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FDA to consider over-the-counter birth control pills

Photo by Reproductive Health Supplies Coalition on Unsplash


HRA Pharma has asked the U.S. Food and Drugs Administration (FDA) to approve their birth control pill for over-the-counter sale.  


This FDA application comes not long after the recent Supreme Court’s overturn of Roe v. Wade which took away the constitutional right to abortion.


Frédérique Welgryn, HRA Pharma’s chief strategic and innovations officer, said to the New York Times that the recent overturn was a “really sad coincidence.” 


"The timing is a bit coincidental. We have been working on that application for the last seven years," Welgryn said to Reuters.  


Birth control, one of the most common forms of contraception in the U.S., has had a prescription requirement for a long time. BBC reports that the U.S. is one of a few countries to require a prescription, as more than 100 countries provide birth control pills over the counter. 


Welgryn said that the firm’s application was “groundbreaking” especially for reproductive equity in the U.S., according to BBC. She said HRA Pharma put in years of research to pass and make a case for the U.S. regulators. 


"Moving a safe and effective birth control pill to OTC [over the counter] will help even more women and people access contraception without facing unnecessary barriers," she said to BBC. 


Many, including Iffath Abbasi Hoskins, president of the American College of Obstetricians and Gynecologists, agree with the HFAA Pharma’s submission to the FDA.


"We know that birth control is not a solution to abortion bans, as people need abortion care for many reasons," Hoskins said to Reuters. However, she said that the pills could help people “control their own reproductive futures.”


Several U.S. medication organizations, such as the American Medical Association and the American Academy of Family Physicians, have also commented previously that oral contraceptive pills should be available without a prescription, BBC reported.


“Years of legal wrangling finally got them to follow the science,” Kelly Blanchard, the president of Ibis Reproductive Health, said to the New York Times. Ibis Reproductive Health is a nonprofit that has partnered with HRA Pharma in conducting research for the FDA application. 


“We hope they follow the science and approve without an age restriction in this case,” Blanchard said.


According to HRA Pharma officials, the company expects a decision from the FDA in about 10 months, the New York Times reported. This is a normal timeframe for an over-the-counter application. If the application is passed, the approval will apply only to the firm’s drug. 


 The FDA has declined to comment on the application, Reuters reported. 


The only over-the-counter contraceptive drug available without a prescription are emergency oral pills, Reuters reported. Also known as Plan B, this drug can only be taken in a short timeframe of three days after having unprotected intercourse. 


The Dobb v. Jackson Women’s Health Organization Supreme Court ruling that overturned Roe v. Wade also had a concurring opinion by Justice Clarence Thomas that addressed contraception, according to the New York Times. The opinion suggested that the 1965 decision that gave a right to contraception should be reevaluated and overturned. 


Edited by: Sara Moreira

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