On April 14, Supreme Court Justice Samuel Alito responded to the emergency petitions filed by the U.S. Department of Justice and Danco, the brand-name manufacturer of mifepristone, and stayed any restrictions on mifepristone until Wednesday, April 19, at 11:59 p.m. The court also asked for any additional filings in the case to be submitted by April 18 at noon. Further action by the court is expected to occur before the Wednesday deadline.
Late in the night of Wednesday, April 12, the 5th Circuit acted to block portions of U.S. District Court Judge Matthew Kacsmaryk’s outrageous April 7 decision that overruled the Food and Drug Administration’s (FDA) decades-long approval of mifepristone in full.
This means that, for the moment, the drug remains approved nationwide. But, in an unexpected move, the appeals court has attempted to essentially turn back the clock by more than seven years and put back into place restrictions that the FDA had determined were unnecessary in March 2016.
Mifepristone—first approved in 2000 for use in the United States—is the first medicine in a two-step regimen for early abortion care. This regimen makes up more than half of all abortion care in the United States and has a long record of safety and effectiveness.
The nation’s leading medical groups—including the American Medical Association—strongly oppose efforts to restrict access to the method. The ongoing litigation represents an egregious intrusion into medicine by far-right activists who hope to take advantage of a politicized judiciary.
Recognizing this affront to medicine, just hours after the 5th Circuit ruled, the DOJ announced they would ask for emergency relief from the Supreme Court. The company that manufactures the brand-name version of mifepristone, Mifeprex, has also announced it will petition the court for emergency relief.
Here are four key takeaways as we await further action from the Supreme Court.
Mifepristone remains approved, but the 5th Circuit has reinstated medically unnecessary restrictions
The 5th Circuit overruled Judge Kacsmaryk’s order for the FDA to reverse its approval of mifepristone in 2000—but the court also required the FDA to reinstate some old restrictions on the drug that the FDA lifted in 2016.
Practically, this means that key points of access will be blocked if the 5th Circuit’s ruling is allowed to stand. For example, under the 5th Circuit’s order, mifepristone will only be approved for use up until seven weeks in pregnancy, as opposed to up to 10 weeks. Furthermore, under the order the medicine is barred from being prescribed through the mail; receiving the medicine by mail allows people to end their pregnancies fully in the comfort and privacy of their own homes. Instead, people will be forced to undergo unnecessary trips to the doctor to qualify for care.
This ongoing judicial interference in drug regulation should continue to be a paramount concern
Despite the upheaval over the past week, one fact remains unchanged: Mifepristone, and medication abortion overall, remains extraordinarily safe and effective. Indeed, in responding to the fact that mifepristone and Ibuprofen have comparable safety risks, the 5th Circuit did not engage with any statistics on that point but, rather, pivoted to differences between the two drugs’ physical labels.
Any decision that seeks to substitute judicial opinion for expert medical determination risks opening the floodgates to political interference in medicine overall. Emboldened far-right activists may target vaccines, fertility treatments—possibly, any treatment such individuals deem personally objectionable—next, expecting at least some sympathy from the judiciary.
While the legal chaos that has resulted over the past week regarding abortion care will continue to have clear harms on ordinary people, the damage this judicial interference in the workings of the FDA is likely to be far-reaching as well if allowed to continue.
This current legal and medical chaos is the result of a politicized judiciary
The activists who first brought the suit seeking to overturn mifepristone’s approval filed their case in a jurisdiction that ensured Judge Kacsmaryk—a controversial Trump appointee with a long record of far-right views and opposition to abortion—would hear the case. This practice, known as “forum shopping,” is undertaken by plaintiffs to try to secure an outcome advantageous to their interests. It lays bare the public’s understandable belief that many judges, far from being impartial, are likely to rule based on ideology as opposed to law and fact.
The Comstock Act
Both Judge Kacsmaryk and the 5th Circuit spoke to the Comstock Act, a law passed in 1873 before women had the right to vote in the United States. The law, among its many provisions, bans material related to abortion from being sent through the mail. As early as the 1930s, appeals courts had declined to robustly enforce the law due to the severe and even illogical repercussions that could result from doing so—and the law’s abortion prohibitions were completely ineffective under Roe v. Wade. Now that Roe is overturned, both activists and Republican Attorney Generals have expressed interest in using the 1800s-era law to prohibit medication abortion.
While not a key part of today’s order, the 5th Circuit signaled an openness to arguments that the law’s abortion provisions should be once again become effective, which would mean Americans’ mail would be subject to invasive searches in order to satisfy the far-right desire to enact a nationwide abortion.
The 5th Circuit’s decision overall does little to ward off concerns of an ideologically driven judiciary. The three-judge panel that issued the decision at hand was made up of two Trump appointees and one appointee of President George W. Bush. The two Trump appointees are responsible for denying the FDA’s judgment for how mifepristone can be prescribed. The third judge would have granted the DOJ’s full request to keep the FDA’s standards for mifepristone intact.
The Supreme Court should act to ensure drug safety is defined by science, not politics
We do not know what the ultimate result of this litigation will be—either legally or medically. Indeed, confusion still abounds from the fact that, on the same night as Kacsmaryk’s ruling, a federal district judge from Washington state issued a decision that directed the FDA not to change the status of mifepristone in 17 states as well as the District of Columbia.
But we do know that the critical question of mifepristone’s approval is now before U.S. Supreme Court. In announcing the DOJ’s intent to ask for emergency relief, U.S. Attorney General Merrick Garland stated that the administration would “defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.”
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Whatever ultimate outcome, these decisions have laid bare the politicization of the courts that must be addressed moving forward.
Drug approval and safety must be based on science and medical best practices. The American people deserve a fair and justice system—and judges who base their decisions in the laws they have sworn to uphold.