Outside advisers to the U.S. Food and Drug Administration (FDA) voted 17-0 on Wednesday to endorse over-the-counter birth control pills, The Hill reported.
The panel of advisers unanimously voted to endorse the drug, called Opill, after deciding that the “benefits…outweigh the potential risks,” the report states. The agency, which does not have to follow the panel’s recommendation, is expected to make a final decision this summer.
FDA scientists notably raised several concerns about giving the green light to over-the-counter birth control pills during the two-day meeting. One of their concerns was the quality of the company’s data, and another concern was whether people will understand the drug instructions and take the pill at the same time every day, according to the report, which continued:
Agency scientists were also concerned about whether women with medical conditions that should preclude them from taking the pill will know to avoid it without talking to a physician first. The agency was also concerned about whether adolescents and people with limited literacy would be able to understand the instructions.
“Yet the panel members largely disagreed, and said they felt the consequences of a lack of access to contraception outweighed the agency’s concerns,” the report continued.
Typically, hormone-based birth control requires a prescription so providers can check for risk of blood clotting, according to the report. Opill, which is manufactured by HRA Pharma, was approved for use with a prescription 50 years ago and is a progestin-only pill instead of a combination pill of progestin and estrogen. However, the pill “can be less effective if not taken around the same time every day,” according to the report.
“Do I think we got perfect data? No. Do I think it was a perfect study? No. Do I think it was adequate to feel reassured that a large number of people can use this drug as intended? Yes,” said Cynthia Baur, a health literacy researcher at the University of Maryland who voted in favor of OTC access.
The abortion giant Planned Parenthood celebrated the news, calling the move a “huge step to increase access to birth control, especially for people who have the hardest time getting a prescription.”
However, Students for Life of America President Kristan Hawkins released a statement via email calling the move “a feckless decision that empowers abusers.”
“Making it easy for abusers to cover up their sexual abuse and statutory rape crimes with Online, No Test Chemical Abortion Pills or over-the-counter birth control sales is negligent public policy,” Hawkins said in part prior to Wednesday’s decision. “The FDA ignores the impact of their policies on minors, including failing to show what the exact long-term impact of such early exposure on young women might be.”
“It’s astounding that an agency established to keep women safe when using any substances is more interested in a quick sale than patient safety. President Biden’s FDA must stop prioritizing the goals of the abortion lobby and put women and young girls first,” she continued. “As I travel on campuses across the country, I find that young women – both pro-life and pro-choice – agree that hormonal birth control causes women many terrible problems. Outside of Washington D.C., young women are very worried about such drugs. As a mother, I also am offended by the FDA’s reported decision in light of the current epidemic of sexually transmitted disease.”