August 27, 2019 at 12:24AM by CWC
Earlier this summer, something strange happened on Twitter: Republican Ted Cruz publicly agreed with a Tweet posted by Democrat Alexandria Ocasio-Cortez which read, “Psst! Birth control should be over-the-counter, pass it on.”
Unlike so many political dialogues—particularly those which concern the bodies of people with uteruses—this exchange felt uncharacteristically sensible and non-controversial. It also made the goal at its center sound easily achievable: for people to be able to buy oral contraceptives at the drugstore just like they buy aspirin or foot fungus cream.
This debate isn’t totally new—advocates have long argued that by taking off the requirement of needing a prescription to get a birth control pill, people would have a much easier time accessing contraception, which would in turn lower the rate of unintended pregnancies. The American College of Obstetricians and Gynecologists (ACOG) said as much in a statement in 2014. With this new bipartisan interest, is it finally time for America to join the 100 countries around the world which allow over-the-counter (OTC) access to birth control, especially given that numerous stateside medical organizations—including The American Academy of Family Physicians, The American Academy of Pediatrics, The American Medical Association, and The Society for Adolescent Health and Medicine, to name a few—have come out in support of the idea?
The answer appears to be yes… with many, many caveats.
The health debate over OTC birth control
One of the biggest questions I had when looking into the over-the-counter birth control debate: How safe is it for people to be able to buy hormonal drugs like BC without a prescription? To answer this, you first have to know about how birth control works. There are two broad types of oral contraceptive pills: progestin-only birth control and combination birth control. The former type, also called “mini pills,” use just progestin—a synthetic form of progesterone—to prevent pregnancy by thinning the lining of the uterus and thickening the cervical mucus to make it harder for a sperm to fertilize an egg. Combination birth control pills use a mix of estrogen and progestin (hence the combination) to prevent pregnancy by stopping ovulation, thinning the lining of the uterus, and thickening cervical mucus.
After speaking with several health professionals—including LA-based OB/GYN Sherry Ross, MD, Emily Rymland, NURX clinical development lead and nurse practitioner, and Birth Control Pharmacist founder Sally Rafie, PharmD, BCPS, APh, NCMP—there seems to be a consensus that progestin-only birth control pills are essentially risk-free to the consumer and are therefore a very safe place to start when it comes to OTC access. “Progestin-only pills are a really great option for an over-the-counter pill because like all birth control pills, they’re highly effective at preventing pregnancy and it’s very rare that there would be a health condition that could make using them risky,” explains Kate Grindlay Kelly, project director for the Free the Pill campaign at the international nonprofit organization Ibis Reproductive Health.
It’s important to emphasize that both types of pill are generally safe and equally effective at preventing pregnancy. But there is concern among the experts I spoke to about making combination birth control available OTC, because it is associated with a slight increased risk of deep vein thrombosis, heart attack, and stroke, per the ACOG. That risk is higher in smokers over the age of 35 and people with multiple risk factors for cardiovascular disease. (Progestin-only pills are not associated with this risk.) That’s why Dr. Ross says while she generally supports OTC access and believes that access is a huge priority, she worries that women would take medications for which they are contraindicated without knowing it, since they are picking it up at the drugstore and not after a consultation with their doctor.
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Rymland agrees, and says that while “all access is good access,” it worries her a bit those at risk demos—like women who smoke and are over 35, women who have hypertension, and women who have migraine with aura, for example—might put themselves on a combination pill unwittingly. That said, she thinks women should be trusted to sort this stuff on their own—and research supports the idea that women and adolescent girls are able to safely regulate their own health (gasp!), too. “People have done studies on patients’ ability to self-assess their medical needs, and they found that people are really good at it, women are good at it, and even young women are good at it,” Rymland explains.
Contraindications aren’t the only issue raised by these health professionals. Dr. Ross also worries that OTC birth control access will result in a drop in critical doctor visits, since many women find their way to the OB/GYN when they need birth control. “My concern would be that women would then forget the basic service and women’s health care routine that needs to happen every year—STI checks, breast exams, talking about mental health issues…. things that gynecologists do as gatekeepers for women, especially [those] under 50,” she says. In their statement of support for OTC birth control, the ACOG caveats that this access should not stand in for regular gynecological exams.
Personally, I wish I had gotten more counseling around birth control from my gyno, even with the prescription requirement, so it worries me that if the pill moves OTC that education could drop to nil. Aumatma Shah, ND, who runs a holistic fertility practice, shares my concern, especially when it comes to educating people about what happens once you’ve stopped the pill and are trying to get pregnant. For example, while hormone conditions like PCOS are often managed with birth control, Dr. Shah says BC can also mask those conditions in undiagnosed people, which can ultimately hinder fertility. These risks are not be adequately addressed with patients as is, she says, so it’s her belief that education needs to improve, regardless of how OTC birth control shakes out.
A complicated legal battlefield
Beyond the concerns in the medical community, congressional support around the issue is not without its disagreements and controversies. Separate bills regarding OTC birth control have been introduced by both sides of the aisle this year, and each includes unique stipulations. The Democratic-led bill, titled “The Affordability is Access Act,” seeks to prevent insurance companies from ceasing to cover birth control if it moves over the counter—a critical step, say its proponents, in ensuring the pill remains financially accessible as it becomes more logistically accessible. The Republican bill, titled “Allowing Greater Access to Safe and Effective Contraception Act,” is focused more on allowing the FDA to fast-track its approval of OTC birth control options, with a stipulation that these options be for people aged 18 and over.
These both may seem promising, but critics are concerned about the Republican-sponsored bill. “The difference between what we’ve seen in the Republican bill, which was introduced earlier this year, and the Democrat bill, which was introduced a couple months later, is that the Democrat bill is focused on affordability through insurance coverage whereas the Republican bill appears to impose an age restriction and it does not include anything on insurance coverage,” explains Kelly. (Instead, the bill focuses on allowing people to use health savings accounts for OTC medications.) The insurance aspect matters because currently, the Affordable Care Act mandates that insurers cover prescription contraception at no additional cost to women. If the pill moves OTC without insurance mandates, insurance companies will cease to be required to cover it—which could undermine the ACA, a long-held goal of the Republican party. In fact, when Republican legislators hoped to strip away certain aspects of the ACA in 2014, they introduced a bill that in part championed OTC birth control access as a way to give women contraception without having to have it covered by insurance, or compel health providers to prescribe it against their personal religious beliefs.
These discrepancies aren’t the only—or the biggest, even—bureaucratic roadblock to OTC access, either. No drug can switch from prescription-only to OTC, regardless of what’s happening in Congress, unless the FDA approves it to do so. This cannot be done quickly or in one fell swoop, either. “There is no precedent for a class switch—one pill would move over the counter at a time, and that means companies would have to apply one by one for their specific pill, and there are many formulations of the pill,” explains Kelly. “Plus, the process for an OTC switch is generally three to five years on average.” So far, only one company—Paris-based HRA Pharma—has begun the application process, and Ibis has been working with them since 2016 to help make the switch. The progestin-only pill they’re trying to bring to market is not one which is currently available, even by prescription, in the U.S., Kelly tells me.
Making accessible birth control a reality
Advocates argue that OTC isn’t the only way to make birth control more accessible. One current prescription-requirement workaround recently enacted in California, Colorado, District of Columbia, Hawaii, Idaho, Maryland, New Mexico, Oregon, Utah, and West Virginia allows pharmacists to prescribe birth control as well as doctors. “We see more and more states trying to pass similar legislation, and actually it’s bipartisan, which is really nice,” says Birth Control Pharmacist founder Sally Rafie, PharmD, BCPS, APh, NCMP. This movement could expand access and education efforts simply because, as Kelly points out, pharmacists are trained to counsel on the side effects of medications, and her organization is working to get them specific training around the pill, too. In this case, a person could utilize a well-informed pharmacist at their local drugstore to help them make the right BC choice, rather than waiting the average 24 days to get an appointment with their OB/GYN.
“In order for an over-the-counter pill to truly be successful in our minds, and to truly increase access, we believe that affordability is crucial.” —Kate Grindlay Kelly, project director for the Free the Pill campaign
This convenient service, however, isn’t free. “One of the biggest hurdles has been around making sure that patients who have insurance are able to use their insurance to cover the visit,” Rafie explains. While the medications are still covered by insurance in this context, she tells me that sometimes insurance companies won’t cover the pharmacist consultation because they don’t recognize pharmacists as health care providers.
The bottom line: More accessible birth control is coming…but slowly. If you’re interested in throwing your weight behind OTC birth control, Kelly tells me you can follow Free the Pill on social media and visit their website for more information. “We also encourage people to help raise their voices in support of this issue generally,” she says. You could also call your Congressional representatives and senators to ask them to support the OTC birth control legislation you’re passionate about. Similarly, if you want to advocate for pharmacy access or coverage, Rafie says her organization is happy to work with anyone trying to organize an effort in their state.
At the end of the day, advocates say the most important thing is remembering to keep birth control as legitimately accessible to as many people as possible. “FDA approval process is one of the key parts of getting an over-the-counter pill, but in order for an over-the-counter pill to truly be successful in our minds, and to truly increase access, we believe that affordability is crucial and that’s why we’re working to ensure that an over-the-counter pill would be covered by insurance without requiring a prescription,” says Kelly. Psst… back to you on that one, then, AOC.