– PRESS RELEASE –
The FDA and Congress Fail Again
On the 20th of April, 2018, the CDER division of FDA in a “Complete Response” denying approval of the New Drug Application (NDA) #209075 for treating skin wounds, such as seen in diabetes, burns, etc., once again sacrificed the American public health to the administrative state. Prescription holders in America cannot get a drug at their local pharmacy that is available to other sufferers worldwide.
With the gravity that this new material has relative to advancing the public health, in 2015, the office of a U.S. Senator was contacted asking for assistance in navigating the out of control bureaucracy of the FDA. Never fulfilling their promise to help those they are elected to represent, it is once again confirmed that many of those we elect are interested only in reelection. Rather than the service and sacrifice of the Framers and Founders, they view their positions of honor and trust as a job to be held onto.
The unfathomable irony is that FDA approved drug manufacturers in the U.S. ship the drug which is the subject of NDA 209075 by the ton around the globe for use in multiple medical indications. Worse, the CDRH division of the FDA approved the material as a “device” for all the indications seeking CDER approval beginning in the 1970s. Broken does not even approach being an adequate description of the FDA failure.
Capable of aiding in the healing of any tissue type that it is in contact with, science has demonstrated its efficacy and 100% safety, whether ingested, surgically applied, or used topically, for over 40 years. Now researchers publish over 200 peer-reviewed scientific articles per year describing its uses.
Government agencies like the FDA rule America without Constitutional authority by making rules for themselves that are published in the Federal Register having the effect of unaccountable law. This is the out of control “swamp” the President Trump is trying to drain!
– PRESS RELEASE