FDA considers whether a birth control pill could be sold over the counter

Angela Maske was a college freshman in Washington, D.C., when she first had trouble getting a prescription for birth control pills.

Her Catholic-affiliated university wouldn't prescribe the medication to students as a sexual contraceptive, so Maske spent three months looking for another doctor's appointment.

More recently, her telehealth provider stopped servicing her area, sending Maske scrambling to find another provider and a new prescription on short notice while juggling a full-time job.

Maske now works with Free the Pill, a coalition of advocates that's spent years dedicated entirely to increasing public access to contraception -- a goal they say is critical to people already struggling to access health care, find time off work or arrange for child care to make a doctor's appointment.

"It's just frustrating because (getting a prescription) feels like yet another barrier that people have to go through to access essential care to control their reproductive and sexual autonomy," said Maske.

The Food and Drug Administration is on the cusp of deciding whether at least one type of hormonal birth control -- a progestin-only drug called "Opill" by French drugmaker HRA Pharma -- is safe enough to be sold over the counter without a prescription and without age restrictions.

First approved by the FDA in 1973, Opill is type of hormonal birth control pill known as the "minipill," which poses fewer risks than combination pills that rely on estrogen. Still, buyers would have to screen themselves for any health risk factors, much as they would other over-the-counter medications.

FDA's panel of scientific advisers are expected to meet next week to discuss the application, and if the agency signs off the drug in coming weeks, the product could be on shelves this summer.

"It is just super exciting that we've gotten here at this moment. It's really historic," said Kelly Blanchard, president of Ibis Reproductive Health, an advocacy organization that has long called for over-the-counter birth control pills.

Blanchard said she hopes other types of birth control pills will follow suit and that states embrace laws requiring insurance companies to cover the costs. Currently, federal law requires free contraception "as prescribed" by a health care provider, although some states have pushed their own mandates for insurance to cover over-the-counter options as well.

The question over increased access to birth control comes amid a heated national debate on women's reproductive rights with the overruling of Roe vs. Wade, which guaranteed a constitutional right to abortion. At least 15 states have barred nearly all abortions so far.

This week, New York Democratic Gov. Kathy Hochul signed a law that authorizes pharmacists to dispense hormonal birth control. Patients there can now rely on a single long-standing order from a doctor, rather than having to return for an updated prescription; if the person does not have a health care provider, the pharmacist could dispense the drug anyway with instructions to consult a doctor.

The vast majority of Americans back widespread access to birth control. Two-thirds of adult women under 50 say they are using some form of contraception, with a third of those relying on birth control pills, according to a 2022 KFF (Kaiser Family Foundation) survey.

Most patients also believe they can screen themselves for risk factors when it comes to hormonal birth control. According to KFF, an estimated 77% of women under 50 say they want birth control pills available without a doctor's prescription if research shows it's safe and effective.

In an initial analysis released Friday, the FDA made clear it still has a lot of questions about whether consumers – young teens in particular -- would use the drug correctly and if they could adequately screen themselves for serious health risks, including the recurrence of certain types of breast cancer in survivors.

For example, more than half of participants in a study cited by the FDA reported unexplained vaginal bleeding – a possible sign of other health problems -- but hadn’t gone to seen a doctor.

On adolescents, the FDA said younger adolescents in particular – ages 11 to 14 – might not use the drug correctly or watch for warning signs. Older teens 15 and up fared better in understanding the label.

“Younger adolescents in particular demonstrated low comprehension of certain key labeling messages,” including the need to use condoms or other backup birth control to prevent pregnancy when first starting the medication or missing a dose, the FDA wrote.

Still, HRA Pharma's federal application for Opill solicited significant support from the medical community, anti-poverty organizations and reproductive-rights advocates that say increasing access to family planning will benefit millions of people, particularly those in rural areas and people of color who struggle to access any health care.

The American Medical Association, for example, told the FDA that decades of data shows the benefits of "widespread, nonprescription availability far outweigh the limited risk associated with their use."

In a separate filing, the American College of Obstetricians and Gynecologists said a patient doesn't need to be examined or tested before taking the drug and that the birth control pill was overwhelmingly safe for most people to take on their own. And while routine exams are critical to a person's overall health, the group says that shouldn't be a reason to make birth control harder to access.

Opponents of the move cited medical risk and teen access as a reason to limit access.

"Even if they read the package insert, evidence documents that teenagers take risks disproportionate to their own safety needs. When this is compounded by the lack of parental notification or health provider supervision, the results could be catastrophic," wrote an objection signed by several Catholic groups, including the US Conference of Catholic Bishops.

Maia Lopez, a 17-year-old high school junior living outside Dallas, Texas, who now works with Free the Pill as a youth advocate, said teens will have sex anyway.

Easier access to contraception and quality education about reproductive health would go farther to protect young people than restricting access to medication that can prevent pregnancy, she said.

"I think they underestimate teens," Lopez said.