By MATTHEW PERRONE, AP Health Writer
WASHINGTON (AP) — For the first time, a pharmaceutical company has applied for permission to sell a birth control pill without a prescription in the United States.
Monday’s HRA Pharma application sets a high-stakes decision for health regulators amid legal and political battles over women’s reproductive health. The company says the timing was unrelated to the recent Supreme Court decision that overturned Roe v. Wade.
Hormone-based pills have long been the most common form of birth control in the US, used by millions of women since the 1960s. They have always required a prescription, usually for birth control professionals. health can detect conditions that increase the risk of rare but dangerous blood clots.
The French drugmaker’s application compiles years of research with the intention of convincing the Food and Drug Administration that women can safely self-screen for those risks and use the pill effectively.
“For a product that has been available for the last 50 years, that has been used safely by millions of women, we thought it was time to make it more widely available,” said Frederique Welgryn, chief strategy officer at HRA.
FDA approval could come as early as next year and would only apply to HRA’s pill, which would be sold under its original brand name, Opill. The company acquired the decades-old drug from Pfizer in 2014, but it is not currently marketed in the US.
Reproductive rights advocates want to see other prescription contraceptives move over the counter and, eventually, abortion pills to do the same.
That potential for a precedent-setting decision again places the FDA under an intense political spotlight.
Late last year, the agency was condemned by opponents of abortion and praised by women’s rights advocates when it relaxed access to abortion pills. The agency faced similar political pressure in 2006 when it approved over-the-counter use of the Plan B emergency contraceptive pill.
Many conservative groups emphasize that they are only interested in restricting abortion, and state bans often explicitly exclude contraception.
Even before Monday’s announcement, Democratic lawmakers were calling on the FDA to quickly consider any such request.
“We urge the FDA to review applications for OTC birth control pills without delay and based solely on data,” more than 50 members of the House Pro-Choice Caucus said in a March letter.
Many common medications have made the switch behind the pharmacy counter, including medications for pain relief, heartburn, and allergies.
In each case, companies must demonstrate that consumers can understand the drug’s labeling, assess its risks, and use it safely and effectively without professional supervision. HRA spent seven years conducting FDA-required studies, including a trial that followed 1,000 women who took its pill for six months.
Behind the company’s efforts is a coalition of women’s health researchers and advocates who have worked for nearly two decades to make contraception more accessible, especially for groups with less access to health care.
The Over-the-Counter Oral Contraceptives Task Force helped fund some of the HRA’s research and is mobilizing support behind a media campaign called Free the Pill.
“Much of our research has focused on making the case to help inspire and support a company to do this work,” said Kelly Blanchard, president of Ibis Reproductive Health, a member of the group that supports abortion and access to care. contraceptives.
Birth control pills are available without a prescription in much of South America, Asia, and Africa. Last year, Paris-based HRA won UK approval for the first contraceptive pill available there without a prescription.
Advocates were particularly interested in the HRA drug because they say it is likely to pose fewer safety concerns.
The pill contains a single synthetic hormone, progestin, which prevents pregnancy by blocking sperm from the cervix.
Most birth control pills contain progestin plus estrogen, which can help make periods lighter and more regular. Progestin-only pills are generally recommended for women who cannot take the more popular combination pills due to health problems.
But estrogen also accounts for most of the risk of blood clots associated with oral contraceptives. The FDA label warns against its use in certain women who are already at risk for heart problems, such as those who smoke and are over 35 years old.
For most women, the drugs are overwhelmingly safe. Of every 10,000 women who take combination pills annually, three to nine will experience a blood clot, according to FDA data. That compares with one to five clots among 10,000 women not taking birth control.
And medical professionals point out that blood clot rates are much higher in women who become pregnant, when hormone levels and reduced blood flow increase the risk of clotting.
“What I definitely see is a misunderstanding of the dangers of these pills. It’s much safer to be on the pill than to be pregnant,” said Dr. Maura Quinlan, a Northwestern University physician and member of the American College of Obstetricians and Gynecologists. She was not involved in HRA’s application or investigation.
The medical association supports making all hormone-based contraceptives available without a prescription. Last month, the nation’s largest medical group, the American Medical Association, endorsed making birth control pills available without a prescription.
Still, support is not universal.
Diana Zuckerman of the National Center for Health Research, a nonprofit organization, says comparing the safety risks of pills to pregnancy is not the right approach.
Many women take birth control pills to regulate their periods or reduce bleeding, said Zuckerman, whose group reviews medical research. “Those are real benefits, but they are not worth the risk of potentially fatal blood clots,” he said.
The FDA has long monitored the safety of oral contraceptives, updating their warnings over the years.
Last year, the agency suspended a study by drugmaker Cadence Health, which has also been working on an over-the-counter pill. The agency told the company to perform additional blood pressure checks on trial participants. The company says it is “working to overcome this regulatory hurdle.”
The FDA must hold a public meeting to review the HRA application before making a decision. Security considerations are likely to take center stage.
Executives at HRA, which is owned by Perrigo Co., expect a decision in the first half of 2023.
Advocates hope it will be the first of many.
“Once we see approval of this product, it will show that it is possible and the data is strong,” Blanchard said. “Hopefully, we’ll see the process accelerate from here.”
Follow Matthew Perrone on Twitter: @AP_FDAwriter.
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