As the post-Roe American landscape continues to take form, the debate over access to abortion services has centered on the availability of prescription drugs.
Last week, a federal judge in Amarillo, Texas heard the first oral arguments in a case where anti-abortion medical associations are challenging the Food and Drug Administration (FDA)’s approval of the abortion pill mifepristone.
The case, Alliance for Hippocratic Medicine v. U.S. FDA, has made headlines in recent weeks as the U.S. awaits Judge Matthew Kacsmaryk’s decision.
The plaintiffs in the case, which are represented by the Christian nonprofit organization Alliance Defending Freedom, argue that the FDA’s approval of the pill was unlawful and that the agency ignored evidence that the medication was unsafe in subsequent reviews.
“By illegally approving chemical abortion drugs, the FDA failed to abide by its legal obligations to protect the health, safety and welfare of girls and women,” the Alliance Defending Freedom wrote in a statement. “The FDA never studied the safety of the drugs under the labeled conditions of use… and eliminated necessary safeguards for pregnant girls and women who undergo this dangerous drug regimen.”
Mifepristone has been around for more than 20 years, with the FDA originally approving the drug in 2000. Over that period, more than 5.6 million women have safely used the medication.
Additionally, the Government Accountability Office (GAO), a U.S. watchdog agency, dug into the FDA’s process for approving mifepristone in 2008. Back then, the GAO released a report concluding that the approval had been consistent with FDA regulations.
Given that the case is before a judge known to have an anti-abortion stance, it has stoked fears that Kacsmaryk could rule to further restrict access to abortion nationwide – nearly a year after the landmark abortion case Roe v. Wade was overturned.
However, the legal implications are a bit more complicated than that, according to David Cohen, professor of law at Drexel University Kline School of Law.
“It’s important to understand that what the plaintiffs are asking for is not to ban the drug, seize the drug or stop anyone from distributing it,” Cohen said. “They’re asking for the judge to order the FDA to withdraw or suspend the approval of the drug. Then it’s up to the FDA to determine what to do.”
Even if Kacsmaryk ruled that the approval of the pill was unlawful, there are several different pathways that could sprout from that ruling.
In one legal interpretation, Cohen pointed to a statute written by Congress that outlines a clear process for how to withdraw approval for a drug. The FDA may interpret a ruling against them as a requirement that they begin that process and investigate whether to withdraw an approval – and this could take months or years, with no guarantee of withdrawal.
A second option is the FDA does end up withdrawing approval – “but just because they withdraw approval doesn’t mean the drug is banned,” Cohen explained.
That’s because the FDA doesn’t regulate doctors, clinics or patients. In that case, it would be up to doctors to decide what to do with the unapproved drug, depending on their state laws. In most states, doctors can prescribe unapproved drugs – though it may not be viewed as best practice, depending on the drug’s potential health risks.
The FDA does have regulation over drug distributors, but it would be up to the agency to decide to what extent they would enforce laws against unapproved drugs to halt distribution of the drug.
“Maybe the FDA would decide they’re not going to enforce these laws in a strict way,” Cohen said. “Maybe they wouldn’t say anything or maybe they would issue a notice saying, ‘We’re not going to enforce this because we just don’t have the resources to go after every unapproved drug out there and we believe this one is safe and effective.’”
In other words, “Just because the approval is withdrawn, it doesn’t mean we’re suddenly going to see this drug disappear in clinics,” Cohen added. “There are a lot of other steps that have to be taken, with a lot of other actors taking them.”
Medication abortions currently account for about half of all abortions in the U.S. The pill has also been a major way for women across the country to access abortion since the overturning of Roe v. Wade.
Still, that hasn’t stopped some states from acting as Wyoming became the first state to officially ban mifepristone last week.
The Alliance for Hippocratic Medicine v. U.S. FDA is unprecedented in that it’s challenging a drug approval that’s based on clinical research and scientific consensus.
Given that context, there are plenty of legal problems littering the case’s pathway to move forward at all. Many legal experts believe the case has no legal merit and it’s only in the beginning stages of the process.
However, Cohen said the problem is that the case is before a conservative, anti-abortion judge who may “overlook all these [legal] problems, and decide the way that’s consistent with his ideology.”
One of the biggest implications of the case, beyond restricting access to medication abortion, is that it could “open up all sorts of avenues for anyone to challenge any drug that’s associated with anything that’s politically charged,” Cohen said.
“There are reasons to be concerned about what this might mean for other reproductive health drugs, gender-related drugs, anything with some political controversy around it,” Cohen continued. “If this judge decides to enter the fray, it’s going to open the door for people to invite other judges to do the same thing.”
Additionally, Kacsmaryk said he would make a decision on the ruling as soon as possible, but that could be anywhere from a few days to weeks.
