Commonwealth Magazine | Bringing the abortion pill litigation into focus

By Jennifer Smith
Story Originally Appeared in Commonwealth Magazine

Late Friday afternoon, two whiplash-inducing rulings out of Texas and Washington State threw the status of a commonly used abortion medication into limbo. Here’s why these cases matter in Massachusetts and what to expect for the next week.

Are these two court rulings about one specific pill, or all types of abortion medication?

They are focused on one drug – mifepristone. Mifepristone was approved by the Food and Drug Administration in 2000 and is part of a common two-drug regimen to end a pregnancy within the first 10 weeks. The FDA approval was “based on a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use,” according to the agency.

Is mifepristone particularly important?

Medication abortions make up more than half of all abortions in the country, with the most common and effective method being mifepristone, followed by misoprostol. The regimen essentially causes a miscarriage. A misoprostol-only regimen is also safely used worldwide, but it can cause more cramping and bleeding, so most medical practices prefer the two-drug combo.

What happened with the Texas lawsuit?

A case challenging the FDA’s approval of mifepristone two decades ago came before US District Court Judge Matthew J. Kacsmaryk, a nominee of former president Donald Trump. The conservative legal group Alliance Defending Freedom sued on behalf of four antiabortion medical organizations and four doctors, arguing the FDA improperly rushed the drug through approvals and did not properly look into health concerns associated with mifepristone. The Biden administration has asserted throughout that the drugs have been widely and safely used for decades.

In a widely-expected move, Kacsmaryk sided with the anti-abortion groups and issued a 67-page order on Friday. He did not attempt to ban the medication outright or order the FDA to take it off the market, but instead stayed the FDA’s 2000 approval of mifepristone and all of the changes and later approvals that depended on that initial approval. This means that mifepristone would become an unapproved drug when the order takes effect.

What is the judge’s reasoning here?

Kacsmaryk’s decision rests in large part on assertions that the FDA illegally rushed the drug’s approval in 2000, having “acquiesced to the pressure to increase access to chemical abortion at the expense of women’s safety.” He agreed with the plaintiff’s arguments that the regulatory framework under which mifepristone was approved was an accelerated process meant to treat “serious or life-threatening illnesses” during which the FDA ignored possible medical risks, and he also asserted that data reflect “little to no benefit over surgical abortion.”

The FDA has argued, and subsequent non-partisan non government reviews concluded, it properly used those regulations to impose safety restrictions on the pill after a sufficiently long study process. An unwanted pregnancy, the groups conclude, is a serious condition and the pills provide meaningful benefits over surgery.

Another part of the case invokes the 150-year old Comstock Act, an anti-vice law virtually unenforced for decades, which prohibits mailing “[e]very article, instrument, substance, drug, medicine or thing” that produces “abortion.” Courts that have grappled with the law since the mid-1900s have largely understood it to apply narrowly, only in cases where someone knowingly mails a contraceptive that would violate existing law. Kacsmaryk concludes that the FDA 2021 decision allowing mifepristone to be mailed rather than exclusively dispensed in-person likely violates the act, regardless of a mailer’s intention. It is one of the first reconsiderations of Comstock in a century and opens the door to future litigation around mailing abortion drugs.

It seems people are mostly talking about the possible impact rather than the underlying merits.

That’s true. And part of that is because this is as much an ideological battle as a legal one. The concern or intention, depending on your viewpoint, is that this is a significant step toward an erosion of abortion rights even if the immediate impacts of this particular ruling are still up in the air.

People responded about how you might expect. Alliance Defending Freedom senior counsel Erik Baptist said the FDA “never had the authority to approve these hazardous drugs and remove important safeguards. This is a significant victory for the doctors and medical associations we represent and, more importantly, the health and safety of women and girls.”

Public health professionals and legal experts said the case just didn’t match the scientific evidence, and abortion providers like the Planned Parenthood League of Massachusetts decried the ruling. “It’s outrageous that one judge’s decision has forced providers to worry about losing the ability to prescribe a medication that has a 99 percent safety record, decades of evidenced-based research affirming its safety and efficacy, and that our patients rely on every day,” said Dr. Danielle Roncari, the organization’s vice president of medical services.

So does this ruling take effect immediately?

No the judge stayed his own order for seven days to give the government time to appeal. The Department of Justice didn’t wait around. It filed its appeal to seek an immediate stay of Kacsmaryk’s decision late Friday, the White House announced. The next leg of the appeal process would be in the Fifth Circuit, which covers Mississippi, Louisiana, Texas, and the Panama Canal Zone, but legal observers expect a push up to the US Supreme Court will be coming soon.

Why is that?

Because of a contradictory ruling out of Washington state that dropped minutes after Kacsmaryk’s decision in Texas. While the Texas case was moving forward, state attorneys general in 17 states and Washington, DC, brought a lawsuit to US District Judge Thomas O. Rice, a nominee of former president Barack Obama, arguing that mifepristone is safe and effective and in fact was subjected to some unnecessarily strict regulations earlier this year. They asked the judge to preserve nationwide access to the drug by preventing the FDA from removing it from the market or enforcing the new restrictions.

In a 31-page ruling, Rice granted an injunction, ordering the FDA to preserve “the status quo” and retain access to mifepristone in the regions that brought the lawsuit. A nationwide injunction would be inappropriate, the judge said, because standards vary state by state and there would likely be competing litigation.

How is Massachusetts involved in this?

It isn’t involved in the Washington case directly, because it wasn’t one of the states to sue. It would, of course, be impacted if the FDA decided to pull the drug from the market to address the Texas order. But because there are now two conflicting interpretations of the FDA’s approval process and the safety of mifepristone, every state is watching to see if this gets kicked up to the Supreme Court to clarify the FDA’s obligations.

What obligations?

This is where it gets tricky. When the Texas case was the focus, the question was essentially “can a single federal district judge override the FDA’s approval process?” There are mixed views. Simply put, the method for reviewing and approving medications is set out by Congress, and the FDA has wide latitude about what regulations it wants to enforce because there are just so many drugs on the market.

So there are competing pushes right now for the Biden administration to just ignore Kacsmaryk’s decision or follow the normal appeal channels. Sen. Ron Wyden, an Oregon Democrat, said in a statement shortly after the Texas ruling, “No matter what happens in seven days, I believe the Food and Drug Administration has the authority to ignore this ruling, which is why I’m again calling on President Biden and the FDA to do just that.”

But remember, the FDA would have that decision to make if there was only one ruling. Now there are two, so the agency will have to sort through both orders to determine which rules to follow, all while the appeal process is ongoing.

Is there any impact here in Massachusetts?

Nothing changes for at least the next week, because of the Texas seven-day stay, but “it’s hard to predict what will happen on day eight,” said Rebecca Hart Holder, head of Boston-based Reproductive Equity Now.

Massachusetts has some of the strongest protections in the country protecting abortion access, so Gov. Maura Healey and reproductive care organizations have spent the past day assuring the state that the procedure will remain legal. Healey said she would lay out some specifics to ensure continued access to mifepristone at a press conference on Monday.

Anything else people should know?

Just keep in mind that this is going to be a weird week. The only parties bound by the Texas order are the FDA – which needs to decide how to approach it – and mifepristone brand name manufacturer Danco Laboratories, which intervened in the suit on the government’s side. No one is walking into a Massachusetts clinic right now and yanking the drug out of patients’ hands, and clinics don’t have to change their behavior without FDA guidance. But confusion is expected on the ground across the country.

This is a confusing time for the government, too. Kacsmaryk’s ruling is unprecedented, and President Biden said in a statement the court had “substituted its judgment for FDA, the expert agency that approves drugs. If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.”