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FDA approves first nonprescription daily oral contraceptive

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Re: FDA approves first nonprescription daily oral contraceptive

#81

Post by yjftsjthsd-h »

willcipriano wrote: post #36
giantg2 wrote: post #18

Earlier quoted context omitted.

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".

Re: FDA approves first nonprescription daily oral contraceptive

#82

Post by jncfhnb »

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 many women could just start taking this and have it derail their lives invisibly to them. Not that the doctors prescription step made this better per se. But it’s hard for someone to take a drug that can potentially materially alter your perception of things in ways that are not intuitive for you to observe. Switching birth control methods sucks. But this shit is not talked about enough. I lean towards believing the pill is riskier than it’s worth. Hormonal IUDs or copper IUDs feel like they’re a much safer choice (higher switching costs though and probably daunting for the very young).

Re: FDA approves first nonprescription daily oral contraceptive

#83

Post by sonigcgg »

candiddevmike wrote: post #12
lalaithion wrote: post #8

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.

What is your point? Eating fast food everyday has a non zero risk. Arguably a really high risk. Do you want a prescription for what you can eat as well?

Re: FDA approves first nonprescription daily oral contraceptive

#84

Post by stcroixx »

willcipriano wrote: post #6

> 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 nonprescript…

Sure, it’s merely a big coincidence the court made a relevant ruling. FDA was bought a long time ago by pharma and hasn’t prioritized citizens since.

Re: FDA approves first nonprescription daily oral contraceptive

#85

Post by ghaff »

huthuthike wrote: post #17
willcipriano wrote: post #6

> 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 nonprescript…

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.

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.

Re: FDA approves first nonprescription daily oral contraceptive

#86

Post by giraffe_lady »

giantg2 wrote: post #68
LostLocalMan wrote: post #46

Earlier quoted context omitted.

Yes there is a lot of gatekeeping happening across the board. From my wife's experience living just outside of Portland Oregon: - Prescription has been cancelled twice for no real reason. - Pharmacists have refused to give more than one month at a time more than once. - Even if everyone is on board and not hostile she's only able to get a few months at a time so she has to do this multiple times a year. I can't imagi…

I've had some prescription issue for other meds as well. Usually an issue of the insurance or pharmacy, not a political motive. They don't like to give long term supplies given the expiration is 1 year from manufacture.

Your original question was whether there were barriers. Now you're clarifying you mean political barriers determined by the intent of the provider, which is of course opaque to us. Is it possible under these constraints to describe a barrier you'll accept?

Re: FDA approves first nonprescription daily oral contraceptive

#87

Post by runako »

rvcdbn wrote: post #73
hanniabu wrote: post #56

This is great, now it can easily be shipped across state lines and given to women that can't access it because the state deemed it illegal

do you know of any states where it isn’t legal? google searching lead me to this: https://www.nytimes.com/2022/06/24/us/birth-control-plan-b-r... which seems to suggest that it’s legal everywhere

Is there anything in current US politics around pregnancy that might make you consider that the legal regime in this area might be changing?

Re: FDA approves first nonprescription daily oral contraceptive

#88

Post by giantg2 »

sugarpile wrote: post #34
runako wrote: post #16

Earlier quoted context omitted.

> but there may be risks, especially if folks don't take the medicine correctly. This describes every over-the-counter drug that has ever been sold. Keeping contraception prescription-only has always been about politics.

How do you think the two are equivalent? Hormone medications can have a profound impact on a person across the spectrum from mental to physical health. Secondly, taking BC wrong may lead to a false sense of security and subsequent unwanted pregnancies. I wouldn't be surprised if there was a, smallish, correlated increase in STDs, as well. Neither of those are a thing someone buying tylenol has to worry about. Disinge…

"I wouldn't be surprised if there was a, smallish, correlated increase in STDs, as well."

I would highly doubt it. Contraception is already abundantly avaliable, including in online visits. I could see people switching from Rx to OTC. But I really don't think you could have a big enough increase in non-users to OTC to have any significant data.

Re: FDA approves first nonprescription daily oral contraceptive

#89

Post by stubybubs »

sugarpile wrote: post #34
runako wrote: post #16

Earlier quoted context omitted.

> but there may be risks, especially if folks don't take the medicine correctly. This describes every over-the-counter drug that has ever been sold. Keeping contraception prescription-only has always been about politics.

How do you think the two are equivalent? Hormone medications can have a profound impact on a person across the spectrum from mental to physical health. Secondly, taking BC wrong may lead to a false sense of security and subsequent unwanted pregnancies. I wouldn't be surprised if there was a, smallish, correlated increase in STDs, as well. Neither of those are a thing someone buying tylenol has to worry about. Disinge…

"Acetaminophen toxicity is the second most common cause of liver transplantation worldwide and the most common cause of liver transplantation in the US. It is responsible for 56,000 emergency department visits, 2,600 hospitalizations, and 500 deaths per year in the United States."

Emerg docs giving out NAC like candy for acetaminophen overdoses. It would never be approved if released today, but we've got a long history with it being OTC, so I don't see that changing.

Re: FDA approves first nonprescription daily oral contraceptive

#90

Post by EatingWithForks »

jncfhnb wrote: 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.

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