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.”
Resources for Episode 020:
Find out more about the work of the EMAA project by visiting their website.
Discover more about the Population Council, an international nonprofit organization that conducts research in biomedicine, social science, and public health to help build research capacities in developing countries.
Kirsten was the President and CEO of the Reproductive Health Technologies Project, a women’s health group based in DC. RHTP was founded in 1988 to help women in the US obtain access to RU-486. In 2006, RHTP experienced a remarkable victory when the FDA made Plan B emergency contraception available over the counter.
Read this NYT article to find out how Health and Human Services Secretary Kathleen Sebelius overruled the U.S. Food and Drug Administration's (FDA) decision to make Plan B One-Step emergency contraception available over the counter for all women.
Read about the work of Everytown for Gun Safety, the largest gun violence prevention organization in America.
Learn more about The Pew Charitable Trusts, an independent, non-profit, non-governmental organization founded in 1948. Their mission is to serve the public interest by "improving public policy, informing the public, and invigorating civic life."
Find out more about FDA user fee programs, what user fees are, and why they are essential for funding the work of the FDA.
When the FDA initially approved mifepristone, it did so under a provision called “Subpart H,” a set of regulations implemented to expedite the approval of “new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses,” like those used to treat HIV.
Learn how the Reagan-Udall Foundation is advancing the mission of the Food and Drug Administration to modernize product development, accelerate innovation, and enhance product safety.
Read this article to find out more about how the FDA rejected two citizen petitions on the use of the abortion pill mifepristone: one from Students for Life of America to reverse the recent modifications for the use of the abortion pill and another from the American College of Obstetricians and Gynecologists (ACOG) to make the pills easier to obtain for patients.
The Food and Drug Law Institute (FDLI), founded in 1949, is a nonprofit membership organization that offers education, training, publications, and professional engagement opportunities in food and drug law.
Public Citizen is a nonprofit consumer advocacy organization that defends democracy, resists corporate power, and fights to ensure that the government works for the people – not big corporations.
The National Consumers League (NCL) is a nonprofit advocacy group providing government, businesses, and other organizations with the consumer’s perspective on concerns including child labor, privacy, food safety, and medication information.
Some Terms and Linked Definitions
The primary purpose of this podcast is to educate and entertain. All views expressed by the persons featured on the Your Health Unlocked podcast are their own and do not reflect the opinions of the NWHN or its affiliates. Information provided in this podcast does not constitute medical advice. Consult your own provider for any medical issues that you may be experiencing.