Washington — More than 60 years after oral contraceptive approval revolutionized women’s sexual health, the Food and Drug Administration supplies contraceptives to counters, similar to the Supreme Court’s decision to overturn the Roe v. Wade case. Received the first application to do. Put access to contraception more honestly at the center of the conflict over reproductive rights.
HRA Pharma, a Paris-based company, announced on Monday that it has requested the FDA to approve prescription tablets for over-the-counter sales in the United States. Cadence Health, another pill maker that is in close discussion with the FDA about switching pills to over-the-counter drugs, said it hopes to get closer to filing an application next year.
The timing of HRAPharma’s FDA submission, just weeks after the Supreme Court’s ruling, is “a really sad coincidence,” said Frédérique Welgryn, Head of Strategy and Innovation at the company. “Contraception is not the solution to access to abortion,” she said.
Under normal circumstances, submitting an application to sell prescription drugs over-the-counter can be overlooked in Washington. However, contraception is a subtle issue for FDA cadence, and HRA Pharma has been plagued by the FDA’s pre-application process for years. Also, formal HRA applications are made during particularly difficult times in reproductive rights campaigns.
Clarence Thomas suggests that the Supreme Court’s decision of the Dobbs v. Jackson Women’s Health Organization, which ruled out the Roe v. Wade case and the constitutional right to abortion, should also overturn the 1965 decision that established the right to contraception. It included a decision of consent by the judge. On Friday, President Biden accused Dobbs of “exercising live political power” and vowed to expand her access to assisted reproductive technology.
Signed by a number of Democrats at Capitol Hill letter Earlier this year, we asked FDA Commissioner Robert Caliph for a “timely review” of applications for taking oral contraceptives over-the-counter. More than 100 Democrats have signed a bill requiring insurance companies to pay for over-the-counter contraception. (The Affordable Care Act already requires insurance companies to cover prescription contraceptives.)
“Well, how can I be sure I can control my life choices,” said Senator Patty Murray, chairman of the Democratic Party of Washington, as he witnesses the collapse and turmoil of the Supreme Court’s ruling. The family is growing. ” Of the Senate Health Commission and the main sponsor of the bill. “We want to have access not only to women, but also to women who are struggling to get it.”
HRA Pharma officials said they expect the FDA’s decision to be made within about 10 months. This is common in off-the-shelf applications. The FDA declined to comment.
Proponents of reproductive rights have also urged Biden to expedite the FDA’s review of over-the-counter contraceptives in light of Dobbs’ decision. Dana Singiser, founder of the Contraceptive Access Initiative, a non-profit advocate, has shown that the experience at Covid-19 shows that the FDA can “urgently address public health emergencies.” Anti-Wade case. “
But Biden has reached out to the FDA Jen Klein, who advises the president on gender policy, and told reporters Friday that authorities “must go through that process.” And if history is a guide, the road to approval is bumpy.
In 2011, the FDA approved the emergency contraceptive Plan B to be sold over-the-counter to teenagers under the age of 16. This is just to get Kathleen Severius, then Secretary of Health of the Obama administration, to take very rare steps. Decision after President Barack Obama has announced a reservation to give minors access to drugs without parental consent. Sebelius was finally dismissed by a federal judge.
“After years of legal debate, they’ve finally become obedient to science,” said Kelly Blanchard, president of Ibis Reproductive Health, a global nonprofit organization. Partnership with HRAPharma To carry out the investigation necessary for submitting the application form. “In this case, I hope they follow the science and approve without age limit.”
However, teenage access can emerge as a problem. The leaders of the anti-abortion movement are not in a position on over-the-counter contraceptives, but are strongly opposed to giving them to minors without the involvement of adults.
“I agree with Obama,” said Kristi Hamrick, a spokeswoman for the anti-abortion group Students for Life. “As the father of two daughters, he can’t remove an adult from the equation. I knew it was a problem. “
About half of all pregnancies in the United States are unintentional, According to the Guttmacher Institute, A research institute that supports the right to abortion. Reproductive rights activists consider over-the-counter oral contraceptives to be an easy and effective tool for avoiding unwanted pregnancies by women in rural areas, the poor, and historically marginalized areas.
Dobbs’ decision spotlighted the barriers faced by women, especially poor women, to gain access to contraception. This is a letter they sent to Dr. Caliph in March by California’s Barbara Lee, Colorado’s Diana Deget, and the Democratic Party chairman of House Prochoice Caucus.
“Despite decades of proven safety and effectiveness, people still face major barriers to contraception due to the systematic inequality of our healthcare system. “The letter signed by 57 other Democrats said. “These barriers are disproportionately burdened by people of color, immigrants, LGBTQ + people, low-income people, adolescents, and rural people.”
In a response on May 18, Dr. Caliph wrote that the FDA “recognizes the public health benefits of increased access to oral contraceptives.” The decision to approve the status of over-the-counter oral contraceptives is “guided by the best science available,” he said.
Young women in particular are enthusiastic about over-the-counter medicines, said Angela Maske, who manages the #FreeThePillYouthCouncil, an advocacy group affiliated with HRAPharma.
Musk, 25, said a student at Georgetown University, a Catholic university, was denied contraception while providing contraception if needed for a medical condition such as acne. That website..
According to her, the policy made me feel as if I was being encouraged to lie, “I felt uncomfortable and immoral.” She said the over-the-counter drug she pointed out is available in more than 100 countries.
Medical experts say that oral contraceptives are one of the safest and most studied drugs on the market, but getting the prescriptions you need can be a barrier to access.Some major medical institutions including American Medical Association, American College of Obstetrics and Gynecology When American Academy of Family Physics Oral contraceptives are said to be suitable for over-the-counter use.
HRA Pharma pills are so-called mini pills. That is, it contains only progestin, a hormone involved in the menstrual cycle and pregnancy.
Although widely used in the UK, minipills make up less than 10% of the US market for oral contraceptives. This is because the pill causes unplanned bleeding and requires more caution on the part of the patient who must take it at the same time. every day. “Combination pills” that contain both progestin and estrogen are much more commonly used.
“Oral contraceptives are safe and safe for most people,” said Dr. Jonas Swarts, an obstetrician and gynecologist at Duke University Health System. “There is good data that can help people screen using either online tools or checklists to determine if they are candidates for combined pills or progestin-only pills.”
Cadence and HRA Pharma, which manufacture combination pills, have been in contact with the FDA for over six years to obtain marketing approval for over-the-counter drugs. Cadences that are not FDA-approved to proceed with clinical trials that are essential to their application may have to wait another two years before they can do so.
Cadence Co-CEO Samantha Miller said the FDA has put the company’s “real-world trials” (a study to determine how women use pills in real-world environments) on hold. Said that he did. She said the company is “actively working” with distributors “to overcome this regulatory hurdle by developing user-friendly technical interfaces for commercial products.”
Recently purchased by Perrigo, a multinational manufacturer of over-the-counter medicines based in Dublin, HRAPharma already sells progestin-only pills at counters in the UK, which is sold under the name Hana. In the United States, it is sold as Opill by prescription.
Cost is almost certain to be an issue. The Affordable Care Act requires insurance companies to cover the cost of prescription contraceptives, so women who are insured and already taking Opill may be reluctant to switch. Welgryn of HRA Pharma said he is determined to make the company’s products “very affordable to consumers.” Cadence made a similar promise.
Oral contraceptives have been intertwined with the women’s rights movement since before 1960, when the first contraceptives were approved by the FDA. In the 1940s and 1950s, Planned Parenthood founder Margaret Sanger closely tracked contraceptive research, according to itself. The history of planned parent-child relationships.
Early pills contained high doses of hormones and were at risk of side effects. It took more than a decade for scientists to recognize these risks and reduce their doses. “I was very enthusiastic about contraception, but I was very cautious about first-generation tablets,” said Carole Joffe, a professor of obstetrics and gynecology at the University of California, San Francisco.
However, Harvard economists Claudia Goldin and Lawrence F. Katz have the prospect that women who are free from childbirth will be able to enter the workplace and plan their specialized courses on their own timetable. “The power of pills.”
However, the Supreme Court established the right to contraception only in 1965, when the groundbreaking case of Griswold vs. Connecticut was ruled, and only for married people thereafter.
“At the age of my grandmother, it was revolutionary because they had no choice,” said Senator Murray of Washington.
For decades, pharmaceutical companies have shown little interest in offering oral contraceptives over-the-counter. Oral contraceptives did not make a big hit, but help the company regain research and development if either HRA or Cadence first approves that type of pill for over-the-counter use. A temporary monopoly is allowed in the market for the purpose of cost.
In the 1980s, a company was fascinated by the idea, but abandoned it, said Dr. Daniel Grossman, an assisted reproductive technology expert at the University of California, San Francisco. And the political and legal battles over Plan B have given pharmaceutical companies a “cool foot,” he said.
“They knew that even if you did the research exactly as the FDA laid them out, you could still be blocked for political reasons,” he said. ..
