US considers first over-the-counter birth control pill
More than 60 years after the US revolutionised the lives of women by approving the birth control pill regulators are considering allowing it to be sold over-the-counter in pharmacies for the first time amid a nationwide battle over reproductive rights.
Two US Food and Drug Administration advisory committees will in November consider an application by HRA Pharma, a subsidiary of Perrigo Company, to sell a previously prescription-only oral contraceptive pill over-the-counter.
It is the first such application to be considered by the agency, which is also in talks with another company, Cadence Health, over its plan to sell contraceptive pills in the same manner.
Cynthia Harper, professor of reproductive sciences at University of California, San Francisco, said over-the-counter access would benefit people who did not have regular access to healthcare providers, such as adolescents, the uninsured and rural dwellers.
Medical experts say there can be negative side effects with birth control pills, such as bleeding between periods and headaches, but these do not impact everyone and usually go away after a few months. Serious problems are rare but some groups — including people who smoke or have had certain types of cancers or blood disorders — are advised to avoid some birth control pills.
Advocates for moving to over-the-counter sales say proper labelling can inform consumers about potential risks. In the UK a brief consultation with a pharmacist is required before selling contraceptive pills.
HRA said its pill is safe for most women to use and has undergone lengthy trials as part of a seven-year pre-application process for over-the-counter access. HRA’s pill, branded Opill, is a “mini pill” that contains progestin, a man-made form of the hormone progesterone that prevents pregnancy.
Cadence plans to ask the FDA to approve a combination pill, which includes progestin and a second hormone, oestrogen.
“The pill has been on the market for 60 years, women know how to use it, they know that it’s basically safe to use. So it makes sense that the pill is also offered as a choice to be available over the counter without prescription,” said Frédérique Welgryn, HRA’s chief strategic operations and innovation officer.
HRA launched a similar over-the-counter pill in the UK last year, which it priced at about £10 per month. No price has been set yet for the US market but it would be affordable, said Welgryn, adding that she expected an FDA decision early next year.
Welgryn said overturning Roe vs Wade meant expanding access to contraception is “more important than ever” in the US. “People really need the full range of reproductive healthcare to plan their lives and futures. So they need contraception, they need emergency contraception . . . and they may need abortion at some point,” she said.
This story originally appeared on: Financial Times - Author:Caitlin Gilbert
