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Why this company has spent 9 years trying to sell birth control pills without a prescription

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Maria Aspan
Maria Aspan
and
Emma Hinchliffe
Emma Hinchliffe
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By
Maria Aspan
Maria Aspan
and
Emma Hinchliffe
Emma Hinchliffe
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March 3, 2023, 8:48 AM ET
Frédérique Welgryn, Perrigo’s global vice president of women’s health poses for a portrait.
Frédérique Welgryn, Perrigo’s global vice president of women’s health.Courtesy of HRA Pharma
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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

The Broadsheet is Fortune’s newsletter for and about the world’s most powerful women. Today’s edition was curated by Emma Hinchliffe. Subscribe here.

ALSO IN THE HEADLINES

- Abundance of caution. Walgreens, led by CEO Roz Brewer, confirmed yesterday that it will not dispense abortion pills in several U.S. states, including several where abortion remains legal, out of an abundance of caution. Nearly two dozen Republican state attorneys general have threatened legal action if Walgreens dishes out the drugs. Currently, Walgreens doesn't distribute the drugs anywhere in the U.S. but is seeking certification to do so in some states. Politico 

- FTC target. Business groups, including the U.S. Chamber of Commerce, are mobilizing in opposition to the Federal Trade Commission's Lina Khan and her proposed ban on noncompete agreements. Business interest groups and conservatives are targeting Khan as "the primary symbol of what they see as wrong with President Joe Biden’s agenda." Bloomberg

- On board. McDonald's shareholders sued members of the fast-food chain's board of directors, alleging that the directors did not uphold their duty to shareholders in handling allegations of sexual harassment and misconduct at the company. But a Delaware court ruled in favor of the board members yesterday, deciding that their response was sufficient. Wall Street Journal

- Not-so-happy meal. And in more McDonald's news, some of the chain's franchisees are refusing to promote a meal sponsored by Cardi B and Offset. They say the rappers' "lyrics and lifestyles" don't align with the company's brand. But their concerns reflect a "racialized and dated definition of family values," argues Bloomberg's Leticia Miranda. Bloomberg Opinion

MOVERS AND SHAKERS: Amanda Brown Lierman, formerly executive director of Supermajority, joined GoFundMe as senior director for policy and engagement for North America. Peloton hired former Twitter exec Dalana Brand as chief people officer. Meta's Diane Jackson joins Makers as VP, global production. Meati Foods hired Elizabeth Fikes as chief supply chain officer. Xponance named Marcy Rappaport director of business development and consultant relations. Hitachi Vantara hired Sheila Rohra as chief business strategy officer. Linktree named Farnaz Azmoodeh chief technology officer and Monica Austin CMO. 

IN CASE YOU MISSED IT

- Tough economics. Three in four U.K. women who pay for childcare say it doesn't make financial sense for them to work, according to a new report. Childcare costs eat up more than half of household income for one-fifth of U.K. parents. Bloomberg

- Faces are freed. Women in Hong Kong celebrated the lifting of an indoor and outdoor mask mandate after three years by rushing out to buy lipstick. Beauty executives expect lipstick sales to rise 20% in Hong Kong compared to a year ago. South China Morning Post

- When and where. As we await an expected ruling on the medication abortion drug mifepristone, this analysis shows in which parts of the U.S. a ban on the pill would have the biggest effects. Experts say the case could, in some ways, be more significant than Dobbs, decided last summer. New York Times

- Political opponents. The rise of Elly Schlein as the new leader of Italy’s center-left Democratic Party places her in opposition to far-right Prime Minister Giorgia Meloni. The two Italian politicians represent opposite sides of the political spectrum. Politico EU

ON MY RADAR

Black teen girls are the curators of culture Vox

The Idol: How HBO's next Euphoria became 'torture porn' Rolling Stone

With her latest media project, Jane Pratt is still telling all Vanity Fair

Merrick Garland is a huge Taylor Swift fan Wall Street Journal

PARTING WORDS

"I’ve never learned so much as being 25 years old. I am just starting to feel like a woman." 

—Camila Morrone, who stars in the new Amazon Prime Video series Daisy Jones and the Six

This is the web version of The Broadsheet, a daily newsletter for and about the world’s most powerful women. Sign up to get it delivered free to your inbox.

About the Authors
By Maria Aspan
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Maria Aspan is a former senior writer at Fortune, where she wrote features primarily focusing on gender, finance, and the intersection of business and government policy.

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Emma Hinchliffe
By Emma HinchliffeMost Powerful Women Editor
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Emma Hinchliffe is Fortune’s Most Powerful Women editor, overseeing editorial for the longstanding franchise. As a senior writer at Fortune, Emma has covered women in business and gender-lens news across business, politics, and culture. She is the lead author of the Most Powerful Women Daily newsletter (formerly the Broadsheet), Fortune’s daily missive for and about the women leading the business world.

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