> The contraceptive efficacy of norgestrel was established with the original approval for prescription use in 1973. HRA Pharma applied to switch norgestrel from a prescription to an over-the-counter product. For approval of a product for use in the nonprescription setting, the FDA requires that the applicant demonstrate that the product can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a health care professional
It took 50 years to make packaging that users could understand?
Yep, because it's relying on the cultural knowledge that has been built up over the years through things like health classes and society talking more openly to share knowledge. And people really don't understand all the potential risks for most medications they're on, whether Rx or OTC.
Couldn't be that doctors wanted all those easy well visits writing scripts for birth control and the recent supreme court ruling encouraged the FDA to finally be reasonable? It's that this exact moment is the first time in human history that women are capable of understanding "once daily".
> It's that this exact moment is the first time in human history that women are capable of understanding "once daily".
Contraceptives have a long-standing problem of people being unable or unwilling to follow the instructions, or not catching little nuances like "this pill lasts for 22 hours, so you really need to take it every day at the same time". For a decent-looking summary, see ex. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7533104/ which includes a lot of lines like,
> Hatcher and colleagues report that for both types of pills, the failure rate is less than 1% with perfect use and 7% with typical use.
So no, empirically, it appears likely that people are not capable of understanding "once daily".
How does the pill being prescribed by a doctor help this? Do you think doctors are actually explaining this to patients? They are not. They don't have time. The PE firms who own them won't let them take the time.
I would expect someone to explain it; if not technically a doctor then a nurse or such, which is consistent with my experience of medical appointments.
Sure, it should be explained, but the point is that there's no value in only enabling a scarce resource (doctors) to explain something that doesn't require any medical training (take this once a day at the same time).
The pharmacist can explain it. You can put it in huge text on the packaging. You can text or email people.
You could literally make someone DocuSign a single page PDF that just says "THIS ONLY WORKS CORRECTLY IF YOU TAKE IT AT THE SAME TIME EVERY DAY" in order to get their prescription.
All of these options get the exact same message across without being inconvenient and causing people to miss taking their birth control because they couldn't get a doctor's appointment, etc. There are costs to making people go into a medical office that you can't ignore here.
"All of these options get the exact same message across without being inconvenient and causing people to miss taking their birth control because they couldn't get a doctor's appointment, etc. There are costs to making people go into a medical office that you can't ignore here."
I mean, the alternative already exists - online appointments. You can even get auto renewing prescriptions through the mail.
What is the need for any kind of appointment with a doctor? There is literally no medical expertise required for what we're talking about here. There is the need to relay an instruction that almost anyone can understand. Why is it a good idea to force patients to make any kind of appointment and to take up the time of very highly trained medical professionals, in order to say "TAKE THIS AT THE SAME TIME EVERY DAY"?
You could train a dog to pass that message across using some of those buttons that say words when pressed. That would actually probably be much more effective than having it come from a doctor, because the dog thing would be much more memorable.
Depends on the result we are expecting as to if it's unreasonable. I would guess at least half of people do not read the paper you get with the medication (any meds).
> So no, empirically, it appears likely that people are not capable of understanding "once daily".
Hilariously, almost all of the "failure rate" of vasectomies is due to people who don't follow the doctor's instructions for how to handle the first few weeks after (you've still got some live swimmers with access to the outside, for a while). Other reasons for failure are so vanishingly rare they're hardly worth mentioning.
So you're thinking about getting the surgery, see the failure rate and are like, "damn, that's low but still a lot higher than I'd expect, given I'm committing to nut surgery"—but no, as long as you don't do the single thing you're not supposed to for the first few weeks, it's basically 100% effective.
Empirically, how much does visiting a doctor change people’s understanding of “once daily”? Measured in percentage terms. Because that’s the important question here.
They have some data in the links in the article. There could be some bias there (pharma likes to guide subject answers, and they dont provide the methodology details), so we would probably need real world data. But based on that limited data it appears to be no different. In theory, the longer the pill is in use and the more people who use it, then the more likely it is that people in society understand that it's one's a day at the same time of day etc.
So literally a vibrating pill box that stays lit and sends smart reminders until someone takes their pill would be 10,000x more effective and cost vastly less than the appointments+opportunity cost+lifestyle cost forced on women by profiteers. Or one of those special purpose reminder apps. Or Google Calendar…
An app can deliver periodic reminders about the potential negative effects of birth control pills. It can have a conversational interface for when someone is having issues with a particular pill, thinking about starting a new pill or type of contraceptive, etc…
Doesn’t sound plausible. Doctors aren’t really casting around for work, these visits aren’t particularly or unusually straightforward for a GP - and at a guess a majority of women who stay on hormonal birth control have had some problems with it at some point. The cultural knowledge aspect is real.
Some people react very badly to hormonal contraceptives, to the degree that it makes a lot of sense to have them actively prescribed so the GP can watch for (or at least warn to watch for) side-effects.
I know people who can't take them because they make them suicidal, of the "spontaneously walking into fast-moving traffic" sort. I don't know if that would happen with this type specifically, but there are reasons to be cautious.
Yeah, I was a bit shocked to see this. Not because it shouldn't be easily accessible, but because most women I've talked to about this has gone through some sort of dialing in process. Whether its for dosage or a different brand. Hormones are not easy.
No medication is completely safe. Any medication approved for use has to be "generally safe" when used correctly. So basically all meds can be dangerous or safe. It's all about informed consent and proper use.
Well exactly. In this case it's more a matter of whether the move to non-prescription introduces significant new risks both that didn't exist before and that the layperson shouldn't be expected to be able to handle.
There's more to it than once daily. I doubt the Supreme Court ruling had any logical impact on the FDA decision, unless it was only an empty political gesture (no real contraception restrictions right now). It's more likely that phrama makes more on Rx prescriptions and had no incentive to make it OTC.
IDK what culture you're referring to but where I grew up in the US it is not legal for the education system to inform students about what contraceptives are and how to use them. So I find this argument of yours completely bogus.
Generics at least aren't big moneymakers. With totally pedestrian insurance I pay next to nothing (or nothing) for the variety of meds that I take. Would probably cost more if I could buy them OTC.
Given the 50 years, I'd say the original investment has paid off many times over, and all the generic brands got their cut. It's more than fair to society to allow the medicine to go over the counter.
Oh I'm not disagreeing in general. There are probably some classes of drugs like antibiotics which probably lend themselves to overuse/misuse and are probably best kept prescription only for the most part (agriculture overuse notwithstanding). But in general, if there's no good reason something shouldn't be OTC, it probably should be.
I'm just saying generic prescription drugs don't necessarily have a huge price uplift vs. OTC.
I think you are looking at the cost of generic prescription drugs vs their generic OTC counterpart. When a drug is first invented it is patented, not generic. The drug company has to look at whether to apply for FDA approval as a prescription or OTC. Most often drug companies look to get approval as prescription, because that is more profitable for patented drugs.
Once the drugs move out of patent, that doesn't mean it is automatically approved for OTC sale. A drug maker can look at getting FDA approval for making it OTC. But it costs time and money to do so, with no guarantee of success. In the case of Norgestrel it took until now before any drug maker thought it would be worth pursuing.
I think you are looking at the cost of generic prescription drugs vs their generic OTC counterpart.
Of course. Drugs that are approved for OTC are almost always generic by that time.
Most often drug companies look to get approval as prescription, because that is more profitable for patented drugs.
No, it's not approved as prescription because it's more profitable, it's approved as prescription because that's all the FDA allows. The safety requirements for OTC are far stricter than prescription. Most patented drugs could never become OTC, ever.
In the case of Norgestrel it took until now before any drug maker thought it would be worth pursuing.
Norgestrel is a generic. All birth control pills pretty much are. The hormones can be in different combinations or formulations, but generally they are all generic components.
So my point stands, it's often more profitable to be OTC than prescription.
It could also be that public familiarity with medication procedures and language has changed over time allowing the FDA to believe that this can be used safely now, whereas the same instructions would not have been as effective 20 years ago?
The same people who hate and politicize abortion also usually hate and politicize contraceptives. I don't know if that had an impact in the choice to seek approval or not, but I wouldn't be surprised.
If it looks like Trump might win the electoral college and the Dems might lose Congress, it might not be the worst thing to have stocked up on.
I'm aware that a significant portion of conservatives are very religious and some religious people object to contraception. But I'm not aware of any concerted effort by Republicans to ban or restrict pre-pregnancy contraceptives in my lifetime.
And while I have plenty of thoughts about Trump, I'm not aware of him ever suggesting an interest in restricting access to contraceptives.
> But I'm not aware of any concerted effort by Republicans to ban or restrict pre-pregnancy contraceptives in my lifetime.
Really? Because Texas has been marching in that direction for some time now. There was a recent ruling that when it comes to contraceptives that agencies cannot protect minor confidentiality from their parents. Multiple republican think tanks push the idea that contraceptives kill babies and should be banned as abortifacients. You can see these attacks starting in multiple locations [1] [2]. The goal is obviously attack anything with dubious claims of abortifacient, then reduce access to anything that is not (by removing contraceptives from sex ed, reducing access, and preventing people from talking to doctors about it).
> There was a recent ruling that when it comes to contraceptives that agencies cannot protect minor confidentiality from their parents.
That issue is about whether parents should have access to private information about their children, not restrictions to contraceptives.
I already acknowledged there are groups who are opposed to contraception. The Catholic Medical Association and Students for Life of America are examples of such groups. And there are undoubtably Republicans who try to appeal to those groups.
But you have not provided compelling evidence of a concerted effort by the GOP to restrict access to pre-pregnancy contraceptives.
It's like claiming the Republican party wants to restore segregation because many Republicans oppose affirmative action and there are racist groups who vote for them.
Students for Life is a republican non-profit organization, same for the Catholic Medical Association. They are pushing concentrated efforts to restrict access to pre-pregnancy contraceptives. You're trying to pull a no true scotsman here and it isn't working.
> That issue is about whether parents should have access to private information about their children, not restrictions to contraceptives.
No, that is exactly the issue. The issue is you have religious parents that are anti-contraceptives. The goal of this is to prevent people from using contraceptives under the watch of their parents. The ruling is specifically around contraceptives, so you trying to say it's not about contraceptives is incredibly weird.
That's not a "no true scotsman" argument. It would be if I claimed something like "they're not real Republicans" but I'm not.
Those are indeed Republican organizations and I did not claim otherwise. So what? Republicans aren't a hive mind. They don't agree on everything. You wouldn't claim the Democratic party wants to ban vaccines just because JFK Jr. is an anti-vaxer.
Supporters of a party aren't always indicative of that party's stance on all issues.
> The ruling is specifically around contraceptives, so you trying to say it's not about contraceptives is incredibly weird.
How is it weird? Parental rights over their children is a frequent focus of Republican politics. They've recently pushed for similar policies in regards to sexuality and gender identity.
I'm not going to pretend there aren't Republican voters whose support for the policy is motivated by the thought process you just layed out. But it's not reasonable to prescribe that motivation to the entire Republican party when there are other explanations that are more consistent with recent and historical Republican ideologies.
The slippery slope you're presenting doesn't hold water. There's a pretty clear difference between abortion and pre-pregnancy contraception. Republicans' stance on the former is not a strong indication of their stance on the later.
The contingent of people who want abortion restrictions and those who want to ban daily preventative contraception is incredibly minimal. There is no serious mainstream movement whatsoever to ban this type of medicine.
This type of hyperbolic proselytizing has no place in reasoned discussion.
The Catholic Church might consider it a sin but that doesn't correlate with American Catholics wanting to ban contraceptives. I'd wager most American Catholics don't agree and then even more don't care about it's legality.
The Catholic Church also considers adultery a sin but that doesn't mean Catholics want adulterers executed.
You're assuming a fundamentally democratic decision-making process that doesn't exist in reality. It's entirely conceivable that a 5-4 Supreme Court majority could outlaw or restrict something that enjoys broad acceptance in the population at large, for example.
In what way would they ban something? I mean, what would that mechanism look like? Honest question. It seems that they would only be able to rule some legislation unconstitutional or to rule on a case to set a precedent.
FWIW I think the Supreme Court overall does an amazing job upholding the constitution. The Roe v Wade upset made sense from a legal perspective and they have a strong recent history of supporting citizens rights in the face of overreaching LE agencies.
Yes, because it’s an incredibly important drug that has massive social implications on it.
So the design, engineering and implementation of the holistic system around it must prove with extremely high confidence that the default usage of it, with no special education, is in line with the idealized social use of it.
Further, it should be shown that non-intended uses or abuses of the drug are rare by chemical function - not simply regulatory.
And while it might not be 50 years, required as the mathematical minimum time for this to be true for this particular drug, that is the amount of time this society has decided would be appropriate to allow for individual decision making to be the discriminatory function for acquiring it.
It took 50 years to make packaging that users could understand?