Dr Frances Kelsey: thalidomide and the precautionary principle

July, 2015

Helena Paul & Philip Bereano

"The case of thalidomide shows how vital it is not to ignore early warning signals or be hurried into premature approvals of innovations, with serious and often irreversible consequences at a later date."

We owe a deep debt of gratitude to Dr Frances Kelsey, write Helena Paul & Philip Bereano. In 1960, she defied her bosses at the FDA to prevent the licensing of thalidomide in the USA, saving thousands from being born with serious deformities. Her tough approach to minimising the risk from new drugs contains lessons we ignore at our peril.