020: How the FDA Works and How Advocates Work With It with Kirsten Moore

Products regulated by the U.S. Food and Drug Administration (FDA) account for roughly 25 cents of every dollar American consumers spend annually. With some critics arguing that the FDA wields too much regulatory power, it’s important to shed light on how the FDA operates and how the agency is held accountable for the regulations it imposes.

Kirsten Moore, creator and director of the Expanding Medication Abortion Access (EMAA) Project, remembers that it was a momentous occasion when the FDA approved the drug mifepristone on September 28, 2000, to be used to end a pregnancy. Commonly referred to as “the abortion pill,” reproductive health organizations and advocates have been striving to bring medical abortion to America after it was approved in France in 1988. However, the approval process came with a myriad of restrictions.

In today’s episode of the Your Health Unlocked Podcast, Kirsten joins us to discuss the evolution of restrictions on medication abortion over the past two decades, as well as the role the FDA plays in this recent push by EMAA and other health justice organizations to get medically unnecessary restrictions on the abortion pill lifted.

In this episode, you will learn:

• What is the FDA, and its relationship to government and nonprofit organizations
• The checks in place to ensure the FDA remains focused on public health and consumer safety
• The role that the FDA plays in this recent push by EMAA and other health justice organizations to get medically unnecessary restrictions on the abortion pill lifted
• All about the work and goals of the EMAA Project
• How the Covid pandemic impacted the mifepristone risk evaluation and mitigation strategy (REMS) requirements

More about Kirsten:

Kirsten came to start The EMAA Project through a winding road of advocacy work. She worked at the Population Council when they got approval to start running clinical trials on what became mifepristone.

In the late ’90s and early 2000s, Kirsten worked for the Reproductive Health Technologies Project, which worked together with The Network to get mifepristone approved in the U.S. She stayed at RHTP until 2012 but left after President Obama’s top health official Kathleen Sebelius overruled government scientists to block wider access to Plan-B contraceptives.

In March 2013, Kirsten began working for Michael Bloomberg’s Mayors Against Illegal Guns. She liaised with advocates, activists, and survivors in the domestic violence and sexual assault communities in pursuit of legislation to protect women, men, and families from an abuser.

After the 2016 election, she needed time out from politics and got a job at The Pew Charitable Trusts, managing a portfolio of work for them on FDA policy. Although her work was not linked to reproductive health or justice, she gained a deeper understanding of how the FDA makes decisions and the people behind the work they carry out.

With that, she decided to figure out how to bring her experience back around to the mifepristone REMS. She is now the creator and director of the EMAA Project, which “seeks to improve the way the medications prescribed for medication abortion care are dispensed in the United States, to make the process consistent with the medical and scientific evidence and to meet women’s needs.”