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Over-the-counter birth control? The drug maker is seeking FDA approval

WASHINGTON – For the first time, a pharmaceutical company has sought permission to sell birth control pills over the counter in the US

HRA Pharma’s filing on Monday poses a high-stakes decision for health regulators amid legal and political battles over women’s reproductive health. The company says the timing is unrelated to the recent Supreme Court decision overturning 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 so health professionals can check for conditions that increase the risk of rare but dangerous blood clots.

The French drugmaker’s application brings together years of research designed to convince the Food and Drug Administration that women can safely screen themselves for these risks and use the pill effectively.

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“For a product that has been available for the past 50 years, that has been used safely by millions of women, we felt it was time to make it more accessible,” said Frederick Welgreen, HRA’s Chief Strategy Officer.

FDA approval could come next year and will only apply to HRA’s pills, which will be sold under its original Opill brand name. The company acquired the decade-old drug from Pfizer in 2014, but it is not currently marketed in the US

Reproductive rights advocates want other prescription contraceptives to go on sale and eventually the abortion pill to do the same.

This potential for a precedent-setting decision once again places the FDA under a strong political spotlight.

Late last year, the agency was condemned by abortion opponents and praised by women’s rights advocates when it loosened 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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Many conservative groups emphasize that they are only interested in restricting abortion, and state bans often specifically exclude contraception.

Even before Monday’s announcement, Democratic lawmakers urged the FDA to quickly review any such requests.

“We urge the FDA to review applications for over-the-counter birth control pills without delay and based solely on the data,” more than 50 members of the House Pro-Choice Caucus said in a March letter.

Many common medications have gone over the counter, including pain relievers, heartburn and allergy medications.

In each case, companies must demonstrate that consumers can understand the drug’s label, assess the 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 taking its pill for six months.

Behind the company’s efforts is a coalition of researchers and women’s health advocates who have worked for nearly two decades to make contraceptives more accessible, especially to groups with less access to health care.

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The Over-the-Counter Oral Contraceptive Task Force helped fund some of the HRA’s research and mobilized support behind a media campaign called Free the Pill.

“A lot of our research went into making the case to help inspire and support a company to take on this work,” said Kelly Blanchard, president of Ibis Reproductive Health, a member of the abortion and contraceptive access group.

Birth control pills are available over the counter in much of South America, Asia and Africa. Last year, Paris-based HRA won UK approval for the first birth control pill available there without a prescription.

Advocates were particularly interested in HRA’s drug because they say it is likely to raise 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 with lighter and more regular periods. Progestin-only pills are usually recommended to women who cannot take the more popular combination pills because of health problems.

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But estrogen also accounts for most of the risk of blood clots associated with oral contraceptives. The FDA label warns against their use in certain women who are already at risk for heart problems, such as those who smoke and are over 35.

For most women, the drugs are extremely safe. For every 10,000 women taking the combined pill annually, three to nine will develop a blood clot, according to FDA data. This compares with one to five clots among 10,000 women not taking birth control.

And medical professionals point out that levels of blood clots 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 the HRA application or research.

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The medical association also supports unrestricted access to all over-the-counter hormonal contraceptives. Last month, the nation’s largest medical group, the American Medical Association, approved making birth control pills available over the counter without an age requirement.

However, support is not universal.

Diana Zuckerman of the nonprofit National Center for Health Research says comparing the pill’s safety risks to pregnancy isn’t the right approach.

Many women take birth control pills to regulate their periods or reduce bleeding, said Zuckerman, whose group evaluates medical research. “These are real benefits, but they are not worth the risk of potentially fatal blood clots,” she said.

The FDA has long monitored the safety of oral contraceptives, updating its warnings over the years.

Last year, the agency put a hold on a study by drugmaker Cadence Health, which was also 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 is required to hold a public meeting to evaluate the HRA application before making a decision. Safety 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 the approval of this product, it will show that it’s possible and that the data is strong,” Blanchard said. “Hopefully the process will accelerate from here on out.”

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Follow Matthew Perrone on Twitter: @AP_FDA writer.

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The Associated Press Health and Science Division is supported by the Howard Hughes Medical Institute’s Division of Science Education. AP is solely responsible for all content.

Copyright 2022 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or distributed without permission.



Over-the-counter birth control? The drug maker is seeking FDA approval

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