Dakota Beacon

A vaccine and treatment protocols for Covid-19 that facilitates a timely return to normal commercial activity demands that the FDA immediately implement just-in-time solutions. In the past, this bloated and sloth-like government agency has systematically increased the cost and duration of its drug regulating responsibilities, likely due to its biggest mistake in its history.

Thalidomide is a sedative drug discovered at the end of the 1950s, which caused a worldwide tragedy. The drug had been prescribed to many pregnant women in order to relieve pregnancy nausea. It was later found that thalidomide caused irreversible damages to the fetus and thousands of children were born with severe congenital malformations. The goal ever since has been to avoid similar outcomes of new drugs.

The Trump Administration's courageous bi-partisan “Right to Try” legislation was the first real legislative push-back to the FDA's bureaucratic one=size=fits-all approach to drug regulating. During the Covid=19 federal response, The President has worked effectively with the FDA to provide timely decisions due to the seriousness of the situation.

It is imperative that the following time lines (with minor variation) are met to prevent a worldwide depression that would kill many more than Covid-19:

Present =  Nationwide re-activation of all food supply activities in accordance with “30 days to slow the spread”.

April 30 - Last day for any Covid-19 vaccine trial to be started. Beginning of putting America back to work with periodic evolving adjustments to physical distancing guidelines to prevent further outbreak spikes.

June 30 – Nationwide implementation of vaccine production of the two most promising trials. Last day to accept Covid=19 treatment protocols for review.

July 31 – Nationwide Implementation of the most promising vaccine in order of the degree of risk. And disinfecting of K-12 facilities nationwide.

August 31 – Return to K-12 education and continued periodic disinfection of facilities. Return to all commercial activity with physical distancing in place.

Failure to implement the above time constraints would cause a worldwide loss of life due to economic stagnation that would be well in excess of the losses to be expected from continuation of the status quo (placing all the risk on health care and goods distribution workers).

This is not a normal medical supply crisis and the FDA cannot afford to treat it like just another quest for perfection due to the memory of thalidomide.