Mifepristone not the first FDA-approved drug to be challenged in court
A Texas judge’s ruling to ban the abortion pill mifepristone last week is the first time a court has ordered an FDA approved drug to be removed from the market. However, this is not the first time FDA approved drugs have been challenged in court. Will Humble, executive director for the Arizona Public Health Association, says FDA-approved drugs are usually challenged or petitioned against.
“It happens all the time where people challenge the approval of a new drug but it's usually a competitor’s," he said. "There's always tension in the approval process and there's often petitions that are filed against drug approvals and things like that."
Aduhelm, an Alzheimer's medication, is a recent example of this. Although still approved, many experts questioned the effectiveness and price of the drug, leading to an investigation of the FDA's approval process.
"It's not a political drug, but the principle was: does it meet the statutory standard and did the FDA follow the Administrative Procedures Act when they made their decision," he said.
Humble says what separates the Texas ruling from most FDA approved drug cases is the motivation. He says most drugs are challenged due to safety or efficacy reasons, whereas mifepristone is being challenged due to political reasons.
