Ultimately, the U.S. Food and Drug Administration (FDA) will make the decision about whether the pill can be sold OTC. The FDA makes this type of change for one brand of pill at a time, and there are over 100 brands of pill now sold in the U.S. Dr. Dan Grossman—a leader of a group of health researchers, advocates, nurses and doctors who argue for switching the pill to OTC—says that to switch, a drug company that makes an FDA-approved pill would have to support two new studies: one showing that women can understand the instructions for taking an OTC pill and one showing “women can appropriately self-select themselves as candidates for the pill and that they can use it safely and effectively for some period of time.” The process will be expensive: someone will have to ante up about $10,000,000 for the two studies. So far, no pill manufacturers or funders have stepped forward.
Making birth control available without a prescription has happened once before: the FDA decided that emergency contraceptive pills could be sold behind-the-counter to anyone 17 or older—although it took years and a court case to make that decision final. The only ingredient of the emergency contraceptive pills Plan B and Next Choice is a progestin. The exact same ingredient is in some brands of progestin-only or mini-pills. The mini-pill is safe for almost all women, including those with high blood pressure and migraines with aura. It could be that a mini-pill will be available without a prescription in the U.S. before a combined hormonal contraceptive pill… Don’t worry, there’s no way you could miss news of any kind of birth control pill going OTC—a hullabaloo is guaranteed, whether a vending machine is involved or not.
*If the pill’s so safe, why’s it prescription-only now? (Or, a quick history of birth control in the U.S., from “lewd and lascivious” to “therapeutic”)
Birth control has a unique history in the United States and the pill was not available here until 1960. By that time, birth control was already firmly the domain of doctors. Nearly a century earlier, in 1873, the Comstock Act had made birth control—and even information about birth control—illegal in the U.S., declaring it obscene and making it a federal offense to distribute birth control in the mail or between states.
Over the next century, this national law and 30 similar state laws were gradually challenged and overturned in courts. One major legal victory over the Comstock Act came with the 1936 U.S. Circuit Court of Appeals decision on United States v. One Package. That decision made it legal for doctors to distribute birth control across state lines. The same year, the American Medical Association recognized that providing birth control was part of a physician’s role. Doctors slowly started offering information and methods of birth control over the next few decades, and some were key players in the legal fight against state Comstock laws.
In 1957, the U.S. Food and Drug Administration (FDA) approved the first pill for therapeutic purposes only—to treat severe menstrual disorders—and not for birth control. Doctors began prescribing it and learned that there was a huge demand for the pill. When the FDA finally approved the pill for birth control in 1960, it was also prescription-only. At the time, that made good sense. It was a new kind of medication, and one that would be taken by healthy women. Following in the footsteps of the pill, all but a few modern methods of birth control are prescription-only. (The exceptions are condoms, spermicides, the sponge, and emergency contraception for women over age 17.)