Doctors and medical associations fought for years to get the FDA back to making decisions based on evidence rather than ideology. Last year, the Supreme Court 
stopped
their litigation for procedural reasons but did not approve the FDA’s conduct. It merely held that those particular plaintiffs lacked standing. In the process, however, the litigation exposed the extraordinary shortcuts taken in approving and deregulating mifepristone, as well as the agency’s long-standing resistance to meaningful oversight. And the evidence for mifepristone’s harm to women is now a matter of public record.
The FDA has been bobbing and weaving for decades, finding one strategy after another to avoid accountability either within the executive branch or the courts. In a recent amicus brief, Advancing American Freedom, where we work, warned that federal agencies increasingly use delay as a litigation strategy. The FDA’s record with mifepristone — in which it stonewalled judicial review for nearly 6,000 days — is a textbook example.
Independent analysis by the Ethics and Public Policy Center found
that nearly 11 percent of women experienced a serious adverse medical event after taking mifepristone — 20 times higher than the rate reported on the FDA label. During his confirmation process, Health and Human Services Secretary Robert F. Kennedy Jr. promised senators that he would take a hard look at mifepristone’s safety; a year later, nothing has happened.
Now, states are stepping in. Louisiana and other states have brought a new lawsuit
challenging the FDA’s removal of the in-person dispensing requirement, which has fueled a boom in mail-order abortion. Nationwide, nearly two-thirds of abortions today are now
caused by drugs rather than performed by surgery. Doctors in pro-abortion states are sending thousands of abortion pills into pro-life states, undermining their ability to enforce their own laws. One of the plaintiffs in Louisiana’s suit is a young woman who was coerced by her boyfriend into taking abortion pills obtained by mail from out of state.
Rather than allowing the case to proceed, the Trump administration has asked the court to put it on hold — again. The FDA claims it needs more time to consider whether it might revisit its own decision, even as drug manufacturers themselves have made clear
there is no scientific evidence supporting an in-person dispensing requirement for mifepristone. It is even fighting us in a Freedom of Information Act lawsuit over mifepristone documents that Congress requested but never received. Enough is enough. Congress generally expects the FDA to act on proposed changes to drug safety restrictions within six months. The agency has already exceeded that timeframe multiple times over. An open-ended delay protects bureaucrats and, in the case of mifepristone, continues to harm women.
