Why Isn't OTC Birth Control Already a Thing?

For anyone hoping for easier access to birth control, recent days have brought good news. A team of experts reviewing decades worth of research concluded that all the evidence supports shifting oral contraceptives from prescription-only to over-the-counter (OTC) availability. (That's true OTC, rather than giving pharmacists permission to prescribe it.) And one pharmaceutical company plans to begin an application with the Food and Drug Administration to offer an OTC birth control pill in the United States.

Making the pill—a daily hormonal medication—available over the counter would increase convenience and likely lower pregnancy rates. The scientific evidence has long supported such a move, and it's one of the few topics that has the backing of the major health authorities and bipartisan support in Congress (with, admittedly the typical wrangling over how it should be done). So why hasn't the shift happened already?

The recent literature review lays out the case. It focused on teenagers, looking specifically at the safety and effectiveness of birth control pills, and whether teens can use them correctly and consistently. It also compared the pregnancy risk with that of other types of contraception, examined if OTC access would have any effect on sexual behavior, and whether teens would be less likely to see their doctors for regular checkups if they didn't need a prescription to get birth control.

Critics of OTC contraception often focus on these areas, arguing that long-term use of birth control may have unforeseen safety concerns, or that wider access could make teens more promiscuous and lead to more sexually transmitted diseases.

But boiled down, research shows that shifting oral contraceptives from prescription to over the counter would likely have only positive effects. According to the National Center for Health Statistics, the pill is the most commonly used hormonal method of birth control in the United States; 54 percent of women ages 15 to 19 have used it. The medical conditions that can increase the risk of serious side effects are rare among teens. Progestin-only pills (rather than combined estrogen and progesterone formulas) are safe for virtually all women, according to the review, and the risk of blood clots that can lead to heart attacks and stroke is up to four times higher during pregnancy compared to the risk when a woman takes a combined pill.

Teens, studies show, are perfectly capable of making decisions about birth control and following through on them. And because taking the pill is a daily behavior not tied to any particular situation (unlike condom use), teens may be even more likely to use it effectively. (Though the pill definitely doesn't prevent STDs, so condoms are still important.) There's no significant difference between contraceptive failure rates in teens versus young women. And examining the use of the progestin-only emergency contraceptive sold as Plan B, which went OTC in 2012, researchers believe that access to birth control did not increase sexual activity. Finally, the authors note that teens rarely see their doctors anyway; there's still more work to be done in getting teenagers to have contraceptive visits with clinicians.

So teens are having sex, and offering easier access to birth control won't make them have more, but it reduces the risk of pregnancy and may help decrease the teen pregnancy rate, which is already near historic lows. Sounds like a win-win."Oral contraceptives are popular, safe and effective methods of pregnancy prevention for women and teens. Our review emphasizes that any future over-the-counter pill has the potential to benefit teens, and there is no scientific rationale to restrict access based on age," the paper's lead author, Krishna Upadhya, said in a statement.

If the science is settled, why does the pill still require a prescription? For decades, the answer has been less based in science than in the fact that no drug companies were willing to go through the laborious process of getting an OTC contraceptive approved. That's where the second piece of good news comes in. French pharmaceutical company HRA Pharma is partnering with nonprofit Ibis Reproductive Health to finally get FDA approval for an over-the-counter oral contraceptive. It's a long, multi-year process; the company shies away from speculating just how long it will take, though the pill will be progestin-only, which should make the process a little easier. There are still social and political hurdles to clear, but at least a smarter solution may finally be on the way.

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