"Emergency Use Authorization" declared regarding H7N9 Influenza?

I believe I need some help understanding this. It is a letter date 19, April 2013 which states the Secretary of Health and Human Services has declared an Emergency Use Authorization relating to the latest Bird Flu strain. This is a bit confusing to me because it is simply talking about the use of In Vitro Diagnostic testing to detect it, yet on an Emergency Basis?

Let me share some specifics from the text and maybe someone else can help make sense of it?

SUMMARY: The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. § 360 bbb-3(b)(4). On April 19, 2013, the Secretary determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves the avian influenza A (H7N9) virus.

On the basis of this determination, she also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the avian influenza A (H7N9) virus pursuant to section 564(b)(1) of the FD&C Act, 21 U.S.C. § 360 bbb-3(b)(1), subject to the terms of any authorization issued under that section.

What's the need and fuss about? They need an emergency declaration to use testing now? There is more here... Much more..that leaves a funny feeling.

Under Section 564 of the FD&C Act, the Commissioner of the Food and Drug Administration (FDA), acting under delegated authority from the Secretary of HHS, may issue an Emergency Use Authorization (EUA):

1) authorizing the emergency use of an unapproved drug, an unapproved or uncleared device, or an unlicensed biological product; or

2) an unapproved use of an approved drug, approved or cleared device, or licensed biological product.

Say huh? What are they talking about here? The focus APPEARS to simply be diagnostic testing to verify the presence of the flu bug. However bad the bug may be, are we so backward now that we don't have the tools to meet the challenge of simply testing for it without Emergency declarations???

One more piece to this....

II. Determination by the Secretary of Health and Human Services

On April 19, 2013, pursuant to section 564(b)(1)(C) of the FD&C Act, 21 U.S.C. § 360bbb- 3(b)(1)(C), I determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves the avian influenza A (H7N9) virus.

Source (PDF File)

Have similar emergency delcarations been made during previous flu outbreaks? Why the need for it here? I know this is a nasty bug and has potential to be exceptionally nasty ..but what does this order allow them to do that cannot otherwise be done without it?

I looked up In Vitro Diagnostics ...and it all sounds quite routine. Hardly the topic I'd think would need these kinds of declarations?

About In Vitro Diagnostics

In vitro diagnostic (IVD) tests are performed to provide a diagnosis by assessing an analyte in a test tube, or more generally, in a controlled environment outside a living organism. The use of the term 'in vitro', which in Latin means 'in glass', is a reflection of the fact that the vast majority of these tests were originally performed in a test tube. The modern IVD industry produces reagents and analytical instruments, used to perform an array of in vitro tests to diagnose and monitor different types of diseases. The reagent used in an IVD test is a highly specialised chemical or biological substance that is able to react with target substances in the biological samples provided by the patient, which may include blood, tissue, urine or another type of sample. This process provides a result that can be measured or seen, helping doctors to make a health-related assesment.

Source

So what am I missing here? What is the purpose? I know we have medical professionals here and some that work around the field of epidemiology, if not directly in it. Perhaps someone can shed some light on this?

I'd also encourage everyone to read the letter this comes from. There are 4 criteria that can justify this order. ONE of them must be met. The 4th is the justification used above in disease outbreak being a National Security threat or threat to US citizens overseas. The other 3 deal with Military crisis, Nuclear/Biological/Chemical attack or agents related to those areas or a "Domestic Emergency" declaration by the Department of Homeland Security.

Obviously, they are working from the 4th one.....yet that's in the same paragraph as those first 3. Those first 3 are essentially states of war to one degree or another ..or very similar in the DHS declaration, to my thinking. What the devil is going on?? The flu bug is looking potentially bad ..but *THAT* bad? At *THIS* point?

I'd love for someone with medical background to say how this is all just a non-starter and nothing at all

I would say it means they can test you without your permission esp. if you have been out of the country and/or the test may not yet be proven. Declaring an emergency would allow this.

This is just a best guess though.

reply to post by Wrabbit2000


I think it is referring to US citizens, or probably anyone, abroad who are trying to re-enter CONUS. Particularly people coming from the areas where the new strain of bird flu has been found or suspected.

Attempting these types of tests on everyone trying to enter the US is just not feasible, but just focusing on people coming from China, and probably soon southeast Asia, is much more realistic.

This is just my opinion based on the wording of your source and common sense. Then again, the US Govt. is rarely guilty of using common sense.

I think it's the high fatality rate that has them worried.

Link to CNN article

Meanwhile, the National Health and Family Planning Commission said in its daily update on H7N9 cases that a total of 109 H7N9 cases have been reported within mainland China, including 23 deaths. Most cases have been confined to Shanghai and neighboring provinces in eastern China.

RSOE Link

List of RSOE updates

24 deaths, of 103 infected... so about 24% chance of dying from it... This is just the cases they admit to though.

IIRC its about as bad as the Spanish Flu

Wiki puts the SPanish Flu killing globally at :

The global mortality rate from the 1918/1919 pandemic is not known, but an estimated 10% to 20% of those who were infected died. With about a third of the world population infected, this case-fatality ratio means 3% to 6% of the entire global population died.[29] Influenza may have killed as many as 25 million people in its first 25 weeks. Older estimates say it killed 40–50 million people,[4] while current estimates say 50–100 million people worldwide were killed.[30]

Wiki

Right now, they only know of (or admit to) 1-2 cases of human to human transfer, tied to close proximity aka caring for the ill.

So right now with out it being able to go directly human host to human host, it's killing about 23% of those that catch it.

Picture it getting out like SARS or the Swine flu.

I think they are right to be concerned about the H7N9, the fact that there are 9 novel variations of it should speak for itself.

M.

reply to post by Wrabbit2000


I am not for sure, but I think this means it authorizes testing prior to return to the USA. Meaning US citizens can/will be tested before boarding a return flight back home to prevent an outbreak here. Or at land border crossings, and at sea ports prior to disembarking.

reply to post by liveandlearn


That actually makes a lot of sense.

Wouldn't the government declaring an emergency and citing national security allow them to enact a sort of "soft" quarantine on travelers?

reply to post by Carreau

I suppose if that is all there is to this and it's simply a defensive measure to test people without getting the "I have my rights!! I'm getting on that plane!! -cough- -cough- -hack- -cough-" Then I'd call it a common sense preemptive measure.

I guess I may be getting a bit cynical in how I'm coming to view emergency anything declarations lately. Although in this case? Who knows... That's why I figured I'd bring it to everyone in as open a way as possible and throw it into the ring for a beating to see what came out in the end.

Hmmm. I think it is to be able to test people to find if they have the flu if they fly to a country where the flu outbreak is. Nothing about restricting people from flying there, nothing about stopping the spread of this virus is being initiated. It seems strange that anything that interferes with capitalism is disregarded, the logical thing to do is to restrict going to these areas till a suitable way to control the spread of this disease is found.

Same with things like zebra mussels, they knew that they could be a problem but because of international trade they disregarded safety and allowed risk to happen. International ships in great numbers did not need to be coming into the great lakes, but I suppose, send the jobs to china means the Iron pellets has to be sent there also.

Originally posted by liveandlearn
I would say it means they can test you without your permission esp. if you have been out of the country and/or the test may not yet be proven. Declaring an emergency would allow this.

This is just a best guess though.

The EUA doesn't authorize involuntary testing or any aspects of a quarantine.

As far as I can tell, this order allows health providers and related entities to use in vitro diagnostic devices and techniques that have not yet been approved by FDA/HHS for use on humans in the U.S.

The order probably covers a wide array of drugs, devices and techniques that haven't been cleared/approved for use so that if the flu outbreak spreads, companies will be able to provide and health care providers able to utilize the not-yet-approved tools to combat the outbreak.

I don't want to downplay the seriousness of any of this, nor the potential danger of the avian flu.

This authorization may suggest the potential for a very serious situation. I do not know how often these are issued.

reply to post by Wrabbit2000


I've been watching this flu bug via the RSOE app for my phone, everyday (or so) there is an update over it. There have been 53 updates alone on this bug, since 1 APR 2013.

I suspect there is a tie in somewhere to the mass pig deaths they had end up in the water as well, but that's just my conjecture at this point.

The big if, or when, if you will, is: How long until it is transmitted by cough / sneeze as well? (Aerosol vector.)

The line from the movie Contagion, where the birds are weaponizing the H5N1, is oddly ironic. Yet in this case the H7N9 is worse.
Latest RSOE bit on the virus. RSOE link

The deadly H7N9 bird flu strain claimed a new victim yesterday when a hospital patient died in China, state media reported, bringing the death toll from the recently identified virus to 24. A patient surnamed Chen died in the eastern city of Shanghai after 12 days of medical treatment failed, Xinhua news agency said. China has recorded more than 120 cases of H7N9 infection so far. Most cases since the new strain was first identified in late March have been confined to eastern China, and the only one reported outside mainland China has been in Taiwan. The Taiwanese victim was infected in China. But experts fear the possibility of the virus mutating into a form easily transmissible between humans, with the potential to trigger a pandemic. The World Health Organization has said there has been no evidence so far of human-to-human transmission but warned that H7N9 was "one of the most lethal" influenza viruses ever seen. Chinese researchers, reporting in The Lancet recently, said they had confirmed poultry as a source of the virus among humans. Chinese health officials have acknowledged so-called "family clusters," where members of a single family have become infected, but have not established any confirmed instances of human-to-human transmission.

M.

There was the Spanish flu of roughly 100 years ago, when the world population as only 3/4 of what it is no, where about 1/2 the world population was wiped out.

Could this happen again, say at least every 100 years or so? Or more frequently as the population and the use of mass-produced livestock farming for food, are both increasing, and the tree/forest population, is decreasing.

The order is to allow the use of newer instant testing kits which have not gone through the multi-year approval process the FDA normally requires.

The logic being that the testing equipment has proven useful and that by the time it went through the normal FDA process the emergency would be past.

As a side note, this also clears the way for vaccines to be used which have not gone through the normal FDA program, similar to the live virus nasal vaccine that was rushed through to the public the last time Avian flu came ot the US.

It's clear they want to be prepared for this new flu to spread to the US, an event which following the normal flu season cycles will be fairly soon.

This is a terrific free book about the bird flu; it's about H5N1 but the information otherwise is pretty on-target.

birdflubook.com...

reply to post by Wrabbit2000


"Don't test, don't find" is the standard policy for dealing with modern pandemics, especially non-contagious environmental diseases - but many contagious diseases are officially "overlooked" too, particularly when people have to pay out-of-pocket for medical tests.

This special order may accomplish several things, including:
* Detainment, testing and quarantine at border crossings;
* Federally funded "free" testing in communities;
* Monitoring of H7N9 pandemic spread.

I do think H7N9 has been spreading for a while in North America - likely a different clade than the one in China - but we don't know because it's never been tested for.

If you missed my post above, check this out for a better understanding of the science, reasoning and objectives:

One Flu

reply to post by soficrow

I really appreciate your weighing in. It sounds like this topic is a niche area of specialty for what you follow or professionally work with? I'm not real clear which, but your contribution is very much appreciated.

It's starting to sound like the emergency declaration is nothing nefarious in this case but a well reasoned reaction to a potential threat with very serious implications. In that case, I'm very happy to learn that in this instance. I know the tendency is to assume every action by the Government is somehow inherently bad or with ulterior motives to fill a dump truck. It's nice, just occasionally, when that may be proven wrong and they're shown to be doing the right thing. As...it seems, this may well be.

well in two weeks im returning to the USA from Vietnam, so i will definitely check back in this thread once ive crossed the border and let you know if there were any delays or setbacks

just checked the local news here and the strain floating around here is the H1N1, havent heard of any reports of the H7N9 around where i am as of yet

Oh this just means that they can test you without your consent.
And then stick you into a FEMA camp until you die..... errr I mean get better.

This has nothing to do with authorization to test people. This is authorization to use an uncertified testing procedure for diagnostic purposes. PointDume spelled it out in an earlier reply. This particular strain is new and there have been no diagnostic tests developed and certified by the FDA. Consequently they need to use basic standard laboratory methods to diagnose.

I have a friend that is fairly high up the chain at the CDC here in Atlanta. I am checking with her later this afternoon on this and will let you know if she has anything to say or if we should actually be worried about anything here. If anyone will know, she will.

She is with the NCEZID (National Center for Emerging and Zoonotic Infectious Diseases) branch so probably is directly involved with the research and findings on this.

National Center for Emerging and Zoonotic Infectious Diseases:

The National Center for Emerging and Zoonotic Infectious Diseases aims to prevent disease, disability, and death caused by a wide range of infectious diseases. We focus on diseases that have been around for many years, emerging diseases (those that are new or just recently identified), and zoonotic diseases (those spread from animals to people). Our work is guided in part by a holistic "One Health" strategy, which recognizes the vital interconnectedness of microbes and the environment. Through a comprehensive approach involving many scientific disciplines, we can attain better health for humans and animals and improve our environment.

I searched for the bill name and found and explanation from Cornell Law
There is further definition of terms and explanation at the link

(a) In general
(1) Emergency uses Notwithstanding any provision of this chapter and section 351 of the Public Health Service Act [42 U.S.C. 262], and subject to the provisions of this section, the Secretary may authorize the introduction into interstate commerce, during the effective period of a declaration under subsection (b) of this section, of a drug, device, or biological product intended for use in an actual or potential emergency (referred to in this section as an “emergency use”).

(2) Approval status of product An authorization under paragraph (1) may authorize an emergency use of a product that—
(A) is not approved, licensed, or cleared for commercial distribution under section 355, 360 (k), or 360e of this title or section 351 of the Public Health Service Act [42 U.S.C. 262] (referred to in this section as an “unapproved product”); or
(B) is approved, licensed, or cleared under such a provision, but which use is not under such provision an approved, licensed, or cleared use of the product (referred to in this section as an “unapproved use of an approved product”).

(3) Relation to other uses An emergency use authorized under paragraph (1) for a product is in addition to any other use that is authorized for the product under a section of this chapter or the Public Health Service Act referred to in paragraph (2)(A).