August 19, 2010

US Government Changing Ways It Works To Fight Diseases

The U.S. government proposed major changes on Thursday that deal with the way it works with companies to try and battle disease threats like the flu.

The Health and Human Services Department said in a report that the U.S. ability to respond to new outbreaks is far too slow and it has laid out a plan for helping academic researchers and biotechnology companies developing promising new drugs and vaccines.

"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 during a news briefing.

The department's report suggests providing clearer guidance to the industry on what types of tests are required for regulatory approval of new drugs and vaccines.  The report also says new teams should be set up by the FDA to help this.

It said that HHS and the Department of Defense should set up Centers for Innovation in Advanced Development and Manufacturing.

"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 the industry and government have agreed for a long time that a new system for producing drugs and vaccines to help fight pandemics is needed.

A vaccine could take months to make to help fight influenza using the current process, and new technology to help speed up the process could still be years away.

"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 in order to give a better warning when a new disease emerges.  Studies found that the H1N1 flu strain had been circulating for weeks or months before it was detected.

Companies have long complained that U.S. federal regulations are confusing and do not help.  The report has taken these complaints into account.

Sebelius told the news conference that there had been little investment in studying the best ways to test the new products.

"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 will also try and find promising ideas for battling a disease as well as 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 told the news conference.

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


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