ALLEGAN – For the first time, a pharmaceutical company has applied for permission to sell an over-the-counter birth control pill in the United States
HRA Pharma – a subsidiary of Allegan and the Ireland-based Perrigo Co. – submitted an application on Monday that sets out 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 overturning Roe v. Wade.
Hormone pills have long been the most common form of birth control in the United States, used by millions of women since the 1960s. They have always required a prescription, usually so medical professionals can screen conditions that increase the risk of rare but dangerous blood clots.
The app from HRA Pharma, headquartered in France, compiles years of research intended to convince the Food and Drug Administration that women can safely screen themselves for these risks and use the pill effectively.
“For a product that has been available for 50 years, that has been used safely by millions of women, we thought it was time to make it more available,” said Frédérique Welgryn, Chief Strategy Officer.
FDA approval could come next year and would only apply to HRA’s pill, which would be sold under its original brand, Opill. The company acquired the decades-old drug from Pfizer in 2014, but it is not currently marketed in the United States.
opponents and supporters
Reproductive rights advocates want to see other prescription contraceptives move without a prescription and, eventually, abortion pills to do the same.
This potential for a precedent-setting decision once again puts the FDA in the intense political spotlight.
Late last year, the agency was condemned by 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.
Many conservative groups emphasize that they are only interested in reducing abortion, and state bans often explicitly exclude contraception.
Even before Monday’s announcement, Democratic lawmakers were calling on the FDA to quickly review such requests.
“We urge the FDA to review applications for over-the-counter 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 come off the drugstore counter, including pain, heartburn, and allergy medications.
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 the studies required by the FDA, including a trial that followed 1,000 women taking its pill for six months.
Research and funding
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.
The OTC Task Force has helped fund some of HRA’s research and is mobilizing support behind a media campaign called Free the Pill.
“A lot of our research has been about advocating for inspiration and support from a company to take on this work,” said Kelly Blanchard, president of Ibis Reproductive Health, a member of a group which supports abortion and access to 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 birth control pill available without a prescription.
Proponents 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, a progestogen, which prevents pregnancy by blocking sperm from the cervix.
Most birth control pills contain progestin and estrogen, which can help make periods lighter and more regular. Progestin-only pills are generally recommended for women who cannot take the most popular combination pills due to health issues.
But estrogen also accounts for most of the blood clot risk associated with birth control pills. FDA labeling warns against their use in some women already at risk for heart problems, such as those who smoke and are over 35.
For most women, the drugs are extremely safe. According to FDA data, for every 10,000 women taking combination pills each year, three to nine will suffer from a blood clot. This compares to one to five clots in 10,000 women who do not take birth control.
And health 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 really see is a misunderstanding of the dangers of these pills. It’s much safer to take 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 application or research of HRA.
The medical association supports unlimited access to all over-the-counter hormonal contraceptives. Last month, the nation’s largest group of physicians, the American Medical Association, approved the availability of over-the-counter birth control pills with no age requirement.
Yet support is not universal.
Diana Zuckerman of the nonprofit National Center for Health Research says comparing the safety risks of pills with pregnancy is the wrong approach.
Many women take birth control pills to regulate their periods or reduce bleeding, said Zuckerman, whose group assesses medical research. “These are real benefits, but they’re not worth the risk of life-threatening blood clots,” she said.
The FDA has long monitored the safety of birth control pills, updating its warnings over the years.
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Last year, the agency suspended a study by drugmaker Cadence Health, which is also working on an over-the-counter pill. The agency asked the company to perform additional blood pressure checks on trial participants. The company says it is “working to overcome this regulatory hurdle”.
The FDA is required to hold a public meeting to evaluate 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.
Fans are hoping this will be the first of many.
“Once we see approval for this product, it will demonstrate that it is possible and that the data is strong,” Blanchard said. “Hopefully we will see the process speed up from here.”