WASHINGTON — More than 60 years after the approval of oral contraceptives that have revolutionized women’s sexual health, the Food and Drug Administration received its first application for a birth control pill sold over the counter — just as cry v. The Supreme Court’s decision to overturn Wade put access to contraception more clearly at the center of the conflict over reproductive rights.
A Paris-based company, HRA Pharma, announced Monday that it had asked the FDA to authorize its pill, available by prescription, for over-the-counter-sale in the United States. Another pill maker, Cadence Health, which is in close talks with the FDA about converting its pill to over-the-counter status, said it expects to move closer to submitting an application in the coming year.
The timing of HRA Pharma’s FDA application, weeks after the Supreme Court ruling, “is a sad coincidence indeed,” said Frederick Welgreen, the company’s chief strategic and innovation officer. “Contraception is not the solution to abortion access,” she said.
Under normal circumstances, filing an application to sell a prescription drug over the counter may go unnoticed in Washington. But birth control is a delicate issue for FDA cadence and HRA Pharma has been mired in the agency’s pre-application process for years, and HRA’s formal application comes at a particularly difficult moment in the reproductive rights campaign.
The Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, which struck down Roe and abolished the constitutional right to abortion, included a consensus opinion by Justice Clarence Thomas suggesting that the 1st Constitutional Right to Contraception Established The 965 decision should also be reversed. On Friday, President Biden denounced Dobbs’ rule as “an exercise in raw political power” and vowed to expand access to reproductive health care.
On Capitol Hill, scores of House Democrats this year signed a letter to FDA Commissioner Dr. Robert M. Calif, requesting a “timely review” of any applications to take birth control pills over the counter. More than 100 Democrats have signed a bill that requires insurance companies to cover the cost of over-the-counter birth control. (The Affordable Care Act requires it, but federal regulations allow insurers to insist on a prescription before paying for an over-the-counter product.)
“As we look at the aftermath and chaos of the Supreme Court ruling, more families are seeing, ‘Okay, how can I make sure I control my choices in life? Senator Patty Murray, a Democrat from Washington, said. Chair of the Senate Health Committee and major sponsor of the measure. “We want to make sure that not only do women have access, but those who have trouble getting it also have access.”
HRA Pharma officials said they expect an FDA decision in about 10 months, which is typical for over-the-counter applications. The FDA declined to comment.
Supporters of reproductive rights are also calling on Biden to move the FDA quickly on a review of over-the-counter contraceptives in light of Dobbs’ decision. Dana Singizer, founder of the Contraceptive Access Initiative, a non-profit advocacy group, said that experience with COVID-19 has shown that the FDA can act “immediately during a public health emergency that women are now faced with reversing.” Have to do it. Roe vs. Wade.”
But Mr Biden has turned his hand to FDA Jane Klein, who advises the president on gender policy, telling reporters Friday that the agency “must go through its own process.” And if history is any guide, the road to approval will be a bumpy one.
In 2011, the FDA approved the over-the-counter sale of Plan B, an emergency contraceptive for teens 16 years of age and younger — only Kathleen Sebelius, then Secretary of Health in the Obama administration, made an exceedingly rare opportunity to eliminate it. Took a step The decision comes after President Barack Obama expressed reservations about giving minors access to the drug without parental consent. Ms Sebelius was eventually dismissed by a federal judge.
“Years of legal struggle finally got them to follow the science,” said Kelly Blanchard, president of Ibis Reproductive Health, a global non-profit group that partnered with HRA Pharma to conduct the research needed to submit the application. ” “We hope they follow the science and approve without age restrictions in this matter.”
But access is likely to emerge as an important point for adolescents. Leaders of the anti-abortion movement have taken no stance on over-the-counter birth control pills, but they strongly oppose giving them to minors without any adult participation.
“I agree with Obama; it is common sense not to recklessly sell these pills,” said Christie Hamrick, spokeswoman for Student for Life, an anti-abortion group. “As a father of two daughters, he understood That taking adults out of the equation is a problem.”
Nearly all pregnancies in the United States occur unintentionally, according to the Guttmacher Institute, a research organization that supports abortion rights. Reproductive-rights activists see an over-the-counter birth control pill as an easy and effective tool for people in rural, poor and historically marginalized communities to avoid unwanted pregnancies, which in turn reduces the abortion rate.
In 2019, some Republicans, including Texas Senator Ted Cruz, called for birth control pills to be made available without a prescription. Planned Parenthood objected, saying doing so could force people to pay out of pocket. A Planned Parenthood official said Monday that the group supported HRA’s application and Ms. Murray’s bill.
Dobbs’ decision casts a spotlight on the barriers, especially poor people, face in gaining access to contraception — a point that Representative Barbara Lee of California and Diana DeGate of Colorado, Democrats who are part of the House Pro-Choice Caucus, face. Lead, was made in. A letter he sent to Dr. Calif in March.
“Despite decades of proven safety and effectiveness, people still face enormous barriers to obtaining birth control because of systemic inequalities in our health care system,” said the letter, also signed by 57 other Democrats. “These barriers are disproportionately borne by people of color, immigrants, LGBTQ+ people, low-income individuals, youth, and people in rural communities.”
In a May 18 reply, Dr. Calif wrote that the FDA “recognizes the public health benefits of increased access to oral contraceptives.” Decisions to approve over-the-counter status for oral contraceptives, he said, “are guided by the best available science.”
Young people, in particular, are eager for over-the-counter pills, said Angela Muske, who manages the #FreeThePill Youth Council, an advocacy group.
Ms Muske, 25, said she was denied contraception while a student at Georgetown University, a Catholic institution whose Student Health Center provides contraception when needed for medical conditions such as acne, “but not directly for contraception.” No,” according to its website.
The policy, she said, made her feel as though she was being encouraged to lie, which “felt strange and immoral.” Over-the-counter pills — which he notes are available in more than 100 countries — would have solved the problem, she said.
Medical experts say birth control pills are among the safest and most studied drugs on the market, but getting the necessary prescriptions can be a hindrance. Several major medical organizations, including the American Medical Association, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians, state that oral contraceptives are suitable for over-the-counter use.
The HRA Pharma pill is a so-called mini pill, which means it contains only the hormone progestin, which plays a role in the menstrual cycle and pregnancy.
The mini pill is widely used in the UK, but accounts for less than 10 percent of the US market for oral contraceptives, partly because the pills can cause unscheduled bleeding and require greater caution on the part of patients. which they should be taken at the same time. Everyday. “Combination pills,” which contain both progestin and estrogen, are more commonly used.
“Oral contraceptives are safe, and they are safe medications for most people,” says Dr., an obstetrician and gynecologist at Duke University Health System. Jonas Swartz said. “There is good data that people can be screened with online tools or checklists to determine if they are not candidates for using combined pills or progestin-only pills.”
Cadence, which makes a combination pill, and HRA Pharma, have been communicating with the FDA for more than six years about getting approval to sell their pills over the counter. Tal, which has not received FDA approval to proceed with the clinical trial required for its application, may have to wait two more years before doing so.
Cadence co-CEO Samantha Miller said the FDA has put the company’s “real use trial” — to determine how women use the pill in a real-world setting — on hold. She said the company is “actively working” with the agency to address this regulatory hurdle by developing a user-friendly technology interface for our over-the-counter product.
HRA Pharma, which was recently purchased by Perigo, a multinational manufacturer of over-the-counter pharmaceuticals based in Dublin, already sells another type of progestin-only pill over the counter in the UK, where the drug is marketed under the name HANA. is done from. In the United States, a prescription drug considered for over-the-counter approval is called Opill.
Cost is almost certain to be an issue. Because the Affordable Care Act requires insurers to cover the cost of prescription contraceptives, people who have insurance and are already taking Opill may be reluctant to switch. Ms. Wellgreen of HRA Pharma said the company is committed to making its product “very affordable for consumers”. Taal has also made the same promise.
Oral contraceptives were associated with the women’s rights movement as early as 1960, when the first birth control pill was approved by the FDA. In the 1940s and 1950s, Planned Parenthood founder Margaret Sanger led research on birth control. Followed closely and funded some. This itself, according to a Planned Parenthood history.
Early pills contained high doses of hormones and carried a risk of side effects; It took scientists more than a decade to identify those risks and reduce the dose. Feminists were “very keen on contraception, but very careful about first-generation pills,” said Carol Joffe, a professor of obstetrics and gynecology at the University of California, San Francisco.
But the prospect of women free from childbirth being able to enter the workplace and chart their own business courses on their own timetables – a development that Harvard economists Claudia Goldin and Lawrence F. Katz called it “the power of the bullet.” ,
But by 1965 with the decision in the landmark case of Griswold v. Connecticut, the Supreme Court established the right to contraception—and then only for married people.
“It was revolutionary because, at my grandmother’s age, she had no choice,” Senator Murray said.
For decades, pharmaceutical companies have shown little interest in offering birth control pills over the counter. Oral contraceptives were hardly a blockbuster moneymaker, although if HRA or Cadence were to first approve their type of pill for over-the-counter use, it would be given a temporary monopoly on that market, aimed at allowing the company to conduct research. is to help with recovery and development costs.
In the 1980s, a company tinkered with the idea but abandoned it, said Dr., a specialist in reproductive health at the University of California, San Francisco. Daniel Grossman said. And the political and legal battle over Plan B, he said, gave drugmakers “cold feet”.
“They noticed that even if you studied exactly the way the FDA prescribed them,” he said, “you can still get blocked for political reasons.”
(This story has not been edited by seemayo staff and is published from a rss feed)