U.S. District Judge Matthew Kacsmaryk’s ruling staying the Food and Drug Administration’s approval of abortion drug mifepristone will almost certainly end up at the Supreme Court in some form.
The Justice Department appealed it Monday, calling Kacsmaryk’s decision “extraordinary and unprecedented.” It now heads to the right-wing 5th Circuit Court of Appeals.
“Plaintiffs lack standing to challenge FDA’s approval of a drug they neither take nor prescribe; their challenge to FDA actions dating back to 2000 is manifestly untimely; and they have provided no basis for second-guessing FDA’s scientific judgment,” government lawyers write. “Those defects foreclose plaintiffs’ claims, and the court flouted fundamental principles of Article III and administrative law in holding otherwise.”
These problems with the case make it an enormous risk — even beyond making mifepristone unavailable for the millions who need it — should Kacsmaryk’s ruling be upheld. It could fling wide the floodgates to those seeking to challenge the FDA’s approval in an attempt to get certain drugs removed from the market.
This danger could also prove mifepristone’s salvation: Even a fundamentally anti-abortion Supreme Court majority might be less inclined to uphold Kacsmaryk’s decision, given the severity of the ramifications.
“Allowing the courts to do this, to do this kind of searching inquiry and overturn FDA if the judge thinks FDA was wrong in combination with the court’s ruling on standing…could allow virtually anyone to challenge any FDA drug approval decision with a good chance at succeeding,” William Schultz, former deputy FDA commissioner and HHS General Counsel, told reporters Monday.
The primary plaintiff in Kacsmaryk’s mifepristone case is a group of anti-abortion doctors — that incorporated itself in Amarillo, where Kacsmaryk sits, just weeks after Dobbs — and that hinges its involvement on the possibility that its physicians may have to treat patients having adverse side effects from mifepristone at some point.
That argument alone stems from years of anti-abortion lies about mifepristone being dangerous and deadly, and leaving women with overwhelming emotional distress.
But if a connection as tenuous as this, that depends on hypothetical, future harms, stands up to scrutiny, it’s not hard to see how other people opposed to a certain drug would reach to establish their own standing.
The statute of limitations poses another glaring problem: Federal agency actions must be challenged within six years. The FDA originally approved mifepristone in 2000. Kacsmaryk argued in his order that the approval had been “reopened” when the agency made changes more recently to the drug’s regulatory scheme (including altering the gestational window when the drug can be used, and changing recommended dosage instructions).
The DOJ responded in its appeal that “The FDA did nothing to reconsider its approval of mifepristone when it modified the conditions of use.”
Such a standard would open many drugs up to having their original approval challenged decades after the fact.
As is now particularly well established in American life, some drugs — vaccines, birth control — already have communities of people that oppose them. It’s all but a certainty that if standing is so expanded and the statute of limitations essentially disregarded, the FDA approval of these drugs will be immediately challenged.
Some have pointed to the chilling effect such a legal threat would have on the research and development of new drugs. They include over 250 executives from pharmaceutical and biotech companies who published a letter Monday warning that Kacsmaryk’s ruling is an existential threat to their industry.
“As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval,” the executives wrote. “Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry.”
