This FDA Program Is Collecting Birth Control Data from Teens

A federal program is collecting a trove of intimate monthly birth control data on hundreds of thousands of patients, many of whom are teens, including the results of mandatory pregnancy tests. In the post-Dobbs world, where anti-choice actors are aggressively hunting down data about women’s reproductive health and teenagers are sentenced to jail time for seeking abortion care, the “iPledge” program stands out as a unique risk to the privacy rights and freedom of young women and AFAB people.

If you haven’t heard of iPledge, you still may have heard of the drug that it regulates: isotretinoin, more commonly known by its brand name of Accutane. This drug treats severe nodular acne and is frequently prescribed to teenagers and young adults, with the “classic age” of treatment being around 13 to 18 years old. Twenty million people have been treated with

Accutane since it was rolled out four decades ago. In 2020, the latest year for which data is available, nearly 420,000 patients were estimated to be on it.

Accutane has notably intense side effects, including the horrific birth defects it causes when people become pregnant during treatment. In response to widespread concerns about those birth defects, the Food and Drug Administration (FDA) developed the iPledge program, which manufacturers are responsible for implementing. If you’re a patient who “can get pregnant” and want to go on Accutane, you’ll be forced to enroll in iPledge, which requires patients and their doctors to fill out an online questionnaire in the iPledge database every month describing the birth control methods they’re using (of which there need to be at least two). Patients must also take monthly pregnancy tests, which must come back negative to continue treatment; if you become pregnant, your provider must report that to iPledge as an “adverse event.” If you fail to do any of these things, your prescription will not be dispensed, and you must wait several weeks and produce a negative pregnancy test before restarting treatment.

In many ways, this program amounts to real-time reproductive tracking. All this data would be an absolute gold mine for someone trying to harass or prosecute a patient for seeking reproductive health care. Unnervingly, the FDA’s iPledge site emphasizes its dedication to complying with court orders and sharing information “as otherwise required by law.” Perhaps even more concerning, iPledge can be acquired by or merged with another party and then transfer data to its new management.

The FBomb asked the FDA if iPledge has cooperated in any legal inquiries seeking to enforce state abortion restrictions or if it plans to in the future. The FDA has not responded to these questions or others from a detailed list about the iPledge program, including whether iPledge is truly a “third party” that can be sold at any time.

It’s unclear why a comparable program does not exist for other drugs that cause severe birth defects. It’s not uncommon for health care providers to test patients for pregnancy before putting them on medications that could cause birth defects. Patients are constantly warned that their medicines could cause pregnancy loss or birth defects: painkillers, SSRIs, drugs for rheumatoid arthritis, and more are all common substances to flag. Patients on chemotherapy drugs or anticonvulsants like lithium and Topamax are all at risk for severe birth defects too, but there aren’t iPledge-type programs for them.

Earlier this year, members of an FDA committee debated iPledge’s requirements, and the American Academy of Dermatology Association (AADA) lobbied for minor improvements (the AADA declined to comment to the FBomb on whether their members have raised patients’ reproductive privacy as an issue regarding iPledge). But the iPledge program continues to stand alone in its invasiveness and obstructiveness, and there hasn’t been any apparent justification for why a program like iPledge must exist when other drugs linked to severe birth defects don’t have a similar system.

I was on Accutane myself for most of 2019. When my dermatologist told me about iPledge, I laughed her off – I have a mechanical heart valve, so I physically can’t carry a pregnancy to term anyway. My cardiothoracic surgeon had a serious conversation with me before proceeding with surgery, ensuring I wasn’t planning on having biological children and making me aware that a pregnancy would be likely lethal for me and inhospitable for a fetus. Given my circumstances, I wouldn’t need to subject myself to the deeply invasive iPledge program, right? But there aren’t exemptions like this for people who want to take Accutane.

As a patient, being on Accutane and complying with iPledge felt menacingly paternalistic. It is condescending to be treated as though we can’t be trusted to understand and manage our medical treatment’s risks and side effects. It is wildly uncomfortable to submit information about our sex lives to the government every month. I understand why providers should test patients at the outset of treatment, thoroughly explain the risks of birth defects, and highlight the importance of using birth control. But iPledge goes far beyond that.

In a pre-Dobbs world, the program was nonsensical and condescending to me. But now, iPledge terrifies me. Without any warning or advisory about the program concerning abortion care bans, it’s hard for patients to know the extent of legal jeopardy they could be in.

It’s not as easy as not taking Accutane, either. It’s a drug of last resort for a type of acne that is particularly obstructive and painful, let alone cosmetically frustrating. The side effects, including severe dry, cracked skin, extreme sun sensitivity, and potential vitamin A toxicity, are incredibly annoying and can even be dangerous. But people continue to take it despite all of this because they need it, and it works.

When I finished my treatment in 2019, I was apparently supposed to return for another urine test a few weeks afterward. I got a sternly worded follow-up letter from iPledge a month later, demanding that I submit that pregnancy test. This letter failed to persuade me. I found it insulting and disturbing that a government program was harassing me for my pee when I literally can’t physically carry a pregnancy to term anyway. Since I wasn’t getting a refill, my reason for complying with the Orwellian reproductive surveillance was gone.

I’m lucky; I’m done, my skin looks great, and I don’t have to tell the FDA what backup birth control I used last month. But hundreds of thousands of patients still have to comply with the iPledge system. Young women and young AFAB people shouldn’t have to sacrifice their reproductive data privacy rights to get medical treatment. We do not ask patients to do this in any other setting; asking them to do it here is wrong and baffling. But for now, it seems like the price of accessing Accutane will continue to be patients’ intimate reproductive data — and in a post-Dobbs world, that’s a dangerous price to pay.