Contraception Empowerment: OTC Access to the Pill Takes a Leap Forward

FDA approves first OTC hormonal contraceptive pill

The Food and Drug Administration (FDA) has approved the first-ever over-the-counter (a.k.a. OTC) birth control pill, trade name Opill®. This is a welcome step forward in reproductive care and rights. 

I am sure there will be plenty (like, puh-lenty) of anti-pill propaganda from pill panic profiteers as well as the religious right, here’s what you need to know. 

Why Should Hormonal Contraception be OTC?

Access to reliable contraception is a human right. 

Any barrier that affects access to contraception puts people at risk for unplanned pregnancies. As hormonal contraception is a treatment for many medical conditions, barriers to access can affect health in other ways as well. For example, oral contraception can be used to treat heavy and/or painful periods. Requiring a prescription is one of those barriers, and can create hassles in a variety of ways. Some providers won’t prescribe the contraceptive pill without an in-person visit, but getting a timely appointment isn’t always easy, and appointments can also be expensive. Filling the first prescription may go fine, but then refills can become a challenge. In addition, it’s possible to encounter a forced birth provider who might provide misleading information about hormonal contraception or refuse to write a prescription. And of course cost of the contraceptive itself can be a barrier.

How many women do these barriers affect? In one study, among women who tried to get a prescription for hormonal contraception, about one-third experienced difficulty getting an initial prescription or refills.

Making hormonal contraceptive pills OTC is a way to reduce some of these barriers. Studies have shown women are perfectly capable of reviewing the information on the package and determining if the pill is safe for them or not, you know, just like they do with acetaminophen. For example, I found out about OTC ibuprofen when I was 18 years old. I had terribly painful periods and a teaching assistant at my university raved about it. So, I bought a bottle…and it mentioned that people with kidney disease (which I had) shouldn’t take the medication, so I never took it. I managed this incredible feat of reading the warning label when I was 18 years old. Also, it’s not like there is a warning label on getting pregnant, and yet that is orders of magnitude riskier than any hormonal contraceptive. We also know that pelvic exams and cervical cancer screening and testing for sexually transmitted infections aren’t needed to start the birth control pill. 

The majority of women want access to the pill OTC and, if it were available, just over one-third of women said they would use this option. Of the people who start oral contraception, by the end of one year about one-third will have stopped using that method, and it should come as no shocker that making it easier to get the pills impacts whether the pill is abandoned as a method of contraception or not. In what seems like a phenomenon too obvious to study (but we always need to study things, because ultimately you don’t know until you prove it) women who were only given a three-month supply of pills and were required to refill the prescription were less likely to still be taking the pill at six months compared with those who were given a seven month supply. 

And draconian forced birth laws add another level of urgency.  It is more important than ever for people to prevent unplanned pregnancies in states with little to no abortion access. Additionally, OB/GYNs are leaving many of these states, decreasing access to medical care. So if you want to start the pill for contraception or for painful periods or heavy bleeding or one of the many other reasons the pill can help, you may encounter more delays. 

We need OTC pills, and while Opill® is not going to solve all of the issues I’ve just laid out, it’s a good first step. 

The Pill 101

All hormonal contraceptives have a progestin, which is a class of synthetic hormones that have progesterone-like properties. Progestins are more potent than progesterone (basically, they do what progesterone does, only better).

Progesterone inhibits the surge of luteinizing hormone that is required for ovulation and. the original pill researchers knew they wanted to harness this effect. Studies showed that progesterone itself could not be given in doses to do the job, but progestins could. And, as it turned out, they also suppress another hormone involved in ovulation, follicle stimulating hormone or FSH, and have a profound effect on cervical mucus, making it hostile to sperm. Basically, with the right dose of progestin, there are two methods of contraception rolled into one. Progestins also thin the endometrium or the lining of the uterus, so they reduce menstrual bleeding and cramps. This isn’t part of their contraceptive effect, but obviously, it can be an added bonus. It can also be an added problem because sometimes this effect on the lining can lead to erratic bleeding. This is one of the reasons that estrogen was added to the original pill because it reduced bothersome progestin-induced bleeding. In addition, adding estrogen improved the contraceptive effect.

Progestin-only Pills 

The birth control pill that most people think of when they think of the pill is this estrogen-containing pill. The first progestin-only pill was introduced in the late 1960s, but this type of pill didn’t really become a viable option for a variety of reasons until the 1970s. The Opill®, which has 0.075 mg of norgestrel, was first FDA approved in 1976 as a prescription.

A common term for these progestin-only pills is the minipill. My understanding is the nickname came from the fact that these first progestin-only pills had less progestin—or a mini dose–compared to an estrogen-containing pill. The lower dose seems counterintuitive, but these pills were born out of early attempts to lower pill-related complications and side effects; at the time, it wasn’t clear whether the estrogen or the progestin was the source of the issues, and it also wasn’t clear what dose of hormone was truly needed for the contraceptive effect. 

What is Different about a Minipill?

The biggest difference and upside of a progestin-only minipill is the lack of estrogen. While serious complications from the estrogen-containing pill are rare, they are essentially all due to the estrogen. Eliminating estrogen makes a contraception method that is already safe, even that much safer. Progestin-only pills aren’t associated with an increased risk of blood clots and won’t raise blood pressure or trigger migraines. They may also help reduce sickle cell crises for people with sickle cell anemia. As for disadvantages, irregular bleeding is more common with progestin-only pills compared with estrogen-containing pills, although this bleeding can often be managed. A progestin-only pill will reduce the rate of endometrial cancer, but we don’t know if it will reduce the risk of ovarian cancer as the estrogen-containing pill does. This is because the minipills have always had a much smaller share of the market, so there aren’t as many large studies here. 

There are only a few reasons why someone shouldn't use these pills, such as current breast cancer or a history of breast cancer, cirrhosis of the liver, and bariatric surgery that affects how absorption from the bowel. However, these are also reasons not to use the estrogen-containing pill, meaning they are not unique progestin-only pill concerns. There is really a short list of reasons someone shouldn’t take the progestin-only pill, and you can find the complete list here. Hence why it is incredibly safe to make it OTC.

There has long been a concern with the minipills that the progestin is barely enough to do the job. Meaning if ovulation is just barely being suppressed and the cervical mucus is just barely hostile enough to sperm if levels dropped at all because of a delayed or missed pill, could the contraceptive effect be compromised? This concern is primarily based on studies looking at the levels of progestins in the blood, which fall to undetectable by approximately 24 hours after a dose. The package insert for Opill® repeats this concern about levels, stating this:

Serum progestin levels peak about two hours after oral administration, followed by rapid distribution and elimination. By 24 hours after drug ingestion, serum levels are near baseline, making efficacy dependent upon rigid adherence to the dosing schedule. There are large variations in serum levels among individual users. Progestin-only administration results in lower steady-state progestin levels and a shorter elimination half-life than concomitant administration with estrogens.

There is actually some controversy here because clinical studies looking at the effectiveness of progestin-only pills versus estrogen-containing pills are actually conflicting. Without definitive data, we typically err on the side of caution and so the “within three hours” rule seemed prudent and also replicates what people are told in studies. And we don’t have any data to definitively say to say this concept of a very narrow window for delayed pills should be discarded.

It’s important to know this background because it has been used to reinforce the erroneous belief that progestin-only pills are significantly less effective than estrogen-containing pills. Let’s look at what happens under study conditions. In the literature this is called  “perfect use,” but I hate that term because a big reason the pill doesn’t get taken every day are the barriers we discussed earlier, and studies, from which we get “perfect use,” eliminate those barriers. When you look at all the studies it’s not possible to definitely say that progestin-only pills have a higher pregnancy rate than estrogen-containing pills in study conditions. In fact, the book Contraceptive Technology, which is written by the top experts in the field, lumps both estrogen and progestin-only pills together from a pregnancy rate perspective–7% for real-world use and 0.3% for study conditions. The package insert for Micronor (also a prescription progestin-only pill) states this about pregnancy rates, “If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills.” The package insert for the Opill® references eight studies, with a combined pregnancy rate of 2%. 

There are a variety of minipills that are available, each one has a slightly different progestin. The pill that has just been approved, the Opill®, contains norgestrel. Each pack has twenty-eight pills, and all pills are active, so one must be taken every day.

What About the Cost?

The biggest concern with Opill® is the price. How much will it cost? One big downside of OTC status for the pill, or any product, is prices often soar. The progestin-only pill with norgestimate used to be available for just over $5.03 a package at Costplus Drugs (they are currently listing it as unavailable, it was withdrawn from the market for business reasons, but it has been picked up by a generic manufacturer so hopefully it will be available again soon). Studies suggest that people may be willing to pay $10-15 a package for over-the-counter contraceptive pills, but that price point may be too high for many.

And of course, contraception should be available free with most health plans in the United States because of the Affordable Health Act, but how that will apply to an OTC medication isn’t clear. 

So…

In my experience, progestin-only pills are well tolerated. For people who want an easily reversible, reliable contraceptive and who can’t take estrogen, either because of medical concerns or for how it makes them feel, they are a fantastic option. They are also a great option for someone who wants the pill but doesn’t want to accept the low risk of blood clots. And now they are an option for someone who doesn’t want the hassle of communicating with a provider.

Side note about menopause. Many women use the pill to control symptoms in the menopause transition, but the minipills are not as good an option as the estrogen-containing pill as they aren’t as effective at controlling chaotic menstrual bleeding and as there is no estrogen, so there is no treatment of hot flashes or night sweats.

The next step? Estrogen-containing contraceptives over the counter!

And finally…

If you enjoyed this, I think you will like my new book, “Blood: The Science, Medicine, and Mythology of Menstruation” because it’s filled with detailed info just like this, along with lots of stories and “Jen-isms” that hopefully make you smile. I wrote a robust section on hormonal contraception to combat all the myths out there! Instagram drove me to it!

Pre-orders help an author immensely. When there are a lot of orders before the on sale date it tells retailers that there is interest in the book. When there are more pre-sales, booksellers often feature a book more prominently or may reach out to the publisher and inquire about a stop on a book tour. Reserving the book at the library is also helpful because a library is more likely to order more copies. And of course, when there is a lot of pre-release buzz, the press gets interested. 

The book comes out on January 23, and there will be a U.S. and Canadian tour. Hey, there is nothing more Canadian than touring the country at the end of January and early February! The US/UK cover is on the left, and Canada is on the right.

If you are interested in pre-orders you can find US sites through this link. If you are interested in an autographed copy in the US, you can order from Book Passage (here is the link), and be specific in the comments section if you want me to personalize the book. “Fuck the Patriarchy” is a popular one! 

In Canada, you can find your retailer of choice at this link. I don’t have a presale link yet for the UK, Australia, and New Zealand, but I’ll share it as soon as I can. 

References

FDA News Release Opill https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive

Progestin-Only Pills, Chapter 9. Raymond EG, Grossman D. In Contraceptive Technology. Hatcher RA, Nelson AL, Trussell J. eds. 2018 Contraceptive Technology Communications, Inc.

Package insert Opill® Tablets https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017031s035s036lbl.pdf

Over-the-counter access to hormonal contraception. ACOG Committee Opinion No. 788. American College of Obstetricians and Gynecologists. Obstet Gynecol 2019;134:e96–105.

Medpage Today First OTC Birth Control Pill Approved, by John Gever. https://www.medpagetoday.com/obgyn/pregnancy/105454?xid=nl_mpt_OB/GYN_update_2023-07-13&eun=g1066163d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Automated%20Specialty%20Update%20OBGYN%202023-07-13&utm_term=NL_Spec_OBGYN_Update_Active