The Paris-based pharmaceutical firm, HRA Pharma, is seeking the approval of the U.S. Food and Drug Administration (FDA) for Opill, an everyday prescription-only hormonal contraception to be allowed for sale over-the-counter, a first in the U.S. The FDA's approval would allow the purchase of the pill without a prescription for the first time since oral contraceptives became widely available in the 1960s.
Although the application came weeks after the Supreme Court overturned the constitutional right to abortion, HRA Pharma said the move to ask for FDA's approval is unrelated, BBC reports. HRA Pharma says that the FDA decision is expected next year, and its approval would only apply to the firm's Opill Drug, which was acquired from Pfizer in 2014 and has been available to patients since 1973.
Frédérique Welgryn, Chief Strategic Operations and Innovation Officer at HRA Pharma, said that the firm's application was a "ground-breaking moment" in reproductive equity in the U.S.
Access to Contraception without Unnecessary Barriers
More than 100 countries provide oral contraceptives without a prescription. In the U.S., however, pills, the most common form of contraception, require a prescription. Survey results from Data for Progress say that most Americans support that birth control pills should be made available without prescription in the country.
As per The Guardian, Welgryn said that making birth control pills available without prescription will help more women "access contraceptives without unnecessary barriers."
In the U.S., nearly half of the pregnancies are unintended, and research shows that almost one-third of all women who have tried to access prescription birth control face obstacles. Reproductive rights activists and researchers say that removing the prescription requirement on oral contraceptives would remove barriers to health care and expand access to birth control throughout the country, especially for poor people in rural communities and marginalized areas.
Several major U.S. medical organizations like the American Medical Association (AMA) and the American Academy of Family Physicians (AMAP) have called on the U.S. authorities to allow the over-the-counter sale of birth control pills. Last month, the AMA urged the FDA to approve over-the-counter access to birth control pills without age restrictions.
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Requirement for over-the-counter drugs
According to TIME, FDA says that for medications to be approved over-the-counter, the pills must be safe and capable of treating a condition that users can self-diagnose. It must also have a low potential for misuse, and it must be something that people can effectively use without the supervision of a health care provider. Many researchers and significant medical associations agree that oral contraceptives meet the FDA's requirements.
While most combined estrogen and progesterone oral contraceptives are exceedingly safe, it traditionally requires a prescription because it is associated with higher risks of blood clots for people with a history of blood clotting and uncontrolled high blood pressure. The HRA's Opill, however, contains only progestin, which is not associated with increased risks of blood clots.
