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