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.
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
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
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