In July 2023, the FDA approved the first over-the-counter oral contraceptive in the United States. Lucy Owen ’87 navigated the long road to get there.

On May 9, 1960, the U.S. Food and Drug Administration approved a prescription oral contraceptive—the pill—for the first time. Sixty-three years to the day later, May 9, 2023, the pharmaceutical company HRA Pharma made its case to the FDA for an over-the-counter (OTC) oral contraceptive—Opill. The FDA Advisory Committee members unanimously supported the move, and Opill was officially approved in July 2023 as the first ever OTC oral contraceptive.

Why did it take 63 years for oral contraception to move from prescription status to OTC? It wasn’t for lack of trying: Reproductive health specialists and advocates, scientists, grassroots movements, and nonprofits had been steadfast in attempting to move the needle on the issue for decades. Some had been involved in the push for OTC oral contraception since the 1960s; others got on board more recently. For Lucy Owen ’87 (P ’21, ’22, ’25), president of the healthcare consultancy Pinney Associates in Bethesda, her official role in this massive project began eight years ago, when HRA Pharma hired her to navigate the company through the regulatory process. But her engagement on the issue started long before that.

“When I graduated from Sidwell, everybody I knew imagined that they would be involved in advocacy and policy making of some kind,” Owen says. “Changing the world was definitely a very simple and natural direction to take. Some of that was generational, and some of it was definitely Sidwell sending people out into the world who wanted to make it a better place.”

Owen attended the University of Michigan, where she studied history. She was interested in reproductive health, though not from a scientific perspective, but she found meaning in volunteering at a home for preteen and teenage girls with babies. “I was partnered with a 12-yearold girl who had a 1-year-old baby,” Owen says. “That had a profound, profound impact on me.” Owen went on to do postgraduate work at Oxford University, where she studied the history of medicine and further pursued her interest in public health.

That soon led Owen to Pinney Associates, where over the last 25 years she has developed a vital specialty: helping companies gain OTC approval for prescription medications, or “OTC switch.” At Pinney, Owen has tackled “Rx-to-OTC” approval for all manner of complicated and politically charged products. One of the signature wins was working to gain FDA approval for OTC sales of the emergency contraceptive Plan B for those 18 and over in 2006, and approval with no age restriction in 2013.

If it seems surprising that FDA would switch the controversial Plan B (often called the morning-after pill) a full decade before switching the comparatively less controversial Opill, Owen has a theory about that. “My belief is that Plan B came first because you take it just once,” she says. “The sooner you take it after unprotected sex, the more effective it is in preventing pregnancy. So, there was a very compelling case to be made to FDA that it was really important for this emergency contraception to be available over the counter because the delay caused by having to find a doctor, get in touch with that doctor, and then have a medical appointment could render it ineffective.”Changing the world was definitely a very simple and natural direction to take. Some of that was generational, and some of it was definitely Sidwell sending people out into the world who wanted to make it a better place.

Non-emergency oral contraception, on the other hand, must be taken daily. “I think FDA was very concerned that women can’t be trusted to take a single pill a day,” Owen says. “One of the things we had to demonstrate, through a very large trial, is that women can take one pill a day. What is so ridiculous about that is, when you’re prescribed an oral contraceptive, you’re handed a prescription and then you don’t see the doctor again—so women are already taking a pill a day on their own. It was very paternalistic.”

Another groundbreaking switch Owen’s consultancy worked on was for nicotine-replacement products such as Nicorette and Nicoderm, which help people quit smoking. Tobacco-control advocates were, and remain, split between those who see nicotine abstinence as the only option and those who support tobacco harm reduction. Originally, FDA leadership strongly opposed the switch because the replacement products still contained nicotine. Importantly though, they did not contain the cancer-causing substances or carbon monoxide found in cigarettes. As Owen and her colleagues argued, “If we cannot get the 20 percent of Americans who still smoke to quit completely, we should at least be giving them safer ways to get their nicotine.” Ultimately, that proved convincing, and the availability of OTC nicotine-replacement products has had a major impact on public health: One study found that nicotine-replacement therapies can prevent tens of thousands of premature deaths from lung cancer and heart disease.

Proving that women can take a daily pill (whether from a doctor or a store) and demonstrating that use of nicotine without tobacco is a net win are the kind of challenges Owen thrives on. Whatever skepticism or opposition stands in her way, Owen believes that facts will win out in the end. “My job is to anticipate all of the issues that FDA and other key stakeholders are going to raise and then figure out how to address every one of those issues compellingly and with the best available science,” Owen says. “My focus is on providing FDA with the data that will reassure them that the benefits of putting this product in the hands of the American consumer will outweigh the risks.”

Owen and her firm’s work on tricky—but public health-focused—OTC switches like Plan B and nicotine replacement products have given her a reputation of being able to handle both the science and any thorny political considerations at play. It’s also why a small pharmaceutical company out of Paris, France, HRA Pharma, reached out to her firm when it decided to develop an OTC oral contraceptive. “When I started working 25 years ago, there were multiple big pharmaceutical companies who were interested in doing this—but not interested enough,” Owen says. “They were too scared to do it. The greatest phone call I ever got was from HRA Pharma asking if we would be willing to work with them to try and make it a reality.”

Owen says the win took eight years. “Most companies who have a product are trying to extend the life cycle of that product with an OTC switch,” she says. “But this company said, ‘We want to do this even though we don’t have a product.’ They were willing to do whatever it took starting from absolute scratch.” HRA Pharma had passion, but also experience in reproductive health, both with emergency contraception and mifepristone (which when used together with misoprostol is used to end a pregnancy). Now they were intent on approval for an OTC oral contraceptive.

But it wasn’t easy. “FDA put up every barrier you can imagine,” says Owen, “and every time, we said, ‘That’s okay. Let’s fix it. We’ll go out and collect more data.’ A lot of companies get scared away during that process, but we had the fire in the belly to get this done, and HRA was willing to do whatever it took.”

Ultimately HRA Pharma, which was acquired by Perrigo Pharmaceutical Company in 2022, acquired a pill with a single hormone: a progestin. Unlike most other birth-control pills, which contain both estrogen and progestin, this progestin-only “minipill” has almost no contraindications, making it an ideal candidate for OTC use. In addition, the pill is safe if inadvertently taken by women who are pregnant or don’t know they are pregnant. In fact, there are many conditions in pregnancy in which women are prescribed progestin.

Once Opill becomes available for purchase in 2024, Owen believes it will improve the lives of millions of women. At the FDA Advisory Committee meeting to consider Opill in May, Helene Guillard, who leads the OTC switch efforts at HRA Pharma/Perrigo, noted that “even women who want children at some point in their life spend most of their productive years trying to avoid pregnancy.”

Moreover, of the approximately 6 million pregnancies in the United States every year, nearly half are unintended despite the wide availability of a variety of contraceptive methods. Amongadolescents and teens, an alarming 72 percent are unintended. “These unintended pregnancies occur in women of all ages, races, ethnicities, and socioeconomic backgrounds,” said Guillard. “In the United States, half of all women will have had an unintended pregnancy by age 45.” And unintended pregnancies are associated with all kinds of societal harms, like lower educational attainment, lower incomes, higher prematurity rates, and greater infant mortality.

“Women in the U.S. face unnecessary burdens in accessing effective contraception, and unfortunately the nonprescription options are limited to the least-effective methods, such as condoms or withdrawal,” Guillard said. “Opill is a more effective option than all current non-prescription methods. … Unfortunately, women currently face barriers to initiating and refilling the most effective methods since they are only available by prescription.” Those barriers include a lack of privacy, access to insurance and doctors, time and travel for an appointment, and dozens more hurdles—all of which are particularly difficult for the youngest and most vulnerable girls and women.

Now, with Opill set to hit the U.S. market in early 2024, the gratification of shepherding the first-ever OTC oral contraceptive through the FDA is tempered by the reality that it is now time for others to carry the project forward into the marketplace.

“The hope is that it will have a major impact on public health,” she says. “The reproductive health community and the reproductive justice community and all the advocates who have taken this journey with us would like the product to be free, as would I.” Of course, there are dozens of factors that go into pricing decisions and insurance coverage. And much has been invested to get the drug to this point. Still, Owen hopes the launch of the product in the United States will at least spark a discussion about making Opill available to the most in need and medically underserved.

“Hopefully,” she says, “we’re going to see it at a very affordable cost—and on lots and lots and lots of shelves.”