June 20, 2024

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The next FDA commissioner must address health disparities and barriers to care

As a practicing obstetrician-gynecologist and advocate for improving access to reproductive and sexual health and resources, I have witnessed firsthand how our health care system too often fails those with the greatest barriers to accessing health care and services.

The Biden administration has a unique opportunity to nominate a Food and Drug Administration (FDA) commissioner who will boldly tackle systemic bias and barriers in health care, champion evidence-based science and advance health equity. The next FDA commissioner will play a pivotal role in determining the direction of our nation’s health care. The administration must consider the needs of people and communities and their ability to access health care. The pandemic has demonstrated how important it is to have leaders in place who are driven by science and committed to equity; however, these principals are also relevant to improving longstanding, recalcitrant health disparities. 

For example, despite the gains driven by the Affordable Care Act and the advancements in contraceptive technology, contraceptive access remains a significant challenge for far too many Americans. The FDA commissioner will have an opportunity to shepherd a major advancement for women’s health and contraceptive access by ensuring that methods of birth control proven to meet the same requirements as other over-the-counter medications become available over the counter. It has been 60 years since the FDA approved birth control for all, but people continue to face medically unnecessary prescription barriers. The ability to access the contraceptive pill without a prescription would offer a safe, low-cost option for contraception.  

It is also essential that the FDA commissioner commits to an evidence-based and timely review of the proposed prescription-to-over-the-counter (OTC) switch. For years, medical associations and physicians across the country have urged the FDA to examine the possibility of OTC access to the pill. In fact, the American College of Obstetricians and Gynecologists has formally endorsed such access for all ages.

Further, any nominee for FDA commissioner must possess a clear understanding of the inequities in our health care system and their effect on the reproductive health of people of color, people struggling to make ends meet, and those from rural areas. In fact, people of limited means who receive medical coverage through Medicaid are more likely to experience gaps in their ability to access contraception. Black women and girls — regardless of income — are also disparately likely to experience gaps in access to contraception. It is critical that the   commissioner understand the FDA’s role in addressing these disparities. 

In addition, women of reproductive age historically were excluded or underrepresented in clinical trials for studies of medical conditions such as diabetes and heart disease — and this exclusion has been even worse for women of color. The lack of inclusion is reflected in incomplete data sets, which prevent some people from making informed decisions about their health care. Thus, any potential nominee must have a plan for how the FDA can improve and modernize clinical trials and ensure the equitable inclusion of people of color and people capable of reproduction.

A potential nominee must trust people to make their own decisions regarding their reproductive health — 70 percent of women of reproductive age favor being able to access the pill on the store shelf. It is long past time for the FDA to take the lead by removing unnecessary barriers. We look forward to working with a commissioner who comes prepared to meet the challenges of all people — especially those who have been inadequately served by our health care system for far too long.

Raegan McDonald-Mosley, MD, MPH, FACOG, is CEO of Power to Decide, chief medical adviser for the Contraceptive Access Initiative, and a practicing obstetrician-gynecologist. Follow her on Twitter @DrRaegan.