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FDA approves first nonprescription daily oral contraceptive

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Re: FDA approves first nonprescription daily oral contraceptive

#231

The pill can have pretty severe mental health impacts on women. I think as long as these are clearly signposted so that women know what they might be getting themselves into, then fair enough. Also tons of other side effects, some of which are pretty severe if taken in combination with the correct (eg most unlucky) underlying health issues.

Meanwhile, my wife depends on birth control pills to stabilize her mental health. She doesn’t take it for the actual birth control aspect.

Re: FDA approves first nonprescription daily oral contraceptive

#232

Writing this entire message without using the word "woman" once is just amazing. As someone living outside the US, I can't understand this mindset.

Trans men and nonbinary people can take norgestrel, the language used is just following standard medical language.

Re: FDA approves first nonprescription daily oral contraceptive

#233
post #94

Earlier quoted context omitted.

More like no one bothered to apply to make it OTC until a year ago. In the US there is more money to be made from selling prescription medication.

Actually, profits are higher for OTC. Check out the cost of a prescription for say esomeprazole versus what Costco sells it for. Price competition across pharmacies is far higher (due to low insurance reimbursement) than cash paying patients.

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.

Re: FDA approves first nonprescription daily oral contraceptive

#234

This is amazing, it will help a lot of people have access to a drug that can vastly improve quality of life without being gatekept by their doctor. Just one note about the phrasing of all the headlines: they’re phrased as if the FDA did a good thing, but it’s better to imagine this as the FDA _stopping_ doing a bad thing. The only reason that we haven’t had over the counter oral contraceptive for the last fifty years…

There's a bit more nuance here. There is certainly a political angle, but there is a non zero risk with taking something like this that should be discussed with a doctor first, IMO. Bypassing a doctor does open up access, but there may be risks, especially if folks don't take the medicine correctly.

> there is a non zero risk with taking something like this that should be discussed with a doctor first, IMO.

This costs money in the US. And it costs time and effort everywhere in the world, with doctors frequently using this as a hook to force you to visit them regularly and bill you or your insurance for that. And it's just disempowering bureaucratic bullshit when the risk is far less consequential than most other risks we take in life. Do you have a permission slip from your doctor for sitting in front of the computer all day? That's far worse to your health than oral contraceptives.

Re: FDA approves first nonprescription daily oral contraceptive

#235
post #132

Earlier quoted context omitted.

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.

I'm going to take a wild guess you have never been prescribed BCP. No, no one explains it. They expect you to read the instructions, which is not an unreasonable expectation.

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).

Re: FDA approves first nonprescription daily oral contraceptive

#236
I'm amazed that with the level of technology we have, the main form of birth control outside of condoms are adjusting hormones.

There has to be some other methods of birth control available that will easily allow couples to effectively manage pregnancy without weird side effects.

I always though Vasagel was an interesting form of contraception (easily reversible procedure for men), but I haven't seen much progress.

Re: FDA approves first nonprescription daily oral contraceptive

#237
This is great. My own experience with my wife and birth control have included

* depo shot - which she did not have great experience with * the pill - which had barriers going to the doctor, to continue getting the prescription. This included a mix of planned parenthood, before we had insurance to get the prescription, and finally getting insurance and finding a doctor. * Finally an IUD

For the pill, a once daily med all the information to know is given with the prescription. Having a pharmacist give this OTC, like say pseudoephedrine, giving the basic instructions for it is enough.

Re: FDA approves first nonprescription daily oral contraceptive

#238
post #76

This reminded me to look up Vasalgel again (a single-application, non-hormonal, long-lasting, reversible male contraceptive that is unfortunately not yet commercially available), and I see that it seems to have taken a meaningful step forward: https://www.parsemus.org/humanhealth/male-contraceptive-rese... Apparently a company's moving forward with an attempt to productize it: https://www.planaformen.com/ With an opt…

It's often funny to me how there will be such a massive gnashing of teeth about whether or not something is prescription or OTC available to women, when Men essentially have no contraceptive choice and have 100% liability the moment it leaves our body, potentially including in cases of paternity fraud. It'd be like if we told women they had to have the baby the moment their egg accepts a sperm, regardless of the reas…

> It'd be like if we told women they had to have the baby the moment their egg accepts a sperm, regardless of the reasons it ended up there.

I'm not sure if you're being sarcastic or not here, but that is pretty much what exactly is happening in much of the USA. It's sad, disappointing and, frankly, irrational, at least from the perspective you present.

Re: FDA approves first nonprescription daily oral contraceptive

#239
post #51

Earlier quoted context omitted.

A lot of that ends up being bureaucratic wastes of time though. My partner was on birth control for years and had to jump through so many hoops - Had to go to yearly appointments to continue receiving it - Could not pick up more than a month at a time, which created logistical issues since they HAD to take it daily - Had to get the prescription renewed every three months or so, which often led to delays filling it It…

You are the first commenter to relate anything like even a secondhand real life experience with oral birth control. This thread (edit: at the time I am posting this) is full of men with little real knowledge of this drug insisting on why it’s reasonable it took 50 years for this to be available OTC. I don’t think the contents of their explanations are likely to be accurate, but I think they still explain why it took…

Totally agree with your take here, although I would like to offer my perspective/speculation as someone who actually takes oral birth control daily:

It may be notable that the pill that got approved is a progestin-only pill that's been on the market for fifty years (so long enough to demonstrate safety/effectiveness) and, crucially, does not contain any estrogen. Because there are risks associated with estrogen-based birth control, to the point where I understand why the FDA might still recommend getting screened by a doctor first—most notably, there's an elevated risk of DVT if you're a smoker.

Granted, given the current, uh, situation in the US, I do think people should be able to make informed decisions about that risk for themselves without needing a doctor's approval. But a progestin-only pill mitigates a lot of that risk anyway while still being a reasonably effective contraceptive.

Re: FDA approves first nonprescription daily oral contraceptive

#240
post #82

Hmm idk. My anecdata of one wife had a really bad time with oral contraceptives. I feel like behavioral side effects are pretty insidious. She got pretty bad anger problems that would only appear to manifest with those she was very close to (and 95% of the time was me). It was difficult to convince her that her emotions were being selectively biased. Which is a bit of a causality minefield to get into. I worry that m…

Counter anecdata: I know several women where oral contraceptives noticeably improved their lives, because their hormones were now being regulated. They got less mood swings and were way more stable. Also, women generally have a larger friend group than men and their friends are more encouraged to stage interventions if their lives are spinning out of control than men.

My wife included. She does far better with the pill than without. It’s not taken for birth control.
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