The case for giving birth control pills over-the-counter access

When the birth control pill hit the market in the 1960s, it was revolutionary. The oral contraceptive pill allowed women to take control of their bodies, enabling them to enjoy sex without fearing an unplanned pregnancy. Sixty years later, the science behind the pill has evolved. It’s not your mama’s pill, but you still have to get it the same way your mama, and perhaps even your grandma, did. It’s long past time for that to change. 

Amid the numerous health care challenges exacerbated by the coronavirus pandemic, the medical community has been rethinking inequitable, unnecessary barriers to care. There are some promising indications that the arcane process of approving over-the-counter (OTC) access for drugs that clearly meet safety criteria may be reformed. Among the medications first in line for over-the-counter access should be contraceptive pills.

More than 10 million women in the U.S. take birth control pills every month. For decades, we’ve known that it would be safe for them to simply pick up their pill packs off a drugstore shelf, at their convenience. Yet we still require them to first get a prescription from a licensed medical provider. Why?

The clinically unnecessary prescription requirement for the pill outlived its usefulness long ago but has been trapped in the slow churn of the Food and Drug Administration’s (FDA) bureaucracy. Policymakers and health care providers have tried to accelerate access around the edges — by allowing online medical visits or, in some states, authorizing pharmacists to prescribe the pill. But the final step — switching to over-the-counter availability — has not occurred, despite the fact that the pill is available over the counter in more than 100 countries.

Now the medical community is urging the FDA to take the next logical step and allow women — finally —  to pick up the pill off the shelf of a pharmacy. For more than four years, the FDA has been involved in the approval process for an OTC pill; two pharmaceutical companies are seeking FDA approval for two common formulations of the pill. The promise of an over-the-counter oral contraceptive appears to be within reach.

Though any medication can have risks and side effects, the pill has a strong safety record for most women after 50 years in the marketplace. Studies have shown that, for most women, the pill is safer than many medications that are already available over-the-counter; the American College of Obstetricians and Gynecologists’ Committee on Gynecologic Practice supports an OTC pill “without age restrictions.” Research also shows that most women can understand how to properly take the pill and screen for potential risks on their own, just as they do for pain and allergy medication and the cold medication they give their children. The fact is, the pill meets the medical criteria for over-the-counter access. 

In addition to the American College of Obstetricians and Gynecologists, availability of an OTC pill has been endorsed by other major medical groups, such as the American Academy of Family Physicians, and dozens of advocacy groups. Even some Republicans and Democrats in Congress have called upon the FDA to approve the pill for over-the-counter use. 

Congress has an opportunity to find common ground on ensuring that an over-the-counter birth control pill is affordable and accessible to all women. Approval of an OTC pill would represent a bright spot in an otherwise difficult time for the health of many in our nation. And the FDA has the opportunity to champion a critical advancement in women’s health and well-being. 

Making the pill more widely available could improve public health. According to the Guttmacher Institute, almost half (45 percent) of pregnancies in the U.S. are unintended. Data modeling suggests that over-the-counter access to the pill could reduce unintended pregnancy in this country by as much as 25 percent. This important health advance may have the greatest benefit for those who have the most barriers to accessing medical care — including people with low incomes, the uninsured, people of color and those who live in rural areas. 

Over-the-counter access to contraceptive pills would be a game-changer for millions of women. Let’s make it happen now.

Raegan McDonald-Mosley, M.D., MPH, is CEO of Power to Decide, chief medical advisor for the Contraceptive Access Initiative, and a practicing obstetrician-gynecologist.