What An Acne Drug Says About Women’s Health Care In 2024
When Grace, 30, a data analyst in North Carolina, got her precious first prescription of isotretinoin, she immediately called her boyfriend. “I feel like I just registered my uterus with the government,” she told him. The yearslong road to obtaining this essential med—which promised to clear her acne-prone skin—had been harrowing and included trying other treatments that failed, dealing with painful pimples and scarring, and joining a government-mandated online registry to ensure she didn’t get pregnant while taking isotretinoin.
Isotretinoin, most often referred to by its original brand name, Accutane, has a higher remission rate than any other acne treatment available. Its effectiveness is unparalleled and has been so since the drug hit the market in 1982, says John Barbieri, MD, director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital. Unlike other acne pills or prescription-strength topicals that work only as long as you take them, a course of isotretinoin, which is prescribed for daily use in pill form for anywhere from four to eight months, can clear up chronic, severe, and scarring acne in about 80 percent of people.
The medication is not without its challenges and risks, though. Isotretinoin is a retinoid, and the highest-strength one you can take (compared with a topical retinol or retinoid). It’s a vitamin A derivative that shrinks sebaceous glands—i.e., the glands that produce the oil that can clog pores and result in acne. And while isotretinoin is extremely effective in clearing up your face, it can wreak havoc on the rest of your body.
For many who have struggled with acne, isotretinoin—which is prescribed to over 1 million people in the U.S. every year—is notorious for its side effects. These include chronically chapped lips, dry eye, fatigue and joint pain, sensitivity to the sun, and mood changes. And since the medicine is processed through the liver, drinking alcohol while taking it is a big no-no. But the side effect that has gotten the most attention from the medical community (and federal government) is its potential to cause birth defects.
The drug is a known teratogen, or substance that causes birth defects (it can result in abnormalities such as small or absent ears, hearing or eyesight problems, and heart defects) if taken while pregnant. In a study of 154 women who took the drug in the 1980s, an estimated 20 to 35 percent of fetuses exposed to isotretinoin were born with any number of cardiovascular, craniofacial, thymic, and central nervous system malformations, per a 2018 review in The International Journal of Dermatology. (If you’re wondering what this might look like, check any isotretinoin pill packet, where images of babies with birth defects are illustrated in detail as a warning.)
Additionally, up to 60 percent of children exposed to isotretinoin in utero showed signs of neurocognitive impairment or behavioral issues in a 1985 study. Dermatologists, patients, the drug’s makers, and the U.S. Food and Drug Administration (FDA) all agree on this: The risks are real.
Where the agreement stops, however, is how to address those risks. Currently, the FDA mandates that women (and everyone else who can get pregnant) take monthly pregnancy tests while on isotretinoin and report the results, in addition to disclosing their birth control methods.
In a post-Roe world where a woman’s ability to make decisions about her body is under attack, a database containing information about your menstrual cycle, form of birth control, and pregnancy test results—as well as a potential unwanted pregnancy while on a drug that causes birth defects—holds new meaning and feels like a risk to a woman’s reproductive autonomy. Women are already scared that their period-tracking app data could be used as criminal evidence in states that ban abortion. And the mandatory registry sounds eerily similar to the Project 2025 directive for increased data collection and surveillance on abortions.
Since the 1980s, the FDA has tried to address isotretinoin’s risks, eventually landing on the iPledge program, a risk evaluation and mitigation strategy (REMS) whose goal is to ensure the benefits of an FDA-approved drug outweigh the risks. Pre-iPledge, there was the Accutane Pregnancy Prevention Program, which was developed in the late 1980s. It asked much of the same things iPledge does: monthly pregnancy tests, use of contraception, and medical counsel outlining the risks. In 2002, a second risk-management program, the System to Manage Accutane-Related Teratogenicity (SMART), was instituted, introducing a requirement of two negative pregnancy tests before starting isotretinoin and a voluntary registry. But regulators still weren’t satisfied with the outcomes.
“The number of bad outcomes, birth defects, miscarriage, and pregnancies was terrible,” says Sandra Kweder, former deputy director of the FDA’s Office of New Drugs, which oversaw the dermatology division when iPledge was being created. “Not every pregnancy exposed to Accutane is a disaster, but there were a number, and any are too many.”
For Kweder and the FDA, addressing the isotretinoin pregnancies was paramount, as was making sure patients and providers were fully aware of the drug’s risks. (At the time, people were not as informed about how to safely take the drug, she says.) So, in 2005, the FDA began enrolling people in its new iPledge program, which sought to curb the number of people getting pregnant on the drug.
Instead, the process ended up leaving some of its female users feeling inconvenienced, surveilled, and patronized. And it is still in effect today. Women’s Health reached out to iPledge for comment, but the organization did not respond.
The Creation Of A Tracking System
Patients, derms, and the FDA have known for decades that isotretinoin’s benefits are significant and that it is important to keep the drug available. So, the FDA’s creation of iPledge—and its success in convincing isotretinoin’s manufacturers to implement it—felt like a huge accomplishment that made accessibility possible.
Today, iPledge is one of 73 different federal REMS programs. Each program looks different: Some REMS allow meds to be dispensed only in a certain setting, while others require providers to be specially certified to counsel a patient on safe use. Patients might be asked to sign a form acknowledging the risks of a drug, commit to lab testing, or enroll in a registry. Isotretinoin users are subject to all three. REMS are also tailored to the medication (and subsequent side effects) it aims to surveil: For isotretinoin, the program focuses on preventing pregnancy, but for a medication like olanzapine (an antipsychotic for people with schizophrenia), a REMS is used to reduce the risk of a rare but serious post-injection syndrome. Mifepristone, a drug used in medication abortions, also has a REMS. In this case, before taking the drug, a patient must sign a form acknowledging that they have decided to take it to end their pregnancy.
While REMS are primarily about patient safety, politics can sometimes play a role, too, which was the case with isotretinoin, according to Dr. Barbieri. Throughout the early 2000s, before iPledge was enacted, the FDA, congressional leaders, and advocacy groups like the March of Dimes had expressed a growing concern about isotretinoin’s risks. The March of Dimes medical director called it a “vanity drug” in a Washington Post article and voiced support for a program like iPledge. Those in favor of regulating isotretinoin suggested it was over-prescribed to patients with mild cases of acne who didn’t need it. Those concerned about isotretinoin’s birth defects wanted to keep its use rare.
That’s where iPledge came in. The platform, which was the brainchild of doctors, researchers, and regulators at the FDA, offered a systematic way to inform patients and dermatologists about the risks of isotretinoin and to closely monitor the process. Nothing as ambitious as iPledge had ever existed; it was one of the first REMS programs developed. “This was cutting-edge public health work,” Kweder says.
Life In An iPledge World
In order to receive a month’s supply of isotretinoin, you’re going to have to jump through a lot of hoops, especially if you have a uterus.
Before you can get started, you need to take a pregnancy test at a lab or a CLIA-certified doctor’s office. Then you’ll read through and sign pages of informed consent forms, a standard practice for many drugs with significant risks and side effects. After that, your dermatologist enters you into the iPledge system and a 30-day waiting period begins, during which you can stew over the alarming things you read about in the consent forms, from vision changes to depression and suicide. Exactly 30 days later (and no sooner!), you can return to your doctor, take another pregnancy test, and finally get your first month’s prescription, provided a few other things happen too. (If this feels confusing and overly technical, you’re already getting the full experience.)
While taking the medication, you’re required to be on two forms of birth control or to pledge abstinence for the duration of your treatment and one month following. This is true even if you don’t have sex with men, have your tubes tied, have a partner with a vasectomy, or are unable to get pregnant for biological reasons. If you’re not already on birth control, this likely means starting some form of hormonal birth control like the Pill or getting an IUD (which are 92 and 99 percent effective when used correctly, according to iPledge’s prescriber guide). Even then, you are supposed to also use a condom, cervical cup, diaphragm, or vaginal sponge while having sex. Oh, and if you don’t like the contraception you’ve chosen during your treatment—if your birth control pill is giving you side effects and you want to switch to an IUD, for example—this could mean you have to delay treatment for one month because you’ll need to reenter into the system.
iPledge requires that you confirm your birth control and receive counseling on contraception from your provider each month, both of which can feel like a strange discussion to have with your dermatologist.
iPledge is a shared-system REMS, which means that patients, providers, pharmacies, and manufacturers all interact with it in order to get a patient a one-month supply. Each month, after you make your way to the dermatologist for a check-in and pregnancy test, your doctor (who must be certified to provide the service) logs the pregnancy test results and the contraception you’re using into the platform, which is owned and operated by the Isotretinoin Products Manufacturers Group (IPMG). Then you must take—and get a perfect score on—a quiz detailing the risks of taking isotretinoin, its potential to cause birth defects, and contraception, all before your pharmacy is cleared to release the pills to you.
You have seven days from the date of your pregnancy test to pick up your prescription. Otherwise, you’ll be locked out of the system and have to wait 19 more days until you can get another prescription, effectively derailing your treatment plan. Patients without uteruses don’t have to deal with these disruptions, which are actually pretty common. (Think about how many times you’ve had an issue picking up a prescription, whether it’s because your doctor forgot to call it in, you had a busy week at work, or insurance was causing problems.)
Kweder knew back in 2005 that iPledge wasn’t going to be popular. (It’s a hassle at every step, she says.) Even the IPMG was reluctant to adopt the system because they worried it would cut into their profits, Kweder says, but today, they’re reluctant to change it because of the legal buffer it provides. And the overkill at least meant that the FDA was doing its job to inform people of its risks. “I’m really proud of building something that hadn’t been done before that kept that drug on the market—and with no regulatory authority,” adds Kweder.
So far, iPledge has had one major change. In December 2021, it updated its language to be gender neutral, designating patients as being able to get pregnant or not, rather than male or female. Still, all the emphasis on reproductive systems can be triggering and “degrading,” according to a trans man and isotretinoin user on Reddit. iPledge’s hyperfocus on pregnancy doesn’t leave much room for compassionate care for trans patients, who may feel misgendered and dysphoric, or that there’s too much focus on this one aspect of the medication, when, in reality, there are many risk factors to consider. “I was immediately treated like a female instead of a man, disrespected, and the entire experience made me dysphoric,” said another poster.
When Big Brother Watches Your Acne Meds
Despite its original intent, iPledge hasn’t overwhelmingly decreased the rate of isotretinoin-exposed pregnancies, which hovers around 0.29 percent per isotretinoin course, according to a 2019 report in JAMA Dermatology. And while 2006 marked a peak in isotretinoin pregnancies, the report suggests that the subsequent downturn can’t necessarily be explained by iPledge. Factors such as increased access to long-term birth control, as well as reporting fatigue, may have contributed, per the report.
“It’s a very paternalistic way of practicing medicine,” says Lindsay Ackerman, MD, a dermatologist at U.S. Dermatology Partners Phoenix. The system is “cumbersome” for patients and providers, she says, and iPledge’s bureaucratic oversight makes it hard for derms to treat their patients. It communicates a lack of trust in derms to do their jobs, and in patients to not get pregnant.
In fact, while iPledge has not been found to reduce pregnancies, it has ushered in a 27 percent decrease in prescriptions, likely because of how many requirements it imposes on providers and patients, according to the 2018 review in The International Journal of Dermatology. Access decreases along racial lines too: 43.5 percent of non-white patients ended their course early compared with 30.1 percent of white patients, due to difficulties associated with iPledge, one 2019 study published in PLOS One found. Non-white patients were also more likely to experience interruptions to their treatment caused by the program. Patients with limited English proficiency experienced more disruptions to their treatment too, according to a 2024 letter to the Archives of Dermatological Research.
Plus, while female and male patients have similar rates of acne in adolescence, women are more likely to have acne as they age—but less likely to be on isotretinoin, says Dr. Barbieri. This could be because female patients have more options to treat their acne, like birth control pills or spironolactone. But these drugs have their own risks and don’t have the same effect on acne as isotretinoin. For Grace, who is now on her second month of isotretinoin, the side effects of spironolactone were so significant that she had to stop the drug. (The side effect: always feeling as if she had to pee—is a common one for this med. “It was awful,” she says. “I couldn’t sleep.”)
Making time—and paying—for monthly appointments and complying with each of iPledge’s strict rules can make treatment and follow-through difficult for patients. “I work from home, I have an incredibly flexible schedule, I fully support myself, I’m educated, and I’m still finding it challenging to keep up with the appointments and with logging in [to iPledge],” says Grace, who actually waited until she was in a place in her life where she could accommodate isotretinoin’s demanding schedule, tests, and appointments. “It’s one more thing on top of a drug that already has significant impacts on things like brain fog, fatigue, depression, and just really shrinks the patient’s bandwidth.”
Besides the strict requirements for obtaining the drug, mandating specific forms of birth control can feel to patients like an overstep. “You want to be able to make your own choices around your reproductive health and your sexual health,” says Mona Gohara, MD, a dermatologist and WH advisory board member. Dr. Gohara understands why the requirement might make patients uncomfortable. “The system heavily requires people to be on some type of contraception or to choose abstinence because of the high risk of birth defects around Accutane.”
The result is that some patients end up lying to their doctors about their contraceptive choices. Grace, for example, is a proud IUD user. She also knows for a fact that she’s not looking to have kids anytime soon. Right now, her priorities are her job and treating her acne. When she began isotretinoin, she said her doctor’s recommendation that she use condoms felt “tongue in cheek,” in that they knew she likely wouldn’t, and they didn’t feel the need to demand it either.
“I had no intention of using condoms,” she says. She felt confident in her contraceptive choices—and her IUD—and also knew she would opt for an abortion if she ended up getting pregnant because of the risks to a fetus. (There have been a number of patients who have gotten pregnant while on isotretinoin over the years and decided to get an abortion.) After discussing contraception with her partner, Grace learned he was passionate about using condoms to comply with the iPledge requirements, so they made that decision together.
And while the implications of sharing such sensitive data about contraception, your cycle, and the outcome of pregnancy tests with a registry that is shared with the FDA might have always felt a little overbearing, in 2024, it feels like a risk to a woman’s reproductive autonomy. For some women like Grace, it’s one of the first things she thought about. “Thank god I don’t live in Texas, because if I got pregnant, it would be documented, and it would make it that much easier for me to get charged because I would be getting an abortion,” Grace says.
iPledge was created under different social and political conditions, at a time when bodily autonomy and reproductive freedoms weren’t under attack the way they are today. It simply strikes a different chord in 2024. “What should be more important is giving women the responsibility to make these decisions for themselves, because they’re perfectly capable of that,” says Dr. Gohara.
And it’s not like isotretinoin is unique in its birth-defect risk. There are many drugs inadvisable to take while pregnant, yet it feels as if isotretinoin is singled out, experts say. “There are a lot of medications I don’t want my patients to become pregnant on, and I have that conversation with them, but I don’t want to mandate a monthly pregnancy test,” says Dr. Ackerman. Within dermatology alone, antibiotics such as doxycycline and hormonal meds, like spironolactone, should not be taken while pregnant.
These young women just want clear skin and full lives—not a constant reminder that the government can make big, important decisions about things like birth control and monitor pregnancy outcomes as well. “I used to hate looking at myself, and I was really, really, really insecure about people looking at me, but ever since I finished my course, I am starting to get used to not having all that on my face and having people look at me,” says Jannesta, 22, a front-desk associate at a spa in California.
Calling For Change
For as long as there has been iPledge, dermatologists have been advocating for changes, and women have been feeling uncomfortable with what the system asks of them.
The database was created roughly two decades ago, at a time when there was no blueprint for it, according to Kweder. Regulators navigating concerns about harming fetuses and calls to remove isotretinoin from the market were tasked with creating something that achieved compliance. As for how to resolve all these moving pieces? “I don’t think there are easy answers to this, and I also think that, over time, the pendulum swings as to what’s acceptable and what’s not,” says Kweder. But looking back, she sees one big problem: lack of input from dermatologists and patients. “I wish we had had the foresight to have more patient engagement, but I don’t think we knew how to do that then,” she says.
But thanks to dermatologists, a shift is coming. In 2023, 300 members of the American Academy of Dermatology (AAD) reached out to the FDA advocating changes to iPledge that would alleviate the administrative burden on providers and patients. And, after they presented to an FDA advisory panel that same year, some of their suggestions—like getting rid of the 19-day lockout period and the requirement to document pregnancies and fetal outcomes—were accepted and sent to the IPMG to implement. But nearly a year later, these changes haven’t come to fruition. “We’re just waiting to see what happens, and there’s no clear timeline,” says Dr. Barbieri, who is chair of the AAD’s iPledge work group.
The IPMG advocated against the modifications, he says. This could be because isotretinoin has been the center of many lawsuits, and having a stricter REMS system in place protects the IPMG from liability. (Isotretinoin’s original producer, Roche, no longer makes the drug in the United States. It does sell a similar drug, Roaccutane, abroad, where restrictions are different from those in the U.S.)
While the FDA ultimately sided with the AAD, it wasn’t entirely on board with the reforms. The FDA did recommend increased transparency from the IPMG as it carries out these changes—something derms are also calling for because, as before, they still feel left out of the conversation. “We basically are excluded from the process, which I think is a potential problem and might lead to bad outcomes in the long run,” says Dr. Barbieri.
For now, derms and patients are waiting to see what the IPMG comes up with and if, perhaps, the program might be improved for future isotretinoin users. “Not only does [iPledge] make people not feel great and do things they may not want to do, it’s also not necessarily that effective, unfortunately,” says Dr. Gohara. “My preference would be that women of reproductive age and with reproductive desires make decisions for their own selves and their own body around their own sexuality.”
Photographed by Joe Lingeman. Styling by Mia Katoh.
Olivia Luppino is an editorial assistant at Women’s Health where she covers health and fitness. She previously wrote for The Cut, POPSUGAR, and Salon and has written about everything from New York Fashion Week to dating app trends to the United States Women’s National Soccer team (a.k.a. her heroes). When she isn’t writing, Olivia is likely catching up on Bravo shows or running late to barre class.
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