The US is considering the first over-the-counter birth control pill

More than 60 years after the US revolutionized women’s lives by approving the birth control pill, regulators are considering over-the-counter sale in pharmacies for the first time amid a nationwide battle for reproductive rights.

Two U.S. Food and Drug Administration advisory committees will review an application by HRA Pharma, a subsidiary of Perrigo Company, in November to sell a previously prescription oral contraceptive pill over-the-counter.

It’s the first such application being reviewed by the agency, which is also negotiating with another company, Cadence Health, over its plan to sell birth control pills the same way.

Both companies told the Financial Times that expanding access to birth control would help combat high rates of unwanted pregnancies in the United States at a time when abortion rights are being overturned following the Supreme Court’s June decision overturning Roe v. Wade. be severely restricted.

“Roe’s fall makes access to contraception much more important than before. It’s always been important, but now it’s more important. And especially in states with [abortion] restrictions,” said Samantha Miller, co-CEO of Cadence.

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

About 45 percent of pregnancies in the United States, about 3 million a year, are unintended, according to a study by the Guttmacher Institute Are defined this as a pregnancy that is either unwanted or wanted in the future but not at this time.

The prevalence of unwanted pregnancies is higher among black women, women on low incomes, and women without a college education.

Research by the Guttmacher Institute and the UN Development Program found that overall unintended pregnancy rates in the US are, on average, higher than in several European countries such as Spain, Germany and Switzerland, and on par with the UK and Sweden.

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Cynthia Harper, a professor of reproductive sciences at the University of California, San Francisco, said over-the-counter access would benefit people who don’t have regular access to health care providers, such as teens, the uninsured and rural residents.

“A visit to the doctor can become prohibitively expensive for people who don’t have insurance. . . and many young people who are insured with their parents don’t want them to know they’re on birth control pills,” she said.

Reproductive rights activists say expanding access to birth control pills is crucial at a time when abortion rights are under attack amid fears contraception could soon be called into question.

In a unanimous opinion in the abortion case, Supreme Court Justice Clarence Thomas earlier this year suggested that other landmark judgments, including those establishing a right to contraception, should also be reviewed. And in July, an attempt by Senate Democrats to speed up legislation to enshrine a right to contraception into federal law failed after opposition from Republican lawmakers.

“I do not think so [birth control] is the next goal. I think it’s a goal already,” said Dana Singiser, founder of the Contraceptive Access Initiative, a group campaigning for over-the-counter access to birth control.

There is some support in Congress for expanding access to the pill. In March, more than 50 Pro-Choice Caucus lawmakers wrote to the FDA, urging the agency to “follow the science” and take “quick action” to approve over-the-counter sales.

So far there hasn’t been much backlash from Conservatives to the HRA’s June request to sell its pills over-the-counter, although some groups have raised concerns about the impact on young people.

Kristan Hawkins, President of Students for Life of America, said she has “enormous concerns” about drugs being given to children without a caring adult involved, especially given the potential for medical side effects.

“It is prudent to have medically supervised distribution of such drugs so that women survive exposure to them,” she said.

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Medical experts say birth control pills can have negative side effects, like bleeding between periods and headaches, but these don’t affect 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 cancer or blood disorders — are advised to avoid some birth control pills.

Advocates of the move to over-the-counter sales say proper labeling can inform consumers of 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 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, which prevents pregnancy.

Cadence plans to seek FDA approval for a combination pill that contains a progestin and a second hormone, estrogen.

“The pill has been around for 60 years, women know how to use it, they know it’s fundamentally safe. So it makes sense that the pill would also be offered as an over-the-counter option,” said Frédérique Welgryn, HRA’s Chief Strategic Operations and Innovation Officer.

HRA launched a similar over-the-counter pill in the UK last year, priced at around £10 a month. A price has not yet been set for the US market, but it would be affordable, Welgryn said, adding that she expects a decision from the FDA early next year.

Welgryn said the Roe vs. Wade upheaval meant expanding access to contraception in the US was “more important than ever.” “People really need the full spectrum of reproductive healthcare to plan their lives and their future. So they need contraception, they need emergency contraception. . . and they may need an abortion at some point,” she said.

https://www.ft.com/content/19599dda-7f4d-41d3-8b27-5eb16aadb458 The US is considering the first over-the-counter birth control pill

Adam Bradshaw

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