A panel of independent medical experts at the Food and Drug Administration on Wednesday voted unanimously in favor of allowing the hormonal contraceptive opil (norgestrel) to be sold over-the-counter rather than by prescription.
The 17-to-0 vote by the panel came after a two-day meeting in which experts reviewed data and analysis from scientists at tablet maker Laboratoire HRA Pharma and FDA, and heard public comments on the potential switch. It has been determined.
Opill is a once-daily tablet containing progestin only. It was first approved in 1973 and has since been proven to be remarkably safe in the 50 years since, even safer than mixed hormonal drugs that carry the risk of blood clots.Experts estimate that opil is about 93% effective against pregnancy in actual use, which is Effectiveness in practice Other readily available methods of contraception, such as condoms (about 87 percent).
If the FDA follows the adviser’s recommendation and chooses to make the pill OTC, it will be the first time a hormonal contraceptive will be available without a prescription or other barriers. The move comes at a time when women’s medical and reproductive autonomy is under intense attack and most abortions are being carried out. Currently banned in 14 states Other restrictions are in place or emerging in many other regions.
A panel of experts received a unanimous vote, FDA said switching to OTC opil would be safe, effective in preventing unwanted pregnancies, and would significantly improve reproductive autonomy and equity in the country. made a strong statement against
“The risks to women from unwanted pregnancies far outweigh anything we’ve discussed about the risks of marketing this drug,” said panel member Catalin Ross, professor of medicine at George Washington University, closing. said in his greeting. “The history of female contraception is a struggle for women to control their reproduction, and we need to trust them.”
In addition to reviewing the safety and efficacy data presented and discussed at the conference, Ross and several other panelists noted the inspiring discussion that took place in the public comment section yesterday, A majority supported the switch to OTC.
Among the commenters was Rebecca Heinbrock, a sophomore in college, who shared a personal example of the struggle for access to contraception in a resource-poor rural setting. Heimbrock grew up in rural Appalachia, where she was denied oral contraceptives to help manage pain from endometriosis. “When I was a teenager, my doctor told me I shouldn’t start taking birth control pills because it made me more likely to be sexually active,” she said. “Of course, we know this is not true, and young people without access to contraception are just having sex without it.”
At the conference, there was some debate as to whether teenagers could successfully proceed with the use of the pill without medical supervision, especially since the effectiveness of the pill is related to continued daily use in the same three-time window. There was much discussion. However, some experts on committees that care for adolescents were not particularly concerned about this. Adherence is a problem overall, they argued, and a brief conversation with a doctor who would see the woman only once a year would not make a noticeable difference than reading the instructions on the box. Overall, the researchers said the ease of access to the pills clearly outweighed the risks.
Elise Barlan, clinical professor of pediatrics at Ohio State University and physician in the Department of Adolescent Medicine at Nationwide Children’s Hospital, defended access for teens. “The barriers to access to contraceptives are real, they are very detrimental, and they are even greater during puberty,” she said in a comment explaining her reasons for voting. These barriers perpetuate health inequalities in communities, including fertility and pregnancy-related morbidity and mortality, she added. “The pregnancy health risks that these products are intended to prevent are far greater than the use of other contraceptives, making this one of the safest contraceptives.”
“I also wanted to emphasize my belief that adolescents will make good decisions about reproductive health,” Barlan concluded. “We can trust our teens to make these decisions.”
While FDA scientists have expressed concerns about the reliability of the data on patient adherence to the once-daily dosing schedule, several panel members have urged regulators to use OTC as more data is collected. requested not to delay the acquisition of
“I think this is a milestone in the history of women’s health,” said Margery Gass, a former professor of obstetrics and gynecology at the University of Cincinnati. “Unwanted pregnancies can be very disruptive to women’s lives, especially adolescents’ lives, so we are very pleased that the FDA is taking this seriously. looking forward to it.”
The Commission’s endorsement of OTC contraception is aligned with major health organizations.of American Medical Association, American College of Obstetricians and Gynecologistsand the American College of Family Medicine All previously supported OTC availability of oral contraceptives.