On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. § 360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency under 42 U.S.C. § 247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents — in this case, swine influenza A (H1N1).
Joshua M. Sharfstein, MD, Principal Deputy Commissioner, Acting Commissioner for the FDA wrote he is “authorizing the emergency use of the Swine Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu Panel) for the presumptive diagnosis of swine influenza A (H1N1) virus infection in human individuals who have been diagnosed with influenza, caused by a virus not subtypeable by currently available FDA-cleared devices, (emphasis mine) subject to the terms of this authorization.”http://www.fda.gov/cdrh/emergency/panel-authorization.html#ft1
An Emergency Use Authorization (EUA) was issued by the Food and Drug Administration (FDA) to allow either the use of an unapproved medical product or an unapproved use of an approved medical product during certain types of emergencies with specified agents.
”The US Centre for Disease Control and Prevention (CDC) sent materials for a quick diagnostic test to Mexico so scientists there can quickly screen people for the new flu. The centre’s Dr Richard Besser said test kits were also en route to health departments in all US states to speed up surveillance.” http://www.prisonplanet.com/mexico-encouraged-by-fall-in-new-flu-cases.htmlWhatever Funny thing is, ” Currently, the EUAs do not include translated versions of fact sheets.”
So what’s the problem? The tests have not been approved, are unreliable and physicians around the world may not be able to read English!
Section 8- “While Tamiflu and Relenza have been previously approved by the FDA, certain aspects of the distribution and use of these products are not covered by their approved applications. An EUA allows these drugs to be legally distributed for the unapproved (empasis mine) uses for which they are being authorized. FDA has authorized emergency use of disposable N95 respirators by the general public during this declared emergency. These respirators may help to keep out germs that may be present in the air you breathe. The rRT-PCR Swine Flu Panel diagnostic test has not been approved or cleared by the FDA. “(empasis mine) An EUA allows this unapproved diagnostic kit to be legally distributed and used for the authorized purposes.
Disposable N95 respirators offered by Survivair say ” The ONE-Fit NBW95 and NBW95V meet NIOSH N95 standards, CDC guidelines for M Tuberculosis exposure control and are recommended as sufficient protection against many substances, including pandemic diseases such as H5N1 Avian Flu and SARS. 
http://www.survivair.com/search/searchResults.asp This mask is a far cry from the paper thin masks I see people wearing. Other sources for masks are here- http://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/n95list1.htmlA EUA is currently in effect. ” The FDA made available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances. On April 27, 2009, the FDA issued EUAs for the use of certain antiviral products (Relenza, Tamiflu), N95 respirators, and for the rRT-PCR Swine Flu Panel diagnostic test. Additional information on these EUAs can also be found on FDA 2009 H1N1 Virus site http://www.cdc.gov/h1n1flu/eua/qa.htm
Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act), amended by the Project BioShield Act of 2004, permits authorization of such products for use in diagnosing, treating, or preventing serious or life-threatening diseases or conditions caused by biological, chemical, radiological, or nuclear agents even when they are not approved AND ,
Even though WHO has renamed the Swine Flu to A/H1N1 or Influenza H1N1, an FDA, CDC report says, “Swine flu is a respiratory disease of pigs caused by type A influenza virus that regularly causes outbreaks of influenza in pigs . Human cases of swine flu virus infection have been identified in the United States and internationally. CDC has determined that this virus is contagious and is spreading from human to human. ” http://www.fda.gov/cdrh/emergency/panel-factsheet2.html
Despite “the fact that it (the test) does not meet certain requirements otherwise required by federal law” it is being distributed to public health and other qualified laboratories and doing so with no liability on the part of the government. Sharfstein also waived any liability for citizens should the test or cure result in additional illness, death or damages. “The Public Readiness and Emergency Preparedness Act (“PREP Act”) enacted as Division C of the Defense Appropriations Act for fiscal year 2006, Pub. L. No. 109-148, added new authorities under the Public Health Service (PHS) Act to alleviate concerns about liability related to the manufacture, testing, development, distribution, administration and use of countermeasures against chemical, biological, radiological and nuclear agents of terrorism, epidemics, and pandemics. http://www.hhs.gov/disasters/emergency/manmadedisasters/bioterorism/medication-vaccine-qa.html
Let’s hope The rRT-PCR Swine Flu Panel speeds up identifying cases. The vaccine for the original swine flu ended up killing more people than the virus itself.
I would expect numbers to rise due localized testing rather than having to send samples direct to the CDC. I find it interesting as well that the CDC says “A negative RT-PCR test should not be interpreted as demonstrating that the patient does not have swine influenza virus infection.” http://www.swinefluprevent.org/interpreting-swine-influenca-rt-pcr-detection-panel-test-results-fact-sheet-for-healthcare-providers
To summarize The rRT-PCR Swine Flu Panel:
1. The test was never approved for this use.
2. The test results are unreliable.
3. There is no liability.
4. Our tax dollars are paying for this for U.S. and world wide distribution.
5. The Instructions are in English.
6. It might save lives just to spite itself.
You might like these related posts-
The most reliable Google Maps on Swine Flu is being put assembled by Henry Niman, founder Recombinomics, who has been tracing the evolution of influenza for the last five years http://maps.google.com/maps/ms?ie=UTF8&hl=en&t=p&msa=0&msid=106484775090296685271.0004681a37b713f6b5950&ll=47.517201,-109.335937&spn=101.871352,255.585938&z=2
Open wide, say ahhh and check out these posts on the A/H1N1 Swine Flu from Ahrcanum, where the conspiracy spreads as fast as the virus itself . Our disclaimer-Swine Flu Conspiracy theory can sometimes be triggered by real world events. https://ahrcanum.wordpress.com/swine-flu-report/
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