DES was presented as a package to the FDA and was coordinated by a committee of drug company representatives, under the auspices of what would become the American Pharmaceutical Society, who pooled favorable research and excluded unfavorable outside research. Not a single durg company did any independent research, much less a controlled study or clinical trial, to determine the safety and efficacy of DES was presented. The FDA’s monitoring budget in 1941, when DES was first approved, was $103,000 to monitor thousands of new drugs, a fraction of what it is today. Setting the stage for The DES Tragedy!
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