Science over Politics: What an Over-the-Counter Morning After Pill Means

Overruling what he called "bad faith," on Friday a federal judge decided that the morning-after pill, often referred to by the brand name Plan B, must be sold over-the-counter in drugstores. The ruling is in keeping with a 2011 decision by a panel of independent doctors and researchers that the side effects of emergency contraception usage were minimal enough to justify over-the-counter purchases.

At the time, the FDA decision was overruled by Health and Human Services Secretary Kathleen Sebelius in an unprecedented move that was thought to have been driven by the Obama administration's election year politics. Now, without the pressure of reelection, science has, for now, won out.

A formal distinction between prescription drugs and over-the-counter (OTC) wasn’t codified in the US until the 1951 Durham-Humphrey Amendment to the Federal Food, Drug, and Cosmetic Act. The initial act gave the federal government authority to oversee the safety of food, drugs, and cosmetics, but this legal delineation wasn’t established until much later. The FDA states that “drugs may be deemed unsafe for nonprescription use because they are habit-forming or toxic, have too great a potential for harmful effects, or are for medical conditions that can't be readily self-diagnosed.”

Many very commonly used drugs have made the Rx-to-OTC switch, including Dimetapp, Nyquil, Aleve, Rogaine, Pepsid AC, nicotine patches, and Allegra. There are over 600 drugs currently available OTC that include some substance that was available only by prescription 20 years ago.

In 2006 Plan B, (levonorgestrel) was approved to make this transition, though its sale was initially restricted to women 18 and over (later reduced to 17) and it is kept behind the pharmacist’s counter. As more and more medications are available without a doctor’s prescription, the amount consumers spend on them is growing annually.

The shift points to a central question: how do the factors the FDA originally used to determine safely—chiefly the restriction of OTC medications for the treatment of conditions that “can’t be readily self-diagnosed”—hold up fifty years later?

We’ve all spent a terrified evening or two, lurking irresponsibly in the depths of WebMD and convincing ourselves we’re suffering from any number of debilitating illnesses. But self-diagnosis for minor conditions is actually legitimately more possible today than fifty years ago. Skin rashes, UTIs, fungal infections—many of these can be self-diagnosed far more accurately today than ever before. With easily accessible medical information available to anyone online, how do we change the terms under which medications are available?

When it comes to emergency contraception, data has shown that the drug is as safe as other OTC  drugs. (Although women 17 and older currently don't need a prescription for Plan B, the pill is available only behind the pharmacy counter and must be purchased with an ID.) The effects of allowing anyone to access this kind of medication could be substantial. Yet much of the backlash surrounding morning-after pill prescriptions arises from an erroneous belief that the medication interferes with implantation of a fertilized egg.

One women’s healthcare researcher I spoke to expressed amazement that this unsubstantiated belief persists.

“Contraceptive makers listed it [disruption of implantation] as a third ‘possible’ mechanism of action, most likely because it was theoretically plausible (I guess) and inspired confidence that birth control was working on our behalf in all kinds of ways," she wrote by email; she asked not to be named. "However, in vivo studies haven't shown any ‘post-fertilization’ effect for daily pills or for progestin-based EC like Plan B.”

In fact, studies show that Plan B’s effectiveness in preventing pregnancy lies in its ability to prevent ovulation (just like traditional hormonal contraceptives), not because it somehow makes the uterus inhospitable to a zygote. Sperm often live on in the body for days after ejaculation. If you can prevent ovulation during the time that the sperm are still alive, you can prevent a pregnancy that would have otherwise occurred.

This myth of their action seems likely to have been from the anti-birth control contingency, who seek to conflate the morning after pill with the actual abortion pill. They work in totally different ways. Pay attention; almost every news story on the subject claims that they work by preventing implantation.

If and when Plan B does become available over the counter for women of all ages—possibly as early as May; the FDA can still appeal the ruling—the effects could be enormous. A study released last week revealed that approximately 30% of teens aged 15 to 16 have had sex. This court decision would expand access to them. And while teen pregnancies are at a historic low in the US, the burden of young motherhood still overwhelmingly reduces educational opportunities and projected lifetime income for teen mothers.

We also have to take into account the fact that many teen pregnancies end in abortion. It’s important for women to be able to access abortion services, but it’s much less emotionally disruptive to empower young women with the chance to actually prevent pregnancy themselves.

From the Comstock Laws of the turn of the twentieth century—laws that prevented the distribution of contraceptives—to this recent ruling, we’ve come a long way in the pursuit of a deceptively simple goal: to let women decide for themselves if they want to have a child.

@kellybourdet