(The Guardian) Ruling tightening mifepristone access could upend US pharmaceutical industry
It’s not just access to medication abortion that could be upended by a supreme court ruling tightening access to mifepristone. As the Guardian’s Jessica Glenza reports, the conservative challengers to the drug have targeted decisions made by the US Food and Drug Administration (FDA) to make it easier to prescribe. But if the supreme court agrees with their complaint, it opens up the possibility of a wave of challenges to other medications that treat a range of issues. Doctors and pharmaceutical companies have become so concerned about the case that they have filed briefs defending the FDA against the conservative challenge.
Here’s more on why the stakes in the case are so high: A supreme court case about one little pill – mifepristone – has the medical and pharmaceutical world on edge. The pill, at the heart of a case that will be argued on Tuesday, is part of a two-drug regimen used to treat miscarriage and end early pregnancies.
Despite a more than 20-year track record of safe real-world use, backed up by more than 100 peer-reviewed studies, a group of anti-abortion doctors is seeking to roll back US Food and Drug Administration (FDA) decisions that changed and relaxed some prescribing rules.
If the doctors succeed, despite contested and in some cases now-retracted evidence of harm, the case could reshape abortion access in the US and have enormous and unpredictable consequences for how drugs are prescribed, regulated and developed.
A ruling in favor of anti-abortion doctors could threaten everything from trust in medicine to specific drugs to the US’s position as the world’s foremost drug innovator.
“I am terrified,” said Juan Hincapie-Castillo, a drug policy researcher, licensed pharmacist and assistant professor of epidemiology at the University of North Carolina. “This case is shifting the whole paradigm of how things could go moving forward”.
Mifepristone was approved by the FDA in 2000 with stringent requirements for how it should be prescribed: only up to seven weeks gestation, dispensed in-person with mandatory follow-up appointments, and with enhanced risk-reporting requirements for doctors. Along with misoprostol, the second drug in the regimen, it is, in effect, designed to induce the equivalent of a miscarriage at home.
After more than 20 years and scientific articles spanning 26 countries, the scientific consensus is that the “abortion pill” has a remarkable track record of safety and effectiveness that, in the media, is often compared to that of Tylenol or Viagra. But following the fall of Roe v Wade in 2022, anti-abortion doctors initiated a lawsuit against the FDA in Amarillo, Texas, arguing that the drug’s approval should be withdrawn. The Trump-appointed judge Matthew Kacsmaryk ruled in favor of the doctors. Were his decision not appealed, it would have resulted in a de facto nationwide ban on medication abortion.
It’s not just access to medication abortion that could be upended by a supreme court ruling tightening access to mifepristone. As the Guardian’s Jessica Glenza reports, the conservative challengers to the drug have targeted decisions made by the US Food and Drug Administration (FDA) to make it easier to prescribe. But if the supreme court agrees with their complaint, it opens up the possibility of a wave of challenges to other medications that treat a range of issues. Doctors and pharmaceutical companies have become so concerned about the case that they have filed briefs defending the FDA against the conservative challenge.
Here’s more on why the stakes in the case are so high: A supreme court case about one little pill – mifepristone – has the medical and pharmaceutical world on edge. The pill, at the heart of a case that will be argued on Tuesday, is part of a two-drug regimen used to treat miscarriage and end early pregnancies.
Despite a more than 20-year track record of safe real-world use, backed up by more than 100 peer-reviewed studies, a group of anti-abortion doctors is seeking to roll back US Food and Drug Administration (FDA) decisions that changed and relaxed some prescribing rules.
If the doctors succeed, despite contested and in some cases now-retracted evidence of harm, the case could reshape abortion access in the US and have enormous and unpredictable consequences for how drugs are prescribed, regulated and developed.
A ruling in favor of anti-abortion doctors could threaten everything from trust in medicine to specific drugs to the US’s position as the world’s foremost drug innovator.
“I am terrified,” said Juan Hincapie-Castillo, a drug policy researcher, licensed pharmacist and assistant professor of epidemiology at the University of North Carolina. “This case is shifting the whole paradigm of how things could go moving forward”.
Mifepristone was approved by the FDA in 2000 with stringent requirements for how it should be prescribed: only up to seven weeks gestation, dispensed in-person with mandatory follow-up appointments, and with enhanced risk-reporting requirements for doctors. Along with misoprostol, the second drug in the regimen, it is, in effect, designed to induce the equivalent of a miscarriage at home.
After more than 20 years and scientific articles spanning 26 countries, the scientific consensus is that the “abortion pill” has a remarkable track record of safety and effectiveness that, in the media, is often compared to that of Tylenol or Viagra. But following the fall of Roe v Wade in 2022, anti-abortion doctors initiated a lawsuit against the FDA in Amarillo, Texas, arguing that the drug’s approval should be withdrawn. The Trump-appointed judge Matthew Kacsmaryk ruled in favor of the doctors. Were his decision not appealed, it would have resulted in a de facto nationwide ban on medication abortion.
