Why Does Birth Control Require a Prescription?

illustration of a monthly pack of birth control pills

RobinOlimb / Getty Images

Key Takeaways

  • HRA Pharma is asking the FDA for an over-the-counter approval of its birth control pill, Opill
  • Studies show an over-the-counter option could increase access to birth control and decrease changes of unwanted pregnancy.
  • FDA regulatory hurdles stand in the way of any immediate action. Out of approximately 150 birth control pills on the market, it’s unclear how many will be submitted for OTC consideration.

HRA Pharma is asking the Food and Drug Administration (FDA) to approve its birth control pill for over-the-counter use. If approval is granted, the medication, called Opill, will be the first over-the-counter birth control available in the United States.

Opill is a progestin-only, once daily birth control pill that was first FDA-approved for prescription use in 1973. According to a press release on Monday, nearly 50 years of evidence on pills like Opill demonstrate that they are safe and effective for most people to use.

"This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the U.S.," Frédérique Welgryn, Chief Strategic Operations and Innovation Officer at HRA Pharma, a Perrigo company, said in the press release. "...Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers."

A Historical Change in Birth Control Access

More than 100 countries make birth controls available over the counter, but to date, the United States hasn't been one of them. Currently, the pill requires a prescription.

This June, the American Medical Association (AMA) called on FDA change to change this, asking for the agency to remove both prescription and age restrictions on the pill. AMA's request follows that of several other organizations who have been advocating for change, including the American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Family Physicians (AAFP).

While this pending change may seem like a long-time coming, easy birth control access may be more important now than ever. In the wake of the Supreme Court’s removal of federal abortion protections conferred by Roe v. Wade, people with unwanted pregnancies may be forced to give birth in certain states. While birth control is not a substitute for abortion care, contraceptive use could be a vital tool for those who are not ready to become parents.

“If you are in a particular state where you truly cannot get an abortion, then you are going to need to rely on a highly highly effective method of birth control, or your life is going to change without your consent,” Elizabeth Ruzzo, PhD, CEO and founder of adyn, a birth control prescription company that uses medical testing to help individuals determine which form of contraception is best, told Verywell.

No U.S. state offers OTC birth control, but 21 states offer pharmacist-prescribed birth control pills, which is a more accessible option than doctor-based prescriptions. Through this method, people do not need to schedule a doctor’s appointment to get the pill, but they still need a prescription.

Here’s why a prescription is currently required, and why experts think that should change.

Having a Few Generic OTC Options Could Hinder Individualized Care

Birth control pills are largely safe and effective. Combination pills or progestin-only pills, like Opill, are 99% effective at preventing pregnancy when used perfectly, and 91% effective when used more realistically, according to Planned Parenthood.

Still, birth control pills are not without side effects, which can make connecting with a physician and getting a specific prescription important. If only certain pills are approved for OTC use, people may not end up with the pill that’s actually best for them. So, if OTC birth control is to serve the masses, more companies may have to follow HRA Pharma's lead in submitting for approvals.

Common Birth Control Pill Side Effects
  • Spotting

  • Sore breasts

  • Nausea

  • Headaches

Rare Birth Control Pill Side Effects
  • Heart attack

  • Stroke

  • Blood clot

  • Liver tumors

“There are over 150 birth control pills on the market, not to mention different types of birth control, like the ring, the patch, the shot, the implant, and the IUD,” Ruzzo said. “If there’s only one formulation available over the counter, that’s hard from a perspective of recognizing that one size doesn’t fit all.”

Even if the FDA clears over-the-counter use, it’s unclear how many pills would actually become available without a prescription. The AMA has encouraged multiple manufacturers of oral contraceptives to apply for this approval, but does has not named a specific product or manufacturer.

Victoria Nichols, project director of Free the Pill, a U.S.-based organization that has been advocating for over-the-counter birth control since 2004, told Verywell in June she was aware of two companies that in talks with the FDA about potential approval. More may follow in the future, but—at least in any initial approvals—customers would not have many options to choose from.

The FDA must evaluate all safety and effectiveness data presented by birth control pill manufacturers before deciding whether or not to approve any for any OTC use. This can be a lengthy process.

The Cost of OTC Birth Control Is Hard to Determine

Because an over-the-counter pill has yet to be approved, it is uncertain how much money it will cost. Insurance typically does not cover over-the-counter medication and. After any move from the FDA to make birth control available OTC, insurance companies will have to decide if and to what extent they will help fund the pills.

Cost will also depend on how many pills are made available OTC, and if manufacturers have competitive pressure to lower prices.

Still, any out-of-pocket price most likely pales in comparison to the financial burden of unwanted pregnancy. The annual cost of unintended pregnancies in the U.S. is estimated to be about $5 billion—without factoring in indirect costs or childcare.

With a prescription, out-of-pocket costs for popular birth control pills can range from about $22 to $79 for a month’s supply for people without insurance, according to GoodRx. That’s between $264 and $948 a year. By using some online prescription services, like Nurx, people can get a supply for as low as $15 without insurance.

Over-the-Counter Access Still Matters

For people within living situations that do not support contraceptive use, purchasing an over-the-counter pill is a way to avoid an unwanted pregnancy without having to engage in uncomfortable or dangerous conversations with the people they live with in order to schedule a doctor’s appointment.

Ruzzo says easier access would particularly benefit “people who are younger, like people who are worried about telling their parents that they want to go on birth control, even if they want to go on it for one of the medical reasons.”

Birth Control Has Multiple Uses

People may want to use birth control pills to manage other health conditions other than unwanted pregnancy. Some people use the pill to treat acne, polycystic ovary syndrome (PCOS), or endometriosis. An over the counter pill would increase access for these uses.

Access and cost barriers may also disproportionately impact people of color, who are already impacted by systemic equalities in health care, Nichols said.

“The barriers to access are lengthy, especially if you’re working to make ends meet,” she said. “Because of the how safe and effective birth control is, having it over to the counter could really expand access to a product that people need and want. At the end of the day, we should all have the freedom to determine our own life path, including what our families look like and what our futures look like.”

Other Countries Make Birth Control Pills More Accessible

Multiple countries in South America, Europe, Africa, and Asia offer over-the-counter versions of the pill, according to Free the Pill.

A Guttmacher report from 2019 showed that the U.S. unintended pregnancy rate is significantly higher than that in other developed countries, at nearly 5% of women in 2013.

“People have really been advocating for this,” Ruzzo said. “If you can get condoms and Plan B over the counter, why can’t you get birth control over the counter? If you asked me if the standard of care in the U.S. today is good enough, I would say no.”

What This Means For You

If the FDA approves an over-the-counter birth control pill, people can access the contraceptive without needing a doctor’s appointment or prescription.

8 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. OCsCTC Working Group. Moving oral contraceptives over-the-counter: frequently asked questions.

  2. Free the Pill. State policies.

  3. Planned Parenthood. How effective is the birth control pill?

  4. Planned Parenthood. How safe is the birth control pill?

  5. Trussell J, Henry N, Hassan F, Prezioso A, Law A, Filonenko A. Burden of unintended pregnancy in the United States: potential savings with increased use of long-acting reversible contraception. Contraception. 2013;87(2):154-161. doi:10.1016/j.contraception.2012.07.016

  6. GoodRx. The annual cost of birth control.

  7. Free the Pill. Where on Earth?

  8. Guttmacher Institute. Unintended pregnancy in the United States.

By Claire Wolters
Claire Wolters is a staff reporter covering health news for Verywell. She is most passionate about stories that cover real issues and spark change.