Against this backdrop, Paris-based HRA Pharma, which belongs to Ireland-domiciled  US drugmaker Perrigo, has applied to the US Food and Drug Administration (FDA) for permission to sell its progestin-only daily birth control pills over the counter.

Oral contraceptives have been accessible in the US with a prescription for around 60 years but this would make at least one available over the counter. HRA Pharma’s pill, called Opill, was approved by the FDA for prescription in 1973 but according to reports has not been sold in the US for more than a decade. It was acquired by HRA Pharma in 2014.

"This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the US," said Frédérique Welgryn, chief strategic operations and innovation officer at the French drugmaker.

The company, which Welgryn said has been aiming to apply for OTC counter status for some time, said its application, if approved, “will provide another option for managing reproductive health.” At the same time, she stressed, “it is not the solution for abortion access.”

“Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers,” Welgryn remarked, adding that HRA Pharma expects the FDA review of the application to take about 10 months.

Biden supports sale of mifepristone

In reaction to nationwide protests against the Supreme Court’s decision and moves by many US states to ban or severely restrict access to abortion, the administration of president Joe Biden has pledged to enable wider use of mifepristone, the so-called “morning-after” pill first formulated by the erstwhile French pharma Roussel-Uclaf and marketed as RU-86.

At present, the pill can be obtained in the US through the mail if the patient has consulted a physician, in person or on a telehealth platform. A hindrance could be the requirement that consultations take place in a state where abortion is permitted. The FDA, however, has meanwhile dropped the requirement that women pick up the pill in person.

Some anti-abortion states have said they will make the use of abortifacients illegal, but US attorney general Merrick Garland said, “states may not ban mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.”

Medication abortion became legal in the US in 2000 with the FDA approval of RU-86, later known in the US as Plan B.  In 2016, the agency lengthened the timeframe within which the drug could be taken, from seven weeks to 10 weeks of gestation.

Women’s health advocates have welcomed HRA Pharma’s plans to market Opill over the counter. Susan F. Wood, a former assistant commissioner for women’s health at the FDA and now director of George Washington University’s Jacobs Institute of Women’s Health Services, said she hoped the FDA would promptly approve the application and not erect any barriers to its use, as initially did for mifepristone.

Along with HRA Pharma, Cadence Health, which bills itself as a telehealth platform, has been working with the FDA to sell oral contraceptives over the counter. The US company said it is developing a pill that is a progesterone-estrogen combination and will conduct additional studies before submitting an application to the FDA.

Author: Dede Williams, Freelance Journalist