FDA Approval of the Pill (1960): Enovid and the Contraceptive Era

The FDA approval of the pill in 1960 made Enovid, produced by G. D. Searle and Company, the first drug in the world approved for use as an oral contraceptive. On 9 May 1960 the US Food and Drug Administration announced that it would license Enovid for birth control, a decision that gave women an effective and private means of preventing pregnancy. Within a few years “the pill” had become one of the most widely used medicines in America and a symbol of social change.

Background: Sanger, McCormick and Pincus

Margaret Sanger had campaigned since the 1910s for women’s access to birth control, which was then restricted by law in many US states. She dreamed of a simple “magic pill”. In 1951 she met Gregory Pincus, a reproductive biologist who had co-founded the Worcester Foundation for Experimental Biology in Shrewsbury, Massachusetts, and persuaded him to look for a hormonal method.

Funding came mainly from Katharine Dexter McCormick, one of the first women to graduate in science from the Massachusetts Institute of Technology and an heir to the International Harvester fortune. From 1953 she gave the project a total usually estimated at around 2 million dollars. Pincus and his colleague Min Chueh Chang showed in animal experiments that progesterone, a natural hormone, could stop ovulation.

Chemistry and clinical trials

Natural progesterone was weak when swallowed, but chemists had recently made stronger synthetic versions known as progestins. Carl Djerassi, Luis Miramontes and George Rosenkranz at the Syntex company in Mexico City synthesised norethindrone in 1951, and Frank Colton at Searle produced norethynodrel in 1952. Pincus chose Searle’s compound. Early batches of norethynodrel turned out to contain small amounts of a synthetic oestrogen, mestranol. When it was removed, users had more breakthrough bleeding, so the researchers kept a small dose in the final formula, creating the combined pill.

The Boston gynaecologist John Rock, a Catholic who had been treating infertile couples, began testing the hormones on patients in the mid-1950s. Because contraception was illegal in Massachusetts, the first trials were framed as fertility research. Large-scale field trials began in 1956 in Río Piedras, Puerto Rico, led by Edris Rice-Wray, and later in Haiti and elsewhere. They showed the method was highly effective, but participants were told little about risks, and the trials are now often cited in debates about research ethics.

Rock also proposed taking the pills for 20 or 21 days followed by a break of about a week, which produced a regular monthly bleed. The schedule was meant to reassure women and doctors that the pill mimicked the natural cycle.

Approval

In 1957 the FDA approved Enovid for menstrual disorders, and hundreds of thousands of women soon obtained it, many in practice for contraception. Searle then applied to market it specifically as a contraceptive. On 9 May 1960 the FDA announced that it would approve the application, and formal approval came on 23 June 1960. The original dose of 10 mg was much higher than in later pills, and the cost of about 10 to 11 dollars a month put it out of reach of some women.

Impact

Demand grew fast. Estimates suggest about 1.2 million American women were taking the pill by 1962 and around 6.5 million by 1965. Legal barriers fell in stages: in 1965 the Supreme Court ruling in Griswold v. Connecticut struck down state bans on contraception for married couples, and in 1972 Eisenstadt v. Baird extended the right to unmarried people. In Britain the pill became available on the National Health Service from late 1961.

The pill was credited with helping women stay longer in education and build careers, and it became bound up with the sexual revolution and the women’s movement, including later milestones such as the Women’s Strike for Equality and Roe v. Wade. It also met opposition: in 1968 Pope Paul VI’s encyclical Humanae Vitae reaffirmed the Catholic Church’s rejection of artificial contraception.

Health concerns grew as reports linked high-dose pills to blood clots and strokes. US Senate hearings led by Senator Gaylord Nelson in 1970 prompted the FDA to require a patient information leaflet, and manufacturers moved to much lower doses.

Timeline

• 1951: Margaret Sanger meets Gregory Pincus; Syntex chemists synthesise norethindrone.
• 1953: Katharine McCormick begins funding Pincus’s research.
• 1956: Large-scale trials begin in Puerto Rico.
• 1957: FDA approves Enovid for menstrual disorders.
• 1960, 9 May: FDA announces approval of Enovid as a contraceptive.
• 1960, 23 June: Formal approval is issued.
• 1965, 7 June: Griswold v. Connecticut strikes down bans on contraception for married couples.
• 1970: Senate hearings on pill safety lead to patient information leaflets.

Why it matters

The pill separated sex from reproduction more reliably than any earlier method and put that control in women’s hands. Its approval in 1960 reshaped family life, work and medicine, and it remains at the centre of debates about health, religion and reproductive rights.