The FDA and its new commissioner must follow the science
The Food and Drug Administration (FDA) has the awesome responsibility to protect public health by ensuring the safety and effectiveness of medications, biologic products, medical devices and the safety of our food supply, among other things. Whether it’s new cancer therapies, COVID-19 vaccines and treatments, or a wide range of prescription and over the counter medicines, we need FDA scientists and policymakers to follow the science for the benefit of us all. That includes the science about risk and benefits of medication abortion care, which provides the option for an early abortion by taking a combination of medicines approved by the FDA.
Without strong independent leadership, political pressures can come to bear on the people reviewing the safety and efficacy of vital health care. As the Senate considers the confirmation of Dr. Robert Califf, President Biden’s nominee to lead the Food and Drug Administration, our senators must ensure we will have that strong, independent leader who won’t bow to political interference. And in one particular area, reproductive health, this appointee will play a critical role. I know this from personal experience.
In 2005, I left my position as assistant commissioner for women’s health and director of the FDA Office of Women’s Health when the agency refused to back science-based decision-making over making emergency contraception available over the counter. I know first-hand that political interference in the FDA’s decision-making can have lasting consequences — as it took 10 years and multiple court rulings before emergency contraceptive pills became fully available over the counter. It was clear to me then that politics were interfering with some of my colleagues’ ability to follow the data and was restricting access to safe and effective medicines that could prevent an unintended pregnancy.
How does this apply to medication abortion? Despite its more than 20-year safety track record and a 99 percent safety rate, the use of medication abortion care still remains a focal point in the long-standing debate on sexual and reproductive health. Currently, medication abortion accounts for up to 40 percent of all abortions. When the FDA updated the label in 2016, it gave more women the opportunity to access this medication when needed up to 10 weeks after her last period. But excessive restrictions placed on access in 2000 needed to be re-evaluated and removed.
This past December, I was pleased to see the FDA permanently lift the requirement that patients receive mifepristone in-person from a clinic, allowing for mail delivery. The data, collected mainly during the pandemic, clearly shows that medication abortion care is safe and effective when distributed through tele-health. This first step is to be applauded though additional barriers to access remain.
In addition, several states continue to place barriers to medication abortion via mail. Currently, 19 states mandate in-person visits or prohibit telehealth options entirely for medication abortion care. Others put cumbersome, unscientific and medically-unnecessary restrictions in place to coerce people away from obtaining the health care they need. Texas and Indiana have banned medication abortion outright after six and 10 weeks, respectively. Meanwhile, abortion clinics in states nationwide have become increasingly inaccessible under hostile laws that force patients to travel far from home to receive care.
Given the science and evidence, there is no reason that this should be the case, because it directly refutes what we know. The science is clear: Medication abortion is among the safest and most effective medications available today. By limiting access, we limit people’s futures.
At this pivotal moment for the FDA, and amidst an ongoing public health emergency that already curtails access to health care, the vote for the next FDA commissioner must be based on their ability to uphold scientific decision-making. If Califf secures the position, it will be absolutely incumbent on him to preserve the agency’s integrity and put science and health first. Millions of Americans rely on the FDA to protect public health and guide advancements in medical care. The decisions of FDA scientists directly affect the health, well-being and lives of people nationwide.
The future FDA commissioner must continue to put science first and give women the agency to control their lives, health and futures.
Susan F. Wood, Ph.D., is a research professor at George Washington University School of Public Health and director of the Jacobs Institute of Women’s Health. She formerly was FDA assistant commissioner of women’s health.