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Washington: US officials have approved the first over-the-counter drug Contraceptive pillswhich would allow American women and girls to purchase birth control medications from the same aisle as aspirin and eye drops.
The Food and Drug Administration said Thursday it has authorized Perrigo’s once-a-day sale without a prescription, making it the first such drug to be moved 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.
Pills containing hormones have always been the most popular form Birth control In the United States, tens of millions of women have been using them since the 1960s. To date, all of them require a prescription.
Medical associations and women’s health groups have pushed for broader access, noting that an estimated 45% of the 6 million annual pregnancies in the United States are unintended. Teens, girls, women of color, and those with lower incomes report greater obstacles to obtaining and obtaining prescriptions.
Some of the challenges can include paying for a doctor’s visit, getting time off work, and finding childcare.
“This is really a shift in access to contraceptive care,” said Kelly Blanchard, president of Ibis Reproductive Health, a nonprofit group that has endorsed approval. “Hopefully, this will help people overcome those barriers that exist now.”
Ireland-based Perrigo did not announce a price. Over-the-counter medications are usually much cheaper than prescriptions, but they are not covered by insurance.
Many common medications have switched to the non-prescription condition in recent decades, including pain, heartburn, and allergy medications.
Perrigo has provided years of research to the FDA to show that women can understand and follow instructions for use of birth control pills. Thursday’s approval came despite some concerns from FDA scientists about the company’s findings, including whether women with certain underlying medical conditions would understand that they shouldn’t take the drug.
The FDA procedure only applies to Opill. It is in an older class of contraceptives, sometimes called the mini-pill, which contain a single synthetic hormone and generally carry fewer side effects than the more common combined hormone pills.
But women’s health advocates hope the decision will pave the way for more over-the-counter birth control options, and eventually miscarriage Pills do the same.
However, the FDA’s decision has nothing to do with the ongoing court battles over the abortion pill Mifepristone. The studies in Perrigo’s FDA request began years before the Supreme Court’s overturning of Roe v Wade, which transformed access to abortion across the United States.
With some states curtailing women’s reproductive rights, the Food and Drug Administration has faced pressure from Democratic politicians, health advocates, and medical professionals to make birth control easier to access. The American Medical Association and the leading professional association for obstetricians and gynecologists supported Opill’s application for an over-the-counter condition.
An outside panel of FDA advisors voted unanimously in favor of the switch at a hearing in May where dozens of public speakers called for Opel’s approval.
Dyvia Huitron was among those who came forward, explaining how she was unable to get a prescription for birth control after more than three years of her sexual activity. The 19-year-old University of Alabama freshman said she still isn’t comfortable getting a prescription because the school’s health system informs parents about exams and medications.
“My parents wouldn’t let me take birth control pills,” Huitron said in a recent interview. “There was a lot of cultural stigma around premarital sexual activity.”
While she uses other forms of contraception, “I would have much preferred to have contraception and use these additional methods to make sure I was as safe as possible.”
Huitron spoke on behalf of Advocates for Youth, one of dozens of groups pushing to make medical contraceptives more accessible.
The groups helped fund some of the studies submitted to Opill and encouraged HRA Pharma, which was later acquired by Perrigo, to submit its application to the FDA.
Defenders were particularly interested in Opill because she raised fewer safety concerns. The birth control pill was first approved in the United States five decades ago but has not been marketed here since 2005.
“It’s been 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, MD, of Ipsys Reproductive Health.
Modern birth control pills usually combine two hormones, estrogen and progestin, that help make your periods lighter and more regular. But their use carries a high risk of blood clots, and they should not be used by women at risk of heart disease, such as those who smoke and those over 35.
Opill contains progestin only, which prevents pregnancy by preventing sperm from reaching the cervix. It needs to be taken around the same time each day to be most effective.
In an internal review published in May, the Food and Drug Administration noted that some of the women in Perego’s study had difficulty understanding drug labeling information. In particular, the instructions warn that women with a history of breast cancer should not take birth control pills because they may stimulate tumor growth.
And women who experience unusual vaginal bleeding are told to speak to a doctor first, as it may indicate a medical problem.
Perrigo executives said the company will spend the rest of the year manufacturing birth control pills and their packaging so that they can be available in stores nationwide and online by early next year.
The Food and Drug Administration said Thursday it has authorized Perrigo’s once-a-day sale without a prescription, making it the first such drug to be moved 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.
Pills containing hormones have always been the most popular form Birth control In the United States, tens of millions of women have been using them since the 1960s. To date, all of them require a prescription.
Medical associations and women’s health groups have pushed for broader access, noting that an estimated 45% of the 6 million annual pregnancies in the United States are unintended. Teens, girls, women of color, and those with lower incomes report greater obstacles to obtaining and obtaining prescriptions.
Some of the challenges can include paying for a doctor’s visit, getting time off work, and finding childcare.
“This is really a shift in access to contraceptive care,” said Kelly Blanchard, president of Ibis Reproductive Health, a nonprofit group that has endorsed approval. “Hopefully, this will help people overcome those barriers that exist now.”
Ireland-based Perrigo did not announce a price. Over-the-counter medications are usually much cheaper than prescriptions, but they are not covered by insurance.
Many common medications have switched to the non-prescription condition in recent decades, including pain, heartburn, and allergy medications.
Perrigo has provided years of research to the FDA to show that women can understand and follow instructions for use of birth control pills. Thursday’s approval came despite some concerns from FDA scientists about the company’s findings, including whether women with certain underlying medical conditions would understand that they shouldn’t take the drug.
The FDA procedure only applies to Opill. It is in an older class of contraceptives, sometimes called the mini-pill, which contain a single synthetic hormone and generally carry fewer side effects than the more common combined hormone pills.
But women’s health advocates hope the decision will pave the way for more over-the-counter birth control options, and eventually miscarriage Pills do the same.
However, the FDA’s decision has nothing to do with the ongoing court battles over the abortion pill Mifepristone. The studies in Perrigo’s FDA request began years before the Supreme Court’s overturning of Roe v Wade, which transformed access to abortion across the United States.
With some states curtailing women’s reproductive rights, the Food and Drug Administration has faced pressure from Democratic politicians, health advocates, and medical professionals to make birth control easier to access. The American Medical Association and the leading professional association for obstetricians and gynecologists supported Opill’s application for an over-the-counter condition.
An outside panel of FDA advisors voted unanimously in favor of the switch at a hearing in May where dozens of public speakers called for Opel’s approval.
Dyvia Huitron was among those who came forward, explaining how she was unable to get a prescription for birth control after more than three years of her sexual activity. The 19-year-old University of Alabama freshman said she still isn’t comfortable getting a prescription because the school’s health system informs parents about exams and medications.
“My parents wouldn’t let me take birth control pills,” Huitron said in a recent interview. “There was a lot of cultural stigma around premarital sexual activity.”
While she uses other forms of contraception, “I would have much preferred to have contraception and use these additional methods to make sure I was as safe as possible.”
Huitron spoke on behalf of Advocates for Youth, one of dozens of groups pushing to make medical contraceptives more accessible.
The groups helped fund some of the studies submitted to Opill and encouraged HRA Pharma, which was later acquired by Perrigo, to submit its application to the FDA.
Defenders were particularly interested in Opill because she raised fewer safety concerns. The birth control pill was first approved in the United States five decades ago but has not been marketed here since 2005.
“It’s been 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, MD, of Ipsys Reproductive Health.
Modern birth control pills usually combine two hormones, estrogen and progestin, that help make your periods lighter and more regular. But their use carries a high risk of blood clots, and they should not be used by women at risk of heart disease, such as those who smoke and those over 35.
Opill contains progestin only, which prevents pregnancy by preventing sperm from reaching the cervix. It needs to be taken around the same time each day to be most effective.
In an internal review published in May, the Food and Drug Administration noted that some of the women in Perego’s study had difficulty understanding drug labeling information. In particular, the instructions warn that women with a history of breast cancer should not take birth control pills because they may stimulate tumor growth.
And women who experience unusual vaginal bleeding are told to speak to a doctor first, as it may indicate a medical problem.
Perrigo executives said the company will spend the rest of the year manufacturing birth control pills and their packaging so that they can be available in stores nationwide and online by early next year.
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