Historic Birth Control Decision Hinges on 2 Questions

The Food and Drug Administration (FDA) will vote this week on whether to allow Opill, an oral contraceptive, to be available without a prescription.

The historic decision could make birth control more accessible to women nationwide, a hotly debated topic since the U.S. Supreme Court overturned Roe v. Wade with the Dobbs v. Jackson Women's Health Organization ruling on June 24, 2022.

The FDA's decision could be instrumental in improving access to women's health care amid national turmoil regarding abortion legality, but the FDA has two chief concerns with the accessibility of an over-the-counter birth control medication.

The FDA is expected to vote on making Opill accessible without a prescription this week, and the decision will hinge on several concerns outlined in briefing documents. The FDA is weighing how likely consumers are to take the contraceptive in a safe and effective manner and if consumers will avoid using the product if it poses a risk to them.

FDA Concerns About Opill

Opill is already an approved birth control medication, but it can be acquired only with a prescription. According to the FDA, officials are concerned that without a prescription, women might not properly follow instructions or might take the pill even if it poses a risk to them because a prescription would no longer be needed.

Like many oral contraceptives, Opill is most effective when taken at the same time each day. The contraceptive's efficacy is dependent on whether the consumer follows the instructions. The pill is less likely to work if consumers don't follow specific instructions.

Opill is a progestin-only oral contraceptive pill, heightening a woman's risk of diagnosis of a progestin-sensitive cancer like some forms of breast cancer. Opill also reacts with certain medications, and having an over-the-counter birth control option makes it less likely that pharmacists and doctors will catch an interaction.

Benefits of an OTC Oral Contraceptive

According to the documents from the FDA, 3 million unintended pregnancies occur each year. If used correctly, oral contraceptives are 99 percent effective at preventing pregnancy. The only available over-the-counter contraceptive methods in the U.S. are condoms and spermicides, which are 98 percent effective if used properly, according to a report by Planned Parenthood. Offering another option such as over-the-counter birth control could decrease the chances of unwanted pregnancies.

"The advantages of the availability of a nonprescription oral hormonal contraceptive include reducing potential barriers females of reproductive potential experience in obtaining effective methods of contraception," the FDA documents said.

However, condoms and spermicides are used on an as-needed basis with sexual activity, and to be effective, Opill must be taken daily at the same time regardless of sexual activity. Another hurdle to comprehension of the pill's instructions, according to the FDA, is the potential of the user having a limited literacy and therefore not comprehending the instructions.

Newsweek reached out to the FDA by email for comment.