First birth control pill receives FDA approval

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WASHINGTON: US officials have approved the first shopping center birth control pillswhich will allow American women and girls to purchase birth control pills in the same way as aspirin and eye drops.
The Food and Drug Administration said Thursday it removed Perrigo’s once-a-day Opill from over-the-counter prescriptions, making it the first drug to be removed from behind the pharmacy counter. The company won’t start shipping the tablets until early next year, and there will be no age restrictions on sales.
Hormonal pills have become very popular parenting in the US, used by tens of millions of women since the 1960s. Until now, they all needed medicine.
Medical associations and women’s health groups have pushed for more access, saying that about 45% of the 6 million pregnant women a year in the US don’t want it. Adolescents and girls, women of color and those with low incomes report significant barriers to accessing and taking medication.
Some of these problems may include paying for doctor’s appointments, getting time off from work and finding childcare.
“This is a real revolution in access to birth control,” said Kelly Blanchard, president of Ibis Reproductive Health, a non-profit group that supported the approval. “We hope this will help people overcome the barriers that exist here.”
Perrigo of Ireland has not announced a price. Over-the-counter drugs are often cheaper than prescriptions, but they are not covered by insurance.
Many commonly used medications have changed over the past few decades, including pain relievers, heartburn and cough medications.
Perrigo dedicated years of research to FDA demonstrating that women can understand and follow the instructions for using the pill. Thursday’s approval came despite FDA scientists being concerned about the company’s side effects, including whether women with certain medical conditions would understand they shouldn’t take the drug.
The FDA action also applies to Opill. It belongs to an older group of birth control methods, sometimes called minipills, which contain multiple hormones that produce fewer side effects than combined hormones.
But women’s health advocates hope that the decision will open the way for contraceptives to be purchased instead of sold, and ultimately, because. abortion pills do the same.
That said, the FDA’s decision is unrelated to the ongoing court battle over the abortion pill mifepristone. The study of Perrigo’s FDA application began years before the Supreme Court overturned Roe v Wade, which raised access to abortion in the US.
With some countries restricting women’s reproductive rights, the FDA has faced pressure from Democratic politicians, health advocates and medical professionals to limit access to birth control. The American Medical Association and a leading group of medical professionals and gynecologists agreed with Opill’s request that they have the opportunity to buy money.
The FDA’s outside advisers voted in favor of the change at a May hearing when many public speakers called for Opill’s approval.
Dyvia Huitron was one of the contributors, explaining how she failed to receive the contraceptive method she received three years after becoming sexually active. A 19-year-old student at the University of Alabama said she still doesn’t feel comfortable receiving medication because school health officials explain medical tests and medications to parents.
“My parents wouldn’t let me take pills,” Huitron said in a recent interview. “There was a lot of stigma surrounding premarital sex.”
Although she uses other birth control methods, “I would have preferred to have birth control and use these additional methods to make sure I was as safe as possible.”
Huitron spoke on behalf of Advocates for Youth, one of the many groups that have pushed to make birth control legal.
These groups funded the studies submitted to Opill and encouraged HRA Pharma, which was later acquired by Perrigo, to submit its application to the FDA.
Agents were particularly interested in Opill because it raised few safety concerns. The pill was first approved in the US fifty years ago but has not been sold here since 2005.
“It’s been around for a long time and we have a lot of data to prove that the pill is safe and effective for use on the computer,” said Blanchard, of Ibsis Reproductive Health.
New birth control pills combine two hormones, estrogen and progestin, which can help make periods lighter and more regular. But their use has a high risk of blood clots and should not be used by women who are at risk of heart disease, such as those who smoke and those over 35 years old.
Opill contains only progestin, which prevents pregnancy by blocking sperm from reaching the cervix. It should be taken at the same time each day to be most effective.
In its internal review published in May, the FDA noted that some women in the Perrigo study had difficulty understanding the written information about the drug. In particular, the guidelines warn that women with a history of breast cancer should not take the pill because it can cause the tumor to grow.
And women who have unusual bleeding are advised to talk to a doctor first, because it may indicate a medical problem.
Perrigo officials say the company will spend the rest of the year developing its tablets and packaging to be available in stores across the country and online by early next year.



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