The Meals and Drug Administration is about to judge an utility for what could be the primary over-the-counter contraception capsule. French pharmaceutical firm HRA Pharma mentioned Monday that it has formally requested the FDA to authorize its contraceptive.
The submission comes as the USA is grappling with a fast-changing reproductive healthcare panorama after the Supreme Court docket ended federal protections for abortion. Justice Clarence Thomas wrote in a Supreme Court docket opinion that the courtroom ought to rethink opinions on rights to contraception. The timing is a coincidence, Frédérique Welgryn, HRA Pharma’s chief strategic operations and improvements officer, instructed The New York Occasions. “Contraception shouldn’t be an answer for abortion entry,” she mentioned. However an over-the-counter contraception capsule would assist take away limitations to contraception, she mentioned in a press release.
Uncommon uncomfortable side effects of contraception tablets can embody blood clots, and a few individuals with medical circumstances that enhance their threat of clots (like historical past of stroke) aren’t beneficial to take them. That’s one motive they’ve required a prescription.
HRA Pharma’s contraception is a “mini capsule” — it solely comprises the hormone progestin quite than a mix of progestin and estrogen. The mini capsule is much less generally utilized in the USA, and other people need to watch out to take it on the similar time every single day. However as a result of it doesn’t comprise estrogen, it doesn’t enhance the danger of blood clots or stroke.
Organizations just like the American Medical Affiliation (AMA) help an over-the-counter contraception capsule. “Offering sufferers with OTC entry to the contraception capsule is a straightforward name from a public well being perspective because the well being dangers of being pregnant vastly outweigh these of oral contraceptive use,” mentioned AMA board member David Aizuss in a press release.
One other pharmaceutical firm, Cadence Well being, can also be working towards an over-the-counter contraception capsule. Its capsule is a mix of progestin and estrogen. Each corporations have been in discussions with the FDA for years.
The FDA is anticipated to take round 10 months to decide on HRA Pharma’s utility.
