UPDATE 2-New US pandemic plan aims to speed products

* Calls for helping biotech companies develop new drugs

* Aims to speed production during pandemics

* US may begin making vaccines in emergencies

(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 academic researchers
and biotechnology companies develop promising new drugs and

“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,” Health and Human Services Secretary
Kathleen Sebelius said at a news briefing.

The report suggests providing clearer guidance to industry
on what kinds of tests are needed for 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.

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.

“Finally, in public health emergencies, these centers may
augment existing United States manufacturing surge capacity
against emerging infectious diseases or unknown threats,
including pandemic influenza.”

Experts in industry and the government have long agreed
that the U.S. system for producing drugs and vaccines to fight
pandemics — especially influenza — is slow and unwieldy.

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 pandemic virus last year, it was already
spreading around the world.


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

The report also calls for better surveillance to give a
much quicker heads-up when new diseases emerge. Studies show
H1N1 had been circulating for weeks or months before it was

Companies have complained that U.S. federal regulations are
confusing and do not help much. The report takes many of the
concerns into account.

Sebelius said there had been little investment in
“regulatory science” — studying the best ways to test new

“Because of this under-investment we are often testing and
producing cutting-edge products using science that is decades
old,” Sebelius said.

“We are also going to reach out to product developers
earlier in the process so they know what to expect.”

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.

She said much of the $2 billion needed to make the first
changes would come from money already allocated to fight H1N1.

(Editing by Eric Beech and Bill Trott)

UPDATE 2-New US pandemic plan aims to speed products