With Roe overturned, can red states ignore FDA rules on abortion pills?

When the Supreme Court overturned Roe v. Wade last month, many abortion rights advocates turned to mail-in pills as a possible option for pregnant women who live in states where abortion is illegal. prohibited.

More than 20 years ago, the Food and Drug Administration approved abortion drugs as safe and effective for terminating early pregnancy. And last year, partly in response to the pandemic, the agency said the pills could be dispensed by a pharmacist or sent directly to a patient’s home by mail or courier.

In recent years, two drugs taken in combination – mifepristone and misoprostol – have become the most common form of abortion in the United States, overtaking in-clinic procedures.

But anti-abortion states questioned the safety of these drugs and restricted their use, even before the right to abortion was revoked. Texas, for example, made it a crime last year for anyone to send or deliver “abortion-inducing drugs” to a pregnant woman.

The federal-state dispute has set the stage for another legal battle that could shape women’s rights in about half the country.

The question is whether federal regulations on safe drugs could override state laws and, if so, provide a legal option for women where abortion is prohibited.

In response to the June 24 court ruling, President Biden and Atty. General Merrick Garland said they would fight to defend the FDA rules.

“States cannot ban mifepristone because of disagreement with the FDA’s expert judgment on its safety and efficacy,” Garland said.

A first case testing the problem is underway in Mississippi. It was one of 19 states that required a doctor to see the patient when the abortion drug was prescribed, and it also stipulated that the patient had to be “in the same room” as the doctor when taking the pills.

Two years ago, attorneys for GenBioPro, the Nevada-based maker of a generic version of mifepristone, filed suit in federal court in Mississippi, claiming its restrictions were extreme and preempted or overridden by federal law. . They argued that the Constitution makes federal law supreme, and they called the state rules “an impermissible effort by Mississippi to establish its own drug approval policy.”

U.S. District Judge Henry Wingate had postponed ruling on the GenBioPro case until the Supreme Court rules on the other Mississippi case — Dobbs v. Jackson Women’s Health — which resulted in the June 24 decision overturning Roe. Now, his decision in GenBioPro v. Dobbs could be the first to determine whether federal drug law means abortion pills can be legally distributed in anti-abortion states.

“We should have a decision soon, but we’ll be pursuing lawsuits in other states as well,” said Ken Parsigian, a Boston attorney who represents GenBioPro. “At this time, we have the only suit available, and we would like the Department of Justice to join us.”

State attorneys have asked that the drugmaker’s lawsuit be dismissed. They said the Supreme Court had given the state “absolute authority” to ban abortion, and that includes any “medicine or drug” that terminates a pregnancy.

Legal experts said both sides in this dispute can claim the law on their side.

“Congress wanted the FDA to be the gatekeeper. States cannot override the FDA and deny the use of approved drugs,” said Temple University law professor Rachel Rebouche. But she added that the state also has a strong case that “it regulates the practice of medicine,” not drug policy.

She and others said they were unaware of any state banning the use of an FDA-approved drug.

Congress hasn’t said directly that federal drug laws always anticipate additional restrictions imposed by a state, and the Supreme Court in the past has been split on the issue.

Twice in recent years, judges have ruled for a maker of a generic drug seeking protection from state restrictions. The question then was whether a drugmaker could be sued under state law and held liable for a patient’s horrific injury because the FDA-approved label didn’t go far enough. to warn of danger.

The court’s conservatives, in a pair of 5-4 decisions, ruled that federal drug laws prevail over additional state restrictions.

“Under the Supremacy Clause, from which our doctrine of preemption is derived, any state law, even clearly within recognized state power, that interferes with or is contrary to federal law, must yield” , Judge Samuel A. Alito Jr. wrote in Mutual Pharmaceutical v. Bartlett. A lower court had ruled the manufacturer could avoid the problem by not selling the drug in a particular state, but Alito said, “We reject this rationale for stopping sales as inconsistent with our preemption case law. .”

But Alito and the court’s conservatives, who just upheld state power to ban abortion, are probably the least likely to uphold the broad reach of federal drug laws when states block the use of abortive drugs.

The Justice Department has not said whether it intends to join the legal battle to defend the FDA rules.

Greer Donley, a law professor at the University of Pittsburgh, said the High Court “has been hostile to the administrative agencies, so it may not be the best thing for the FDA to lead the charge.”

Parsigian, GenBioPro’s attorney, said he expects a long legal battle. “I think we’ll win in some courts, lose in other courts, and eventually take the matter to the Supreme Court.”

This story originally appeared in the Los Angeles Times.

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