WASHINGTON — The United States Supreme Court ruled Friday that the nation’s most used abortion medication will remain on the market as a court case makes its way through the system.
The final vote was 7-2. The justices delivered the decision in a Texas case where Judge Matthew Kacsmaryk decided to overturn the Food and Drug Administration’s approval of the pill mifepristone.
Judge Kacsmaryk sided with an anti-abortion rights group that had filed a lawsuit claiming the FDA rushed its approval of the drug more than two decades ago.
The Justice Department, on behalf of the Biden administration and drugmaker Danco Laboratories, appealed the ruling to the Fifth Circuit Court of Appeals, which ruled that the drug could still be prescribed nationwide, with limits.
“The Justice Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal,” Attorney General Merrick Garland said in a statement.
Mifepristone was invented in 1980 and won French medical approval in 1988, according to NPR. The drug was later approved in China, the United Kingdom, and Sweden. According to NPR, the drug would receive approval in another dozen countries by 1999.
The FDA first started considering mifepristone for approval in 1996. It wasn’t until September 2000, after multiple rounds of reviews, that the drug received FDA approval. It was approved for medical termination of pregnancy through seven weeks gestation and later extended to ten weeks.
According to the FDA, from September 28, 2000, through June 30, 2022, the drug has been used more than by more than 5.6 million women. There have been 28 reports of deaths with the drug, though all may not be linked directly to the drug, the FDA said. The 28 deaths translates to 0.00005 percent of those who have taken it have suffered a fatal side effect.
The FDA said during the same time frame, there have been a total of 4,213 adverse events (.0008%) related to mifepristone and a total of 1,048 hospitalizations (0.00018%), not including deaths.
“It’s a medication that’s safer than Tylenol, safer than medications like Ibuprofen or Viagra…When we see people trying to limit access to this drug, it’s not about safety. It’s ultimately about limiting access to abortion,” Dr. Gopika Krishna, OB/GYN in New York and a fellow at Physicians for Reproductive Health told USA Today.
Mifepristone is one of two drugs currently approved by the FDA to terminate a pregnancy, and it's used in more than half of all abortions in the U.S.
