One of the greatest innovations in human history is oral contraceptives, commonly known as the Pill. With access to the Pill, every woman can exercise her right to decide when to be pregnant and when not to be pregnant, something which is an unambiguous human right. Not only that, but the Pill is the only medicine that a doctor can prescribe which significantly reduces the likelihood of three different cancers by as much as 50 percent. On its cancer fighting ability alone, the Pill is a unique and powerful medical intervention.
This seemingly miraculous drug has been on the market since the 1960s, and its safety and efficacy at preventing both pregnancies and cancers is well documented. One study followed 23,000 women using the Pill and 23,000 matched controls for over 30 years. Nevertheless, millions of women in the United States lack access to it. Some women are also misinformed believing use is dangerous and may cause cancer. It is essential that women over 35 who smoke should not use the Pill, but otherwise the Pill is safer than aspirin.
Despite its ease of use, safety, and ability to improve the lives of countless women and their families, the Pill requires a prescription; women cannot purchase the pill over the counter, like aspirin. Instead, women must make an appointment with a gynecologist and then wait for a prescription to be filled. This is unfortunate. One in six American women cannot afford to ask a doctor to write a prescription. Millions more have busy lives; they have parents, children and jobs to manage. At a minimum, it is a huge hassle to go to the doctor three or four times a year to fill a prescription. And that assumes that all women have insurance; one in six American women don’t, and that economic reality puts oral contraception further out of reach.
And for those on the margins—the undocumented—going to a doctor and getting a prescription is a fraught decision; is filling a prescription worth potentially drawing the attention of immigration authorities?
Compounding matters further, unintended pregnancies, of which there are over 2 million in the U.S. every year, cause the greatest economic hardship for society’s least privileged people. An unplanned pregnancy can result in lost work, unaffordable medical bills, and ultimately another mouth to feed that can stress a family already living on the verge. A small regulatory change—making the pill available over the counter in pharmacies in the same way as Ibuprofen or Tylenol—would result in significant improvements in women’s lives and flourishing in society at large by averting many of these pregnancies until a time of the woman’s choosing.
Billions of doses of the Pill have been taken by women since the 1960s, with great economic and health benefits to them and their families. Women who are able to choose when they become pregnant are able to make other decisions as a consequence, such as attending school, starting businesses or building careers. These sorts of activities help build a thriving middle class and ultimately lead to healthier children with greater opportunities in life. Even the American College of Obstetricians and Gynecologists has recommended that the Pill be made available over the counter.
So how can it be that after sixty years on the market, the Pill still requires a prescription when increasing access to it would be a net positive for women and society?
The nature of the pharmaceutical industry has certainly been a contributing factor. By and large, pharmaceutical companies make more money from prescriptions than over the counter drugs. In order to make the Pill available over the counter, a company must not only own the intellectual property or more accurately, the regulatory rights (NDA rights) to a particular oral contraceptive, but also want to make it available without a prescription. Without pressure from an industry player to make the Pill available over the counter, there has been no reason for the FDA to change the rules.
We founded Cadence Health out of a belief that a “little pharma” approach can change this and make oral contraceptives available over the counter. This process is long and expensive, potentially costing tens of millions of dollars, yet we believe that our highly focused approach (supported in part by Templeton World Charity Foundation) will be successful. We are seeking FDA approval to sell the Pill over the counter under the brand name Zena. Accomplishing this requires not just a clear roadmap for the company and the budget and financing to see it through, but also the successful completion of safety tests and a lengthy test process for packaging and marketing before the agency will consider approving it. We deliberately chose a formulation of the Pill that had been on the market for decades and which had sold more than a billion doses, to generations of women, proving its safety and efficacy over time. The evidence of safety goes back a long way, and it’s quite overwhelming.
Naturally, when we are successful in getting Zena on the market as an over the counter oral contraceptive, major pharmaceutical players may also rush to get their own competing drugs on the shelves of pharmacies. This would be a benefit for women, increasing access and affordability. At the same time, Cadence Health may benefit if they are the ones to make this ‘first in class’ switch by having a three year window of exclusivity to build brand loyalty. Yet Zena’s success is important for more than purely commercial reasons. Not only will it help women take greater control over their lives and health, but FDA approval of the Pill for over the counter sale will have a global impact as well.
While the Pill has been available over the counter in nations like India and China for many years, that is not the case everywhere. Leaders in some nations such as Uganda have explicitly said that they are awaiting FDA approval before making the Pill available without a prescription. Many wealthy nations, including all of the G7 countries, likewise require a prescription. While they would not directly follow FDA guidance, relying instead on their own regulators, such a move by the United States would immediately increase pressure to follow suit. Cadence’s success in the U.S. will not just help millions of American women but may have a regulatory knock-on effect around the world that could benefit billions.
The long-term benefits of over the counter access to the Pill are enormous when aggregated over the lives of millions of women each year. These benefits include everything from reducing the burden of an unintended pregnancy, reduced risk of life-threatening cancers, fewer maternal deaths during childbirth for young mothers, and economic improvements as a result of more women completing their education and having the opportunity to pursue careers before having children. One small regulatory change to how a tried-and-true drug is sold can help millions flourish. It’s an easy decision.
Dr. Malcolm Potts is the Co-Founder of Cadence Health and a renown pioneer in human reproductive sciences. As the first Medical Director of the International Planned Parenthood Federation, he redefined family planning and introduced modern methods to developing countries around the world. As CEO of Family Health International in the 1980s he oversaw numerous clinical studies of contraception and launched the first USAID funded initiatives to slow the spread of HIV in Africa. Malcolm is a professor at the University of California, Berkeley Graduate School of Public Health; founding director emeritus of the Bixby Center for Population, Health and Sustainability; and the inaugural Fred H. Bixby-endowed chair in Population and Family Planning. Malcolm has served on the founding boards of Marie Stopes International, Population Services International Family Health International among others. Malcolm received the 2000 Carl S. Schultz Award for Lifetime Achievement in Public Health. He earned his MD and PhD at Cambridge University.
Nap Hosang, MD MPH MBA is a retired obstetrician who practiced in California for 24 years while teaching family planning and maternal mortality reduction at the School of Public Health at UC Berkeley. He is the recipient of the 2016 American Public Health Association Charles S. Shultz lifetime achievement award for his work in reproductive health. He and Professor Potts are 2 of the 3 co-founders of Cadence Health, (Oakland, CA) who have been working with the FDA since 2016 to obtain FDA approval for Zena to be sold as an over the counter medicine like Tylenol.
