It’s been a long seven months for Perrigo's HRA Pharma, the company making a historic request to expand American access to birth control. But at least, after nine years of regulatory red tape, its executives know how to be patient.
In July, the pharmaceutical company made a landmark—and tragically well-timed—application to the U.S. Food and Drug Administration. The Supreme Court had just overturned Roe v. Wade. And as tens of millions of women lost access to abortion almost overnight, the Court also signaled that access to contraceptives could be next in the legal crosshairs.
These massive, mounting threats to reproductive health sent shock waves through American society. At the same time, they created a potential business silver lining for HRA Pharma, a French company owned by pharma giant Perrigo. HRA owns the rights to the Opill, a prescription daily birth-control pill that the FDA approved back in 1973. The company’s executives, and many medical and reproductive-rights experts, want the drug to become the first such pill to be sold in the U.S. without a prescription. And because America is one of the relatively few countries in the world that doesn’t yet offer birth-control bills over the counter, the potential market is huge.
But getting access to that market has proven to be a long ordeal. HRA bought the Opill back in 2014; since then, it has been involved in years of expensive behind-the-scenes research studies and intense discussions with U.S. regulators that executives admit today “took longer than we expected it to.” Even though the drug has already been approved once, it must go through a new approval process for non-prescription use, with Perrigo on the hook to satisfy regulators that it’s safe for people to use without first consulting a physician. (And Perrigo isn’t the only pill manufacturer trying to jump through these hoops; an Oakland-based startup called Cadence Health has also spent several years working towards switching its pill to over-the-counter status.)
Finally, last July, Perrigo announced that it had officially applied to the Food and Drug Administration for approval to “switch” the drug from prescription to over-the-counter status. But the waiting isn’t over. The FDA generally makes decisions on such applications within a 10-month window. But in late October, the agency told Perrigo that it could take an additional three months to review its application—meaning that the FDA may not make a decision until August 2023. At the same time, the agency postponed a November public meeting on the company’s application, saying it needed more time “to review new information.” Three months later, the FDA has yet to reschedule this meeting.
“It’s been a long journey,” Frédérique Welgryn, a longtime HRA executive who’s now Perrigo’s global vice president of women’s health, said during a Zoom interview last week. “And I'm not going to tell you that it's nice and easy and rainbows and unicorns.”
It's also a familiar journey for industry executives and reproductive-health experts. The prolonged, expensive, stop-and-start regulatory process is one of several huge business hurdles for companies selling contraceptives, at a time when access to birth control is more crucial than ever. While such challenges are common across the business of women's health, as this Fortune series is exploring, Perrigo's current limbo also brings back bad memories for some reproductive-rights advocates. In the past, they say, the FDA moved particularly gingerly with drugs related to contraception and abortion—sometimes out of fear of political opposition, and out of a greater-than-usual caution when it comes to products affecting women’s reproductive health.
“It's not necessarily always Political with a capital P,” says Susan Wood, a professor emerita at George Washington University and the former director of the FDA’s Office of Women’s Health, who resigned in protest in 2005 when the agency refused to make emergency contraception available over the counter. “But I do think there's hesitancy to move these products forward without a very cautious approach—perhaps more cautious than with other products.”
Welgryn is still optimistic about her company’s application. She tells me that Perrigo expects the FDA to announce the rescheduled public meeting “soon,” and that “hopefully this would happen maybe in Q2 of this year.”
But the FDA this week declined to confirm Welgryn’s hopes; a spokesperson told Fortune by email that the meeting “has been postponed to a date not yet determined,” and did not comment further on Perrigo’s application.
Wait and see
A French native who spoke by Zoom from her Paris apartment, Welgryn is a pharmaceutical industry veteran who joined HRA Pharma in 2010 and has been working on its Opill application since inception. The company introduced a “morning-after” pill in France in 1999, and in 2010 received FDA approval to sell emergency contraception in the United States. Four years later, it bought the rights to a 41-year-old Pfizer product called Opill, and started working on all the research studies and pre-application discussions before the FDA would officially allow it to apply for over-the-counter (OTC) status. (In September 2021, Dublin-based Perrigo agreed to buy HRA Pharma for about $2 billion; the deal closed last May.)
Doctors and reproductive-health advocates had already been working for at least a decade to convince regulators that it’s safe to sell birth control pills over the counter. Many of them have teamed up with HRA Pharma, which in 2016 officially started working with a coalition run by Ibis Reproductive Health, a nonprofit advocacy group. More than 100 countries—mostly across South America, Asia, and Africa—already allow the birth-control pill to be sold without a prescription; and in this country, professional medical groups, including the American Medical Association and the American College of Obstetricians and Gynecologists, support “over-the-counter access to hormonal contraception without age restrictions.”
Welgryn is careful to acknowledge the burden and responsibility the FDA faces with her company’s drug application, especially as it would mark the first birth-control pill to be sold over the counter in this country. “I can’t blame them for being thorough,” she says. “You have to convince the FDA that, without medical supervision, the product can be used safely and effectively. It's painful. It’s long. But that’s basically the case for pretty much all [drug] sponsors.”
Yet she laughs ruefully when asked if she expected this application process to take quite this long: “No,” she says. “I have to admit that the launch plans were supposed to come earlier.”
Welgryn declined to go into specifics about why the FDA postponed the November meeting, aside from stating that the agency is “actively reviewing” the submission, she says. “They’re asking questions, it’s a back-and-forth process, and we’re just waiting for a date to go to the advisory committee.”
Reproductive threats and risks
With every day bringing new attempts to further restrict abortion in the United States, birth control can seem like a decidedly secondary reproductive-health priority. But its importance can’t be overstated: More than 72 million U.S. women are of reproductive age—and 99% of those who are sexually experienced have used at least one contraceptive method, according to the Guttmacher Institute. As products that touch the lives of almost every woman—and as products that can prevent the need for an abortion in the first place—contraceptives are now more important than ever.
They’re also more threatened. When the Supreme Court overturned Roe, Justice Clarence Thomas urged the Court to “reconsider” other past rulings, including the case codifying the right to contraception. Conservative groups are already bringing legal and legislative challenges; in December, a Texas judge appointed by President Donald Trump ruled that people under 18 could no longer receive birth control at federally funded clinics without parental permission.
Even before these developments, access has been a problem. One study conducted in 2011 found that 29% of U.S. women who tried to get a prescription for hormonal birth control couldn’t afford it, didn’t have insurance, couldn’t get an appointment with a physician or get to a clinic, or ran into other barriers. As always, Black and brown women, lower-income women, and all those who already lack adequate access to healthcare are most affected by these mounting restrictions on reproductive rights.
“The reality is that it can actually be really, really hard to get access to a very basic service like contraception. And in particular, it can be hard in places where abortion is highly restricted or completely banned,” says Dr. Raegan McDonald-Mosley, an ob/gyn and the CEO of reproductive-rights nonprofit Power to Decide, which is in the coalition of advocacy groups supporting HRA Pharma’s application.
The FDA first approved a hormone-based pill in 1960, and such pills remain some of the most common types of contraception for millions of American women. Still, health concerns remain around hormonal birth control, which can come with the risks of several side effects—including rare but dangerous and sometimes-lethal blood clots.
Most oral contraceptives contain the hormones progestin, which prevents pregnancy by blocking sperm from the cervix, and estrogen, which can help make periods lighter and more regular. But estrogen also increases the risk of blood clots. HRA Pharma’s Opill contains only progestin, which doctors and contraceptive experts say is a safer drug for women to take without a prescription or a doctor’s visit.
“Progestin-only absolutely tends to be safer,” says Diana Zuckerman, president of the nonprofit National Center for Health Research. “But I’m very concerned that, once you allow one hormonal contraceptive to be available, without prescription, over the counter, there's a good chance that will be followed by others—and the others won't be as safe necessarily.”
So the FDA has good reasons to be deliberate about deregulating oral contraceptives for the first time. But these delays with HRA Pharma’s application, and the company’s long journey to even get to this point, bring back old concerns among some advocates for contraceptive access and women’s reproductive health in general. They remember the FDA’s history of regulatory caution—and occasionally politicized decision-making—around previous products relating to contraception and abortion, including “Plan B” emergency contraception and abortion pills.
For example, when the FDA approved the abortion drug mifepristone in 2000, it heavily limited where the pill actually could be dispensed—restrictions that it finally started lifting last year. And in 2003, an FDA advisory panel approved Plan B for over-the-counter use—but the agency’s then-leaders refused to sign off for another three years, leading to Wood’s resignation over what she calls “political interference” in the agency’s mission. (The FDA then restricted over-the-counter sales to those over age 17, a restriction the agency only lifted, on a federal judge's order, in 2013.)
In contrast, as Wood points out, some drugs of the same era sailed through the FDA process. One in particular, a blockbuster pill for men, was patented by Pfizer in 1996, and won FDA approval a mere two years later. This drug was even related to contraception, at least by increasing the overall need for it—although the drug wasn’t exactly marketed that way. It was, of course, Viagra.
These days, “I do trust the FDA to be science-based,” says Mara Gandal-Powers, director of birth control access and senior counsel for the National Women’s Law Center. But still, she adds, “my gut instinct is that I worry about what will happen at the FDA—and that was really formed by what happened with Plan B.”
Former FDA insiders and many industry members watching HRA Pharma’s application say they are mostly not worried—yet—about politics interfering with the agency’s deliberations. But they do see a paternalistic sort of caution, which represents a larger challenge for women’s reproductive health: A regulatory landscape that is more demanding at best, and that can make it difficult for companies to justify the time and expense of developing new products that would better serve women.
“We have seen too often reproductive health face unnecessary barriers, delays, complications, stigma, and bias,” says Dana Singiser, co-founder of the Contraceptive Access Initiative, a nonprofit advocacy organization in the coalition supporting HRA Pharma's application. “It ultimately interferes with women having access to the care that they need—and that they deserve.”
A grant from the NIHCM Foundation helped fund reporting for this story.
