A French-based pharmaceutical company has requested the United States Food and Drug Administration (FDA) for approval of an over-the-counter abortion pill.
The request comes as millions of Americans have used hormone-based birth control pills for decades that required prescription. HRA Pharma reportedly sent its application to the FDA on Monday and said that the timing is unrelated to the recent overturning of Roe v. Wade and was based on years of research.
Over-The-Counter Abortion Pills
Healthcare professionals, when prescribing birth control, check patients for conditions that increase the risk of exceedingly rare blood clots. However, HRA Pharma says that its research shows women can safely self-screen.
The recent request now places the FDA under political pressure as the decision is closely tied to the debate about reproductive rights and follows the Supreme Court's decision to overturn Roe v. Wade. The French-based company expects the agency to reach a decision in the first half of next year, as per The Daily Beast.
HRA Pharma said, in a statement, that the historic application marks a groundbreaking precedent in contraceptive access and reproductive equity. The remark was made by the company's chief strategic operations and innovation officer, Frederique Welgryn.
The official added that more than six decades ago, prescription birth control pills in the U.S. empowered women to plan if and when they wanted to get pregnant. He added that moving a safe and effective prescription birth control pill to become over-the-counter will help even more women and people access contraception without facing unnecessary barriers.
According to ABC News, despite the current requirement of prescription to purchase birth control pills, doctors say that the risk is minimal for the vast majority of the population. They note that pregnancy can carry its own significant health risks to the mother.
Overturning Roe v. Wade
Reproductive rights advocates have argued that an over-the-counter pill would make it easier for women without access to healthcare to obtain contraceptives. The situation comes after Michigan Gov. Gretchen Whitmer said that it is crucial to make it easier and more affordable for everyone to secure contraception.
She said they must take bold steps to protect women by ensuring that health, not politics, guide medical decisions. It also comes as the Centers for Disease Control and Prevention's (CDC) data shows that 65.3% of women aged 15 to 49 use contraception, with 14% of them taking pills.
In the wake of the Supreme Court's ruling on Roe v. Wade, Senate Republican Leader Mitch McConnell said that the 50-year-old landmark was "one of the most egregious legal and moral mistakes of the 20th century." However, many Americans fear that the fallout from Roe's reversal will lead the court to overturn other constitutionally-protected rights.
Supporters of reproductive rights have also called on United States President Joe Biden to push the FDA to hasten its review of over-the-counter contraceptives. In March, scores of House Democrats inked a letter (PDF) to FDA Commissioner Robert Califf, M.D., petitioning for the "timely review" of any applications to take birth control pills over-the-counter, FiercePharma reported.
