Much has been made of the birth control pill’s revolution from the perspective of allowing women the choice to become a mother, or enter the workforce and delay marriage/childbirth, engage in recreational sex, etc.
But little has been mentioned of the changes the pill brought to regulatory science.
“Many of the steps that underlie modern drug approvals — extensive clinical trials, routine referrals to panels of outside experts, continuing assessments of a medicine’s safety, and direct communications between the F.D.A. and patients — were pioneered to deal with evolving concerns about the pill’s safety,” writes Gardiner Harris in the New York Times, who says the pill, now fifty years old, is the most significant scientific breakthrough of the 20th century.
It’s hard to argue with that. “In regulatory terms, the pill brought about a kind of reformation: just as Martin Luther insisted that individual Christians could communicate directly with God without the mediation of priests, the pill eventually led the F.D.A. to communicate directly with patients without going through doctors.”