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FDA approves first nonprescription daily oral contraceptive

fda.gov

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Re: FDA approves first nonprescription daily oral contraceptive

#51

Post by elijaht »

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.

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 led to a ton of needlessly frustrating situations since the pill is so dependent on taking it daily.

Re: FDA approves first nonprescription daily oral contraceptive

#52

Post by jxramos »

candiddevmike wrote: post #9
fswd wrote: post #2

[flagged]

No, but maybe blood clots: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3025417/

Interesting never knew they had an ascribed mechanism in place. I like how the article funneled in from the generic physical causes MECHANISMS OF VENOUS THROMBOSIS to the particular HORMONE-INDUCED THROMBOTIC STATE, that was a great transition.

Re: FDA approves first nonprescription daily oral contraceptive

#53

Post by giantg2 »

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".

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.

Re: FDA approves first nonprescription daily oral contraceptive

#54

Post by zinclozenge »

Scubabear68 wrote: post #33
dmoy wrote: post #28

Earlier quoted context omitted.

> Bypassing a doctor does open up access, but there may be risks, especially if folks don't take the medicine correctly. In related news, it is shockingly easy to get messed up real bad by Tylenol. But you can get it in a 500-pill bottle from Costco.

My cousin is a toxicologist and he was talking about this in the 1980s - that the public had no idea how incredibly toxic Tylenol is and how easy it is to over dose on it and cause significant damage to your liver and other organs.

The worst is that if you "OD" on tylenol, you won't die right away, but instead slowly and increasingly painfully over time, perfectly aware of what's going on.

Re: FDA approves first nonprescription daily oral contraceptive

#55

Post by quercusa »

schoolornot wrote: post #13
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…

Maybe it's time for the FDA to just do quality checks but otherwise screw off. I'm tired of having to order 100% safe drugs from Indian pharmacies. No question they are colluding with Big Pharma. Is there any reason the "Farmacia" model of Latin American countries, where you go in and pay per-pill for whatever you want wouldn't work here?

The plant in India’s southern Tamil Nadu state produced eyedrops that have been linked to 68 bacterial infections in the U.S., including three deaths and eight cases of vision loss. Four people have had their eyeballs surgically removed due to infection. The drops were recalled in February by two U.S. distributors, EzriCare and Delsam Phama.

https://www.pbs.org/newshour/health/fda-finds-sterility-issu...

Re: FDA approves first nonprescription daily oral contraceptive

#57

Post by ultrarunner »

sixothree wrote: post #25
schoolornot wrote: post #13

Earlier quoted context omitted.

Maybe it's time for the FDA to just do quality checks but otherwise screw off. I'm tired of having to order 100% safe drugs from Indian pharmacies. No question they are colluding with Big Pharma. Is there any reason the "Farmacia" model of Latin American countries, where you go in and pay per-pill for whatever you want wouldn't work here?

Out of curiosity (and ignorance), what kind of things are available in India that are gatekeeped here?

For the longest time, something as simple as Voltarin was not available OTC in the US, but could easily be obtained from other countries. It's an anti-inflamatory cream used for joint pain that you don't have to eat, so lower risk of side-effects to stomach, liver, and kidneys.

Re: FDA approves first nonprescription daily oral contraceptive

#58

Post by tyre »

runako wrote: post #16
candiddevmike wrote: post #12

Earlier quoted context omitted.

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.

> 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.

The FDA regulates both risks and efficacy. The efficacy of hormonal birth control plummets if not taken consistently, which for progestin-only pills (like this) includes the same time of day[0]. Talking to a doctor ensures that people really understand this.

The downside of forgetting to take more advil in time is short-term pain. The downside of not understanding that your birth control isn't working is a child.

As we've seen with patients stopping antibiotics early, even though they're prescription!, people make uninformed choices with medication. Depending on what it's for, there are more or less risks of making it OTC.

All of that said, I agree that this has mostly been politics.

[0]: https://www.plannedparenthood.org/blog/is-the-birth-control-...

Re: FDA approves first nonprescription daily oral contraceptive

#59

Post by renewiltord »

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.

Wait, what exactly has a zero risk? Drinking water has a non zero risk. Breathing air has a non zero risk. I once looked up at the sky. Pretty sure the risk wasn't zero.

Re: FDA approves first nonprescription daily oral contraceptive

#60

Post by foooorsyth »

zdragnar wrote: post #50
willcipriano wrote: post #36

Earlier quoted context omitted.

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".

Doctors (the ones writing the prescriptions) aren't involved in this process at all.

The AMA is absolutely involved in the medical regulation arena. What are you talking about?
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