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US considers first over-the-counter contraception capsule


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.

Both companies told the Financial Times expanding access to birth control would help tackle high rates of unintended pregnancies in the US at a time when abortion rights are being severely restricted following the Supreme Court’s decision in June to overturn Roe vs Wade.

“The overturn of Roe makes access to contraceptives much more important than it was prior. It has always been important but it is more important now. And particularly in states with [abortion] restrictions,” said Samantha Miller, co-chief executive of Cadence.

More than 100 countries provide oral contraceptives over-the-counter, but in the US women still require a prescription from a doctor to obtain them Most major medical groups, including the American Medical Association, support allowing over-the-counter sales, saying it would lead to fewer unplanned pregnancies.

About 45 per cent of pregnancies in the US, roughly 3mn every year, are unintended, according to research by the Guttmacher Institute, which defines this as a pregnancy that is either unwanted or wanted in the future but not at that point in time.

The prevalence of unintended pregnancies is higher among black woman, women on low incomes and those without a high school education.

Research from the Guttmacher Institute and the UN Development Programme found unintended pregnancy rates in the US overall to be higher on average than in several countries in Europe such as Spain, Germany and Switzerland, and on par with rates in the UK and Sweden.

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.

“A doctor’s visit can become prohibitively expensive for people who are uninsured . . . and many young people on their parent’s insurance would not want them to know they are getting birth control pills,” she said.

Reproductive rights campaigners say expanding access to birth control pills at a time when abortion rights are under attack is critical, amid fears that contraception could soon be challenged.

In a concurring opinion in the abortion case, Supreme Court Justice Clarence Thomas suggested earlier this year that other landmark judgments, including those establishing a right to contraception, should also be revisited. And in July an attempt by Senate Democrats to fast-track a bill seeking to enshrine a right to contraception into federal law failed after encountering opposition from Republican lawmakers.

“I don’t think it [birth control] is the next target. I think it is already a target,” said Dana Singiser, founder of Contraceptive Access Initiative, a group lobbying for over-the-counter access to birth control.

Some support exists in Congress for expanding access to the pill. In March more than 50 lawmakers from the Pro-Choice Caucus wrote to the FDA urging the agency to “follow the science” and take “swift” action to authorise over-the-counter sales.

So far there has not been a major backlash from conservatives towards HRA’s application in June to sell its pills over-the-counter, although some groups have expressed concerns about the impact on young people.

Kristan Hawkins, president of Students for Life of America, said she had “tremendous concerns” with drugs given to children without a caring adult being involved, particularly given the potential for medical side effects.

“It’s wise to have medically supervised distribution of such drugs so that women survive their exposure to them,” she said.

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.

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