Many women have experience with using or trying to attain access to contraceptives. According to the CDC, 65.3% of women aged 15-49 in the United States are currently using a method of contraception. Of those, 14% use birth control pills, which are the second most commonly used method of contraception in the United States after tubal ligation (also known as “tying your tubes”). More than 100 countries offer contraception over the counter; however, the United States is not one them.
In the United States, women who want access to birth control pills must first see a physician and obtain a prescription. This applies to all types of oral contraceptive pills (OCPs), including combination pills, progestin-only pills and extended cycle pills. The only exception is the emergency pill or the “morning after pill,” which is a form of backup contraception that can be used up to 72 hours after unprotected sex or contraceptive failure, and can be purchased over the counter.
However, officials are now debating whether OCPs should be offered over the counter. This would mean the pill could be sold alongside other drugs like Tylenol and Benadryl. Since 1976, many drugs have made the switch from prescription to over the counter (OTC) like Sudafed, Rogaine, Advil, Allegra and many more.
Proponents of making the pill available OTC argue that it would increase access for low income and medically unserved populations, while lowering the rate of abortions and teen pregnancy. They argue that OCPs are safe and effective. In the United States, there is only one health care center for every 1,000 women in need of publicly funded contraceptives. Of the 66 million women of reproductive age in the United States, 19 million live in “contraceptive deserts,” defined as areas where the number of health care centers providing contraceptives is not enough to meet the needs of the county. If OCPs were available over the counter, women in underserved communities could more easily find a local drug store for medication. In a study by the journal Contraception, 11-21% of sexually active low-income women expressed that they would be more likely to use OCPs if they were available OTC.
From 2007 to 2013, the nationwide teen pregnancy rate dropped 36% among those aged 15 to 19 because of increased contraceptive use. In a report by the Journal of Adolescent Health, Krishna Upadhya MD, MPH stated, “Decades of research show that a majority of adolescents initiate sex before the age of 18 and that earlier use of contraception reduces the risk of teen pregnancy. Our review strongly suggests that giving teens easier access to various contraceptives will not lead to more sex but would result in fewer unwanted pregnancies … [and] any future over-the-counter pill has the potential to benefit teens.”
In a survey of women seeking abortions, 72% said that they were pregnant because they could not get the contraception they needed and 32% reported an institutional reason such as lack of prescription. These obstacles resulted in a 35% reduction in the use of contraception. The American College of Obstetricians and Gynecologists states, “the most effective way to reduce abortion rates is to prevent unintended pregnancy by improving access to consistent, effective, and affordable contraception … [and a] strategy for improving access to contraception is to allow over-the-counter access to oral contraceptive pills.”
The pill carries no risk of addiction and a low risk of overdosing, while the risk profile of OCPs is comparable to that of other common OTC drugs such as ibuprofen and Tylenol. Plan B and other over-the-counter emergency contraceptives carry the same ingredients as OCPs and are available without prescription. While OCPs are not without potentially dangerous side effects, it is generally agreed upon that the pill is safe.
On the other hand, opponents may say that OTC birth control could raise the cost of the drug, lead to health complications and decrease overall choice. As previously stated, OCPs are generally considered a safe drug; however, there are serious side effects and contraindications that should be noted. Absolute and relative contraindications for birth control pills include smoking, diabetes, heart disease, blood clots, Breast cancer, stroke, liver disease, high blood pressure or migraines. Dispensing OCPs over the counter would remove the counseling patients receive when they are given a prescription, which is helpful if the patient has questions or concerns. Additionally, patients could be at risk if they are not screened by a physician for a pertinent past medical or family history.
Another concern is possible drug-drug interactions. When doctors or pharmacists administer OCPs to a patient, they can provide education about any possible interactions. Drugs that can interfere with birth control pills include the antibiotic rifampin, many anti-HIV drugs, antifungal medications, anti-seizure drugs, modafinil, medications for bipolar disorder and many herbal remedies including flaxseed and St. John’s wort.
Making OCPs available without a prescription means that insurance will not cover the cost and women will pay out of pocket for the medication. For example, before Plan B became available OTC, the drug cost $12 for the brand name and $5 for the generic through Medicaid. After the drug became OTC, the cost increased to $50 for the brand name and $41 for the generic. Many researchers believe that the same will happen if the pill becomes available OTC.
There are over 40 brands of birth control currently offered, consisting of many different types of contraceptives. By making certain choices available OTC, women are more likely to choose available options at drug stores rather seek a prescription, even if it is not the best variety of birth control for them. Some FDA-approved contraceptive methods that would not be available OTC include IUDs, the implantable rod, Depo-Provera injections and sterilization procedures, all of which can be more effective than OCPs. These types of birth control will still require a visit to the doctor’s office.
A recent survey by the Kaiser Foundation demonstrated that 74% of women support having OCPs available over the counter. Switching from prescription to OTC availability requires FDA review and approval, which can take up to three to four years. In order for the FDA to approve the conversion to OTC status, a drug must meet certain criteria: Users must be able to easily diagnose their own need for the drug and monitor use without clinician screening. The drug must have low toxicity, low potential for abuse, few interactions with other drugs and the drug must not have properties that make it impractical for OTC use.
Research shows that oral contraceptives generally meet these requirements. As of late 2021, there are many groups lobbying for FDA approval, including Ibis Reproductive Health which has partnered with HRA Pharma to submit an application to the FDA. They have created a group called Free the Pill which seeks to educate, engage and build support for over the counter birth control.
There are many factors to consider before making a drug available OTC without a prescription, and OCPs are no different. While no solution can be perfect, the benefits must outweigh the risks to approve OTC contraception. Access to reliable contraception in the United States needs to improve, and by carefully considering this discussion we may be taking a vital step in that direction.