FDA to pull over-the-counter sales of birth control pills

FDA to pull over-the-counter sales of birth control pills
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WASHINGTON — More than 60 years after the approval of oral contraceptives revolutionized women’s sexual health, the Food and Drug Administration has accepted the first application for a birth control pill — just as the Supreme Court ruled in Roe v. Wade put contraception more precisely at the center of the clash over reproductive rights.

Paris-based HRA Pharma announced Monday that it is asking the FDA to approve the prescription pill for over-the-counter sales in the United States. Another pill maker, Cadence Health, which has been in intense dialogue with the FDA about moving the pill to over-the-counter status, said it hopes to get closer to filing an application next year.

The timing of HRA Pharma’s FDA submission, just weeks after the Supreme Court ruling, is “a really sad coincidence,” said Frédérique Welgryn, the company’s chief strategy and innovation officer. “Birth control is not a solution to access to abortion,” she said.

Under normal circumstances, applying to sell a prescription drug over the counter may go unnoticed in Washington. But birth control is a delicate matter for FDA Cadence and HRA Pharma it has been in the swamp for years in the agency’s initial application process, 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. to the Jackson Women’s Health Organization, which overturned Roe and overturned the constitutional right to abortion unanimous opinion Justice Clarence Thomas also proposed overturning the 1965 decision establishing the right to contraception. On Friday, President Biden denounced Dobbs’ ruling as an “exercise of raw political power” and vowed to expand access to reproductive health care.

Scores of House Democrats on Capitol Hill signed on letter This year, FDA Commissioner Robert Califfe called for “timely review” of any application to make birth control pills available over the counter. More than 100 Democrats have signed a bill requiring insurance companies to cover the cost of over-the-counter birth control. (The Affordable Care Act requires this, but federal regulations allow insurers to insist on a prescription before paying for an over-the-counter product.)

“As we see the collapse and chaos of the Supreme Court decision, more families are asking, ‘Well, how do I make sure I’m in control of my choices in life?'” said Sen. Patty Murray, D-Washington, chair of the Senate Health Committee and lead sponsor of the measure. that not only are women gaining access, but those who are struggling to gain access are gaining 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.

Proponents of reproductive rights also appeal to Mr. Biden urged the FDA to quickly review over-the-counter contraceptives in light of the Dobbs decision. Dana Singiser, founder of the Contraceptive Access Initiative, a nonprofit advocacy group, said the experience with Covid-19 shows the FDA “can act with urgency in a public health situation. Roe v. Wade.”

But Mr. Biden has taken a hard line against the FDA’s Jen Klein, who advises the president on gender policy, telling reporters on Friday that the agency “has to go through the process.” 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 younger — only Kathleen Sebelius, then the Obama administration’s health secretary, accepted. is an extremely rare step President Barack Obama reversed the decision after expressing reservations about allowing minors to use drugs without parental consent. Mrs. Sebelius was eventually overturned by a federal judge.

“Years of legal wrangling finally forced them to follow the science,” said Kelly Blanchard, president of Ibis Reproductive Health, a global nonprofit organization. Partnered with HRA Pharma conduct the research necessary to submit an application. “We hope they will follow the science and in this case approve without age restrictions.”

But for teenagers, entry can appear as a difficult point. Leaders of the anti-abortion movement have not taken a position on over-the-counter birth control pills, but strongly oppose giving them to minors without an adult present.

“I agree with Obama; “It’s common sense not to recklessly sell these pills,” he said.

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 advocates see the over-the-counter birth control pill as an easy and effective way for people in rural, poor and historically marginalized communities to avoid unwanted pregnancies, which in turn reduces the number of abortions.

In 2019, some Republicans, including Texas Senator Ted Cruz, called for over-the-counter birth control pills. But Planned Parenthood has objected, saying it could prevent access by forcing people to pay out of pocket.

The Dobbs decision drew attention obstacles Women, especially the poor, struggle to access contraception – Reps. Barbara Lee of California and Diana DeGette of Colorado, the House Pro-Choice Caucus chaired by Democrats Dr. Califf in March.

“Despite decades of proven safety and effectiveness, people still face significant barriers to access to birth control because of systemic disparities in our health care system,” the letter, which was also signed by 57 other Democrats, said. “These barriers are disproportionately faced by people of color, immigrants, LGBTQ+ people, low-income individuals, youth, and people living in rural communities.”

In his response on May 18, Dr. Califf wrote that the FDA “recognizes the public health benefits of increased access to oral contraceptives.” He said decisions about whether to approve over-the-counter status for oral contraceptives are “driven by the best available science.”

Young people in particular are eager for over-the-counter pills, said Angela Maske, who runs the #FreeThePill Youth Council, an advocacy group.

Mrs. Maske, 25, said she was denied contraception while a student at Georgetown University, a Catholic organization whose student health center provides contraception when needed for medical conditions like acne, “but not directly for contraception.” his website.

He said the policy made him feel encouraged to lie, which “felt disgusting and immoral”. He said over-the-counter pills, which he noted are available in more than 100 countries, would solve the problem.

Medical experts say birth control pills are among the safest and most studied drugs on the market, but getting a proper prescription can be a barrier to access. Several major medical organizations, including American Medical Associationthe American College of Obstetricians and Gynecologists and American Academy of Family Physicianssay that oral contraceptives are suitable for over-the-counter use.

The HRA Pharma pill is a so-called mini-pill, which means that 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, partly because the pills can cause unscheduled bleeding and must be taken at the same time by patients. .every day. “Combination pills” that contain both progestin and estrogen are 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 information that people can screen with online tools or checklists to determine whether they are candidates for using combined pills or progestin-only pills.”

Both Cadence and HRA Pharma, which make the combination pill, have been dealing with the FDA for more than six years to get approval to sell their pills over the counter. Cadence, which has not received FDA approval to undergo a clinical trial critical to its application, may have to wait another two years before it can do so.

Samantha Miller, Cadence’s chief executive, said the FDA has suspended the company’s “actual-use testing” — an investigation to determine how women use the pill in the real world. The company is “actively working” with the agency to “overcome this regulatory hurdle by developing a user-friendly technology interface for our over-the-counter product,” he said.

HRA Pharma, which was recently bought by Dublin-based multinational over-the-counter pharmaceuticals maker Perrigo, already sells pills containing another type of progestin over-the-counter in Britain, where the drug is sold under the name Hana. In the United States, the over-the-counter drug is called Opill.

The issue of cost is almost certain. Because the Affordable Care Act requires insurers to cover the cost of prescription contraceptives, people with insurance who already take Opill may be reluctant to switch. Mrs. HRA Pharma’s Welgryn said the company is committed to making its product “very affordable for consumers.” Cadence 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, Planned Parenthood founder Margaret Sanger closely followed birth control research and funded some of it. according to him History of Planned Parenthood.

Early pills contained high doses of hormones and carried the risk of side effects; it took more than a decade for scientists to recognize these risks and reduce doses. Carole Joffe, a professor of obstetrics and gynecology at the University of California, San Francisco, said feminists were “very eager for contraception, but very cautious about the first generation of pills.”

But the prospect of being able to separate sex from childbearing allowed women to enter the workplace and chart their own careers on their own schedules—a development that Harvard economists Claudia Goldin and Lawrence F. Katz have called. “The power of the pill.”

But it wasn’t until 1965, when Griswold v. In Connecticut, the Supreme Court established a right to contraception – and then only for married people.

“It was revolutionary because at my grandmother’s age they didn’t have a choice,” said Sen. Murray of Washington.

For decades, pharmaceutical companies have shown little interest in offering birth control pills over the counter. Oral contraceptives were unlikely to make big money, although if HRA or Cadence were the first to approve its type for over-the-counter use, it would gain a temporary monopoly on the market and help the company pay back research and development. expenses.

In the 1980s, a company flirted with the idea but abandoned it, Dr. Daniel Grossman, a reproductive health expert at the University of California, San Francisco. The political and legal battle over Plan B, he said, has given drugmakers “cold feet.”

“They found that even if you do the research the way the FDA says you can, you can still be blocked for political reasons.”

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