
The organization claimed in a statement that the change would make it easier for women to obtain contraceptives.
Opill’s maker has predicted that it will likely be sold over the counter in the first half of 2024.
Since the progestin-only pill, also referred to as the “minipill,” does not contain oestrogen, it is considered to be a very safe method of contraception with fewer side effects and health hazards.
Opill’s most frequent adverse effects are irregular bleeding, headaches, nausea, and vertigo.
The birth control pill is now available over-the-counter in the US, joining more than 100 other nations, including the majority of those in Latin America, as well as India, China, and the United Kingdom.
“When used as directed, daily oral contraception is safe and expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
The decision was made after an FDA expert advisory panel in May unanimously recommended that the medication be sold without a prescription. First US over-the-counter birth control is approved by panel
Some scientists had expressed concern during the hearing that young individuals and persons with low reading levels might not be able to grasp the instructions, which included not taking the medication if they had a history of breast cancer.
However, the committee came to the conclusion that women with breast cancer were already likely in contact with their doctors and aware they shouldn’t use chemical contraception.
In the end, the panel determined that Opill, which the FDA first approved in 1973, has a history of safety and effectiveness in preventing pregnancy.
According to experts, women – and particularly teenagers – face a number of obstacles when trying to get reproductive health care, such as a lack of health insurance and trouble getting to doctor’s appointments.
In addition, doctors and parents have been known to stigmatize and shame women who try to get the pill.
One such person is Dyvia Huitron. For three years, she has had difficulty getting the birth control pill.
The 19-year-old attempted to obtain a prescription for the first time when she started having sex at age 16 while growing up in a predominantly Hispanic, religious neighborhood in the border town of McAllen, Texas.
But since they were concerned that the contraception would encourage her to participate in more sexually risky behavior, her parents, who had her while they were teenagers, refused to give her the necessary consent.
Then, at the age of 18, Ms. Huitron enrolled in college in Alabama, where the legal age of majority is 19. This required her to wait another year because her parents could still evaluate her medical records.
She told the BBC, “Because I came from teen parents, that was one of my worst anxieties. “I wanted to take every precaution to stop that from happening again… But there were so many hoops I had to jump through.
A number of health advantages, including fewer unwanted births, have been claimed by doctors and advocates who support making birth control available to women and teenagers like Ms. Huitron without a prescription.
According to some surveys, as many as 50% of all pregnancies occur in the US.
Most of the time, the discussion about whether to make contraception more accessible has not generated as much controversy as the one about how easy it is to get an abortion.
Several anti-abortion organizations, including National Right to Life and Susan B. Anthony Pro Life America, claimed in remarks to the BBC that they do not have a position on birth control.
On Thursday, a number of medical and advocacy organizations applauded the FDA’s decision. Advocates for Youth, a nonprofit organization that promotes reproductive health rights, referred to the clearance as “long overdue” and praised the FDA’s action.
The group claims that the pill’s price is still an issue, particularly for young people. The group intends to lobby insurance companies to take into account paying for the over-the-counter transactions.
Opill’s retail price has not yet been determined, but the Biden administration stated that Perrigo, the pill’s producer, will set it.
BBC
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