Good morning, Broadsheet readers! Business interest groups mobilize against the FTC's Lina Khan, McDonald's franchise owners refuse to promote Cardi B's meal, and Fortune's Maria Aspan explains why one company has spent nine years trying to sell birth control pills—without a prescription. Have a restful weekend.
- Decade-long effort. Long before the Supreme Court overturned Roe v. Wade last summer, executives at HRA Pharma saw a business opportunity in women’s reproductive health care.
They’re some of the only ones. U.S. pharmaceutical companies have largely walked away from investing in women’s health, as our ongoing Fortune series is exploring. And the business of reproductive health has been particularly fraught—even before the abortion bans, lawsuits, and other threats to both abortion and contraception that keep on mounting. (For example, a federal judge in Texas is likely to rule soon in a case that could block distribution of mifepristone, a drug used in more than half of all U.S. abortions.)
“We have seen too often reproductive health face unnecessary barriers, delays, complications, stigma, and bias,” says Dana Singiser, cofounder of the Contraceptive Access Initiative, a nonprofit advocacy organization. “It ultimately interferes with women having access to the care that they need—and that they deserve.”
But HRA Pharma, a French company now owned by pharma giant Perrigo, in 2014 decided to bet on birth control. It bought the rights to a Pfizer daily prescription pill that the U.S. Food and Drug Administration approved back in 1973, and started trying to make the product available over the counter.
If it succeeds, Perrigo will own the rights to the first such pill to be sold in the U.S. And because America is one of the relatively few countries in the world that doesn’t yet offer these contraceptives over the counter, the potential market is huge.
But will Perrigo’s years-long bet ever pay off? In July, the company officially applied to the FDA to “switch” its pill from prescription to over-the-counter status. But in October, the FDA postponed a scheduled public meeting on Perrigo’s application, saying it needed more time “to review new information.” Months later, the agency hasn't rescheduled that meeting—leaving Perrigo and others who have spent years or decades working to expand birth-control access in limbo.
“It’s been a long journey,” Frédérique Welgryn, an HRA veteran who’s now Perrigo’s global vice president of women’s health, told me recently. “And I’m not going to tell you that it’s nice and easy and rainbows and unicorns.”
An FDA spokesperson said by email last month that the meeting “has been postponed to a date not yet determined,” and did not comment further on Perrigo’s application.
I spoke with Welgryn—as well as doctors, reproductive-health advocates, former FDA officials, and other experts—about the complicated regulatory landscape and history of reproductive health care. Yet navigating that tough terrain is only the first of several huge hurdles for companies selling contraceptives, at a time when access to birth control is more crucial—and more threatened—than ever.
Read the full article here, and stay tuned for future reporting in this series.
Maria Aspan
maria.aspan@fortune.com
@mariaaspan
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