Posted: 04/18/2021 15:00:04 PM
Mr. Joe Curran, author of the April 7 guest column on “Opportunities lost…” due to “complexity [FDA] regulations ”, might be interested to know that families in the United States were largely spared the tragedy of the“ thalidomide babies ”thanks to the diligence of Dr. Frances Oldham Kelsey, a physician-researcher who served as as responsible for regulatory review for the FDA from 1960-2005.
Although thalidomide was widely distributed in Europe and other countries in the 1960s as a sleeping pill and treatment for morning sickness during pregnancy, Dr Kelsey was concerned that the safety studies had not been adequate. Despite constant pressure from the pharmaceutical company to seek approval to market the drug in the United States, Dr Kelsey refused to approve the request due to its insufficient evidence of safety.
We owe a debt of gratitude to Dr Kelsey and other diligent scientists and regulators who work quietly and out of the spotlight in the interest of the people.
As imperfect and vulnerable to bureaucratic slowness as the agency is, the FDA’s goal is to protect public health. And however creative, exciting and valuable the contributions of private enterprise may be, the purpose of private enterprise is to make money.