Last week, I sent Cecily to observe the Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs. It was way more exciting than it sounds, especially for a cervical mucus fairy. After all, the panel was weighing whether progestin-only pills should be made available over the counter, and these pills rely heavily on cervical mucus. (More on all of that below.) I stayed home and went to what I have to admit was my very first school board meeting.
When I started at SIECUS many moons ago, my job was to help community members across the country fight the good fight for comprehensive sexuality education. This often meant giving them advice on how to address their school board. Typically, people would call us when a small group of parents was trying to get the board to adopt a strict abstinence-only-until-marriage program. I would walk them through the arguments against this approach, offer advice on public speaking, and help them craft talking points to share with neighbors. I would also work with them on editorials for the local paper (because this was before all school board negotiations took place on Facebook forums). Many of the parents I worked with lost their battles, but in some communities they managed to convince the board that fear and shame were not the way to go. I like to think I helped make that happen.
Despite that and despite 11 years as a parent in a suburban district, I had not attended a school board meeting until last week. This debate wasn’t about the curriculum, and it had nothing to do with sex education. The board was voting on whether to renew contracts—an annual vote that should really be a rubber stamp of what the Superintendent suggests. Over 100 people were on the list to be renewed, including the beloved principal of the high school. Rumors began to swirl a few hours before the meeting that a majority of members had singled him out along with two other administrators and were secretly planning to effectively fire them. This seemed both overreaching and sneaky; at least three members of the board (one of whom is on the personnel committee) had not been invited to earlier meetings in which this plan was hatched.
The town turned up in force hoping to save these jobs. The public comment section lasted almost four hours. The students went first and blew us all away. These kids showed up at 6:30 pm having had only two hours to prepare comments, and they waited more patiently than the adults while the board held a two-hour private session in another room.
Then one-by-one they spoke about how this man who arrived at the beginning of the pandemic had managed to create a sense of community even on Zoom, how he listened to their complaints and suggestions, and how he made them feel safe despite asking them to practice active shooter drills at least once a month. They talked about the ways in which he’d gone above and beyond, like chaperoning a Model UN trip to DC when the advisor quit mid-year, checking in on dance rehearsals every night to make sure the troupe didn’t forget to eat dinner, and staying behind until 11:30 the night before homecoming to help decorate.
Each of them spoke directly but politely to the board members and said things like, “You ran on a platform of students first. Well, here we are,” and “You’re not going to have live with the repercussions of this decision. We are, every day when we don’t have a leader we trust.” My favorite moment of the meeting was when one board member (the alleged ringleader of the coup) started scrolling on her phone and the kids on the sidelines screamed, “Get off your phone, these people are talking to you.” Ahh, role reversal.
Many impassioned parents spoke as well, but I think it was the students who convinced all but one member of the board to keep their principal.
This was a fantastic lesson in civic engagement for all of those students and their peers. It was a lesson in civic engagement for me as well. I didn’t want to go and watch yet another elected body ignore the will of the voters, and there was a mountain of laundry to fold. I figured there would be lots of other like-minded parents there to do my bidding for me. There were, of course, but if we’d all had that same thought—that our one voice was unnecessary—then we wouldn’t have had the strength in numbers we needed. I honestly believe that without a strong showing from the community, the outcome would have been different.
In this day of voter suppression, political dirty tricks, and efforts to silence opponents, this one small victory gave me hope. Plus, the students who spoke all vote in 2024!
FDA Advisory-Panel Votes Yes on Over-the-Counter Birth Control Pills
A 17-member advisory panel unanimously recommended that the FDA approve over-the-counter sale of Opill, a progestin-only birth control pill made by HRA Pharma. If the FDA takes the advice of its own experts, we will soon be able to walk into a drug store and grab a pack of pills off the shelf like they do in over 100 other countries.
This is the right outcome. Anything that expands access is important—especially for people who are already struggling to get the reproductive health care they need because they’re uninsured, can’t afford it, can’t take the time off of work for appointments, don’t have childcare, or don’t want their parents to find out. Moreover, Opill is more effective than any of the methods of contraception currently available on the shelf, which right now only includes condoms and various spermicides that are not really meant to be used alone. (We used to have the contraceptive sponge which had die-hard fans but only mediocre effectiveness ratings and is no longer manufactured.) And Opill carries fewer risks, including serious risks like blood clots, than methods that also contain estrogen (which makes those unlikely to ever be approved for OTC sale).
Still, I have concerns, some that I’ve been voicing for years and some that come from reading the document that the FDA prepared ahead of the advisory panel meeting.
The FDA had concerns about the efficacy. We all know that the progestin-only pills (POPs) are not the most effective weapon in our arsenal. They are certainly not as good as “set-it-and-forget” methods like IUDs and implants that take user error out of the equation by working for three to ten years without any help from the person trying to prevent pregnancy. Research also suggests they might not be as good other hormonal methods, including combined oral contraceptive pills, that contain both estrogen and progestin. POPs, sometimes referred to as the minipill, thicken cervical mucus and thin the lining of the uterus to prevent the sperm from making its way to the egg (hence Cecily's testimony). They can also prevent ovulation, but they don’t do that as consistently as methods with estrogen.
In reviewing the effectiveness data on Opill—including the original prescription drug application submitted in 1973, a meta-analysis of studies from 1968-1993, and the additional studies HRA conducted for this approval process—the FDA questioned whether this pill might be less effective than originally thought. The agency noted that the original data had different criteria than a modern contraceptive efficacy study would, such as enrolling women over 35 who might be less fertile and not excluding cycles in which participants also used condoms. The agency also questioned whether an increase in Body Mass Index (BMI) among women in this country might account for a slightly higher failure rate in the newer research.
Advocates rightly dismissed these issues as outside the scope of this application. The question in front of the FDA was not whether the drug worked (that was decided in 50 years ago), but whether it could work as well if taken without the knowledge and advice of a healthcare provider. Moreover, healthcare providers are not asked to take BMI into consideration when prescribing this or other birth control pills.
While these concerns shouldn’t keep Opill off the market, they deserve further attention. We know that emergency contraceptive pills don’t work as well for women with higher BMIs, so it seems possible that minipills would have a similar problem. As advocate and educators, we should be part of the call for more research on this subject.
The FDA had concerns about the instruction. The main question that the FDA needed to answer was whether users could understand the instructions about how the pill should be taken and who should not take them. I understand why the FDA’s concerns sounded patronizing. Women have been taking the pill for 60 years; it’s practically common knowledge that you’re supposed to take it at the same time every day, and we don’t need our intelligence doubted by a group of old men. (I added that last part: the reviewers might not be old and they’re probably not all men.)
But the question at hand isn’t whether women can take it right, it’s whether women take it right based on this set of instructions, and the results called that into question. The FDA felt that too few participants understood that people with a history of breast cancer shouldn’t take the drug and that too many participants with a history of breast cancer failed to “deselect” themselves as candidates for this pill. The agency also noted that many people who reported unexplained vaginal bleeding considered themselves a candidate, despite instructions that suggested they talk to a healthcare provider first. Moreover, 1% of participants took the pill during the study while also taking another hormonal method, despite instructions telling them not to double up.
The strangest result was that 30% of users reported taking more pills than they’d actually been given. Obviously they didn’t take nonexistent pills, but the anomaly was not explained by further analysis, and the FDA questioned what this meant for reliability of the rest of the research study.
The committee read the briefing document, listened to public commentary, and ultimately approved the application for OTC status. Maria Coyle, a pharmacist from Ohio State University who served as committee chair, concluded, “In the balance between benefit and risk, we’d have a hard time justifying not taking this action.” Cynthia Baur, a health literacy and health-communication specialist at the University of Maryland who also served on the committee, summed it up this way: “Do I think that we’ve got perfect data? No. Do I think it was a perfect study? No. Do I think it was adequate to feel reassured that a large number of people can use this drug as intended? Yes.”
I whole-heartedly agree with them (and 100% acknowledge that their expertise and the expertise of many of the advocates who worked hard on this issue exceeds my own).
In my ideal world, all birth control pills and patches and rings would be available for free in CVS, they’d offer Depo shots behind that vaccine curtain, and you could get an IUD inserted in the drive-thru. (Okay, not that last part. It would be too hard to find the right position, even in a minivan.) We’re not going to get that, and I’m not suggesting we hold out for it. I just worry that the minipill now has an ease-of-access advantage that will overshadow other, possibly better, methods.
So while we celebrate this victory, let’s continue to remind people who should and shouldn’t use this new option and give them instructions on how to best take it, even if they might already know. Let’s also remind people that online providers (like Nurx, Hers, and Pandia Health) will deliver prescription hormonal methods right to their door often without requiring even a virtual appointment, and let’s help them find local places that offer long-acting methods like the IUD or the implant (in a proper office setting, not the backseat of a car).
Having more options is better, and we now have a responsibility to educate people about what is the best method for them.