Abortion Pills Could Force States and the FDA into a Deadlock

For drug abortions, arranging federal precedence will require new lawsuits, likely to be filed in states already hostile to abortion, and — depending on the outcome — could lead to a Supreme Court that has already denied abortion rights. Legal experts worry that this could lead to findings with broader implications for federalism as a whole. “In more than 230 years of Supreme Court jurisprudence and the practice of law and the rule of law, it has always been the case that federal laws and regulations govern our nation’s laws,” said Michele Bratcher Goodwin, a law professor and founding director. director of the Center for Biotechnology and Global Health Policy at the University of California, Irvine. “But there could very well be challenges to how we understand that rule of law, and what we’ve known for over 230 years could be wiped out.”

On the day of the Dobbs decision, President Joe Biden and Attorney General Merrick Garland separately stated that the federal government would protect the right of pregnant people to access the drugs that cause abortion drugs: mifepristone and misoprostol. “We stand ready to partner with other branches of the federal government that want to use their lawful authorities to protect and preserve access to reproductive care,” Garland said. “The FDA has approved the use of the drug mifepristone. States should not prohibit mifepristone based on disagreement with the FDA’s expert judgment as to its safety and efficacy.”

So far, however, there has been no public commitment to action. Four days after the Dobbs ruling, Xavier Becerra, secretary of the Department of Health and Human Services, said in a media briefing that his team would work to increase access to medication abortion, but told reporters to “stay informed” when they asked for details.

The Justice Department may be able to defend the rights of the FDA. Goodwin points out that the agency contributed to the fight against the Jim Crow laws of the early 20th century; she argued in The Atlantic in May that nullifying access to abortion creates a “Jane Crow” regime that similarly infringes on constitutional rights. But those watching this issue evolve say the more likely scenario is that the drug manufacturers will sue.

There is already such a lawsuit: GenBioPro is suing Mississippi because the state’s restrictions go beyond the FDA’s. However, that lawsuit was brought before the Dobbs decision. Last week, the company and the defendant — Mississippi state health officer Thomas Dobbs, named the Dobbs in the Supreme Court decision — filed competing motions arguing whether the Dobbs ruling and the Mississippi Trigger Act would take effect immediately afterward. invalidated the lawsuit. GenBioPro’s attorneys argued that their lawsuit against the state restrictions should go ahead.

Whatever the outcome, that lawsuit only pertains to the law in Mississippi. To ensure wider distribution, a company would require a greater challenge. “A drug manufacturer materially affected by a ban could sue on a national or state basis,” said Rachel Rebouché, associate dean for research at Temple University’s James E. Beasley School of Law and one of the authors of a widely read legislative review article stating that there are precedents for preemption. A company could sue a single state’s ban, she says, but could ask the federal court in that state to make its finding nationally applicable to any state where a similar ban exists.

What bolsters the primacy argument — the claim that the FDA’s judgment has more force than state law — is that the abortion pill regimen has been scrutinized by the agency in a way few other drugs have. Mifepristone, which causes a pregnancy to end by blocking a hormone that supports the lining of the womb, isn’t just a prescription drug. It is also subject to a rare form of extra scrutiny called the Risk Evaluation and Mitigation Strategy, which the FDA otherwise only applies to drugs with serious side effects. (The imposition of this extra layer of regulation on mifepristone is widely regarded as a result of political pressure rather than a pharmaceutical risk; mifepristone causes fewer side effects than penicillin or Tylenol.) Both the prescribing physician and dispensing pharmacy must be separately certified by the FDA , and the recipient must read educational materials and then sign a ‘patient agreement form’.

“By creating an FDA, Congress said that’s how we get a nationally unified market of safe and effective drugs.” Zettler says. “FDA has considered a wide variety of questions about this drug and made the careful consideration that Congress has asked regarding its evaluation of the safety and effectiveness of this drug, and came up with this schedule for regulating the drug. And the question will be: can states deviate from that arrangement?”

That question will be asked in a legal context in which a federal court in April overruled the Centers for Disease Control and Prevention’s authority to establish mask mandates, and in which the Supreme Court both invalidated a vaccine mandate set by the Occupational Safety and Health Administration and shifted the balance of power to regulate emissions to Congress and away from the Environmental Protection Agency. In other words, it is a setting in which the power of the federal government is scaled back. That inevitably leads to the question of how far the FDA’s power could also be reduced.

Prevention is an important issue to watch, Zettler says, because “it could limit the ways states can regulate other types of drugs that are not part of the abortion debate, or it could open the door to more state regulation. The effects outside the context of reproductive health care may also be important.”