WASHINGTON — More than 60 years after the approval of oral contraceptives revolutionized girls’s sexual well being, the Food and Drug Administration has obtained its first utility for a contraception capsule offered over-the-counter — simply because the Supreme Court’s determination to overturn Roe v. Wade has put entry to contraception extra squarely on the coronary heart of the conflict over reproductive rights.

A Paris-based firm, HRA Pharma, introduced on Monday that it had requested the F.D.A. to authorize its capsule, which is obtainable by prescription, for over-the-counter-sales within the United States. Cadence Health, one other capsule producer that has been in shut dialogue with the F.D.A. about switching its capsule to over-the-counter standing, mentioned it hopes to maneuver nearer to submitting an utility within the coming yr.

The timing of HRA Pharma’s F.D.A. utility, simply weeks after the Supreme Court determination, is “a really sad coincidence,” mentioned Frédérique Welgryn, the corporate’s chief strategic and improvements officer. “Birth control is not a solution for abortion access,” she mentioned.

Under unusual circumstances, submitting an utility to promote a prescription drug over-the-counter may go unnoticed in Washington. But contraception is a fragile difficulty for the F.D.A. Cadence and HRA Pharma have been mired for years within the company’s pre-application course of, and HRA’s formal utility comes at an particularly fraught second within the marketing campaign for reproductive rights.

The Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization, which struck down Roe and eradicated the constitutional proper to abortion, included a concurring opinion by Justice Clarence Thomas suggesting that the 1965 determination that established a proper to contraception also needs to be overturned. On Friday, President Biden denounced the Dobbs ruling as “an exercise in raw political power,” and vowed to broaden entry to reproductive well being care.

On Capitol Hill, scores of House Democrats signed a letter this yr to Dr. Robert M. Califf, the F.D.A. commissioner, requesting a “timely review” of any purposes to take contraception drugs over-the-counter. More than 100 Democrats have signed on to a invoice requiring insurance coverage corporations to cowl the price of over-the-counter contraception. (The Affordable Care Act requires it, however federal laws permit insurers to insist on a prescription earlier than paying for an over-the-counter product.)

“As we are seeing the outfall and the chaos of the Supreme Court decision, more families are looking to, ‘Well, how can I make sure I control my own choices in life?’” mentioned Senator Patty Murray, Democrat of Washington, the chairwoman of the Senate Health Committee and the lead sponsor of the measure. “We want to make sure that women not only get access, but those who have trouble affording it get access as well.”

HRA Pharma officers mentioned they count on an F.D.A. determination in about 10 months, which is typical for over-the-counter purposes. The F.D.A. declined to remark.

Supporters of reproductive rights are additionally calling on Mr. Biden to have the F.D.A. transfer shortly on its assessment of over-the-counter contraceptives in gentle of the Dobbs determination. Dana Singiser, a founding father of the Contraceptive Access Initiative, a nonprofit advocacy group, mentioned the expertise with Covid-19 confirmed that the F.D.A. “can work with urgency during a public health emergency, which is what women are facing right now with the overturning of Roe v. Wade.”

But Mr. Biden has taken a hands-off posture towards the F.D.A. Jen Klein, who advises the president on gender coverage, informed reporters on Friday that the company “has to go through its process.” And if historical past is any information, the trail to approval will probably be bumpy.

In 2011, the F.D.A. permitted the over-the-counter sale of Plan B, an emergency contraceptive, to youngsters 16 and youthful — solely to have Kathleen Sebelius, then the well being secretary within the Obama administration, take the exceedingly uncommon step of overruling its determination after President Barack Obama expressed reservations about giving minors entry to the drug with out parental consent. Ms. Sebelius was ultimately overruled by a federal decide.

“Years of legal wrangling finally got them to follow the science,” mentioned Kelly Blanchard, the president of Ibis Reproductive Health, a worldwide nonprofit group that partnered with HRA Pharma to conduct the analysis wanted to submit the applying. “We hope they follow the science and approve without an age restriction in this case.”

But entry for youngsters is prone to emerge as a sticking level. Leaders of the anti-abortion motion haven’t taken a place on over-the-counter contraception drugs, however they strongly oppose giving them to minors with none grownup involvement.

“I agree with Obama; it’s common sense not to recklessly sell these pills,” mentioned Kristi Hamrick, a spokeswoman for Students for Life, an anti-abortion group. “As a father of two daughters, he understood that taking adults out of the equation is a problem.”

Roughly half of all pregnancies within the United States are unintended, based on the Guttmacher Institute, a analysis group that helps abortion rights. Reproductive-rights activists view an over-the-counter contraception capsule as a straightforward and efficient device for folks in rural, poor and traditionally marginalized communities to keep away from undesirable pregnancies, which in flip reduces the abortion price.

In 2019, some Republicans, together with Senator Ted Cruz of Texas, known as for making contraception drugs obtainable and not using a prescription. Planned Parenthood objected, saying that doing so may impede entry by forcing folks to pay out of pocket. A Planned Parenthood official mentioned on Monday that the group supported HRA’s utility, and Ms. Murray’s invoice.

The Dobbs determination has forged a highlight on the obstacles girls, particularly poor ones, face in getting access to contraception — some extent that Representatives Barbara Lee of California and Diana DeGette of Colorado, the Democrats who lead the House Pro-Choice Caucus, made in a letter they despatched to Dr. Califf in March.

“Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our health care system,” mentioned the letter, additionally signed by 57 different Democrats. “These barriers are disproportionately borne by people of color, immigrants, L.G.B.T.Q.+ people, low-income individuals, young people and people in rural communities.”

In a May 18 reply, Dr. Califf wrote that the F.D.A. “acknowledges the public health benefits of increased access to oral contraceptives.” Decisions on whether or not to approve over-the-counter standing for oral contraceptives, he mentioned, are “guided by the best available science.”

Young folks, specifically, are anticipating over-the-counter drugs, mentioned Angela Maske, who manages the #FreeTheCapsule Youth Council, an advocacy group.

Ms. Maske, 25, mentioned she was denied contraception whereas a pupil at Georgetown University, a Catholic establishment whose pupil well being middle offers contraception if wanted for medical circumstances, resembling zits, “but not directly for contraception,” based on its web site.

The coverage, she mentioned, made her really feel as if she had been being inspired to lie, which “felt icky and immoral.” Over-the-counter drugs — which she famous can be found in additional than 100 international locations — would have solved the issue, she mentioned.

Medical specialists say that contraception drugs are among the many most secure and most-studied medicines available on the market, however that getting the required prescription is usually a barrier to entry. Several main medical organizations, together with the American Medical Association, the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians, say that oral contraceptives are acceptable for over-the-counter use.

HRA Pharma’s capsule is a so-called mini capsule, that means it incorporates solely the hormone progestin, which performs a job within the menstrual cycle and being pregnant.

The mini capsule is broadly utilized in Britain, however accounts for lower than 10 p.c of the U.S. marketplace for oral contraceptives, partly as a result of the drugs may cause unscheduled bleeding and require larger vigilance on the a part of sufferers, who should take them on the similar time every single day. “Combination pills,” which embrace each progestin and estrogen, are far more generally used.

“Oral contraceptives are safe, and they are safe medications for most people,” mentioned Dr. Jonas Swartz, an obstetrician and gynecologist at Duke University Health System. “There’s good data that people can do screening with, either online tools or checklists, to determine if they are not candidates for using combined pills or progestin-only pills.”

Both Cadence, which makes a mixture capsule, and HRA Pharma have been speaking with the F.D.A. for greater than six years about getting approval to promote their drugs over-the-counter. Cadence, which has not obtained F.D.A. approval to proceed with a scientific trial that’s important to its utility, could have to attend one other two years earlier than it could achieve this.

Samantha Miller, the co-chief government of Cadence, mentioned the F.D.A. has put the corporate’s “actual use trial” — its examine to find out how girls use the capsule in a real-world setting — on maintain. She mentioned the corporate is “actively working” with the company “to overcome this regulatory hurdle by developing a user-friendly technology interface for our over-the-counter product.”

HRA Pharma, which was not too long ago bought by Perrigo, a multinational maker of over-the-counter prescription drugs based mostly in Dublin, already sells one other kind of progestin-only capsule over-the-counter in Britain, the place the drug is marketed underneath the identify Hana. In the United States, the prescription drug being thought of for over-the-counter approval is named Opill.

Cost is sort of sure to be a difficulty. Because the Affordable Care Act requires insurers to cowl the expense of prescription contraceptives, individuals who have insurance coverage and are already taking Opill could also be loath to modify. Ms. Welgryn of HRA Pharma mentioned the corporate is decided to make its product “very affordable for consumers.” Cadence has made an analogous promise.

Oral contraceptives had turn out to be entwined with the ladies’s rights motion even earlier than 1960, when the primary contraception capsule was permitted by the F.D.A. In the Forties and Fifties, Margaret Sanger, the founding father of Planned Parenthood, carefully adopted analysis on contraception and funded a few of it herself, based on a Planned Parenthood historical past.

The early drugs included excessive doses of hormones and carried the chance of unwanted effects; it took scientists greater than a decade to acknowledge these dangers and decrease the doses. Feminists had been “very eager for contraception, but very wary about the first generation of pills,” mentioned Carole Joffe, a professor of obstetrics and gynecology on the University of California, San Francisco.

But the prospect of having the ability to separate intercourse from childbearing freed girls to enter the office and to chart their very own skilled programs on their very own timetable — a growth that the Harvard economists Claudia Goldin and Lawrence F. Katz have known as the “power of the pill.”

But it was not till 1965, with the ruling within the landmark case of Griswold v. Connecticut, that the Supreme Court established a proper to contraception — after which just for married folks.

“It was revolutionary, because in my grandmother’s age, they had no choices,” mentioned Senator Murray.

For a long time, pharmaceutical corporations demonstrated little curiosity in providing contraception drugs over-the-counter. Oral contraceptives had been hardly blockbuster moneymakers, though if both HRA or Cadence turns into the primary to have its kind of capsule permitted for over-the-counter use, it is going to be granted a brief monopoly on that market, meant to assist the corporate recoup analysis and growth prices.

In the Nineteen Eighties, an organization flirted with the concept, however deserted it, mentioned Dr. Daniel Grossman, an skilled in reproductive well being on the University of California, San Francisco. And the political and authorized battle over Plan B, he mentioned, gave pharmaceutical producers “cold feet.”

“They saw how even if you had done the studies exactly the way F.D.A. had laid them out,” he mentioned, “you could still get blocked for political reasons.”