An excerpt from Your Body, Your Health Care.
Tens of millions of American women—more than four out of five women who have had sexual intercourse—have used oral contraceptives, which are crucial for reducing unwanted pregnancies and the incidence of abortion. Obtaining a physician’s prescription can add up to $200 plus time and inconvenience to the cost of “the pill.” Nearly a third of American women who seek prescriptions for oral contraceptives report having difficulty obtaining them, citing nonmonetary obstacles, such as getting to their doctors’ appointments, twice as often as they cite the difficulty of paying for the appointments.
The Institute for Women’s Policy Research recommended in 2000 that the Food and Drug Administration (FDA) let women obtain birth control pills over the counter. The American College of Obstetrics and Gynecology has called on the FDA to remove the prescription requirement on all hormonal contraceptives since the early 2000s. In 2019, the College reiterated its call, adding that women of all ages should have over-the-counter access to hormonal contraceptives. That’s a rather compelling position for the College to take, considering that OB-GYN doctors are paid to prescribe hormonal contraceptives. The American Academy of Family Physicians and the American Medical Association have long echoed the American College of Obstetrics and Gynecology’s position. Women in more than 100 countries can get birth control pills over the counter. Yet the U.S. government requires women to ask other adults for permission slips, in the form of a prescription, before getting access to hormonal contraceptives.
After medical experts had been clamoring for years, the FDA finally announced in mid-2023 that it would permit women to obtain one brand of one form of oral contraceptive without a prescription: the so-called “mini-pill,” a progestin-only pill, which is not as easy to use as combination oral contraceptives.
Unlike regular birth control pills, which contain two female hormones, estrogen and progesterone, the mini-pill doesn’t affect milk production in nursing mothers and is less likely to cause blood clots in women who smoke. But, to add perspective, pregnancy is much more likely to cause clots than any pill designed to prevent it. And while the mini-pill may be slightly safer than combination birth control pills, it has significant drawbacks. For example, women must take the mini-pill at the same hour each day. If they take it three hours late, they must use another form of contraception for the rest of the month and start the cycle again. It’s the same if they miss a day. With regular (combination) birth control pills, if women miss a day in the cycle, they can take two pills the next day.
Alas, the FDA doesn’t trust women to use combination pills correctly or to seek advice from experts. This is nothing new. It took years of prodding and a federal court order to get the FDA to allow women of all ages to obtain emergency contraception—the so-called “morning-after pill.” One famous brand is “Plan B.” The FDA started permitting women to buy emergency contraceptives with a prescription in 1999. Shortly after that, various medical experts, women’s advocacy groups, and even FDA advisory panels urged the agency to let women of all ages obtain them without a prescription. Finally, in 2013, a federal court ordered the FDA to let women of all ages obtain emergency contraception over the counter. Today, people can get emergency contraceptives in vending machines. It’s a sad irony that the government lets women get “Plan B” over the counter but doesn’t let them get what many women might call “Plan A.”
The FDA does not limit its paternalism to women. For years, experts have called on the agency to let people obtain naloxone, the opioid overdose antidote, without a prescription. Residents of Italy have been able to buy naloxone over the counter for more than 20 years, and Australians have been doing so since 2016.
The FDA has allowed clinicians to prescribe naloxone since 1971. The drug works by blocking opioid receptors. It is an effective remedy that laypeople can safely administer with minimal training, using either a nasal spray or an intramuscular auto-injector. The FDA, aware of the drug’s safety profile, began in 2016 to directly and indirectly ask the makers of naloxone nasal spray to request that the agency reclassify the drug as over-the-counter. The agency can make the switch without the manufacturer requesting it. However, the agency deferred to the drug maker, who lacked the financial incentive to market naloxone over the counter. (Third-party payers rarely pay for over-the-counter drugs, and the makers of naloxone were charging them higher prices than they would be able to get for the drug in an over-the-counter market.) Most states have developed workarounds to make it easier for opioid users and people close to them to obtain naloxone. That usually involves authorizing pharmacists to prescribe the drug or letting licensed clinicians issue a “standing order” that lets pharmacists distribute it without a patient-specific prescription. Finally, in early 2023, the FDA reclassified naloxone nasal spray as over-the-counter. Injectable naloxone still requires a prescription.
Jeffrey A. Singer is a surgeon and the author of Your Body, Your Health Care.
