Fda To Weigh In On Over The Counter Birth Control Pills

A Paris-based company, HRA Pharma, announced Monday that it has asked the FDA to approve its prescription pill for over-the-counter sales in the United States. Cadence Health, another pill maker that has been in close dialogue with the FDA about moving its pill to over-the-counter status, said it hopes to get closer to filing next year. The timing of HRA Pharma’s FDA submission, just weeks after the Supreme Court decision, is “a really sad coincidence,” said Frédérique Welgryn, the company’s chief strategy and innovation officer. “Birth control is not a solution to abortion access,” she said. Under normal circumstances, applying to sell a prescription drug over the counter can go unnoticed in Washington. But birth control is a sensitive 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 time in the campaign for reproductive rights. The Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, which overturned Roe and eliminated the constitutional right to abortion, included a concurring decision by Justice Clarence Thomas that suggested that the 1965 decision establishing the right to contraception should also be overturned. On Friday, President Biden denounced the Dobbs decision as an “exercise of brute political power” and vowed to expand access to reproductive health care. On Capitol Hill, dozens of House Democrats signed a letter earlier this year to FDA Commissioner Robert Califf asking for “prompt review” of any applications for over-the-counter birth control pills. More than 100 Democrats have signed a bill that would require insurance companies to cover the cost of over-the-counter birth control. (The Affordable Care Act already requires insurers to cover prescription contraceptives.) “As we see the fallout and chaos of the Supreme Court’s decision, more families are looking, ‘Well, how can I make sure I’m in control of my own choices in life?’ said Sen. Patty Murray, D-Washington, chair of the Senate Health Committee and lead sponsor of the measure. “We want to make sure that not only women have access, but also those who have trouble affording it.” 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. Reproductive rights advocates are also calling on Mr. Biden to ask the FDA to move quickly to review over-the-counter contraceptives in light of the Dobbs ruling. Dana Singiser, founder of the Contraceptive Access Initiative, a nonprofit advocacy group, said the experience with Covid-19 shows that the FDA “can work with urgency during a public health emergency, which is what women are dealing with.” at the time of overturning Roe v. Wade.” But Mr. Biden has taken a reluctant stance toward the FDA, Jen Klein, who advises the president on gender policy, told reporters on Friday that the agency “has to go through its process.” And if history is any guide, the road to approval will be bumpy. In 2011, the FDA approved the over-the-counter sale of Plan B, an emergency contraceptive, to teens 16 and under — only to force Kathleen Sebelius, then the Obama administration’s health secretary, to take the extremely rare step of overriding it. decision after President Barack Obama expressed reservations about giving minors access to the drug without parental consent. Ms. Sebelius was eventually overruled by a federal judge. “Years of legal wrangling finally made them follow the science,” said Kelly Blanchard, the president of Ibis Reproductive Health, a global nonprofit group that partnered with HRA Pharma to conduct the research needed to file the application. “We hope they follow the science and approve without age restriction in this case.” But access for teenagers is likely to emerge as a sticking point. Anti-abortion leaders have not taken a stand on over-the-counter birth control pills, but strongly oppose giving them to minors without any adult involvement. “I agree with Obama. it’s common sense not to recklessly sell these pills,” said Christy Hamrick, 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.” About half of all pregnancies in the United States are unintended, 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 women in rural, poor and historically marginalized communities to avoid unwanted pregnancies, which in turn lowers the abortion rate. The Dobbs decision has shone a spotlight on the barriers women, especially poor women, face in gaining access to contraception — a point made by Reps. Barbara Lee of California and Diana DeGette of Colorado, the Democrats who preside over the House. Pro-choice group. a letter they sent to Dr. Califf in March. “Despite decades of proven safety and effectiveness, people still face enormous barriers to birth control because of systemic inequities in our health care system,” said the letter, which is signed by 57 other Democrats. “These barriers fall disproportionately on people of color, immigrants, LGBTQ+ people, low-income people, youth, and people in rural communities.” In a response dated May 18, Dr. Califf wrote that the FDA “recognizes the public health benefits of increased access to oral contraceptives.” Decisions about whether to approve over-the-counter status for oral contraceptives, he said, are “guided by the best available science.” Young women, in particular, are eager for over-the-counter pills, said Angela Maske, who runs the #FreeThePill Youth Council, an advocacy group aligned with HRA Pharma. Ms. Maske, 25, said she was denied contraception while a student at Georgetown University, a Catholic institution whose student health center provides contraception if needed for medical conditions such as acne, “but not directly for contraception,” according to with his website. The policy, she said, made her feel like she was being encouraged to lie, which “felt uncomfortable and unethical.” Over-the-counter pills — which he noted are available in more than 100 countries — would have solved the problem, he said. Medical experts say birth control pills are among the safest and most studied drugs on the market, but getting the necessary prescription can be a barrier to access. Several major medical organizations, including the American Medical Association, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians, say oral contraceptives are safe to use without a prescription. The HRA Pharma pill is a so-called mini-pill, i.e. it contains only the hormone progestin, which plays a role in the menstrual cycle and pregnancy. The mini-pill is widely used in Britain but accounts for less than 10 percent of the US market for oral contraceptives, in part because the pills can cause unplanned bleeding and require greater vigilance on the part of patients, who must taken at the same time each day. “Combination pills,” which include both progestin and estrogen, are much more commonly used. “Oral contraceptives are safe and are safe medications for most people,” said Dr. Jonas Swartz, an obstetrician and gynecologist at Duke University Health System. “There is good data that people can screen with, either online tools or checklists, to determine if they are not a candidate for combination pills or progestin-only pills.” Both Cadence, which makes a combination pill, and HRA Pharma have been contacting the FDA for more than six years about getting approval to sell their pills over the counter. Cadence, which has not received FDA approval to proceed with a clinical trial necessary for its application, may have to wait another two years to do so. Samantha Miller, Cadence’s chief executive, said the FDA has put the company’s “real-world use trial” — its study to determine how women use the pill in a real-world setting — on hold. He said the company is “actively working” with the agency “to overcome this regulatory hurdle by developing a user-friendly technology interface for our OTC product.” HRA Pharma, which was recently bought by Perrigo, a multinational over-the-counter pharmaceuticals company based in Dublin, already sells its progestin-only pill over the counter in Britain, where the drug is marketed as Hana. In the United States, it is sold by prescription as Opill. Cost will almost certainly be an issue. Because the Affordable Care Act requires insurers to cover the cost of prescription contraceptives, women who have insurance and already take Opill may be reluctant to switch. HRA Pharma’s Ms Welgryn said the company was determined to make its product “very affordable for consumers”. Cadence has made a similar promise. Oral contraceptives were entangled with the women’s rights movement even before 1960, when the first birth control pill was approved by the FDA In the 1940s and 1950s, Margaret…