F.D.A. Approves First U.S. Over-the-Counter Birth Control Pill
Category: Health, Science & Technology
Via: hallux • 2 years ago • 144 commentsBy: Pam Belluck - NYT
S E E D E D C O N T E N T
The Food and Drug Administration on Thursday approved a birth control pill to be sold without a prescription for the first time in the United States, a milestone that could significantly expand access to contraception.
The medication, called Opill, will become the most effective birth control method available over the counter — more effective at preventing pregnancy than condoms, spermicides and other nonprescription methods. Experts in reproductive health said its availability could be especially useful for young women, teenagers and those who have difficulty dealing with the time, costs or logistical hurdles involved in visiting a doctor to obtain a prescription.
The pill’s manufacturer, Perrigo Company, based in Dublin, said Opill would most likely become available from stores and online retailers in the United States in early 2024.
The company did not say how much the medication would cost — a key question that will help determine how many people will use the pill — but Frédérique Welgryn, Perrigo’s global vice president for women’s health, said in a statement that the company was committed to making the pill “accessible and affordable to women and people of all ages.” Ms. Welgryn has also said the company would have a consumer assistance program to provide the pill at no cost to some women.
“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” Dr. Patrizia Cavazzoni, director of the F.D.A.’s Center for Drug Evaluation and Research, said in a statement. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”
Since the Supreme Court overturned the national right to an abortion last year, the accessibility of contraception has become an increasingly urgent issue. But long before that, the move to make a nonprescription pill available for all ages had received widespread support from specialists in reproductive and adolescent health and groups like the American Medical Association , the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians .
In a survey last year by the health care research organization KFF , more than three-quarters of women of reproductive age said they favored an over-the-counter pill, primarily because of convenience. Nearly 40 percent said they would be likely to use it. Those most likely to opt for the product included women already taking birth control pills, women without health insurance and Hispanic women, the survey found.
And strikingly, at a time of fierce divisions over abortion, many anti-abortion groups have declined to criticize over-the-counter birth control. Opposition appears to come primarily from some Catholic organizations and Students for Life Action.
In May, a panel of 17 independent scientific advisers to the F.D.A. — including obstetrician-gynecologists, adolescent medicine specialists, a breast cancer specialist and experts in consumer health behavior and health literacy — voted unanimously that the benefits of making a birth control pill available without a prescription vastly outweighed the risks.
Several panelists said there was a pressing public health need for an over-the-counter option in a country where nearly half of all pregnancies are unintended.
“The evidence demonstrates that the benefits clearly exceed the risks,” said one advisory committee member, Kathryn Curtis, a health scientist with the Centers for Disease Control and Prevention’s division of reproductive health.
She added: “I think Opill has the potential to have a huge positive public health impact.”
For proponents of over-the-counter pills, the main issue is affordability.
“If available equitably — meaning that they are priced affordably and fully covered by insurance — over-the-counter birth control pills will be a game-changer for communities impacted by systemic health inequities,” said Dr. Daniel Grossman, director of Advancing New Standards in Reproductive Health, who has led research on over-the-counter contraception.
The Affordable Care Act requires heath insurance plans to pay for prescription contraception, but not over-the-counter methods. Some states have laws mandating coverage of over-the-counter birth control, but most states do not. The KFF survey found that 10 percent of women would not be able or willing to pay any out-of-pocket cost for contraception. About 40 percent would pay $10 or less per month, and about a third would pay $20 or less.
Under a recent executive order by President Biden , the federal government could soon take steps toward requiring insurers to cover over-the-counter birth control. And Senate Democrats have reintroduced legislation to require such coverage.
“We need to make it affordable and available,” Senator Patty Murray, a Democrat from Washington State and the lead sponsor of the bill, said in an interview in May. “Let’s provide women what they need and make sure it’s affordable so there’s equity, and women who are low-income, women who for whatever reason are struggling don’t have to be forced to not have any birth control simply because they can’t afford it today,” she added.
Opill is known as a “mini pill” because it contains only one hormone, progestin, in contrast to “combination” pills, which contain both progestin and estrogen. A company that makes a combination pill, Cadence Health, has also been in discussions with the F.D.A. about applying for over-the-counter status.
The F.D.A. analysts who evaluated the data Perrigo submitted in its application for a nonprescription Opill had raised concerns about whether women with medical conditions that should preclude them from taking birth control pills — primarily breast cancer and undiagnosed vaginal bleeding — would follow the warnings and avoid the product. The F.D.A. analysts also raised questions about whether younger adolescents and people with limited literacy could follow the directions.
But in a memo explaining the approval decision on Thursday, Karen Murry, deputy director of the F.D.A.’s office of nonprescription drugs, wrote, “For an individual consumer of the product, the risk is very low, and almost nonexistent if they read and follow the labeling.”
“Overall,” she continued, “the total public health impact of the potential harm related to incorrect use by people with progestin-sensitive cancer is likely outweighed by the probable larger public health impact of prevention of a large number of unintended pregnancies with all their attendant harms.”
Several advisory committee members said patients with breast cancer, the main medical condition that precludes taking hormonal contraception, typically have doctors who would advise them to avoid birth control pills. They also said that Opill might actually be safest for adolescents because they are very unlikely to have breast cancer. And because young people often start off with contraception they can buy over-the-counter, it is especially important for them to have easy access to a method more effective than condoms and other birth control products available in retail stores, the panelists said.
Perrigo reported that participants in a study took Opill on 92.5 percent of the days they were supposed to take it. Most participants who missed a pill reported that they had followed the label’s directions to take mitigating steps, such as abstaining from sex or using a condom, Dr. Stephanie Sober, the company’s U.S. medical liaison, said at the advisory committee hearing. She said that among 955 participants, only six became pregnant while using Opill.
Most people who said they had missed doses attributed that to running out of pills before they could get to one of the study’s resupply sites, results that, Dr. Sober said, “illustrate precisely the barriers to adherence that could be lessened” by making the pill available over the counter.
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This should freakout a number of States.
that could prove to be a bit more difficult for the thumper scum in america to end run with legislation ...
That neither parental nor spousal notification or approval are required will cause meltdowns...
A little over 50 years too late (had an interesting youth).
God is fucking pissed.
He was pissed on day 6.
And he's been throwing a tantrum ever since.
No she's not
This is a good thing
It’s about time. There are already a lot of otc drugs you can buy that are potentially dangerous (sleeping pills, for example). This is not worse. Only our national prudishness has kept this from happening sooner.
Stop abortions by stopping unwanted pregnancy!
This is not directed to Jbb.The rest of these comments were removed for trolling and sealioning. Stop it. Only warning.
Thank you. I hope you assigned points...
It's about time.
something new to blame future climate change calamities on by the fake xtians...
I was thinking the same thing
Have to wonder if it will affordable and IF Pharmacies or workers can say no to selling it.
Before I get the inevitable "go to a different store" - I grew up in a town with 1 pharmacy - no choice on where we bought medications (other than aspirin).
no worries, big pharma is part owner of the GOP...
the only thing I have proof of here is demonstrated by each of your comments...
the endless whining and pissing and moaning and deflecting and claims with no proof is so fucking tiresome
you can stop now, I'd say the evidence is overwhelming at this point...
So let's put this thing to bed. Here is the breakout by party, that receives money from big pharma:
that's the reported money ...
oh crap, now I need to check my ticket list... /s
Yes, like big banking and big finance, big pharma covers all its bets regarding its politocal donations, but the gop has been way more consistent in voting to protect big pharma's big profits...
The Democrats support laws allowing Medicare and Medicaid being allowed to negotiate drug prices the gop opposes!
And the fact that they are allowed to do this, means our representatives don't represent out best interests.
This is true.
federalists/SCOTUS
The whole point of political donations is to persuade. Otherwise, why bother?
Do you know how to make a comment without making it personal?
As in influence, not actual ownership. And you know what I meant.
I never said that. Someone else did. Please respond to me using my words.
And that comment, even though not made by me is not personal, unless you are part of big pharma. Are you?
no.
a popular concept possibly beyond your grasp. apologies.
whatever is easier than replying to the inference I made that apparently can't be understood...
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All it takes, on occasion, is a single word to make a point.
Only far-right wing fascists have a problem with teacher's unions.
Teaching is the most underpaid underappreciated job on the planet.
When I taught martial arts, I charged top dollar just to weed out those who weren't committed. Too bad public schools can't do the same.
The world also needs ignorant, uneducated ditch diggers.
who's the ghost?
Have to wonder if it will affordable and IF Pharmacies or workers can say no to selling it.
It should be free to anyone who wants it. Amazon has figured out how to get people same day deliveries, you’d think pro-lifers would do whatever it takes to stop unwanted pregnancies.
I agree. This country should be leading the charge in matters like this instead of lagging behind all other developed countries.
They really do not care about unwanted pregnancies - they really just care that women are making decisions on their own to have sex. Only their father or husband should make those decisions & forget BC - that should be hubby's decision as well. ~SARC~
No but they should be compensated by the government which will benefit immensely from it.
Do you have any sense of pragmatism whatsoever? Unwanted pregnancies brought to term incur a multitude of economic and social problems. Grow the fuck up and accept that some big problems have actual solutions that are cheap, effective, and contrary to your pathetic worldview. Your nonstop contrarian existence here is exhausting and boring as hell.
hmmm... I see no point in paying for red state welfare either, but since pregnancy rates are going up in anti-abortion states we'll all end up paying something anyway. It's a case of paying a little upfront (some bc meds) or paying a lot more later (welfare child care).
Abortion would cost less to taxpayer than what taxpayers buy for that child to reach age of 18
I just object to paying costs of raising children that parents should pay for themselves
Then, What about the costs of other's kids?
you can pay a little for prevention or a lot for lack of prevention
I feel the same way about the previous resident of the white house, but we all share the burden.
The cost is going to be there no matter what we want, just like a lot of other things
I am for the cost effective solution
solve the problems we can first
In principle, so do I. I also know you can't fix stupid and those who are trying to make correct decisions don't control every facet of the world around them and shit happens. Ignoring those issues don't make them go away nor make them cost less when then they happen.
I suppose children starving in the streets is another option but, hey, let's cut taxes!
Not before widening the lavatory doors on commercial aircraft, first things first.
you can pay your share of pills for a predictable number of people, or your share of raising an unpredictable number of children that weren't supposed to be born and all the additional variable costs, in addition to all the associated costs with raising those children that have made it into the system for other reasons, whatever you think would be less expensive...
They don't want women having sex and enjoying it because they're not getting any.
... but nobody better not take away their boner pills!!!
personally I would love it if we made deadbeat dads get vasectomies and deadbeats moms have their tubes tied but know that won't ever happen.
So typical of the right, where the cruelty is the point. You’d rather pay for the people you find despicable to have surgical procedures forced on them against their will than pay pennies for them to have access to birth control. In fact, as expressed above, you’d love it.
And you’d cut off your nose to spite your face in order to punish them for not meeting your standards.
Again, Hal,
They want birth control they pay for it. Easy as 1,2,3.
Yet you will pay to forcibly castrate men?
Just where in the hell did I say that? Where is that Stretch Armstrong meme when you need it?
And besides that, you don't seem to know what a vasectomy is compared to castration. Suggest you look it up and edit your comment before you get discovered. You're welcome
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And how many Americans were once immigrants?
"Give me your tired, your poor, your huddled masses yearning to breathe free."
My great grandparents were processed through Ellis Island.
How about idiots who already have kids they can't support who become pregnant? Should they be prevented from having more?
Should they be required to have more?
thumpers are pissed about the declining birth rates among young white women...
Let's not forget the prison system. How many unwanted children (that could have been prevented by free or low cost birth control) end up in the prison system?
To avoid having to deal with the self-appointed Christian moral police and community busybodies, birth control pills really should be made available online by pharmacies that offer online ordering so women have easy access and possibly competitive pricing.
It's doubtful this will reduce the number of abortions.
It is doubtful that even you believe that...
Gotta love it.... so many that are against abortion & claim there are tons of BC around t o prevent pregnancies, but when it becomes easier for women to obtain it via OTC now it is all - "it isn't needed - there are plenty of others out there - they don't need this".... makes me think their whole objection to all of it has to do with controlling women & their sex lives.
Exactly. The exact same political forces most opposed to legal terminations are also those aligned against easier access to birth control, sex education and family planning services!
Not true.
I hear thumping...
Several of the GoP have been vocal about getting this approved, but Dems have been hitting back saying it's a smokescreen because insurers who now cover no cost contraceptives usually don't cover over the counter medications. Access may ultimately come down to pricing.
As most things...I am lucky when it comes to OTCs (not that I need BC anymore), I have an HSA with my employer backed insurance. They match my contributions dollar for dollar.
I remember arguing with someone on the old NV about HSAs... It took a minute to figure out they were really against High Deducible Health Plans that HSAs are attached to and I had to shake my head trying to explain the difference. I think the Feds should make it legal for EVERYONE to contribute up to $2k annually, tax free, to an HSA and detach them from insurance plans altogether.
That would be a good option for a lot of people. I am just lucky my employer offers it along with a very good insurance package. They also contribute to a retirement plan.
I remember one of those most opposed to the ACA on NV dying without needed healthcare because he never applied for the ACA, although he was eligible in his state. He was a likeable guy but was so hard against "Obamacare", yet claimed he went without because of the costs...
That would be illegal.
it's all about forcing the acceptance of a biblical gender role as a less than equal person, in a country where that is forbidden by law.
... not while I'm still breathing.
Over all i think this is a good idea however I am concerned about men taking this pill. Do we know what the side effects may be?
hopefully terminal, for any male that fucking stupid... /s
the FDA may need to consider a for women only label in southern states...
And detailed instruction in a few northern states not to insert them up their asses.
who up north would use the goober pill dispenser you just described?
Anybody stupid enough to vote for Biden in 2024.
that was funny