For the first time, a pharmaceutical company has asked for permission to sell a birth control pill over the counter in the U.S.
HRA Pharma's application on Monday sets up 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 Supreme Court's recent decision overturning Roe v. Wade.
Hormone-based pills have long been the most common form of birth control in the U.S., used by millions of women since the 1960s. They have always required a prescription, generally so health professionals can screen for conditions that raise the risk of rare, but dangerous, blood clots.
The French drugmaker's application compiles years of research intended to convince the Food and Drug Administration that women can safely screen themselves 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 available," said Frederique Welgryn, HRA's chief strategy officer.
An FDA approval could come 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's not currently marketed in the U.S.
Reproductive rights advocates want to see other prescription contraceptives move over the counter and, eventually, for abortion pills to do the same.
That potential for a precedent-setting decision once again places the FDA under an intense 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 pressures in 2006 when it approved over-the-counter use of the emergency contraception pill Plan B.
Many conservative groups stress they are only interested in curtailing abortion, and state bans often explicitly exclude contraception.
Even before Monday's announcement, Democratic lawmakers were calling on the FDA to swiftly consider any such requests.
Many common medications have made the switch from behind the pharmacy counter, including drugs for pain relief, heartburn and allergies.
In each case, companies must show that consumers can understand the drug's labeling, evaluate its risks and use it safely and effectively without professional supervision. HRA spent seven years conducting the FDA-required studies, including a trial that followed 1,000 women taking its pill for six months.
Birth control pills are available without a prescription across much of South America, Asia and Africa. Last year, Paris-based HRA won U.K. approval for the first birth control pill available there without a prescription.
Advocates were particularly interested in HRA's drug because they say it's 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 make periods lighter and more regular. Progestin-only pills are generally recommended for women who can't take the more popular combination pills due to health issues.
But estrogen also accounts for most of the blood clot risk associated with oral contraceptives. FDA's labeling warns against their use in certain women already at risk for heart problems, such as those who smoke and are over 35.
For most women, the drugs are overwhelmingly safe. For every 10,000 women taking 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 who aren't 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 clotting risk.
The FDA is required to hold a public meeting to evaluate HRA's application before making a decision. Safety considerations are likely to take center stage.
Additional reporting by The Associated Press.
