The Food and Drug Administration approved Thursday the first over-the-counter birth control pill as concerns about cost, health hazards and correct usage take a back seat to reproductive rights after the fall of Roe v. Wade.
Nearly 60 years after oral contraceptives were first made available in the U.S., the FDA lifted the prescription requirement by allowing Perrigo’s Opill to be sold over the counter, concluding that the benefits of expanded access outweigh the risks.
The FDA said that making Opill available without a medical visit “may help reduce the number of unintended pregnancies and their potential negative impacts.”
“Almost half of the 6.1 million pregnancies in the U.S. each year are unintended,” said the agency in a Thursday statement. “Unintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental and child health outcomes.”
Opill, a once-daily progestin-only tablet made by HRA Pharma, which was acquired last year by Ireland-based health care firm Perrigo, is expected to arrive in U.S. pharmacies, supermarkets and online outlets in the first quarter of 2024.
Democrats and pro-choice groups cheered the FDA’s announcement as a victory in the battle for reproductive justice in the wake of Dobbs v. Jackson Women’s Health Organization, the Supreme Court’s June 2022 decision that overturned Roe.
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“Today’s decision is a huge deal for women in America — and finally, some good news in the fight to allow women to make their own decisions about their health care,” said Sen. Patty Murray, Washington Democrat. “The fight to expand access to contraception is even more important today in a world without Roe, and over-the-counter birth control is going to be a real game-changer.”
Former Republican Sen. Cory Gardner, who sponsored legislation in 2015 to loosen the prescription mandate, tweeted Thursday: “The right decision even if it did take way too long to make.”
The right decision even if it did take way too long to make. https://t.co/sa1C00vz69
— Cory Gardner (@CoryGardner) July 13, 2023
Polls show 7 in 10 Americans favor offering birth control pills over the counter, but legislative efforts to offer the pills via retail have run aground over financial and medical issues. That changed after the Supreme Court overturned Roe in June 2022, sending decision-making on abortion back to the states.
Since then, the FDA has faced growing pressure from Democrats, reproductive health groups and major medical associations to introduce an over-the-counter pill. President Biden marked the first anniversary of Dobbs v. Jackson last month by calling for expanding access to nonprescription contraception.
One hurdle: cost. The Affordable Care Act requires all private insurers to cover without copays contraception “prescribed by a health care provider,” but not nonprescription methods, raising concerns that over-the-counter pills would wind up becoming less affordable.
Ms. Murray called for passing the Affordability is Access Act, which would extend insurance coverage to over-the-counter oral contraceptives approved by the FDA.
“It’s not enough for an over-the-counter birth control pill to be available to women — it has to be affordable, too,” she said. “That’s why we need to pass my legislation that would make certain insurers fully cover over-the-counter birth control without any out-of-pocket costs.”
Another major concern centers on medical oversight. Making doctor appointments each year to renew birth control prescriptions may be a hassle, but taking health care providers out of the equation also has its drawbacks.
They include increasing the likelihood that the pills will be used incorrectly or by women who should not be taking them, such as those who have had or have breast cancer. Oral contraceptives have been shown to increase breast cancer risk.
The FDA addressed the issue, saying that studies showed “consumer understanding of information on the Opill Drug Facts label was high overall and that a high proportion of consumers understood the label instructions.”
Another benefit of annual medical visits to renew birth control prescriptions: They offer a check on bad actors seeking to place girls or trafficking victims on the pill.
Kristan Hawkins, president of Students for Life of America, said Thursday that “separating girls from those who could report abuse abandons the vulnerable to make pill pushing easier.”
“Who knew that sex abusers had such a powerful lobby at the FDA, which has abandoned all medical ethics by making it easier for criminals to cover up their sexual abuse and statutory rape crimes,” she said. “Sexual exploiters are the big winner with this decision, while young girls lose the protection of informed consent along with any adult engagement on all the risks they may be facing.”
Meanwhile, the American Medical Association applauded the FDA’s ruling, saying it would remove barriers to contraception at a time “when reproductive health care services are becoming increasingly limited and reproductive health clinics are closing in several states.”
Twenty-four states have implemented tougher restrictions on abortion access since the court’s ruling in Dobbs v. Jackson, causing some abortion clinics to close or relocate to states with more liberal laws.
“We know barriers to oral contraceptives can lead to inconsistent or discontinued use,” said AMA President Jesse M. Ehrenfeld. “While it is important [that] patients maintain relationships with their physician to stay up to date on screenings, requiring an office visit to begin birth control is an unnecessary hurdle for patients who must take time off work, find childcare, and travel to appointments.”
More than 100 countries now allow oral contraception to be sold over the counter, according to the American Academy of Family Physicians.
“Today marks a truly momentous day for women’s health nationwide,” said Perrigo President and CEO Patrick Lockwood-Taylor. “Opill has the potential to radically transform women’s access to contraception and is a true testament of Perrigo’s unwavering commitment to deliver impactful solutions that truly make lives better.”
Opill is part of an older class of contraceptives that contain a single synthetic hormone as opposed to next-generation pills that combine two hormones, estrogen and progestin. The newer pills are more effective in regulating periods and making them lighter.
The FDA emphasized that Opill should be taken at the same time every day and that other medications could decrease its potency, raising the risk of unintended pregnancies.
In May, the FDA’s Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee voted 17 to 0 to recommend approving Opill for nonprescription use.
The ruling on Opill is unrelated to the ongoing legal battle over the FDA’s 2000 approval of mifepristone, one of two ingredients in the abortion pill. Pro-life groups have challenged the decision, accusing the agency of putting “politics over science.”
• The Associated Press contributed to this report.
• Valerie Richardson can be reached at vrichardson@washingtontimes.com.
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