Over-the-counter birth control? Drug manufacturer seeks FDA approval

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

HRA Pharma’s filing on Monday represents a high-level decision for health officials amid legal and political wrangling over women’s reproductive health. Wade was lifted.

Hormone-based pills have long been the most common form of birth control in the United States, used by millions of women since the 1960s. You’ve always needed a prescription, generally so medical professionals can check for conditions that increase the risk of rare but dangerous blood clots.

The French drugmaker’s application pools years of research aimed at convincing the Food and Drug Administration that women can safely screen for these risks and use the pill effectively.

“For a product that’s been available for 50 years and used safely by millions of women, we thought it was time to make it more available,” said Frederique Welgryn, HRA’s Chief Strategy Officer.

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

Reproductive rights advocates want other prescription contraceptives to go over the counter and eventually abortion pills to do the same.

This potential for a precedent-setting decision once again puts the FDA in an intense political spotlight.

Late last year, the agency was condemned by anti-abortion advocates and praised by women’s rights activists for loosening 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 government bans often explicitly exclude contraception.

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

“We urge the FDA to review applications for over-the-counter birth control pills promptly and solely on the basis of the data,” more than 50 members of the House of Representatives pro-choice caucus said in a March letter.

Many common medications have made the switch behind the pharmacy counter, including drugs for pain relief, heartburn, and allergies.

In all cases, companies must demonstrate that consumers can understand the medicine’s labeling, assess its risks and use it safely and effectively without professional supervision. HRA conducted the studies required by the FDA for seven years, including a study that followed 1,000 women who took the 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, particularly to groups with less access to health care.

The OTC Working Group has helped fund some of HRA’s research and is mobilizing support for a media campaign called Free the Pill.

“A lot of our research revolved around making a case to inspire and support a company to do this work,” said Kelly Blanchard, president of Ibis Reproductive Health, a group member that supports abortion and contraceptive access.

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

Proponents were particularly interested in HRA’s drug because they say it’s 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. Progestogen-only pills are generally recommended for women who cannot take the more popular combination pills for health reasons.

But estrogen is also responsible 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: B. Smokers and over 35-year-olds.

For most women, the drugs are overwhelmingly safe. According to FDA data, three to nine out of every 10,000 women who take COCs every year will develop a blood clot. That’s comparable to one to five blood clots in 10,000 women not using 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’m definitely seeing is a misunderstanding of the dangers of these pills. It’s much safer being on the pill than being pregnant,” said Dr. Maura Quinlan, a physician at Northwestern University and a member of the American College of Obstetricians and Gynecologists. She was not involved in HRA’s promotion or research.

The Medical Association advocates the over-the-counter availability of all hormone-based contraceptives. Last month, the country’s largest medical association, the American Medical Association, advocated making birth control pills available over-the-counter.

Still, support is not universal.

Diana Zuckerman of the nonprofit National Center for Health Research says comparing the pills’ 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’re not worth the risk of potentially fatal blood clots,” she said.

The FDA has long monitored the safety of oral contraceptives and has updated its warnings over the years.

Last year, the agency withheld a study by drugmaker Cadence Health, which was also working on an over-the-counter pill. The agency asked the company to perform additional blood pressure checks on study participants. The company says it is working to “overcome this regulatory hurdle.”

The FDA must hold a public meeting to review the HRA’s request before making a decision. Security considerations are likely to be the focus.

HRA, which is owned by Perrigo Co., executives expect a decision in the first half of 2023.

Proponents hope it will be the first of many.

“Once we see approval of this product, it will show that it can be done and that the data is strong,” Blanchard said. “Hopefully we’ll see the process accelerate from here.”

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Follow Matthew Perrone on Twitter: @AP—FDAwriter.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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