Greggory Blundell
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Saw it in a Reuters report on Yahoo news. Can't figure how to post the link; maybe someone can. Just thought it was very odd timing...http://news.yahoo.com/s/nm/us_flu_usa
FDA Just Announced New Plan To Handle New Pandemics
- Thread starter Greggory Blundell
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JT1024
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Here is the text:
New U.S. pandemic plan aims to speed products
By Maggie Fox, Health and Science Editor
2 hrs 30 mins ago
WASHINGTON (Reuters) The U.S. government proposed major changes 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 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 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 said.
"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.
SPEEDING RESPONSE
"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 detected.
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 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 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)
New U.S. pandemic plan aims to speed products
By Maggie Fox, Health and Science Editor
2 hrs 30 mins ago
WASHINGTON (Reuters) The U.S. government proposed major changes 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 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 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 said.
"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.
SPEEDING RESPONSE
"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 detected.
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 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 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)
Greggory Blundell
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Thanks, JT1024
urbantravels
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It is interesting...but I don't think hugely relevant to The Artist Formerly Known As XMRV, I think it's more about things like flu that can become serious pandemics when certain strains appear. I think the timing of the announcement has more to do with the recent announcement that the H1N1 pandemic is officially over.
pictureofhealth
XMRV - L'Agent du Jour
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"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.
I wonder if this is a reference to the WPI and whether this means that big federal funding may be more readily available for them in future?
I wonder if this is a reference to the WPI and whether this means that big federal funding may be more readily available for them in future?
toddm1960
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I wonder if this is a reference to the WPI and whether this means that big federal funding may be more readily available for them in future?[/QUOTE]
That's exactly what it means, the government is lining up to cover themselves knowing what's coming out from the FDA. You can almost feel the puckering going on right now, someone knows (or they're just finding out) this has been covered up for 25 years.
That's exactly what it means, the government is lining up to cover themselves knowing what's coming out from the FDA. You can almost feel the puckering going on right now, someone knows (or they're just finding out) this has been covered up for 25 years.
eric_s
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Hmm.. i don't know, it might be pure conincidence, but then if you think that there's a possibility that in 3 weeks the news will go all around the world that 5% or more of the population have a virus that might cause a number of diseases, the people will want to see a government that is prepared and has already started to learn it's lessons from the mistakes.
George
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I like it. Can we all just get like a sign or something and wear it with the new non word designation? (grins)
I think this was in response to the Swine Flu (yea right) "epidemic" that never happened and not XMRV. Agree, these people are so behind the times and still working on Swine Flu and NO, not XMRV. Just my opinion. Read something about this new fast change in the same article as the Swine Flu non-epidemic - you know, the one that costs hundreds of millions of vaccines to burn just for fun! Thanks WHO and CDC - Great job - yet again.
Typical Washington: Respond to what happened and not what may or is likely to happen in the future...
Typical Washington: Respond to what happened and not what may or is likely to happen in the future...
Exactly. They're "streamlining" the process to burn taxpayers more more rapidly. Brilliant.
taniaaust1
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who knows.. maybe this is one of the reasons why they delayed the positive findings on XMRV.. XMRV could be the "new" epidemic.
Ive always wondered if the holding up of the study was due to the government and health system wanting to be more ready for it .
Ive always wondered if the holding up of the study was due to the government and health system wanting to be more ready for it .
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long overdue
The way I see it, History will show that the United States went through a period of laissez faire, de-regulated government mentality that allowed insurance companies, oil companies, banks, and large coorporations to run roughshod over the environment and human rights, and most importantly health. The information age has ushered in a new era where information flows freely and allows for individuals and small groups to call BALONY when they see it.
It may seem like the horse has already left the barn becuase the regulation and oversight we have been missing for way for longer than I have been alive, is now getting addressed correctly. But that is just how our free market society has worked for so long, chasing the next buck and focusing on today rather than the long term.
At least now we have a president who wants to make things right, and stop the deception and corruption that has ruled for way too long. The are getting the message folks, thousands of them daily. Obviously it is too late for many of us, but they might prevent the next crisis
About time, its way overdue.
The way I see it, History will show that the United States went through a period of laissez faire, de-regulated government mentality that allowed insurance companies, oil companies, banks, and large coorporations to run roughshod over the environment and human rights, and most importantly health. The information age has ushered in a new era where information flows freely and allows for individuals and small groups to call BALONY when they see it.
It may seem like the horse has already left the barn becuase the regulation and oversight we have been missing for way for longer than I have been alive, is now getting addressed correctly. But that is just how our free market society has worked for so long, chasing the next buck and focusing on today rather than the long term.
At least now we have a president who wants to make things right, and stop the deception and corruption that has ruled for way too long. The are getting the message folks, thousands of them daily. Obviously it is too late for many of us, but they might prevent the next crisis
About time, its way overdue.
I think if XMRV was a new epidemic, a much, much higher number of people would be sick. As others have mentioned on other threads, only (approximately) 8% who have XMRV have ME/CFS. I have a feeling that the latter is the case...they're trying to get their ducks in order, especially regarding the blood supply issue.
*GG*
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I have seen this article posted in a few other places on the forum, but I think this is a great article where we can add comments and bring people's attention to many of our issues.
I already made a comment with regards to the CDC/Gov't/WPI/XMRV/poor funding, famous sufferer and suicide etc..
I think we should not bombard this thread, but put comments in here and there, not sure how we could/would coordinate this? But I think instead of a "slug" of comments that could be missed by many, if we just put comments in here and there, then it is more likely people will see it. Agree?
I think my comment should show up at around 200 if you want to give it a "thumbs up"?!
Can someone move this Thread to under Action Alerts and Advocacy so we can do the ideas I suggest above? thoughts?
I already made a comment with regards to the CDC/Gov't/WPI/XMRV/poor funding, famous sufferer and suicide etc..
I think we should not bombard this thread, but put comments in here and there, not sure how we could/would coordinate this? But I think instead of a "slug" of comments that could be missed by many, if we just put comments in here and there, then it is more likely people will see it. Agree?
I think my comment should show up at around 200 if you want to give it a "thumbs up"?!
Can someone move this Thread to under Action Alerts and Advocacy so we can do the ideas I suggest above? thoughts?
All posts for a given topic belong in a single thread. There is no evidence that XMRV is a pandemic and this thread is properly placed in "Other Health News and Research".