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F.D.A. Approves First U.S. Over-the-Counter Birth Control Pill

  

Category:  Health, Science & Technology

Via:  hallux  •  11 months ago  •  144 comments

By:   Pam Belluck - NYT

F.D.A. Approves First U.S. Over-the-Counter Birth Control Pill

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.




The panel cited the long history of safety and efficacy of Opill, which was approved for prescription use 50 years ago. The over-the-counter pill will be identical to the prescription version, which is 93 percent effective at preventing pregnancy with typical use.




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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Hallux
PhD Principal
1  seeder  Hallux    11 months ago

This should freakout a number of States.

 
 
 
devangelical
Professor Principal
1.1  devangelical  replied to  Hallux @1    11 months ago

that could prove to be a bit more difficult for the thumper scum in america to end run with legislation ...

 
 
 
JBB
Professor Principal
1.2  JBB  replied to  Hallux @1    11 months ago

That neither parental nor spousal notification or approval are required will cause meltdowns...

 
 
 
cjcold
Professor Quiet
1.2.1  cjcold  replied to  JBB @1.2    11 months ago

A little over 50 years too late (had an interesting youth).  

 
 
 
Hal A. Lujah
Professor Guide
2  Hal A. Lujah    11 months ago

God is fucking pissed.

 
 
 
Hallux
PhD Principal
2.1  seeder  Hallux  replied to  Hal A. Lujah @2    11 months ago

He was pissed on day 6.

 
 
 
Gordy327
Professor Expert
2.1.1  Gordy327  replied to  Hallux @2.1    11 months ago

And he's been throwing a tantrum ever since. 

 
 
 
Trout Giggles
Professor Principal
2.2  Trout Giggles  replied to  Hal A. Lujah @2    10 months ago

No she's not

 
 
 
charger 383
Professor Silent
3  charger 383    11 months ago

This is a good thing

 
 
 
Tacos!
Professor Guide
4  Tacos!    11 months ago

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.

 
 
 
JBB
Professor Principal
5  JBB    11 months ago

Stop abortions by stopping unwanted pregnancy!

 
 
 
Perrie Halpern R.A.
Professor Principal
5.2  Perrie Halpern R.A.  replied to  JBB @5    11 months ago

This is not directed to Jbb.The rest of these comments were removed for trolling and sealioning. Stop it. Only warning.

 
 
 
JBB
Professor Principal
5.2.1  JBB  replied to  Perrie Halpern R.A. @5.2    11 months ago

Thank you. I hope you assigned points...

 
 
 
sandy-2021492
Professor Expert
6  sandy-2021492    11 months ago

It's about time.

 
 
 
devangelical
Professor Principal
6.1  devangelical  replied to  sandy-2021492 @6    11 months ago

something new to blame future climate change calamities on by the fake xtians...

 
 
 
Gordy327
Professor Expert
6.2  Gordy327  replied to  sandy-2021492 @6    11 months ago

I was thinking the same thing

 
 
 
Greg Jones
Professor Participates
8  Greg Jones    11 months ago

It's doubtful this will reduce the number of abortions.

 
 
 
JBB
Professor Principal
8.1  JBB  replied to  Greg Jones @8    11 months ago

It is doubtful that even you believe that...

 
 
 
Texan1211
Professor Principal
8.2  Texan1211  replied to  Greg Jones @8    11 months ago
It's doubtful this will reduce the number of abortions.

It may have some small effect, but BC is widely and easily available now, so I don't think this one thing will have that much of an impact.

 
 
 
Perrie Halpern R.A.
Professor Principal
8.2.1  Perrie Halpern R.A.  replied to  Texan1211 @8.2    11 months ago

Actually, abortion rates have gone down since the 1970's:

512

 
 
 
Texan1211
Professor Principal
8.2.2  Texan1211  replied to  Perrie Halpern R.A. @8.2.1    11 months ago

A fact I have never denied.

Why would I?

I think a woman should have all the abortions she wants and can afford.

 
 
 
JBB
Professor Principal
8.2.3  JBB  replied to  Perrie Halpern R.A. @8.2.1    11 months ago

Three things have been proven to stop unwanted pregnancies which drive the demand for termination services...

Easy access to all forms of birth control.

Universal sex education prior to puberty.

Easy access to family planning services.

The true abortion rate in countries where abortion has been illegal or unavailable, like Mexico, is about twice that of the US because the demand is predicated on the incidence of unwanted pregnancies. In patriarchal places where birth control is illegal or difficult to obtain and where women already have more children than they can properly care for or provide for the demand for terminations is much greater.

 
 
 
Perrie Halpern R.A.
Professor Principal
8.2.4  Perrie Halpern R.A.  replied to  Texan1211 @8.2.2    11 months ago

You said:

It may have some small effect, but BC is widely and easily available now, so I don't think this one thing will have that much of an impact.

So I am showing you the impact of having BC on abortion, and that was when you needed to go to your doc. I am sure that this will make it that much easier for young people not to get themselves into trouble.

 
 
 
Texan1211
Professor Principal
8.2.5  Texan1211  replied to  Perrie Halpern R.A. @8.2.4    11 months ago
I am sure that this will make it that much easier for young people not to get themselves into trouble.

Maybe.

We don't know what the cost will be and if someone under 18 will even be allowed to purchase it or not.

Also, we all know how young people can be irresponsible at times and it is a distinct possibility that the new pill wouldn't be taken as directed because people forget.

 
 
 
Greg Jones
Professor Participates
8.2.6  Greg Jones  replied to  JBB @8.2.3    11 months ago
Easy access to all forms of birth control.

Universal sex education prior to puberty.

Easy access to family planning services.

Women in the US have had that for decades.  

 
 
 
charger 383
Professor Silent
8.2.7  charger 383  replied to  Greg Jones @8.2.6    11 months ago

Not really

 
 
 
Trout Giggles
Professor Principal
8.2.8  Trout Giggles  replied to  Greg Jones @8.2.6    10 months ago

Apparently you don't live in rural America

 
 
 
independent Liberal
Freshman Quiet
10  independent Liberal    11 months ago

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?

 
 
 
devangelical
Professor Principal
10.1  devangelical  replied to  independent Liberal @10    10 months ago

hopefully terminal, for any male that fucking stupid... /s

 
 
 
devangelical
Professor Principal
10.1.1  devangelical  replied to  devangelical @10.1    10 months ago

the FDA may need to consider a for women only label in southern states...

 
 
 
George
Junior Expert
10.1.2  George  replied to  devangelical @10.1.1    10 months ago

And detailed instruction in a few northern states not to insert them up their asses.

 
 
 
devangelical
Professor Principal
10.1.3  devangelical  replied to  George @10.1.2    10 months ago

who up north would use the goober pill dispenser you just described?

 
 
 
George
Junior Expert
10.1.4  George  replied to  devangelical @10.1.3    10 months ago

Anybody stupid enough to vote for Biden in 2024.

 
 
 
Trout Giggles
Professor Principal
10.2  Trout Giggles  replied to  independent Liberal @10    10 months ago

that was funny

 
 

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