Health
US FDA approves over-the-counter oral contraceptives for sale
US federal regulators have approved the country’s first over-the-counter oral contraceptive in a landmark decision to ease access to contraceptives.
Key Point:
- Opil will be on sale from the beginning of next year at an undecided price
- This approval was obtained despite concerns over misleading labels and instructions.
- Proponents say the tablets pose fewer safety concerns and are effective for over-the-counter use.
The Food and Drug Administration (FDA) has approved once-daily Opil for sale without a prescription, making it the first such drug to be moved from behind a pharmacy counter.
Ireland-based manufacturer Perrigo plans to start shipping the tablets early next year, and there is no age limit for sales.
Hormone-based pills have long been the most popular form of birth control in the United States, used by tens of millions of women since the 1960s, and until now, all required a prescription.
Medical societies and women’s health groups have been calling for greater access for decades, noting that an estimated 45% of the 6 million pregnancies in the United States each year are unintended.
Teens and girls, women of color, and low-income individuals report higher hurdles to picking up and receiving prescriptions.
Challenges include paying the doctor’s fees, taking time off from work, and securing childcare.
Some people who use other forms of contraception are unable or uncomfortable to seek prescriptions because of cultural stigma or parental opposition.
“This is truly a transformation in access to contraceptive care,” said Kelly Blanchard, chairman of the nonprofit Ibis Reproductive Health, which supported the approval.
“I hope this helps people overcome the barriers that currently exist.”
Opil is important for the estimated 15 million American women — one-fifth of women of childbearing age — who are not currently using contraception or using less effective methods such as condoms, said Perigot. He said it could be a new option.
But how many women will actually get access depends on the price of the drug, which Perrigo plans to announce later this year.
Dr. Pratima Gupta of the American College of Obstetricians and Gynecologists said, “The reason many of us have worked tirelessly for years to obtain over-the-counter oral contraceptives is to improve their availability. Yes, and price should not be one of those barriers.” .
Most older contraceptives cost $15 to $30 ($21 to $42) a month without insurance coverage.
Over-the-counter drugs are generally much cheaper than prescription drugs, but they are usually not covered by insurance.
Women’s advocacy groups are calling on the Biden administration to implement federal regulatory changes to force insurance companies to use over-the-counter contraceptives.
Pill approved amid abortion debate
Amid legal and political battles over reproductive health, including last year’s Roe v. Wade reverse trial, FDA approval gives American women a new contraceptive option and undermines access to abortion across the country. repeated.
Opil’s approval is unrelated to the ongoing legal battle over the abortion drug mifepristone.
Also, anti-abortion groups generally stress that contraceptives are meant to stop pregnancy and are not against those used to terminate pregnancies.
But that has done little to allay concerns that contraception will one day become a target.
When the Supreme Court overturned the Roe decision, Justice Clarence Thomas wrote another opinion, explicitly asking his colleagues to bring the High Court’s contraception case to the table.
Over the last year, the FDA has come under pressure from Democratic politicians, health advocates and medical experts to improve access to contraception.
The American Medical Association and other major medical groups have supported Opil’s over-the-counter marketing application.
Oral contraceptives are available without a prescription in many parts of South America, Asia, and Africa.
Perrigo has submitted years of research to the FDA to show that women can understand how to use the pill and follow directions.
Thursday’s approval came despite FDA scientists’ concerns about the company’s results, including whether women with certain underlying conditions would understand that the drug shouldn’t be taken.
FDA’s action applies only to opil, which is in an older class of contraceptives sometimes called the minipill. Opil contains a single synthetic hormone and generally has fewer side effects than the more common hormone combination tablets.
Women’s health advocates hope the decision will pave the way for more over-the-counter contraceptive options, and eventually abortion pills will do the same.
An external panel of FDA advisers voted unanimously in favor of the switch at a hearing in May when dozens of hearings called for Opil’s approval.
Proponents were particularly interested in Opill because it poses fewer safety concerns.
It was first approved in the United States 50 years ago.
“It’s been around for a long time and there is a wealth of data supporting that this tablet is safe and effective for over-the-counter use,” Ms Blanchard said.
Newer pills usually combine two hormones, estrogen and progestin, to help make your menstrual cycle lighter and more regular, but their use increases the risk of blood clots.
Opil contains only progestin, which prevents pregnancy by blocking sperm from reaching the cervix. For best results, it should be taken at approximately the same time each day.
In an internal review published in May, the FDA noted that some women who participated in the Perrigo study had trouble understanding the drug’s label information.
In particular, the instructions warn women with a history of breast cancer not to take the pills, as they may promote tumor growth.
According to the FDA, common side effects include irregular vaginal bleeding, headaches, dizziness, and cramping.
The label also warns that certain medications, such as those used to treat seizures, HIV, and high blood pressure, may interfere with Opil’s effectiveness.
Perrigo executives said the company plans to spend the rest of the year manufacturing the pills so they can hit stores early next year.
AP/ABC
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