May 9, 1960: FDA approves first birth control pill

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Gregory Goodwin Pincus was 47 when he first met Margaret Sanger in 1950 at a Manhattan apartment. Though widely regarded as a genius, especially by himself, Pincus was an acknowledged expert in mammalian reproduction. But his reputation for eccentric scientific research had left him marginalized in professional and academic circles.

Sanger, of course, was the legendary feminist and founder of what became Planned Parenthood Federation of America. Sanger, then 71, had endured more than her share of ostracism and arrests in her pursuit of gender equality, sexual freedom and what she referred to as “voluntary motherhood.”

From her earliest years, Sanger had advocated for a wide variety of social issues. But on this particular evening, she urged Pincus to begin research into one of her own lifelong quests: an oral medication that would allow any woman—in the angry words of a judge who had once sentenced her—“the right to copulate with a feeling of security that there will be no resulting conception.”

What she proposed to Pincus bore considerable risk. In 1917, Sanger was imprisoned for distributing family planning information. At least 30 states still carried criminal restrictions against selling or distributing contraceptive devices, and some still made it illegal to counsel couples, even married couples, on family planning and birth control. In Massachusetts, where Pincus conducted his laboratory research, his work on a contraceptive might well have been a felony.

Contraception, particularly for women, varied from the mythical to the crude. Sanger was insisting that Pincus develop something for women that didn’t depend on the vagaries of the menstrual cycle or internal methods such as the diaphragm or cervical caps.

What Sanger had dreamed of was a pill that would impede conception without other forms of intervention—something safe, inexpensive and unobtrusive that women could control.

Pincus believed that was possible. His theory was elegant, and in its own way, natural. He pinned his research on the use of progesterone, a natural hormone that intercedes in the female reproductive cycle when a woman becomes pregnant. By introducing progesterone into the body before pregnancy, Pincus believed a woman’s reproductive system would respond by keeping her from becoming pregnant.

Pincus tested his theory first on rabbits and rats, reporting a 90 percent success in suppressing conception using progestin, a chemically produced progesterone. But that fell far short of what Pincus believed or expected. In his search for a more effective progesterone, he began to use norethynodrel, a synthetic progesterone produced by a small pharmaceutical company outside Chicago, G.D. Searle. Concerned with potential liabilities attached to the project, the company provided the progestin to Pincus and his colleagues—but in unmarked containers.

In early 1957, after several trials at birth control clinics in Puerto Rico, as well as smaller trials among patients in the U.S., Searle first submitted the new pill, a combination of estrogen and progesterone labeled Enovid, to the U.S. Food and Drug Administration 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 “birth control pill” had already proved highly effective. But with a regulatory storm gathering over birth defects attributed to the popular sedative thalidomide, legal and moral objections were yielding to concerns that the hormonal compound would have dangerous side effects or long-term consequences to fertility.

A survey of 60 physicians who had prescribed Enovid produced tepid support for approval, but none reported safety concerns. And on May 9, 1960, the FDA announced with absolutely no fanfare that it would approve the medication for contraception. “We had no choice as to the morality that might be involved,” the FDA noted its official press release.

In its 1965 decision Griswold v. Connecticut, the Supreme Court eviscerated state laws against the dissemination of contraception. And by the time of their deaths—Sanger in 1966, Pincus in 1967—the sexual revolution was in full fury, exactly as the two had envisioned. 


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