Paris-based HRA Pharma said in a news release that it submitted its application to the U.S. Food and Drug Administration for a progestin-only daily oral contraceptive. Progestin is a synthetic form of the hormone progesterone.
“This is good news,” 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, said in an email. She said she hoped the FDA would promptly approve the application and “doesn’t put any barriers” for its use, referring to the age limits the agency initially imposed for Plan B, the emergency contraceptive.
“This is not a substitute for access to abortion care in the U.S., but will provide one more tool for the toolbox for preventing unintended pregnancies and more options for family planning,” Wood said.
Oral contraceptives have been available in the United States with a prescription for six decades. The HRA Pharma pill, called Opill, was approved by the FDA on a prescription-only basis in 1973 and marketed for several years by Pfizer. It has not been sold in the United States for more than a decade, and HRA Pharma acquired it in 2014.
Frédérique Welgryn, chief strategic operations and innovation officer at HRA Pharma, said in an interview that the company has been working on switching the pill to over-the-counter status for years.
Welgryn said the application “is coming at the right moment,” given the Supreme Court’s overturning of Roe v. Wade last month.
“It will provide another option for managing reproductive health,” Welgryn said. “But it is not the solution for abortion access.”
Welgryn said the company expects the FDA review of the application to take about 10 months. The FDA declined to comment.
Women’s health groups and major medical organizations such as the American Medical Association and the American College of Obstetricians and Gynecologists have expressed support for years for making birth control pills available over the counter.
President Biden on Friday announced steps aimed at bolstering abortion rights, responding to growing demands from activists that he take bolder and more forceful action weeks after the Supreme Court decision. But his remarks were short on details; instead, he directed Health and Human Services Secretary Xavier Becerra to explore ways to protect access to abortion, including access to FDA-approved abortion medication.
Some advocates have wondered whether the White House will press the FDA to move quickly to approve the over-the-counter switch for the birth control pill.
But a senior administration official said the White House will probably be careful not to place overt pressure on the agency, saying that tactic carried political risks and would fly in the face of the administration’s oft-cited pledge that it will follow the science on medical decisions. The official spoke on the condition of anonymity because they were not authorized to discuss the issue publicly.
Pressure to make birth control pills available over the counter — as they are in more than 100 countries — has been building for years. In March, more than 50 members of the House’s Pro-Choice Caucus wrote to FDA Commissioner Robert Califf urging the agency to move to make oral contraceptives available without prescriptions.
“Birth control pills are one of the most studied medicines on the market today and they meet FDA’s standards for over-the-counter status,” the letter said. “Additionally, evidence supports the safety and benefits of over-the-counter birth control pills with no age restriction, and adolescent sexual and reproductive health experts support access for people of all ages.”
The agency is increasingly finding itself in the middle of battles over reproductive health and abortion. In December, it dropped a requirement that women seeking the abortion pill pick up the medication in person at a doctor’s office; now, patients can take part in a telehealth appointment and receive the medication in the mail, in states where that is permitted.
The agency approved over-the-counter use of the emergency contraception pill, Plan B, also known as the “morning after pill,” in 2006, but the medication became available without age limits only in 2013 after years of wrangling, political controversy and legal battles.
“As we learned with Plan B, the initial age restrictions were entirely unnecessary, and when these age restrictions were finally dropped did not increase any risks for young people. (The sky did not fall!),” Wood said. “In fact, expanded access to anyone needing contraception will only reduce the risk of unintended pregnancy, hopefully something we all agree on.”
In addition to HRA Pharma, another company, Cadence Health, has been working with the FDA to move oral contraceptives over the counter. Cadence, which is working on a pill that is a progesterone-estrogen combination, has said that it will conduct additional studies before submitting an application to the FDA.
#Drugmaker #seeks #approval #nonprescription #birth #control #pill