Thursday, July 13, 2023

the "pill"

 

 

The battle for reproduction freedom in America has been going on for more than 100 years.

Margaret Sanger used her writings and speeches primarily to promote her way of thinking. She was prosecuted for her book Family Limitation under the Comstock Act in 1914. She feared the consequences of her writings, so she fled to Britain until public opinion had quieted. Sanger's efforts contributed to several judicial cases that helped legalize contraception in the United States. Due to her connection with Planned Parenthood, Sanger is frequently criticized by opponents of abortion. Sanger drew a sharp distinction between birth control and abortion, and was opposed to abortions throughout the bulk of her professional career, declining to participate in them as a nurse. Sanger remains an admired figure in the American reproductive rights movement. She has been criticized for supporting negative eugenics; Sanger opposed eugenics along racial lines and did not believe that poverty was hereditary. However, she would appeal to both ideas as a rhetorical tool

(Texas judge Andrew Kaczmaryk cited the Comstock Act for his decision to ban the use of mifepristone, marking the first time a court tried to invalidate the approval of a drug over the FDA's objection.)

In 1916, Margaret Sanger opened the first birth control clinic in the U.S., which led to her arrest for distributing information on contraception, after an undercover policewoman bought a copy of her pamphlet on family planning. Her subsequent trial and appeal generated controversy. Sanger felt that for women to have a more equal footing in society and to lead healthier lives, they needed to be able to determine when to bear children. She also wanted to prevent so-called back-alley abortions, which were common at the time because abortions were illegal in the U.S. She believed that, while abortion may be a viable option in life-threatening situations for the pregnant, it should generally be avoided. She considered contraception the only practical way to avoid them.[

https://en.wikipedia.org/wiki/Margaret_Sanger

Fortunately, common sense on birth control emerged the other day.

U.S. officials have approved the first over-the-counter birth control pill, which will let American women and girls buy contraceptive medication from the same aisle as aspirin and eyedrops.

The Food and Drug Administration said Thursday it cleared Perrigo’s once-a-day Opill to be sold without a prescription, making it the first such medication to be moved out from behind the pharmacy counter. The company won’t start shipping the pill until early next year, and there will be no age restrictions on sales.

Hormone-based pills have long been the most common form of birth control in the U.S., used by tens of millions of women since the 1960s. Until now, all of them required a prescription.

Medical societies and women’s health groups have pushed for wider access, noting that an estimated 45% of the 6 million annual pregnancies in the U.S. are unintended. Teens and girls, women of color and those with low incomes report greater hurdles in getting prescriptions and picking them up.

Some of the challenges can include paying for a doctor’s visit, getting time off from work and finding child care.

“This is really a transformation in access to contraceptive care,” said Kelly Blanchard, president of Ibis Reproductive Health, a non-profit group that supported the approval. “Hopefully this will help people overcome those barriers that exist now.”

The Food and Drug Administration said Thursday it cleared Perrigo’s once-a-day Opill to be sold without a prescription, making it the first such medication to be moved out from behind the pharmacy counter. The company won’t start shipping the pill until early next year, and there will be no age restrictions on sales. Hormone-based based pills have long been the most common form of birth control in the U.S., used by tens of millions of women since the 1960s. Until now, all of them required a prescription.

Ireland-based Perrigo did not announce a price. Over-the-counter medicines are generally much cheaper than prescriptions, but they typically aren’t covered by insurance.

Forcing insurers to cover over-the-counter birth control would require a regulatory change by the federal government, which women’s advocates are urging the Biden administration to implement.

Many common medications have made the switch to non-prescription status in recent decades, including drugs for pain, heartburn and allergies. Birth control pills are available without a prescription across much of South America, Asia and Africa.

Perrigo submitted years of research to FDA to show that women could understand and follow instructions for using the pill. Thursday’s approval came despite some concerns by FDA scientists about the company’s results, including whether women with certain underlying medical conditions would understand they shouldn’t take the drug.

FDA’s action only applies to Opill. It’s in an older class of contraceptives, sometimes called minipills, that contain a single synthetic hormone and generally carry fewer side effects than more popular combination hormone pills.

But women’s health advocates hope the decision will pave the way for more over-the-counter birth control options and, eventually, for abortion pills to do the same.

That said, FDA’s decision has no relation to the ongoing court battles over the abortion pill mifepristone. The studies in Perrigo’s FDA application began years before the Supreme Court’s reversal of Roe v. Wade, which has upended abortion access across the U.S.

With some states curtailing women’s reproductive rights, the FDA has faced pressure from Democratic politicians, health advocates and medical professionals to ease access to birth control. The American Medical Association and the leading professional society for obstetricians and gynecologists backed Opill’s application for over-the-counter status.

An outside panel of FDA advisers unanimously voted in favor of the switch at a hearing in May where dozens of public speakers called for Opill’s approval.

Dyvia Huitron was among those who presented, explaining how she has been unable to get prescription birth control more than three years after becoming sexually active. The 19-year-old University of Alabama student said she still isn’t comfortable getting a prescription because the school’s health system reports medical exams and medications to parents.

“My parents did not let me go on the pill,” Huitron said in a recent interview. “There was just a lot of cultural stigma around being sexually active before you’re married.”

While she uses other forms of contraception, “I would have much preferred to have birth control and use these additional methods to ensure that I was being as safe as possible.”

Huitron spoke on behalf of Advocates for Youth, one of the dozens of groups that have pushed to make prescription contraceptives more accessible.

The groups helped fund some of the studies submitted for Opill and they encouraged HRA Pharma, later acquired by Perrigo, to file its application with the FDA.

Advocates were particularly interested in Opill because it raised fewer safety concerns. The pill was first approved in the U.S. five decades ago but hasn’t been marketed here since 2005.

“It’s been around a long time and we have a large amount of data supporting that this pill is safe and effective for over-the-counter use,” said Blanchard, of Ibsis Reproductive Health.

Newer birth control pills typically combine two hormones, estrogen and progestin, which can help make periods lighter and more regular. But their use carries a heightened risk of blood clots and they shouldn’t be used by women at risk for heart problems, such as those who smoke and are over 35.

Opill has only progestin, which prevents pregnancy by blocking sperm from reaching the cervix. It must be taken around the same time daily to be most effective.

In its internal review published in May, the FDA noted that some women in Perrigo’s study had trouble understanding the drug’s labeling information. In particular, the instructions warn that women with a history of breast cancer should not take the pill because it could spur tumor growth. And women who have unusual vaginal bleeding are instructed to talk to a doctor first, because it could indicate a medical problem.

Common side effects of the pill include bleeding, headaches, dizziness, nausea and cramps, according to the FDA. The label also cautions that certain drugs can interfere with Opill’s effectiveness, including medications for seizures, HIV and hypertension.

Perrigo executives said the company will spend the rest of the year manufacturing the pill and its packaging so it can be available in stores early next year.

https://www.chicagotribune.com/nation-world/ct-aud-nw-birth-control-pill-fda-20230713-pbvurzejyrekpbjvuif7a5c2z4-story.html?lctg=C5C404BD7462B338E352F3185F&utm_source=newsletter&utm_medium=email&utm_term=https%3a%2f%2fwww.chicagotribune.com%2fnation-world%2fct-aud-nw-birth-control-pill-fda-20230713-pbvurzejyrekpbjvuif7a5c2z4-story.html&utm_campaign=CT-Breaking-News&utm_content=alert

I’ve written about abortion a few times in the past. If you’re interested, you can read them here:

https://tohell-andback.blogspot.com/2022/04/the-day-of-unborn-child_3.html

https://tohell-andback.blogspot.com/2018/07/roe-v-wade-is-in-news-again.html

https://tohell-andback.blogspot.com/2011/01/roe-vs-wade.html

 

The Dobbs decision of June of 2022 overturned more than 50 years of precedent when it overturned Roe v. Wade. Almost immediately several states implemented strict anti-abortion laws. In some cases, abortions were prohibited after six weeks of pregnancy – before women know they are pregnant.

https://www.nytimes.com/interactive/2022/06/24/us/politics/supreme-court-dobbs-jackson-analysis-roe-wade.html

 

At the same time, other states LOOSENED their abortion laws, which is a very smart political move, since 71% of the American public (in both parties) say decisions about terminating a pregnancy should be left to a woman and her doctor, rather than regulated by the government. But that support is not absolute: 26% of respondents polled said abortion should be legal in all cases while 10% said it should be illegal in all cases

https://www.reuters.com/world/us/broad-us-support-abortion-rights-odds-with-supreme-courts-restrictions-2022-06-24/

The mid-term elections of 2022 pointed out two important facts:

1)    The vast majority of the American public disagrees with the Dobbs decisions

2)   The American public is not interested in supporting extreme candidates for office. In Arizona, for example, ALL of the extreme candidates lost the election, even if Kari Lake still won’t admit it.

Regardless of our political party, we would all like to see fewer abortions, but there are only two ways to do that:

1)    Make birth control more widely available

2)   Mandate comprehensive sexual education inschools in every state.

The FDA’s decision to make “the bill” available over the counter will likely face resistance from the more conservative members of our society – but it’s the only thing that makes sense, and reproductive freedom will be THE most important topic in the 2024 elections - even in conservative states like Oklahoma.

 

 

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