Mifepristone Marks 25th Anniversary Amidst Growing Threats to Its Future
On September 28, 2000, the US Food and Drug Administration (FDA) approved mifepristone for use in abortions, revolutionizing access to the procedure. Twenty-five years later, the drug faces unprecedented threats as anti-abortion Republicans push to revoke its FDA approval.
"Mifepristone has been a game-changer for abortion access," said Dr. Daniel Grossman, director of the Advancing New Standards in Reproductive Health (ANSIRH) program at the University of California, San Francisco. "It's allowed people to have abortions safely and privately in their own homes, reducing barriers to care."
Mifepristone, a progesterone blocker, is the first of two drugs used in the standard abortion pill regimen. When combined with misoprostol, it causes the uterus to contract, expelling the pregnancy. Initially approved for use up to seven weeks of gestation, mifepristone has since been expanded to 10 weeks.
The FDA's approval of mifepristone was a significant milestone in the US, coming more than a decade after its introduction in France. The drug's impact was immediate, with studies showing that it reduced complications and improved patient satisfaction compared to surgical abortions.
However, anti-abortion lawmakers have long sought to restrict access to mifepristone. In 2014, Congress passed a provision requiring the FDA to reapprove the drug every five years. This year, Republican lawmakers introduced legislation to revoke its approval altogether.
"Mifepristone is a threat to human life, and we must take action to protect it," said Rep. Chris Smith (R-N.J.), sponsor of the bill to repeal FDA approval. "We cannot allow this deadly medication to continue to be available in our country."
The push to restrict mifepristone access has been met with opposition from reproductive health advocates, who argue that such measures would disproportionately harm marginalized communities.
"Mifepristone is a safe and effective option for people seeking abortion," said Dr. Jamila Perritt, president of the American College of Obstetricians and Gynecologists (ACOG). "Revoking its approval would be a devastating blow to reproductive health care in this country."
As the debate over mifepristone's future continues, patients and providers are bracing for potential disruptions to access. The FDA has yet to make a decision on reapproval, but advocates warn that any restrictions could have far-reaching consequences.
"The stakes are high," said Dr. Grossman. "We must continue to fight for the right to safe and accessible abortion care, including mifepristone."
Background:
Mifepristone was first approved in France in 1988 under the brand name RU-486. It quickly gained international attention as a safe and effective alternative to surgical abortions.
Additional Perspectives:
"The FDA's approval of mifepristone marked a significant shift in abortion policy, recognizing that medication abortion is a safe and viable option for many patients," said Dr. Rachel Jones, senior research associate at the Guttmacher Institute.
"Mifepristone has been a game-changer for rural communities, where access to surgical abortion services can be limited or non-existent," added Dr. Grossman.
Current Status:
The FDA's reapproval process is ongoing, with no timeline for a decision. In the meantime, advocates are urging patients and providers to continue using mifepristone as prescribed.
"We will not let politics stand in the way of safe and accessible abortion care," said Dr. Perritt. "We will continue to fight for the rights of our patients."
*Reporting by Motherjones.*