In a major move, US federal officials authorized the nation’s first without a prescription birth control pill, potentially easing access to contraceptive drugs.
Once-daily Opill became the first such drug to be sold outside of a pharmacy when the FDA (Food and Drug Administration) approved its sale without a prescription.
There will be no age cap on sales, and the maker, Ireland-based Perrigo, will begin selling the pill early in the following year.
According to Perrigo, Opill might be a significant new alternative for the approximately 15 million US women who now use ineffective birth control or less efficient options such as condoms and account for one-fifth of all women of child-bearing age.
However, how many women will be able to obtain the drug is dependent on the price, which Perrigo hopes to reveal later this year.
Without insurance, most older contraception medications cost $US15 to $US30 ($21 to $42) for one month’s supply.
Over-the-counter medications are normally significantly less expensive than prescriptions, however they are not typically covered by insurance.
Clearance of Pill Sparks Abortion Debate Frenzy
The FDA clearance provides another birth control choice for US women in the midst of legal and political conflicts over reproductive rights, including last year’s Roe v Wade reversal, which has upended abortion access throughout the country.
The licensing of Opill has nothing to do with the ongoing legal challenges over the abortion drug mifepristone.
Furthermore, anti-abortion organizations have often stated that they are not against contraception, which is meant to prevent pregnancies rather than end them.
The FDA’s action only applies to Opill which is in an older class of contraceptives, sometimes called minipills, that contain a single synthetic hormone and generally carry fewer side effects than more popular combination hormone pills.
Women’s health advocates hope the decision paves the way for more over-the-counter birth control options and, eventually, for abortion pills to do the same.
An outside panel of FDA advisers unanimously voted in favor of the switch at a hearing in May where dozens of public speakers called for Opill’s approval.
Advocates were particularly interested in Opill because it raised fewer safety concerns.
It was first approved in the US five decades ago.