Monday, May 14, 2012

ITS AN FDA WORLD AFTER ALL

Apr 23, 2012 The FDA released a document that seems to have fallen under the radar of the press and of the general population.  A press release reads:

“As our world transforms and becomes increasingly globalized, we must come together in new, unprecedented, even unexpected, ways to build a public health safety net for consumers around the world,” said FDA Commissioner Margaret A. Hamburg, MD.1 
 
This corresponded to the release of the, Global Engagement Report, 2 detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency.”1 It is a must read and a must re-read.  Welcome to the New World Order, Big Brother FDA.

This is a 40 page PDF file that illustrates the plan for the integration of the FDA with several other organizations throughout the world in a mission to protect the health and welfare of the people of this planet, while assuring the citizens of the United States of America that their food, medical devices and medicines are up to FDA standards.

The report has a highlighted quote in its early pages that states:

“Over the next decade, FDA will continue to transform from a predominantly domestically focused Agency, operating in a globalized economy, to an Agency fully prepared for a regulatory environment in which FDA-regulated products know no borders.”  Deborah Autor, FDA Deputy Commissioner for Global Regulatory Operations and Policy.

At first look this is a worthy and humanitarian ideology, with better, safer, standardized and uniformly regulated jargon that feels warm, fuzzy and just darn nice of us to enter into this project.  There are examples of the triumphs of the FDA in the past as it helped wage war on HIV and its less successful interventions such as the melamine tainted animal chows and heparin preparations that were substandard.

In short there is a significant message here that the United States Government is going global and if you don’t meet our standards then you will be banned from importation.  This is also to include pharmaceuticals that are now to be intercepted by postal authorities when shipped into the United States for personal use, to assure us that we are not getting substandard medications.

There is also reference to tobacco and smokeless tobacco products in one sentence and inference that they are both responsible for the thousands of deaths that have occurred to lung disease.

The report is a warning to the populace that the FDA is going to regulate and control everything it can through not only border inspection, but through direct intervention on a global scale.  The tactics of influencing the regulatory standards of the world are imperialistic at the least.  The inference that there is significant doubt as to the validity of offshore research is also made.

In its triumphant ending is the comment that there is to be leverage to assist in the implementation of the American way.  This is politely defined as cooperation, but is seen more as political and economic blackmail if looked at from another level.

The bottom line is that this is the beginning of the global microscope of the FDA and a flexing of its muscles to the world.  Along with this is the protection and adoption of a best for America nanny state that makes decisions for the populace that are based on its own ideology.  The report is highly referenced, the majority FDA or other government publications that on review are fact and data sheets with no traceable foundations other than other government documents.

It is a noble ideal to have regulation and standards that enhance the safety of the populous.  It is not a noble ideal to imply that the citizens of the United States of America are not intelligent enough to make any decisions without a regulatory stamp affixed.  The generic medications that are available from Canadian Pharmacies would be curtailed and confiscated should this be FDA’s whim. 
 
The regulators need to be overseen and not have a carte blanc check to enter into the world market and decide for us what is good for us and what is not without good reason and fairness.
In reality the ones that will benefit from this are the usual big corporate interests; Big Pharma, Big Tobacco and the Device Manufacturers in the US.  There will be a de jure monopoly for some of these companies if foreign manufacturers see upping standards and testing requirements that may be accepted in their countries, but not by the FDA, as too costly, redundant or frankly unnecessary. 
 
If there is risk and harm by all means let us minimize this risk and harm.  But to take on a theme of Manifest Destiny to the world in the health, food and medical devices frontier is arrogant and FDA like.
 
Remember this is the organization that still allows Chantix to be sold.

That in itself is enough said.






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