By Matthew Perrone
Associated Press
For the first time, a pharmaceutical company has applied for permission to sell a contraceptive pill without a prescription in the United States.
HRA Pharma submitted the request on Monday, so health authorities must make a high-impact decision amid legal and political battles over women's reproductive health.
The company said the timing of the filing is not related to the recent Supreme Court decision that ended the constitutional right to abortion.
Hormone-based pills have long been the most common form of birth control, and have been used by millions of women since the 1960s. They have always required a prescription, so doctors can screen for clot risks of blood, which are rare but dangerous.
The request from the French pharmaceutical company compiles years of research with the intention of convincing the Food and Drug Administration (FDA) that women can detect these risks and use the pill safely and effectively.
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“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.
Birth control pills have been used for more than 50 years. Rich Pedroncelli / AP
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 now marketed in the United States.
Reproductive rights advocates want other contraceptives to be sold without a prescription, and
eventually abortion pills as well.
Late last year, the agency came under fire from abortion opponents and praised by women's rights advocates when it eased 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.
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Even before Monday's announcement, Democratic lawmakers had called on the FDA to quickly consider such requests.
“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 are now sold over the counter, including drugs for pain relief, heartburn, and allergies.
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In each case,
companies must demonstrate that patients
can understand the drug's labeling, assess its risks, and use it safely and effectively without medical 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.
This OTC oral contraceptive task force helped fund some of HRA's research and is mobilizing support behind a Free the Pill media campaign.
“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.
Proponents of this initiative 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 who take combination pills annually, three to nine will suffer 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 clots.
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“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 Maura Quinlan, a Northwestern University physician and member of the American College of Obstetricians and Gynecologists.
She was not involved in the HRA investigation.
The medical association supports unrestricted access to all over-the-counter hormonal contraceptives as well.
Last month, the nation's largest medical group, the American Medical Association, endorsed making birth control pills available for purchase without a prescription without an age requirement.
Still, support for this initiative 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 correct.
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're not worth the risk of potentially fatal blood clots," he said.
The FDA has long monitored the safety of oral contraceptives, updating their warnings.
Last year it 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."
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The FDA must hold a public meeting to review the HRA application before making a decision.
The debate is likely to focus on drug safety considerations.
Executives at HRA, which is owned by Perrigo Co., expect a decision in the first half of 2023.
Proponents of this initiative hope that this is the first case of many.
"Once we see approval of this product, it will show that it's possible and the data is strong," Blanchard said, "hopefully, we'll see the approval process accelerate from here."