Over-the-Counter Birth Control Pill Now Backed by FDA: What to Know

Birth control pills have been approved in the US for over half a century. They are more than 99% effective in preventing unwanted pregnancies when used correctly. However, oral contraceptive pills are prescription drugs that can only be obtained with a doctor’s order. But this may change soon.

Expert advisers to the U.S. Food and Drug Administration (FDA) have unanimously recommended making a birth control pill called Opill available over the counter. This is currently a prescription drug that has been available for decades. In the past, there were concerns that adolescents and people with limited literacy may not understand how to take the pill correctly at the same time every day in a non-prescription setting. However, all 17 FDA scientists voted that people were likely to use over-the-counter contraception properly and that the benefits outweighed the risks.

How Will Over-the-Counter Birth Control Pills Work?

The FDA is not obligated to take the advice of panel members and approve Opill as an over-the-counter birth control pill. However, recommendations from FDA advisers play an important role in the decision-making process. Therefore, there is a good chance an over-the-counter birth control pill could be approved for the first time in the US later this year.

Perrigo and HRA Pharma, the manufacturer of Opill, called it a “groundbreaking move for women’s reproductive health.” Over-the-counter access to oral contraceptives will make it easier for women to obtain low-cost, safe, and effective contraception.

If approved by the Food and Drug Administration, Opill will be the first birth control pill available over-the-counter in the US. It is a progestin-only mini pill that contains 0.075 mg of a single active ingredient, norgestrel. Norgestrel is a synthetic form of the hormone progesterone. It prevents unintended pregnancy by suppressing the release of an egg from the ovary, thickening the cervical mucus to prevent penetration by sperm, and changing the lining of the uterus to prevent a fertilized egg from attaching. However, a norgestrel mini pill cannot be used for emergency contraception after unprotected sex. Also, you must take one pill at the same time every day for the birth control to be effective.

Who Can Take Over-The-Counter “Opill” Birth Control Pills?

It is worth noting that Opill may not be suitable for all women of reproductive age. For example, women who have a known or suspected pregnancy, undiagnosed abnormal uterine bleeding, known or suspected breast cancer, benign or malignant liver tumors, active liver disease, or an allergy to any ingredients in the mini pill should not take this form of birth control. The FDA has raised concerns that women who should not take Opill may not fully understand the drug label warning or perform proper self-screening without the help of health care providers.

Notably, unlike a combined oral contraceptive, a mini pill such as Opill does not contain estrogen hormone. Combined oral contraceptive use has been linked to an increased risk of health problems such as blood clots.

Given that almost half of all pregnancies in the US are unintended pregnancies, the FDA has been under pressure from health care providers and advocates of women’s health to approve increased access to oral contraception in an over-the-counter setting. Other agencies, such as the American Medical Association, the American College of Obstetricians and Gynecologists, Planned Parenthood, and the National Family Planning and Reproductive Health Association, have been urging the FDA to remove prescription barriers to birth control pills.

An unintended pregnancy can have huge consequences on a woman’s life, especially an adolescent’s life. The availability of OTC contraception on store shelves is a step towards making effective contraception easily accessible by doing away with prescription requirements.

Evidence demonstrates that the prescription status of hormonal contraceptives, cost barriers, and age restrictions are the biggest hurdles to accessing oral contraceptives. If the FDA goes ahead with approving Opill for over-the-counter access, it will increase access to contraception for all women of reproductive age and give women increased autonomy in their health care and reproductive health.

Yet, studies on women’s one-year contraceptive use patterns have shown that there are significant gaps in proper contraceptive use. Counseling from family physicians or other health care providers is necessary to help women choose the right birth control method and continue its correct use.

This puts the FDA in a difficult position. The final decision on whether to make Opill an over-the-counter birth control pill is pending. There may still be some roadblocks to approving the first over-the-counter birth control pill in the US.

The Deputy Director of the Food and Drug Administration’s Office of Nonprescription Drugs, Dr. Karen Murray, has hinted that the agency would have preferred an actual use study from the manufacturer that was easier to interpret. In the data submitted by the manufacturer, one-third of the study participants reported taking more pills than they were dispensed, referred to as “improbable dosing.” Therefore, the FDA may request more data from the manufacturer before approving Opill as an over-the-counter birth control.

What Are The Next Steps To Approval?

The agency does not want to delay access to over-the-counter birth control pills. But there are additional concerns, for example, about the effectiveness of Opill (norgestrel) in preventing unwanted pregnancies when taken in a non-prescription setting. This birth control pill may not be as effective as when it was originally approved decades ago due to an increased prevalence of obesity in the US. Insurance coverage is another factor to consider since many over-the-counter drugs are not usually covered under health insurance plans.

Only time will tell whether the Food and Drug Administration will approve Opill as an over-the-counter birth control pill without any age restriction and whether it is a good idea to trust women to take this oral contraceptive without supervision from a health care provider.

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