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The Pill | Article

The FDA Approves the Pill

On October 29, 1959, the pharmaceutical company G.D. Searle filed an application with the U.S. Food and Drug Administration (FDA) to license their drug Enovid for use as an oral contraceptive. Less than a decade after birth control activist Margaret Sanger first told scientist Gregory Pincus about her hopes for a "magic pill," it appeared that success was imminent.

John Rock. Timepix

Hopes For Quick Approval
The trials presented in the application for FDA approval of Enovid as an oral contraceptive were the largest drug trials ever run. In the trials, 897 women had taken 10,427 cycles of the Pill with no side effects the doctors considered harmful. In 1959 the main hurdle to FDA approval for any new drug was that it be proven safe. Efficacy was not yet a requirement. Since the FDA had already reviewed the issue of safety when it approved Enovid's use for menstrual disorders in 1957, Searle assumed the application would glide through the process. Searle and the Pill researchers were soon disappointed.

A Drug for Healthy People
The FDA sat on the application, and months went by without any word. Safety wasn't the issue clogging up the review process. It was the revolutionary nature of the Pill itself. Oral contraceptives would be the first drugs whose purpose was not to cure a medical ailment. Instead, the Pill would be given to healthy women for long-term use for a social purpose, and the FDA was uncomfortable with the concept.

Inauspicious Meeting
John Rock, the renowned Catholic obstetrician and gynecologist working with Pincus on the Pill trials, was now 70 years old and not content to sit by and let the application get buried. Taking matters into his own hands, Rock requested a hearing with the agency. On a bitterly cold day in late December, Rock and Searle's medical director, Irwin Winter, boarded a train to Washington to confront the U.S. government. The pair was kept waiting in a cold, barren, vestibule of the barracks-like wooden building for an hour and a half. Finally, they were escorted in to meet the hearing officer. Sitting before them was thirty-year-old Pasquale DeFelice, barely out of medical school and not even a board-certified physician.

Inexperienced Administrator
Rock was incredulous that the FDA could place the Pill's application in such young and inexperienced hands. After expressing the FDA's concerns over possible links between the Pill and cancer, DeFelice went on to detail potential religious and moral objections to the Pill. Rock was furious. Irwin Winter later recalled, "Rock wouldn't even refer to him by his name and kept calling him 'young man.' He told that kid, 'I don't know how much training you've had in treating women with cancer, but I have been treating patients my entire life and you have no idea how wrong you are.'" But DeFelice refused to budge on his position, and told the men that the meeting was over.

Limited Approval
It would be five months before Rock and Searle would hear from the FDA again. The agency was comfortable with short-term usage of Enovid for therapeutic purposes, but the reviewers were anxious about the safety of long-term usage for contraceptive purposes. Eventually, the FDA avoided the question of long-term safety by approving contraceptive usage of Enovid for no more than two years at a time, and on May 11, 1960, the FDA officially announced its approval of the contraceptive pill. The famous journalist and playwright Clare Boothe Luce echoed the thoughts of many when she declared, "Modern woman is at last free as a man is free to dispose of her own body."

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