Family physician Montida Fleming, MD, who played a role in norgestrel (Opill)'s road to FDA approval, presents what providers need to know about this soon-to-be-available option, from mechanisms of action to the data on efficacy and safety. She also discusses Opill's advantages in a world where patients face numerous barriers to prescription contraceptives and in a political climate that has made reliable methods more crucial than ever. Hear her thoughts on how medical professionals can help ensure equitable access for patients of all ages, gender identities, income levels and personal circumstances.
Thank you so much for having me. Um So I go by my um my Fleming. I usually they pronounce. I am a um assistant clinical professor at U CS F in the Department of Family and Community Medicine. I primarily work um with the Family Medicine residency program at San Francisco General Hospital. And I also work um at UC Berkeley and the Student Health Center um on top of a number of other um different jobs. Um But I um I am definitely happy to be here um have been um sort of a part of some of the advocacy efforts that led to the passage of this um of this medication over the counter. And so I'm excited to um share a little bit about um the process um and uh and a little bit about this medication as it becomes available to our patients. Um I definitely wanna leave plenty of room for questions at the end. Um So any um questions big or small that come up, definitely feel free to add them in the Q and A. OK. Oh um Here are our objectives um to really understand the context for the FDA approval. Of the pill for over the counter use. Um as our, as the United States, very first over the counter um hormonal contraceptive option, um understand the mechanism of a of progesterone only pill is kind of a reminder um reviewing the safety and efficacy data for this particular progesterone only pill. Um and then just kind of discussing the implications in a in a broader context um with um the current reproductive health access crisis that we are currently facing in this country. Um And this image is from um a uh uh an or a coalition um called Free The Pill that is was hosted at ibis Reproductive Health, um who really laid the groundwork for um a lot of the research and advocacy efforts that led to the passage of this pill. Um So, just to kind of put this into context. So over the counter contraception and, and specifically over the counter hormonal contraception as a concept is definitely not new on a global scale. Um Although we were a little bit slow to adopt here in the United States. Um So this is a map that um is based off of a 2012 survey um where they took a look at all of the different countries um in the world to see what is um what hormonal contraception options exist for folks um to access over the counter. Um And it demonstrated that um over 100 countries uh have over the counter access to oral contraceptives in one way shape or form either legally available without prescription or without any sort of health screening. Um, uh which is accounts for 24% of the countries, 8% legally available without prescription, but with a health screening, um and then 38% while technically, um legally, uh, legally speaking, not necessarily available without a prescription. Um, many of the retail outlets and pharmacies do sell um contraception over the counter. Um uh and it is readily available for folks um since this map was published, um the United Kingdom has also joined the ranks of, of countries that have started to offer over the counter um hormonal contraceptive options with two different progesterone only pills that are now available um within that um within that country to um over the counter um uh patients. Um and now the United States is, is the most recent one. So um this is really exciting to kind of uh join this global effort and, and you know, a global compilation of, of data essentially on the safety of, of using um some of these medications over the counter. Um and the the uh route to get this FDA approval also is not something that um is new or novel. It definitely didn't come out of the blue. This is actually part of over 20 years of um of research and effort um on behalf of researchers, scientists, um the pharmaceutical company um as well as um as well as local grassroots advocates to get this to happen and it just only recently um ended up making news and so more people sort of knew about it. Um This uh essentially in order to switch a medication from prescription only to over the counter use, it requires robust research demonstrating that the product meets the criteria for over the counter use. And that includes that people can understand how to use the product by reading the drug facts label on the back of the pack. Um and can understand it and use it safely, um, are independently able to determine whether out oversight from a health care provider if the pill is appropriate for them to use or not by reading that label. Um And that they can take the product as indicated on the label and those are the criteria that it needs to meet. Um And then once the, um once all of that research is sort of compiled, um and the, the pharmaceutical company and the researchers feel that they have made a compelling enough argument and then they submit a completed application to the FDA after which it's a 10 month review process to make a determination of whether or not to approve it. Um And it was, it was sort of unclear when it first kind of came to the FDA. The application came to the FDA in 2022 whether or not they would go forward and, and approve it. Um And uh they really thought a lot of um advice and testimony from uh scientists and leader, uh health care leaders in the field in order to make a determination. Um And, and really, um so a lot of strong evidence was really presented to make the case that the, that this medication is in fact safe for over the use um over the counter use. Um and can really go a long way in um in helping folks realize their reproductive autonomy. So, just a quick kind of pharmacology review, how progesterone only pills work. Um So, uh the primary method that progesterone only pills um work to prevent pregnancy is by thickening the cervical mucus. This essentially creates a barrier or a wall through which um sperm is really finds a difficult time to enter. There are a number of secondary um mechanisms as well. Um Although are sort of less prominent as compared to uh combine hormonal contraceptives. And this includes preventing ovulation via feedback, inhibition of the um gonadal pituitary, uh the hypothalamic pituitary gonadal axis. Um So, feedback inhibiting GNRH um from the hypothalamus um as well as LH and FSH from the pituitary. Um It also thins the endometrial lining, creating a, an inhospitable um uh home for a pregnancy and it affects tubal motility, meaning that even if an ovulation does occur, um that that released egg has a really hard time making its way through the um through the fallopian tube to even um get to a place where it could be implanted. So, there are a number of mechanisms of action but the primary driver of uh of the contraceptive e efficacy of progesterone only pills is really that um cervical mucus thickening. Um There are a few different formulations that are commercially available in the United States. Um Nora Syndrome is kind of the one that most of us have the most familiarity with. Um So this is uh the mini pill um is, is the, is the name that we often hear it by, it is a lower dose than the progestins in combined. Um Hormonal contraceptive, it does require strict adherence. And so typically, we say that um if you aren't able to take it within a three hour, the same three hour time window, day to day, that it may have decreased efficacy. Um And so, um you would, you know, consider using a backup method for up to 48 hours if you do um take that pill within outside of that three hour time window um that it, it is a a pill that taken continuously. So there is no um hormone free interval. So there's no sort of um uh period where you stop the pill or at least stop the hormonally active pill for a withdrawal bleed. And this can sometimes lead to some more irregular um bleeding patterns. Studies have shown that uh that the mini pill is not um very uh potent or not very reliable at inhibiting ovulation. About 40 to 50% of people taking Noro syndrome at um 0.35 mg continue to ovulate. Um And, and again, the primary mechanism of action is the cervical mucus thicken. And because of that, um norgestrel uh 0.75 mg, this is the medication that is going to be in the pill. It is actually technically not commercially available at this current time. It was up until about 2005 and the manufacturers actually took it off of the market, not for any sort of safety reasons at all. Um, but they, um they just decided to, I guess hang on until they were able to um get it for over the counter use. Um, but similar medications are regularly available abroad um in European countries as well as Canada. Um And uh this, uh this medication at this dose has been shown to inhibit ovulation and about two thirds of people. So 66% of people will have their ovulation inhibited. So a little bit more reliable um ovulation inhibition as compared to North syndrome. Um but um and it will still be labeled for, um to uh for like a three hour window period um of adherence. Although there have been studies and I will review this in a little bit, um, that indicates that it may actually be um in, in reality much more forgiving than this than this. Um three hour time period, but just um we don't have enough data to, to change the label at this time. Uh Similar to North End drone. It's a medication and that you take continuously without any withdrawal period. Um So it may also have some more irregular bleeding patterns. Um And then the very last one was also a relatively newer approved medication. Just know um this is a progesterone medication that is taken at a much higher dose than typical um uh progesterone progestin components of a combined hormonal contraceptive. So it's form milligrams. The brand name is blend. It's only available by brand at this time. So it can be a little bit more expensive for folks. Um It does actually prevent ovulation reliably and that is the main mechanism of action of that one. So it's a little bit different. The mechanism of action is, is a little bit more similar to combined hormonal contraceptive and it has a 24 hour time window um due to its longer half life. And so, um it's not sort of um maintain to that three hour time window as the other um progesterone only pills. And so, uh and it, and it also has a four day hormone free period for more scheduled withdrawal bleeds in the hopes that that leads to a more regular bleeding pattern. Although have demonstrated that people still continue to have some unscheduled bleeds in the studied populations with this, with this medication so it more mimics the estrogen containing birth control pills in, in the ways in which it um it works the flexibility in taking it. Um And um uh and it is often um kind of on the more expensive side because it's still um under, under brand patent. And so with Norgestrel, um which is again, the, the progestin that will be in the over the counter pill. Um It uh the studies have actually demonstrated a really low failure rate. Um And so the, an actual, you study demonstrated a pearl index of 4.4% that means 4.4% failure rate for 100 woman years. Um which is, you know, the way that we uh report failure rates for all contraceptives and, and as a comparison point, um that we sort of think about the, the typical versus perfect use of, of contraception options and we say that most likely um most people are gonna fall than the typical use. And so that's usually the number that we end up thinking about and sticking to. So for um all progesterone only pills as well as combined hormonal contraceptives. So, estrogen containing um contraceptives is about 7% with typical use condoms are about 14% and spermicides are about 28%. So, as we can see, um it is much more effective than um the other over the counter um contraceptives that are currently available including condoms and spermicides. And so, um and it's, it's very similar to other um prescription strength um oral contraceptive as well. Um They, there was also a study and this is kind of about the, the flexibility with adherence timing. There was a study that looked at deliberate non adherence um with a six hour delay at um uh from the time window when the pill was supposed to be taken as well as the full 24 hour delay. And actually, they, they took a look at ovulation rates as well as the um uh the cervical mucus thickness, um which they scored in the study. And it actually demonstrated that even with a 24 hour delay, there was really little effect on the contraceptive protection of uh of the, the nogal pill. And so it probably does have a little bit more um more window period than what it will be labeled for. Um be because this is a, a single study. It's not correlated to clinical outcomes. It's more just looking at sort of measures of cervical mucus thickness and whether or not an ovulation occurred. Um And no other similar studies have been done to corroborate the findings. It's kind of just not enough data to actually change the labeling yet. Um data uh does support that um people who have access to over the counter contraception, use it and use it really reliably and actually much more reliably than people who use prescription contras um hormonal contraceptive. And that is often because there are less barriers to over the counter access as compared to um prescription access. And so, you know, if a person is able to regularly um just go to the pharmacy or store and purchase their next pack without having to wait for a provider to get through their, their um full inbox to find that they have requested um a, a new prescription or a refill. Um That is now, you know, sometimes a few days or a few weeks later than what the person had actually wanted. Um then uh or, or passed um them running out of that medication, um then they actually end up having less mis doses. Um and, and more reliable use. Um So we know that this um this is something that is really represents a promising um improvement for efficacy because the more mis doses there are more delays that people have in obtaining their next pack of pills, the less likely they are to have an interim unintended pregnancy. Um It's also extremely safe. So, progesterone only pills are typically the pills that we usually prescribe for folks who have underlying health conditions anyways, right? And so um there is only really one strict contraindication um as uh on the CDC medical eligibility criteria and that is current active breast cancer. Um There are a few other uh kind of precautions um to think about as well. Um And typically these, these precautions are not necessarily because it makes it unsafe in any way. It just may mean that the um these underlying conditions may make the contraception a little bit less effective. Um But the contraception does not actually have an impact on worsening these underlying health factors. So, for instance, um people who have a, a gastric bypass or male absorptive procedure and this is specifically like a ruin why gastric bypass rather than like a sleeve or another restrictive. Um It may um uh it, it may decrease the efficacy um by I impacting the amount of the progesterone that's able to be absorbed um by the gut. Um although there's some conflicting results on the efficacy for that anyways, um anti convulsants, certain anticonvulsants um can uh decrease uh the efficacy of the contraceptive as well. Um This encompasses most anti convulsants except for lamoTRIgine, which um does not have that interaction. Um For progesterone only pills, same thing with rifAMPin and some of the other um uh uh similar category tuberculosis medications um can decrease the efficacy of the contraceptive. Um decompensated cirrhosis is really just uh more of a theoretical concern um due to the liver metabolism of progestins. But um there have been good reliable studies that demonstrate that um progestin contraceptives do not affect disease progression or severity of the underlying liver disease. Um And so, um and so it's, it, it is a reasonable option um for folks uh to use and, and certainly when we sort of think about these pregnancy is certainly high risk for many of these patient populations. And so, thinking about the relative risks and benefits of, you know, the medications, um uh taking the medication, taking the contraceptive as compared to having a pregnancy. Um uh really often we in favor of going ahead with the uh with the contraception, um hepatocellular adenoma. There's actually no data um for progesterone only pills combined, oral contraceptives can lead to the development of hepatocellular adenoma. Um But it's sort of unknown whether progesterone only have um have similar effects. And the the the thought is that most likely it's related to the estrogen component combined pills. Um But just because we don't have enough data to know um is why it's a category three. And then same thing, antiphospholipid antibody positive. Um These folks have really high thrombosis risks. It's really um uh un um unwise to use estrogen containing um birth control pills for, for this category of folks. And we have good evidence showing that there is a really low um and an almost negligible impact for a thrombosis risk with progestin progestins can be safely used for folks with other um BT E risk factors. But again, just because we don't have specific data about this category of um of people. Uh that uh the CDC conservatively puts it as a category three. Um There have also been studies that patients can really reliably self screen themselves for these rare contraindications and so, um data supports the reliability of self screening that um that is similar to provider based screening. Um and, and also includes youth, right? So youth adolescents um minors um have also been shown to be able to reliably self screen themselves um just as well as the provider can for these rare contraindications um in order to um prevent um uh prevent uh use um in a way that is not intended. Um and the medication is also really safe and effective in breastfeeding in breastfeeding patients as well. And so, you know, this becomes really important because uh there are many, many barriers to prescription contraception that people face, right? And this is why it is so important to have access to over the counter pills for people to um be able to really take this matter into their own hands and access um a reliable, safe and effective um uh forms of pregnancy prevention um without the need of, of uh you know, medical provider um uh intervention. And so uh studies have shown that nearly one in three individuals have reported significant barriers to accessing contraception. Um And for the number of people of childbearing, uh childbearing age who wish to uh or childbearing potential who wish to prevent pregnancy, that's really a huge number of people um in the United States who have had already experienced significant barriers to accessing contraception. Um Some of the most common barriers that have been reported include stigma. Um you know, stigma related to contraception use can lead to a sense of shame or embarrassment to obtain the services or fill prescriptions at the pharmacy counter. Um difficulties with appointment availability. So thinking about wait times for appointments, inability to take off time at work or school in order to get to an appointment during um you know, during usual business uh clinic, business hours, transportation barriers and cost of transportation. And especially if folks don't have a regular primary care provider or they're not really sure where to go if they don't really access healthcare. And um for any other reason, these can all be um appointment related barriers. Um And then if they don't have insurance or they're un under insured with high deductible plans, um the cost of the visit itself may be way too expensive for folks to even access. Um And then there are some in insurance coverage gaps, right? So um when the Affordable Care Act was passed, um it did lead to the requirement of private insurance carriers to cover FDA approved contraception with at least some option, at least one option of every single category of contraception that is available um to be covered without cost sharing to the patient. But there's been really uneven coverage and coverage gaps for some people's preferred contraception method due to some language in the law that allows insurance to dictate the terms of coverage um leading to an insurance based barriers and that includes, you know, um if they have one generic um that is available at no cost, but alternative formulations may not be covered. Um And a person's uh preferred um contraception. Um Maybe another one that's not cause sometimes it involves um doing uh prior authorizations which may or may not be accepted um requires um trying uh uh uh higher prefer a more preferred form uh me on formulary before uh before going to a another one that is less preferred. Um All of these things lead to a lot of barriers for folks accessing um the contraception that they want and need and in addition, religious exemptions exist and for some employer based insurance plans and that, and they, and that continues to leave many people of reproductive potential without any covered options. Um Confidentiality ends up being a huge issue as well and particularly when we think about um adolescents and, and young people, um you know, contraception and sexual health falls under um con confidential care. Um But considering, um you know, whether uh the name of the clinic um that shows up on a person's insurance or um explanation of benefits, um may uh may um uh make it obvious what sorts of services are being sought out or um or uh uh utilized um transportation barriers to a clinic, right? If um young folks maybe um don't have access to a car, don't have a driver's license, may not have funds or money um in order to um be able to um get transportation in order to be able to um pick up uh or fill a prescription at the pharmacy um without the knowledge or help of an adult. Um that those are all things that um young people face uh that are uh that continue to be barriers for prescription access. Um and then uh additional con confidentiality issues when it comes to people facing reproductive coercion in I PV. Um you know, um they may be prevented by partners from seeking health care um or um or for seeking confidential health care um from having their visit um be be kept prudential or, or um or uh being in the room alone with a healthcare provider um may all be barriers as well. Um And, and discrimination being um another common uh barrier that has been reported um particularly a survey of youth um reported facing difficulties. Um you know, on top of kind of lack of transportation and difficulties with scheduling appointments from stigma um from both parents and health care providers. And more than half of those surveyed, uh young people reported that one or more of those barriers actually prevented them from getting birth control at all. Um Black and Latino people and those of low English proficiency have um been demonstrated to report lower rates of high quality contraceptive counseling that focuses on their values and their preferences. Um And so, um they may uh be more likely to have discriminatory experiences um including having stereotyped assumptions, being about them being pressured to use certain types of contraceptives over others, being more likely to be counseled towards alert contraception. And all of this has been documented in the literature. Um and transgender non binary people who can become pregnant um also face discrimination and stigma sometimes um have health care providers who lack training and providing gender inclusive care. And a lot of these things can be addressed by having availability of over the counter um hormonal contraception option. Um When folks don't have to um face these potentially stigmatizing um and discriminatory healthcare experiences by being able to just go to their local um corner pharmacy and pick up a medication from the shelf um and just bring it to the register without having to sort of face all of these um these barriers. So, you know, what could this equitable access look like? Um So it's not enough to just have had this uh this path. Um But there are many steps that we need to take in order to ensure that the the medication, even though it is approved and available that it's actually accessible to people. Um because if it's not accessible, then it's really kind of what's the point, right? Um And again, while the AC A requires insurance coverage of FDA approved contraception without cost sharing, um Insurance companies are able to still require a prescription in order to cover um the the pill. Um And, and again, we just talk through all of the reasons why uh why getting a prescription is not easy for a lot of people and prevents a lot of people from being able to actually access contraception at all. Um Additionally, pharmacy employees must be adequately prepared and educated and so as not to create any additional barriers, um often unintentional barriers by um having inaccurate information um uh that they tell patients by having um the medication behind the pharmacy counter rather than on the shelf where people can sort of access it themselves. Um And, and, and this is not coming without basis, right? When um over the counter plan B or emergency contraception was initially a approved, we saw all of these things. There was a study of essentially um researchers who acted as secret shoppers for the emergency contraception pills and heard all sorts of, of um inaccurate information told to them by um by pharmacy employees. Um And, and actually had a really difficult time accessing the medication even though it had already been approved um for over the counter use. Um There is a um a bill uh that has been introduced um in order to help address some of these concerns, it's called the Affordability is Access Act and that would remove the prescription requirement. Um So essentially, it would legislate um that insurance providers cannot require a prescription in order to have it covered. Um that it would also prohibit retailers that sell over the counter birth control pills from interfering in any way with people trying to purchase them. Um and ensure that uh any FDA approved over the counter contraception. So including a pill and anything that may come after this um would be covered by private insurance without a prescription um and without stipulations. And so, um if that passes, that would be an incredible step in the right direction to make sure that the, that the medication is actually accessible to the folks who need it. Um beyond insurance coverage, it's also really critical that any future over the counter birth control pill is priced affordably. Um So that people who, who don't have insurance or can't use insurance are still able to access the, the care that they need and want. Um this onus will be on the drug manufacturer. Um whose name is Perrigo. Um The cost hasn't yet been announced and the thought is that the um the the medication will come to the over the counter market sometime in early 2024. You know, we're only a month for less two weeks away from that time point and they still haven't announced a cost. Um And so we have yet to see what that will look like. But if we also look at um emergency contraception, if that is sort of any indicator over the counter plan B can cost up to 40 to $50 for one pill, right. So, um you know, and that, that for many people is extremely inaccessible pricing. Um There was a survey um that the Kaiser Family Foundation did that found that 84% of people are not able or willing to pay more than $20 a month for, for their hormonal contraception. Right. So, um if they price it more than $20 a month and then the majority of people uh are, uh you know, particularly for those who don't have insurance, um are underinsured, uh are likely not gonna be able to access these medications. And we see these things really, um really we bear out in disparities, particularly in places where um there has not been Medicaid expansion, right? So in certain states that also face the highest rates of um maternal morbidity and mortality, um the highest rates of, of um health disparities as related to social and structural determinants of health. Um And so, um it will be really important um to continue to advocate with the, with the pharmaceutical company to make sure that the pricing is, is equitable and accessible for folks. Um It also needs to be accessible on the shelf rather than behind the counter without ID requirements or age requirements. Um Again, we've sort of seen a lot of um a lot of effort in kind of the voter suppression realm of requiring I DS. Um and that is something that um we have not been able to, um, uh, that people are not able to kind of access the care that they, uh, sorry, um, that people are, um, sorry, I just had a distraction behind me and lost my train of thought. Um, that, um, there are a number of people, um, who may not necessarily have AAA State ID, um, who may need to access these medications. Um, and then, um, and particularly young people in adolescents may not necessarily have an ID um in order to access these medications. Um and then, um particularly folks who are at risk of experiencing um stigma and discrimination including um black indigenous and people of color. Um Transgender, non-binary folks are gender expansive folks, people with discipline. Um just making sure that folks are able to easily access the medication without being subjected to negative health care experiences. Um again, being able to just kind of grab what you need off of the, off of the shelf along with any other things that you're gonna be grabbing at the pharmacy rather than having to go and speak to a pharmacist, speak to a pharmacy staff at that um behind the counter. Um And then having home delivery service services available also without pharmacy restrictions can additionally improve access for everybody. So, um all of this is really, really timely um because we are um living in an unprecedented time here in the United States um where people are unable to access a um a critical piece of their reproductive health care, which is abortion care. Um And in a large, large swaths of the country, right. Um And it is in a lot of these states that have, um these complete bans, um where a lot of those um significant health care disparities occur where also are the same places that uh men has not been expanded, right? Um And so these are also folks who are at high risk of being unable to access this medication if it's priced unaffordable. Um And if they're, um and if they're, if they don't have insurance, um because they are in that uh Medicaid gap um due to their state not expanding Medicaid for them. Um So currently, uh in the United States, there are 14 states with complete abortion bans, 10 states with partial bans um or bans that um that are complete, that are currently enjoined in court proceedings. Um And um and despite all of this, there is recent data that actually the total number of abortions in the United States have increased in the last year since um since Dobb struck down Roe V Wade. Um And since abortion access has not been protected across the country. And so, um what that means is that many people who are um getting abortions are traveling across state lines to do so if they're even able to. But many of the same barriers that we've already talked, talked about um in terms of accessing prescription birth control are also the same barriers that people face um when they are trying to access abortion care. And so for a lot of people travel is just not an option and folks are being forced to carry pregnancies to term against their will. And so what that means is that having a more accessible option um to prevent pregnancy, one that is highly effective, reliable and safe and much more effective than most of what we have. Um you know, over the counter um is in incredibly important for pe for the people who wish to prevent pregnancy. Um And as, and, and the impact again will be seen for a really long time. Um There have been studies that show that there are generational consequences when a desired abortion is denied to, to folks and so preventing a pregnancy um that um in which a person would want to seek an abortion and are then denied one becomes incredibly important as well. Um So that is all I have. Um I would love to open it up to any questions that might come through.