quotes, details)

By Maggie Fox, Health and Science Editor

WASHINGTON, Aug 19 (BestGrowthStock) – The U.S. government proposed
major changes on Thursday to the way it works with companies to
fight new 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

“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

She said much of the $2 billion needed to make the first
changes would come from money already 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 (AZN.L: ).

Sebelius said the plan calls for $170 million to kickstart
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

“These centers will provide assistance to industry and
government by advancing state-of-the-art, disposable, modular
manufacturing process technologies,” the report said.

“We will not be producing the vaccine,” HHS’s Robin Robinson
said. “We will be there to help manage the products as they go

It takes months to make a vaccine against influenza using
current processes. While companies are working to modernize
their abilities, any big changes are still years away.

By the time companies were able to make a vaccine against
the H1N1 swine flu virus last year, the pandemic had already
peaked twice.

“We can use existing tools to cut days, weeks or even a
month or two out of our current vaccine production methods,”
said Dr. Tom Frieden, director of the U.S. Centers for Disease
Control and Prevention.

“Accelerated delivery of vaccines by even a few weeks can
mean saving tens of thousands of lives,” added National Cancer
Institute director Dr. Harold Varmus, who helped write a
separate, related report from the Presidential Council of
Advisors on Science and Technology.

The report calls for better surveillance 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.

(Editing by Bill Trott)

UPDATE 3-US tries to fix slow response to outbreaks