Maria Aspan, Fortune, February 10, 2023
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.
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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.
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“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.”
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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.
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