The FDA has the power to protect abortion pills: It’s time to use it

The Fifth Circuit ruling last night restored a fraction of the abortion rights that anti-abortion Texas Judge Matthew Kacsmaryk had tried to snatch away. However, this is not a “win” for abortion rights as many headlines and tweets would have us believe. And it was certainly not justice.

Judge Kacsmaryk’s lower court ruling is widely believed to be the first time that a court has attempted to withdraw any FDA-approved drug from the market. Call it “abortion exceptionalism.”  

The politically-infused decision ordering the FDA to un-approve mifepristone is drastic. Medication abortion repeatedly, and globally, has been demonstrated to be safe and effective.

Pregnancy has been shown to be comparatively much riskier. Much of the underlying bases for the district and Fifth Circuit rulings are grounded in anti-abortion myths rather than science. 

Thankfully, support for abortion rights is deep. The outcry has been enormous, and widespread. Last week, a Washington court ordered the FDA to not restrict approval for mifepristone —  a direct contradiction of the Texas ruling. And yesterday, the Department of Justice announced it will appeal the Fifth Circuit’s ruling. 

Earlier this week, hundreds of pharmaceutical company executives stepped up to condemn the trial court’s decision. These are not green-bandana-waving abortion rights activists, but rather c-suiters concerned about the extreme nature of the decision and that it could disrupt FDA approval of a whole range of pharmaceuticals. 

The Fifth Circuit’s narrowing of that ruling dangerously legitimized some of the unscientific and specious findings by the District Court. For example, the Fifth Circuit upheld turning back the clock on medication abortion, restoring restrictions (“REMS”) that have been proven unnecessary over the past 1.5 years. During the height of the pandemic, the FDA removed this in-person requirement and telemedicine medication abortion flourished as a safe alternative to travel.   

The Fifth Circuit even gave a nod to the district court’s resurrection of the Comstock Act — an 1873 law making it illegal to send “obscene, lewd or lascivious,” “immoral,” or “indecent” publications through the mail. Author Amy Sohn has described Comstock as a puritanical man who “delighted in punishing those radical, intellectual women whose views on contraception stemmed from liberal ideas about women’s rights.”  

Everything old is new again.  

The plaintiffs/doctors who complained that they had “no other choice but to perform surgical abortions” for any woman who showed up in their emergency room experiencing significant abortion complications were coddled by the Fifth Circuit. The court quoted one anti-abortion doctor who groused about “the significant amount of time” spent working to save a patient’s life rather than tending to other patients.   

The blame and shame game is straight out of the anti-abortion playbook. But it is unsound judicial practice. Giving a doctor standing to sue as a way of protesting a patient’s choice is a bridge too far. 

Would we stop serving beer at Yankee Stadium if too many people end up in the ER on game day? Or close the ski slopes if orthopedic surgeons complained of being overwhelmed? Not likely. But here, we have abortion exceptionalism once again. 

As has been widely noted, this ruling is (another) example of how abortion opponents are willing to undermine some pretty basic tenets of the judicial process and the separation of powers to achieve their goal of putting abortion out of reach.   

Waiting for the ultra-conservative Supreme Court to come in and take the higher ground on medication abortion access is not a sound strategy. Instead, let’s demand that the FDA step up and roar its own defense and that of medication abortion. FDA Commissioner Dr. Robert M. Califf and Health and Human Services Secretary Xavier Becerra need to assert that their agency has independent discretion to decide what medications get dispensed safely in America. The FDA regularly does this based on scientific evidence, of which there is plenty to support mifepristone’s safety.   

The agency’s “wait and see” approach is directly harming women. We need the FDA to resist being manhandled and to assert that the court does not have the authority to order this executive branch agency to rescind its approval of mifepristone. At a minimum, the FDA must confirm that mifepristone has been proven safe and therefore they will not take steps against those who use it off-label.  

Ultimately the FDA could do a new, apolitical review of mifepristone. Let’s ask them to look at the evidence fairly and determine if these in-person requirements and other medically unnecessary restrictions should be abolished once and for all. Bring it on, we have science on our side.  In the meantime, there is no justification or evidence to support the FDA removing its approval of mifepristone.   

Furthermore, women need access to medication abortion but traveling to states where it is available cannot be the only option. For too many women and pregnant people, travel is expensive, stigmatizing and simply unnecessary. Abortion rights advocates should provide everyone with reliable information, safe medications and a chance to decide what works best for them even when their choices are far from ideal.

With the legal landscape cluttered and confused, and FDA action uncertain, we need bold action by our abortion-rights governors now. Allies like New York Gov. Kathy Hochul (D) and California’s Gavin Newsom (D) need to lean in and pass telemedicine abortion shield laws immediately. These laws significantly diminish doctors’ fear of prosecution, extradition or loss of license when providing services across state lines. They are also a way to let women in abortion-hostile states know that we care. Massachusetts has done so and we urgently need New York, California, Vermont and Colorado to take their bills over the finish line.

Lately, we’ve been told to be patient, be reasonable, and wait and see what the courts say and how the FDA reacts. That smacks of a luxury that the women and pregnant people in abortion-hostile states don’t have. Time to stand up, speak out and protect our pills. 

Julie F. Kay is a human rights lawyer who successfully argued against Ireland’s ban on abortion before the European Court of Human Rights and is the co-author of “Controlling Women: What We Must Do Now to Save Reproductive Freedom.”