FDA Approves First Birth Control Pill

• Author: Allen Pusey
• Pages: 72-72

PHOTOS BY BETTMANN/CONTRIBUTOR; UNDERWOOD ARCHIVES/GETTY IMAGES; SHUTTERSTOCK

72 || ABA JOURNAL MAY 2019

Precedents || By Allen Pusey

GREGORY GOODWIN PINCUS was 47 when

he fi rst met Margaret Sanger in 1950 at a

Manhattan apa rtment. Though widely regarded

as a genius, especia lly by himself, Pincus was an

acknowledged exper t in mammalian reproduc-

tion. But his reputation for eccentric scientifi c

research had lef t him marginalized in profe s-

sional and academic cir cles.

Sanger, of course, was the legendar y femi-

nist and founder of what became Plan ned

Parenthood Federation of America. Sanger, then

71, had endured more than her sha re of ostracism and

arrests in her purs uit of gender equality, sexual freedom

and what she referred to as “ voluntary motherhood.”

From her earliest years, Sa nger had advocated for a

wide variety of so cial issues. But on this particula r eve-

ning, she urged Pincus to b egin research into one of her

own lifelong quests: an oral medicat ion that would allow

any woman—in the angry words of a judge who ha d once

sentenced her—“the right to copulate w ith a feeling of

security that t here will be no resulting conception.”

What she proposed to Pincus bore c onsiderable risk. In

1917, Sanger was imprisoned for distributing fami ly plan-

ning information. At least 30 s tates still carried cr iminal

restrictions aga inst selling or distributing contracept ive

devices, and some stil l made it illegal to counsel couples,

even married couples, on fam ily planning and birth con-

trol. In Massachuset ts, where Pincus conducted his lab-

oratory researc h, his work on a contraceptive might

well have been a felony.

Contraception, par ticularly for women, varied

from the mythica l to the crude. Sanger was insist-

ing that Pincus develop something for women that

didn’t depend on the vagaries of the menstr ual cycle

or internal methods such a s the diaphragm or cervi-

cal caps.

What Sanger had drea med of was a pill that

would impede conception without other forms of

intervention—something safe, inex pensive and

unobtrusive that women could control.

Pincus believed that wa s possible. His the-

ory was elegant, a nd in its own way, nat-

ural. He pinned his resea rch on the use

of progesterone, a natural hor mone that

intercedes in the female reproduc tive cycle

when a woman becomes pregnant. By

introducing progesterone into the body be fore

pregnancy, Pincus believed a woma n’s reproduc-

tive system would respond by keeping her from

becoming pregnant.

Pincus tested h is theory fi rst on rabbits and

rats, reporting a 90 perc ent success in suppress-

ing conception using progestin, a chemic ally

produced progesterone. But that fell far short of

what Pincus believed or exp ected. In his search

for a more e ective proge sterone, he began to

use norethynodrel, a sy nthetic progesterone

produced by a small pharma ceutical company outside

Chicago, G.D. Searle. Concerned w ith potential liabilities

attached to the project , the company provided the pro-

gestin to Pincus a nd his colleagues—but in unmarked

container s.

In early 1957, aft er several trials at birth control cli nics

in Puerto Rico, a s well as smaller trials among patients

in the U.S., Searle fi rst submitted the new pill, a combi-

nation of estrogen and progesterone labeled E novid, to

the U.S. Food and Drug Admini stration for its approval.

In June, the FDA approved Enovid—though not for birth

control but for menstrual disorders.

By 1960, when the FDA was asked to approve Enovid

for contraception, the “bir th control pill” had already

proved highly e e ctive. But with a regulatory st orm gath-

ering over birth defect s attributed to the popular seda-

tive thalidomide, legal and moral objections were y ielding

to concerns that the hormona l compound would have

dangerous side e ec ts or long-term consequence s to

fertility.

A survey of 60 physicians who ha d prescribed

Enovid produced tepid support for approval, but

none reported safety c oncerns. And on May 9,

1960, the FDA announced with abs olutely no

fanfare that it would approve the medic a-

tion for contraception. “We had no choice as

to the morality that might be i nvolved,” the

FDA noted its o cia l press release.

In its 1965 decision Gri swold v.

Connecticut, the Supreme Court e viscer-

ated state laws agai nst the dissemina-

tion of contraception. And by the time of

their deaths—Sanger in 1966, P incus in

1967—the sexual revolution was in fu ll fury,

exactly as t he two had envisioned. Q

May 9, 1960

Gregory Pincus

Margaret Sanger

FDA Approves First Birth Control Pill