Following eight years of litigation, a federal trial court in Hawaii ruled the FDA violated federal law by imposing medically unnecessary restrictions on mifepristone, which is used for early abortion. Ruling in Purcell v. Kennedy, the court held that the FDA has a legal obligation to fairly evaluate and weigh the decades of extensive research affirming mifepristone’s safety, noting the agency had failed to justify its restrictions on access to mifepristone.
The court’s ruling requires the agency to consider the peer-reviewed evidence proving mifepristone’s safety, including its use via telemedicine, and to assess how the agency’s restrictions burden patient access. The ruling does not immediately change access to the medication, but it puts pressure on the FDA to follow the science rather than be swayed by political pressure.
“The FDA’s needless restrictions on mifepristone make our jobs harder without any safety benefit,” said Dr. Lisa Folberg, chief executive officer of the California Academy of Family Physicians. “We appreciate that the court recognized how FDA failed to consider the toll its restrictions take on physicians trying to provide a safe and effective medication to their patients.”










